lab medical international vol.28.6-7

Vol. 28 No.4 • 6-7/2011ISSN 1068-1760

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AAblood test for latent tubercu-losis infection (LTBI) should

be the primary test in certain sus-pect groups suggests a recent offi-cial recommendation.

The innovative blood test, calledthe interferon-gamma release assay(IGRAs), is now thought to be morereliable than the Mantoux Tuber-

culin Sensitivity technique espe-cially where the individual hasalready been vaccinated or wasskin test positive.

In recognition of the mountingclinical evidence in favor of IGRAtechnology, the UK NationalInstitute for Health and ClinicalExcellence (NICE; London, UK;

Tuberculosis Blood Test Recommended for Key Groups

DAILY CLINICAL LAB NEWS

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TThermo Fisher Scientific hasagreed to acquire Phadia, the

Swedish-based in vitrodiagnostics concern, forUS$3.52 billion in cashfrom Cinven, a privateequity firm. Phadia is slated tobecome part of Thermo Fisher's spe-cialty diagnostics business within its

analytical technologies segment. With Phadia, Thermo Fisher is

bound to strengthen itsdiagnostics range for al-lergies and autoimmunedisorders. Part of Phadia’s

research efforts are focused on devel-oping tests that can identify sensitivi-ty to a large variety of allergies.

Cont’d on page 64

New Immunoassay Diagnoses Spinal Muscular Atrophy


Image: Colored scanning electron micrograph (SEM)

of two nerve cells (red) in the grey matter of the spinal cord

Image: Colored scanning electron micrograph (SEM)

of two nerve cells (red) in the grey matter of the spinal cord

Spinal muscular atrophy(SMA), an autosomal re-

cessive disorder and theleading genetic cause ofinfant mortality, is broughtabout by reduced levels ofsurvival motor neuron (SMN)protein. An immunoassaysystem is now available forthe identification and detec-tion of that protein.

See article on page 4

Cont’d on page 8 Cont’d on page 6

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M icroarray technology has been applied to thediagnosis of genetic syndromes during devel-

opment of the fetus. The system uses genomichybridization genetic chips with a diagnostic res-olution 100 times greater than the common cyto-genetic techniques. A standard amniocentesisis undertaken by the specialist gynecologistand only 8 mL - 10 mL of amniotic liquid are

Influenza Detection AssayUndergoing Clinical Trials

AA fully automated molecularassay for detecting the In-

fluenza viruses A and B is under-going clinical trials in the US.

The instrument platform com-bines fully automated sampleextraction with real-time poly-merase chain reaction (PCR) amp-lification and detection system that

Rapid Diagnostic Test for Blood Cancer

AA test combines several DNAtechnologies into a single

diagnostic chip, which deter-mines a patient’s risk profile foracute myeloid leukemia (AML).

The assay uses the patient’s bonemarrow collected in anticoagulanttubes and reveals that the prognosisfor AML can be established to a

Blood Proteins Predict Ectopic Pregnancy

PP regnant women have proteinsin their blood that could be

used for early diagnosis of ectopicpregnancy (EP).

Scientists analyzed the proteinsin blood from women with ectopicpregnancies and compared themto those in the blood of womenwith normal pregnancies. They

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Advanced Prenatal Diagnostic System Based on Microarray Technology

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AAn enzyme was identified that could be usedto diagnose colon cancer earlier. It is possible

that this enzyme also could be a key to stoppingthe cancer.

Scientists studied colon cancers from 40patients and found a form of the enzyme knownas ALDH1B1 present in every colon cancer cell in39 out of the 40 cases. The enzyme, which is nor-mally found only in stem cells, was detected atextraordinarily high levels.

The study was led by Cancer Center investiga-tor Vasilis Vasiliou, PhD, professor of molecular tox-icology at the University of Colorado School ofPharmacy (Denver, CO, USA; www.ucdenver.edu/academics/colleges/pharmacy/Pages/SchoolofPharmacy.aspx). Prof. Vasiliou’slaboratory specializes in understandingthe role of enzymes called aldehydedehydrogenases in drug metabolism,metabolic diseases, cancer, and normaland cancer stem cells.

“Other potential colon cancer bio-markers have been identified in thepast, but none thus far are present in

such a high percent of the cancer cells and virtu-ally none are overexpressed like this one,” saidCancer Center investigator David Orlicky, PhD,associate professor of pathology at the CU medicalschool and a member of the team.

Up-regulation of this enzyme into colon cancercells and its exact role in the physiology of thetumor cells is now being studied. The team also isseeking to understand the substrate, inhibitors,and activators of ALDH1B1.

Image: Colored scanning electron micrograph (SEM)of the mucosa of the colon of a patient suffering from colon cancer (Photo courtesy of SteveGschmeissner / Science Photo Library).

Enzyme Could Diagnose Early Colon Cancer


Molecular PrenatalDiagnostic Device Based

On Amniocentesiscont’d from cover

put in a tube, which is sent to a laboratoryvia messenger, exactly as with the usualgenetic tests. The new device, known asAmniochip, is able to detect 150 geneticsyndromes. This includes currently validat-ed genetic syndromes, including malforma-tions and idiopathic mental deficiency notdetected with a conventional kariotyping.As a cell culture is not necessary, the wait-ing time for the results with the new deviceis reduced to 48 hours, in contrast to thethree weeks it currently takes through con-ventional kariotype techniques

The device for enhanced prenatal diag-nosis, developed by Genetadi Biotech SL,(Derio, Spain; www.genetadi.com) is basedon Comparative Genomic Hybridizationmicroarray technology. In this technique,the sample under study and a referencesample are marked with different fluo-rochromes. These DNA hybridize on a crys-tal that contains thousands of different seg-ments of human DNA. The regions selectedon the Amniochip belong to regions of thehuman genome involved in more than 150already known syndromes. Subsequently,computer software is used to identify theareas of differential hybridization betweenthe patient and the DNA control, thus indi-cating the existence of an alteration in itsdosage, either a micro-deletion or a micro-duplication.

The prenatal device was presented dur-ing the XXVI Human Genetics NationalCongress, held from March 30 to April 1,2011, in Murcia, Spain.

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3 LabMedica InternationalJune-July/2011

TThe enzyme-linked immunosorbent (ELISA)assay kit provides a reliable and widely acces-

sible means to measure SMN protein levels, and itgreatly simplifies and accelerates efficacy assess-ment of potential drugs in clinical trials that aredesigned to increase SMN protein levels.

The assay has been validated for use withhuman and mouse-cell lysates and tissuehomogenates, such as peripheral blood mononu-clear cell lysates, and will be marketed throughEnzo Biochem, Inc. (New York, NY, USA;www.enzo.com) worldwide sales and marketinggroup. The kit is the result of a collaborativeagreement between Enzo Biochem and the Spinal

Muscular Atrophy Foundation (New York, NY,USA; www.smafoundation.org) for the develop-ment of reagents and assays for SMN protein. Theavailability of an effective SMN ELISA could fur-ther enable and expedite drug discovery, develop-ment, and therapy for Spinal Muscular Atrophy(SMA), the leading genetic cause of mortality ininfants and toddlers.

Spinal Muscular Atrophy is a genetic, neuro-muscular disease caused by progressive degenera-tion of nerve cells in the spinal cord that leads tomuscular weakness and atrophy and increasedrisk for early death due to respiratory failure. It isestimated that SMA affects approximately 1 in

6,000 to 1 in 10,000 live births worldwide. Thedisease is linked to a mutation in or deletion of theSMN1 gene, resulting in reduced levels of SMNprotein. An active area of therapeutics develop-ment has been elevation of SMN protein levels.

Wayne Patton, PhD, Chief Scientific Officer atEnzo Life Sciences, said, “During the assay devel-opment, the SMA Foundation facilitated the sup-ply of assay kits to affiliated investigators in the USand abroad. This allowed us to validate the assayin-house while simultaneously receiving valuablefeedback about assay specifications, performance,and protocols from scientists who will ultimatelybe using the kits in their studies.”


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World Record for Numberof Tests in Single DNASequencing Analysis

UUp to now, researchers have been limit-ed to running just a few DNA samples

at a time, at a cost of about US$16,000 perrun. Swedish researchers have devised anew method that allows 5,000 samples to berun at the same time and at the same price.This cuts the cost per sample result consider-ably and constitutes a world record for thenumber of tests run in a single DNAsequencing analysis. “We were virtuallyforced to invent a method for runningnumerous DNA tests at once. Otherwise ouranalyses would have taken an incrediblylong time and would have cost enormoussums of money,” said Dr. Peter Savolainen, aresearcher in biology at the Royal Institute ofTechnology (KTH; Stockholm; www.kth.se).He, his research colleague Dr. AfshinAhmadian, and the then doctoral candidateMårten Neiman jointly developed the newtechnique, which means that DNA sequenc-ing analyses can be performed both in recordtime and at a remarkably low cost.

“Today the great majority of samples arerun 10 at a time. This yields a cost of SEK10,000 [about US$1,600] per sample. Wehave run 5,000 samples at the same time atthe same cost, that is, SEK 100,000. Thiscomputes to SEK 20 per sample,” noted Dr.Savolainen. He pointed out several areaswhere his and his colleagues’ new technol-ogy can have a great impact. One of themis cancer research; where there is a greatneed to scan numerous cell samples frommany individuals.

“Another field where our method can beof huge importance is in organ transplants.Many DNA analyses are needed to create adatabase for matching organ donors withtransplant recipients. This will be of majorimportance to DNA research,” stated Dr.Savolainen. He added that now, even beforethe method is validated, there are severalprojects at the Science for Life Laboratory(where KTH is involved) in line to use thismode of analysis. Moreover, it is possible toscale up the method so that even more sam-ples can be tested simultaneously.

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www.nice.org.uk), recommend directly using anIGRA blood test in a number of specified instances.These include: in an outbreak situation when largenumbers of individuals may need to be screened;recent arrivals from high incidence countries who arefrom 16 to 34 years old; the immunocompromisedand some people with human immunodeficiencyvirus (HIV); new health service employees who haverecently arrived from high incidence countries orwho have had contact with patients in a settingwhere tuberculosis is highly prevalent.

These interventions are designed to identify sub-jects with LTBI so that they can be treated beforethey convert to active disease. This proactiveapproach will help to reduce the rates of active TBdisease in the UK, which have been rising over thepast decade. The IGRA blood test is produced byOxford Immunotec (Marlborough, MA, USA;www.oxfordimmunotec.com) and sold under thename T-SPOT.TB test.

Peter Wrighton-Smith, PhD, CEO of OxfordImmunotec, said, “I very much welcome the newguidelines from NICE which recognize the superioraccuracy and convenience of IGRA testing in many

populations. I am optimistic that the adoption of theseguidelines will help to reverse the steadily increasingrates of TB seen in the UK over the past decade.” TheT-SPOT.TB test is approved for sale in Europe, USA,Canada, and over 40 other countries worldwide andis designed to replace the 115-year-old tuberculin skintest. It offers a substantially more accurate and effec-tive tool for controlling the spread of TB.

Image: Colored scanning electron micrograph (SEM) ofMycobacterium tuberculosis bacteria (yellow) infecting amacrophage white blood cell (Photo courtesy of SciencePhoto Library).

Tuberculosis Blood Test Recommended For Key Groups

cont’d from cover

significant degree by measuring specific aberrations inthe patient’s DNA. The test, called the AMLprofiler, usesDNA-chip technology. This new method can replaceseven different tests of which three are chromosomalaberrations, two gene-mutations, and two aberrantgenetic activities. At present, these tests are often carriedout one by one, which takes more time and may resultin incomplete availability of important diagnostic infor-mation. By contrast, the AMLprofiler delivers these testresults in one assay within four days. This reduces thepatient’s period of uncertainty and offers the physician

more time to arrange the most appropriate treatment. The AMLprofiler was developed by Skyline

Diagnostics BV (Rotterdam, The Netherlands; www.skyline-diagnostics.com) using the diagnosticallyapproved Affymetrix microarray platform (Affymetrix,Santa Clara, CA, USA; www.affymetrix.com) and spe-cially developed Information Technology (IT) infrastruc-ture. The AMLprofiler is a cost-effective, standardizedprocedure for diagnosing AML. This test is the world’sfirst diagnostic DNA chip that makes it possible tomeasure the activity of disease-related genes anywherein the world. In addition, it can be of great value forclinical research into new cures for leukemia. TheAMLprofiler has received CE-certification.

Acute Myeloid Leukemia is the most lethal form ofblood cancer, responsible for over 9,000 deaths peryear in the US alone. Its progress varies widely in dif-ferent patients. Research has revealed that the prog-nosis for this disease can be established to a signifi-cant degree by measuring specific aberrations in thepatient’s DNA.

Image: The AMLprofiler rapid diagnostic test (Photo cour-tesy of Skyline Diagnostics).

Rapid Diagnostic Test for Blood Cancer








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Influenza Detection Assay Inaugurated for

Clinical Trials

cont’d from cover

has been specifically designed for the particularneeds of infectious disease testing. The startingmaterial for analysis is a capped tube containing uni-versal transport medium and a nasopharyngealswab, which uniquely is inserted directly into theconsumable cartridge. The test is anticipated to takeless than one hour to perform, and results are dis-played in a number of simple to interpret formats bythe integrated touch screen. Current methods forviral detection often require many manipulativesteps for sample handling and subjective interpreta-tion from highly skilled laboratory technicians,which can take several days to process from thetime of collection.

The Enigma Mini-Laboratory (ML) InfluenzaA/B detection assay is produced by EnigmaDiagnostics Limited, (Porton Down, UK; www.enigmadiagnostics.com). The Enigma ML systemwas specifically designed as a rapid fully automatedsystem enabling raw sample to result testing withuncomplicated read-outs and allowing for lowertechnical skill users. Clinical trial site initiationsand the enrollment of subjects for the US based trialbegan in late March after Enigma worked closelywith the US Food and Drug Administration, (FDA;Silver Springs, MD, USA; www.fda.gov) on theclinical trial design for both 510(k) clearance andpotential Clinical Laboratory ImprovementAmendments-(CLIA) waiver of the system. Up toeight clinical study sites across the US will partici-pate in patient enrollment and onsite testing of theEnigma ML system.

John McKinley, Chairman of Enigma Diagnostics,said, “It is estimated that over 12 million influenzatests are performed yearly in the USA and typicallybetween 5% and 20% of the US population are infect-ed with seasonal flu every year. Faster and more accu-rate tests are needed to satisfy this growing marketand the features of the Enigma ML instrument makeit ideally suited to meet this demand.”

Image: The Enigma Mini-Laboratory (ML) system(Photo courtesy of Enigma Diagnostics).



MManual reading of cervical smear slides issuperior to automation-assisted reading at

detecting abnormal cells. Technology is available which can assist in cer-

vical screening by automatically detecting abnor-mal fields on a slide and presenting them on anautomated microscope, and is analogous to man-ual cytological microscopy.

Scientists at the University of Manchester(Manchester, UK; www.manchester.ac.uk), com-pared automation-assisted reading of cervicalcytology with manual reading using the histologi-cal end point of cervical intraepithelial neoplasiagrade II (CIN2) or worse (CIN2+). Samples wereobtained from women aged 25-64 years undergo-ing primary cervical screening in GreaterManchester (UK), with small proportions fromwomen outside this age range and from womenundergoing colposcopy. Over 70,000 sampleswere randomized and assessed either by automat-

ed and manual reading or by manual reading only.The study was carried out between March 1,2006, and February 28, 2009.

Liquid-based cytology samples were obtainedin primary care, and a small number of abnormalsamples were obtained from local colposcopy clin-ics, from different women, in order to enrich theproportion of abnormals. All of the samples wereread in a single large service laboratory. Liquidresidues used for Human papillomavirus (HPV)triage were tested in specialist virology laboratory.Histopathology was read by a specialist gynecolog-ical pathology team blinded to HPV results andtype of reading.

The principal finding was that automated read-ing was 8% less sensitive relative to manual, 6.3%in absolute terms. The FocalPoint Slide Profiler(Becton Dickinson, Franklin Lakes, NJ, USA;www.bd.com), especially “No Further Review”was very reliable and, if restricted to routine screen-

ing samples, as less than 1% of CIN2+ would havebeen missed. Automated and manual were verysimilar in terms of cost-effectiveness despite a 60%- 80% increase in productivity for automation-assist-ed reading. The authors concluded that the inferiorsensitivity of automation-assisted reading for thedetection of CIN2+, combined with an inconse-quential increase in specificity, suggests thatautomation-assisted reading cannot be recom-mended for primary cervical screening.

Henry Charles Kitchener, MD, professor ofgynecological oncology and lead author said,“Although automated reading could achieve pro-ductivity gains in terms of the numbers of slidechecked, on the basis of this evidence there doesnot appear to be sufficient grounds to recommendautomation.” The trial also found that the cyto-screeners preferred manual reading as automation-assisted reading was monotonous. The article waspublished in January 2011, in Lancet Oncology.

Manual Cytology Preferred to Automatic Method


Blood Glucose MeasurementsCan Be Made From Tears

AAnew sensor would enable people to draw tearfluid from their eyes to get a glucose-level test

sample. Glucose in tear fluid may give an indicationof glucose levels in the blood as accurately as a testusing a blood sample.

The technology was designed by bioengineerJeffrey T. LaBelle, a professor in the School ofBiological and Health Systems Engineering, one ofthe Arizona State University (Tempe, AZ, USA;http://asunews.asu.edu) Ira A. Fulton Schools ofEngineering. Prof. LaBelle is leading the ASU-Mayoteam along with Mayo Clinic (Scottsdale, AZ, USA;www.mayoclinic.org/arizona) physicians Curtiss B.Cook, MD, an endocrinologist, and Dharmendra(Dave) Patel, MD, chair of Mayo’s Department ofSurgical Ophthalmology.

Many people with diabetes suffer due to the diffi-culty of managing their blood glucose levels. It is rec-ommended that they monitor their own glucose lev-els, but current monitoring devices typically requirepatients to perform the painful task of pricking theirfinger to draw blood for a test sample – and manypatients must do it several times each day.

“This new technology might encourage patientsto check their blood sugars more often, which couldlead to better control of their diabetes by a simpletouch to the eye,” said bioengineer Jeffrey T. LaBelle.

The major challenges are performing the testquickly, efficiently, with reproducible results, with-out letting the test sample evaporate and withoutstimulating a stress response that causes people torub their eyes intensely, Prof. LaBelle said.

Because of its potential impact on health care, thetechnology has drawn interest from BioAccel(Phoenix, AZ, USA; www.bioaccel.org), an Arizonanonprofit that works to accelerate efforts to bringbiomedical technologies to the marketplace.

“With funding provided by BioAccel, the scientif-ic team will conduct critical experiments to deter-mine how well the new device correlates with use ofthe current technology that uses blood sampling,”said Ron King, BioAccel’s chief scientific and busi-ness officer.


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AA fully automated system easilyand accurately assesses HER2

gene status in breast cancer tissue.The system uses an optimized

ready-to-use HER2 fluorescence insitu hybridization (FISH) reagent kitwith a BOND protocol to produceconsistent, high quality stainedslides. The system enhances the lab-oratory workflow, increasing effi-ciency, and enabling the laboratoryto provide a responsive service totheir clinicians and clients.

Designed by Leica Microsystems(Buffalo Grove, IL, USA; www.leica-microsystems.com) the HER

FISH system detects amplificationof the HER2/neu gene via FISH informalin-fixed, paraffin-embedded(FFPE) human breast cancer-tissuespecimens. The Leica HER2 FISHSystem is indicated as an aid in theassessment of patients for whomHerceptin (trastuzumab) treatmentis being considered.

Designed for easy and accurateassessment of HER2 gene status inbreast cancer tissue, the Leica HER2FISH System combines the use ofthe gold standard PathVysion HER2FISH probes, supplied by AbbottMolecular Inc. (Des Plaines, IL,

USA; www.abbottmolecular.com)with Leica’s industry-leading BONDautomated platform, deliveringaccurate results for diagnostic confi-dence.

The Leica HER2 FISH Systemwas compared to the AbbottMolecular PathVysion HER2 DNAprobe kit assay on an independentset of samples and found to provide

acceptably concordant results. Theactual correlation of the results ofthe Leica HER2 FISH System toclinical outcome has not beenestablished.

Image: Breast Cancer Specimenstained with the Leica HER2 FISHSystem showing amplification of theHER2 gene (Photo courtesy of LeicaMicrosystems).

HER2 Gene Status Accurately Assessed in Breast Cancer Tissue


IIncreased levels in the blood of aspecific biomarker are significantly

associated with the prevalence andseverity of Alzheimer’s disease (AD),but not with the risk of onset of newdisease.

The protein clusterin, also knownas apolipoprotein J, have been foundto be increased in brain and cere-brospinal fluid of patients with AD,and have been suggested to beinvolved in the pathogenesis of AD.

Scientists at Erasmus UniversityMedical Center (Rotterdam, TheNetherlands; www.erasmusmc.nl)analyzed the plasma levels of clus-terin measured at baseline from 1997to 1999, in 60 individuals withprevalent AD, a random subgroup of926 participants, and an additional156 participants diagnosed with ADduring the average 7.2 years of fol-low-up, until January 2007. Clusterinlevels were analyzed via multipleximmunoassay on a human multiana-lyte profile at the Rules-Based Medi-cine’s multiplexed biomarker testinglaboratory, (Austin, TX, USA; www.rulesbasedmedicine.com). The low-est detectable level was 1.3 µg/mL.The intra-assay variability was lessthan 4% and the interassay variabilitywas less than 13%.

The scientists found that the likeli-hood of prevalent AD increased withincreasing plasma levels of clusterin,with the odds increased by 63% forevery standard deviation increase inclusterin levels, after adjusting forage, sex, education level, apolipopro-tein E status, diabetes, smoking, coro-nary heart disease, and hypertension.Among patients with AD, higherclusterin levels were associated withmore severe disease. There was nostatistically significant association ofplasma clusterin levels with new ADduring total follow-up or with newAD within or after three years ofbaseline. The results for all-causedementia and vascular dementiawere similar.

The authors of study concludedthat the data from the general popu-lation show that increased plasma-clusterin levels are associated withprevalent AD and are higher inmore severe cases of AD. However,increased levels of clusterin do notprecede development of AD andtherefore are not a potential earlymarker of subclinical disease. Thestudy was published in the April2011 edition of the Journal of theAmerican Medical Association(JAMA).

Blood Biomarker Linked to Risk of Alzheimer’s



AAn assay that can detect the toxin Bgene associated with Clostridium

difficile infection (CDI) in stool samplesis now available.

The assay is fully automated andworks on the GeneXpert Dx System todetect toxin gene sequences associatedwith toxigenic C. difficile. The Gene-Xpert Dx System consists of an instru-ment that houses single-use disposablecartridges, a personal computer, andsoftware that allow a laboratory techni-cian to run tests and view test resultsquickly.

The test, Xpert C. difficile/Epi assaydetermines if C. difficile is in a patient’sstool and also detects if the C. difficile isthe epidemic 027/NAP1/BI strain,

which has been associated witha marked increase in the severi-ty and incidence of CDI inNorth America and Europe overthe past decade. The test utilizesautomated real-time polymerasechain reaction (PCR) to detectC. difficile DNA. The test isintended for use as an aid in thediagnosis of CDI. The detection

of the 027/NAP1/B1 strain is for epi-demiological purposes only and shouldnot be used to determine or monitortreatment. Health care facilities shouldmonitor the number of C. difficile infec-tions and, especially if rates at the facilityincrease, the severity of disease andpatient outcomes.

Both the Xpert C. difficile/Epi assayand GeneXpert Dx System are manufac-tured by Cepheid, (Sunnyvale, CA, USA;www.cepheid.com). The US Food andDrug Administration, (FDA; SilverSprings, MD, USA; www.fda.gov), havecleared the test for clinical laboratoryuse. Alberto Gutierrez, PhD, director ofthe Office of In Vitro Diagnostics DeviceEvaluation and Safety in the FDA’sCenter for Devices and RadiologicalHealth, said, “Healthcare professionals inthe infectious disease community whohave seen various outbreaks of CDI asso-ciated with aggressive strains in recentyears, now have a new testing tool todetect this disease.”

Image: The Xpert C. difficile/Epi assay(Photo courtesy of Cepheid).

Assay Detects Bacterial Toxin That Causes Diarrhea


AAprototype blood test for diagno-sis of variant Creutzfeldt-Jakob

disease (vCJD) in symptomatic indi-viduals could allow development oflarge-scale screening tests for asymp-tomatic vCJD prion infection.

A solid-state binding matrix wasutilized to capture and concentratedisease-associated prion proteins; thiswas coupled to direct immunodetec-tion of surface-bound material.

Scientists from the MedicalResearch Council (MRC) Prion Unit,based at University College London(United Kingdom; www.prion.ucl.ac.uk), working with the NationalPrion Clinic at the National Hospitalfor Neurology and Neurosurgery(NHNN; London, United Kingdom;www.uclh.nhs.uk/ourservices/ourhospitals/nhnn) tested 190 bloodsamples, including 21 from individu-als known to have vCJD. The bloodtest was able to detect blood spikedwith a dilution of vCJD to within onepart per ten billion – 100,000 timesmore sensitive than any othermethod developed so far.

Variant CJD, the human form ofbovine spongiform encephalopathy(BSE) commonly known as mad cowdisease first emerged in 1995. Thedisease, which affects the brain, is

believed to have passed from cattle tohumans through infected food. Itcauses personality change, loss ofbody function, and eventually death.

Prions, the infectious proteins thatcause vCJD and other fatal prion dis-eases, can inhabit a person’s body forup to 50 years before presentingsymptoms. During this time there is achance a carrier of vCJD infectioncould pass on the infection to others,for example through blood transfu-sion or even through surgical andmedical instruments because prionscan easily attach onto metal surfaces.

The work was published online inthe February 3, 2011, edition of theLancet. Lead author Dr. GrahamJackson, program leader at the MRCPrion Unit, said: “This test comes atthe end of many years of meticulous,painstaking research in our Unit andthe NHS National Prion Clinic.Although further larger studies areneeded to confirm its effectiveness,it’s the best hope yet of a successfulearly diagnostic test for the disease.This test could potentially go on toallow blood services to screen thepopulation for vCJD infection, assesshow many people in the UK are silentcarriers and prevent onward trans-mission of the disease.”

Blood-Based Assay Detects vCJD Prion Infection




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AAmicrowave-accelerated andmetal-enhanced fluorescence

(MA-MEF) technique was used todetect the protein troponin I (TnI), aspecific indicator of damage to theheart muscles.

The technique is based on thecombined use of low-power micro-wave heating, silver nanoparticlefilms (SNFs), and fluorescence spec-troscopy for the detection of TnI fromhuman whole blood samples.

The silver nanoparticles weredeposited onto amine-modified glassmicroscope slides by use of Tollen’sreaction scheme and characterized byoptical absorption spectroscopy andscanning electron microscopy. The

detection of TnI from buffer solutionsand human whole blood samples onSNFs was carried out by using fluores-cence-based immunoassays at roomtemperature. A control immunoassay,which took two hours total assaytime, was compared with themicrowave heating MA-MEF–basedimmunoassay, which took oneminute total assay time.

Scientists at Morgan StateUniversity (Baltimore, MD, USA;www.morgan.edu) found that thelower limits of detection for TnI frombuffer solutions in the controlimmunoassay and MA-MEF–basedimmunoassay were 0.1 µg/L and0.005 µg/L, respectively. However, they were unable to detect TnI in

whole blood samples in the controlimmunoassay owing to the coagula-tion of whole blood within five min-utes of the incubation step. The use ofthe MA-MEF technique alloweddetection of TnI from whole bloodsamples in one minute with a lowerdetection limit of 0.05 µg/L.

The authors concluded that theMA-MEF–based immunoassay is oneof the fastest reported quantitativedetection methods for detection ofTnI in human whole blood and haslow detection limits similar to thoseobtained with commercially available

immunoassays. Troponins are meas-ured in the blood to differentiatebetween unstable angina and myocar-dial infarction in patients with chestpain or acute coronary syndrome. Apatient who had suffered from amyocardial infarction would have anarea of damaged heart muscle and sowould have elevated cardiac troponinlevels in the blood. The study waspublished online on March 11, 2011,in Clinical Chemistry.

Image: Light micrograph of human car-diac muscle following infarction (Photocourtesy of Astrid & Hanns-FriederMichler / Science Photo Library).

Rapid Blood Test DetectsDamaged Cardiac Muscle


cont’d from cover

identified almost 70 proteins occur-ring in unusual levels in the blood inpatients with EPs. One of the pro-teins is called Adam12 and it mightbe a particularly good early warningsign for EP, because it appears at lev-els that are 20 times lower than innormal pregnancies.

Ectopic pregnancy happens whenan embryo does not attach normallyinside the mother’s uterus, butinstead attaches and begins growingelsewhere. Most occur inside one ofthe Fallopian tubes, which link theovaries to the uterus. As the embryogrows, the tube can rupture, result-ing in the loss of the embryo andthreatening the life of the pregnantwoman. Ectopic pregnancies occur inabout one in 40 to 100 pregnancies,and are a leading cause of death inthe first trimester of pregnancy. Thereis no single proven blood test forectopic pregnancy, and current diag-nosis relies on the use of ultrasound.

The study was carried out by sci-entists at The Wistar Institute(Philadelphia, PA, USA; www.wistar.

org) and the University of Penn-sylvania School of Medicine (Phila-delphia, PA, USA; www.med.upenn.edu). It was reported in the AmericanChemistry Society’s February 16,2011, issue of the Journal of Pro-teome Research.

“Here we describe a group of pro-teins that, with further refinement,could make a simple blood test forectopic pregnancy,” said David W.Speicher, PhD, professor and co-leader of Wistar’s Molecular andCellular Oncogenesis Program anddirector of Wistar’s Center forSystems and Computational Biology.“This is also a proof-of-principledemonstration of a new method forthe discovery of new blood-bornemarkers that may serve as diagnosticblood tests to detect or predict avariety of clinical conditions and dis-eases, from ectopic pregnancy tocancer.”

“The next step is clearly to test thecandidate biomarkers on a larger,independent patient group, both indi-vidually and in multibiomarker pan-els,” the report states.

Blood Proteins Predict Ectopic Pregnancy



UUnique proteins in spinal fluidcan distinguish between

patients suffering from neurologicpost-treatment Lyme disease(nPTLS) and those with the ChronicFatigue Syndrome (CFS).

Investigators found that bothconditions involve the central nerv-ous system and that protein abnor-malities in the central nervous sys-tem are causes and/or effects ofboth conditions, which present withsimilar clinical symptoms.

Spinal fluid was analyzed fromthree groups of people. One groupconsisted of 43 patients who fulfilledthe clinical criteria for ChronicFatigue Syndrome (CFS). The second

group consisted of 25 patients whohad been diagnosed with, and treat-ed for, Lyme disease but did not com-pletely recover. The third group con-sisted of 11 healthy control subjects.

The fluids were analyzed usinghigh-powered mass spectrometryand protein separation techniques.Each group had more than 2,500detectable proteins. The team dis-covered that 738 proteins wereidentified only in CFS but not ineither healthy normal controls or inpatients with nPTLS; 692 proteinswere found only in the nPTLSpatients.

The study team was led bySteven E. Schutzer, MD, of the

University of Medicine and Den-tistry of New Jersey (Newark, NJ,USA; www.umdnj.edu), and RichardD. Smith, PhD, of Pacific NorthwestNational Laboratory (Richland, WA,USA; www.pnl.gov). The findingswere, published in the February 23,2011 edition of the journal PLoSONE.

According to Dr. Schutzer, spinalfluid proteins can probably be usedas a marker of disease. “One next

step will be to find the best biomark-ers that will give conclusive diagnos-tic results,” he said. “In addition, ifa protein pathway is found to influ-ence either disease, scientists couldthen develop treatments to targetthat particular pathway.”

Image: Colored Scanning ElectronMicrograph (SEM) of Borreliaburgdorferi bacteria, the cause ofLyme disease in humans (Photo cour-tesy of the Eye of Science).

Lyme Disease Distinguished from Chronic Fatigue Syndrome

AA flow cytometry-based assayidentifies parameters of the

immune response correlated to pro-tection against tuberculosis (TB).

The assay derives functional signa-tures of immune responses toMycobacterium tuberculosis (Mtb),the causative organism of TB, such asthe cytokines and leucocytes, at dif-ferent stages of the disease.

The new tool has been developedby scientists at the University ofLausanne, (Lausanne, Switzerland;www.unil.ch), that distinguishesbetween active and latent TB. A studyrecruited 283 participants from a hos-pital in Switzerland based on positiveMtb-specific interferon gamma (IFN-γ) enzyme-linked immunosorbent spotassay (Becton Dickinson, Allsch-wil, Switzerland; www.bdbiosciences.com). A validation cohort of 114 par-ticipants was obtained from two clini-cal sites from Switzerland and SouthAfrica. For the flow cytometry analy-sis cells were stained with antibodiesspecific for a range of cytokines.

The scientists were able to showthat the immune response by thecytokines such as tumor necrosis fac-tor alpha (TNF-α, interleukin 2 (IL-2)and IFN-γ, were correlated to the dif-ferent stages of tuberculosis disease.

The flow cytometry-based assay read-out is focused on the immuneresponse and not on microbiologicalparameters, thus explaining its relia-bility and quickness. The sensitivityof the assay was 62% and specificitywas 92% for the different stages ofTB. The results showed substantialincrease in the proportion of single-positive TNF-· Mtb-specific CD4+ Tcells, a type of white cell, in subjectswith active disease. This parameterwas the strongest predictor of diagno-sis of active disease versus latentinfection.

Giuseppe Pantaleo, MD, professorof medicine and lead author of thestudy, said, “This assay and the func-tional signatures of TB-specificimmune responses are not only rele-vant for discriminating betweenactive TB disease and latent infection,but may be also instrumental in mon-itoring the response to TB therapy.”The authors concluded that althoughthe flow cytometry-based assayrequires specific equipment and skill-ful laboratory personnel, further tech-nological development is alreadyunder way to make the assay widelyaccessible. The study was publishedonline on February 20, 2011, inNature Medicine.

Flow Cytometry Assay DifferentiatesActive from Latent Tuberculosis







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AAbiomarker in the blood has been identified thattracks how effectively the immune system is

able to clear the brain of amyloid beta, which formsthe plaques that are the hallmark of Alzheimer’s dis-ease.

The biomarker is the gene that encodes for theenzyme beta-1,4-mannosyl-glycoprotein 4-beta-N-acetylglucosaminyltransferase, (MGAT3), which isessential in clearing amyloid beta, and is expresseddifferently in heterogeneous groups of Alzheimer’spatients.

Scientists at the University of California LosAngeles (UCLA; USA; www.ucla.edu) drew bloodsamples from 20 Alzheimer’s disease patients and20 healthy controls and then isolated criticalimmune cells from the blood called macrophages,which are responsible for the phagocytosis of amy-loid beta and other waste products in the brain and

body. These immune cells were incubatedovernight with amyloid beta to test the cells’ abilityto express the gene MGAT3. They also added a syn-thetic form of curcumin to some of the cells togauge the effect it had on MGAT3 expression andthe absorption of amyloid beta.

The scientists identified three groups ofAlzheimer’s patients: Type 0 patients who had verylow expression of MGAT3 and very low absorptionrates of amyloid beta; Type I patients who also hadlow expression of MGAT3 and low amyloid betaabsorption rates, but the strength of the MGAT3message and the absorption of amyloid betaincreased when the investigators stimulated themacrophages with synthetic curcumin; and Type IIpatients who initially had high amyloid beta absorp-tion rates, but when scientists added synthetic cur-cumin, MGAT3 expression lessened and absorption

was reduced. Fourteen of the 20 Alzheimer’s dis-ease patients have been followed for two years, andresearchers noted that those who were Type 0 hada worse two-year prognosis regarding the loss oftheir ability to live independently than the othertwo types of patients.

Milan Fiala, MD, the lead author of the investi-gation, said, “A larger clinical trial needs to be com-pleted to validate findings from this pilot study. Hesaid that while vitamin D3 seems to be helpful tomost people, the benefits of synthetic curcumin aremore individualized, depending on the patient. Inthe future, a commercially available test may be ableto check for MGAT3 immunity.” The finding maybe useful in providing more highly individualizeddisease prognoses in the future. The study was pub-lished online in January 2011, in the Journal ofAlzheimer’s Disease.

Blood Biomarker Gauges Alzheimer’s Prognosis



FFour novel biomarkers have been identified thatmay help in the diagnosis and management of

asthma and chronic obstructive pulmonary disease(COPD), according to a study conducted byAustralian researchers, who determined the bio-markers may be utilized in different combinationsto effectively identify patients with either of the air-way diseases.

The study’s findings were published online inMarch 2011 ahead of the print edition of theAmerican Thoracic Society’s American Journal ofRespiratory and Critical Care Medicine. “Using aproteomics approach, we have identified a panel offour blood-based biomarkers that, when used incombination, can discriminate between healthycontrols, asthmatics, and individuals with COPD,and has the potential to be a valuable tool in theclinical diagnosis of respiratory disease,” said PeterG. Gibson, MD, conjoint professor at theUniversity of Newcastle’s School of Medicine andPublic Health (Newcastle, Australia; www.newcastle.edu.au/school/medicine-public-health). “The proteins in the diagnostic biomarkerpanel are all involved in the regulation of inflam-mation, and usually function as anti-inflammatoryproteins. These results were confirmed in a secondclinical population of older adults with airflowobstruction.”

The proteins identified in the study are predom-inantly liver-synthesized proteins that can have sig-nificant anti-inflammatory activity through the inhi-bition of oxidative stress, which has been implicat-ed in several diseases, including heart disease,Alzheimer’s disease, and Parkinson’s disease.

To identify potential biomarkers, blood sampleswere collected from 43 subjects with a mean age of48 years, including 21 with asthma, 5 with COPDand 17 healthy controls. Using proteomic tech-niques, plasma proteins were separated from allblood samples. Once protein biomarkers were iden-tified and selected, the researchers measured thebiomarkers’ abilities, individually and in combina-tion, to differentiate between the groups ofpatients.

To confirm their results, the researchers con-ducted two additional evaluations. In the first

assessment, the original group was supplementedwith an additional seven asthmatics and ninepatients with COPD, and repeated the biomarkerassessment. The second assessment involved a sep-arate population of 73 older subjects (over 55years), including 14 with asthma, 22 with COPD,14 with both conditions, and 23 healthy controls.Results were confirmed in both validation groups.

Identifying biomarkers that are involved in thedevelopment of airway diseases may allow clini-cians to diagnose the diseases in their earlier, andoften more treatable, stages, Dr. Gibson noted. “Ourstudy identified a panel of highly discriminatory pro-teins that could be extremely useful in a clinicalcontext,” Dr. Gibson said. “Since these biomarkersare detectable in blood, which is readily obtainablefrom patients, and substances are currently availablefor testing the abundance of these proteins, thispanel of biomarkers has the potential to become anextremely useful addition to the clinical diagnosisand management of respiratory disease.”

Dr. Gibson noted proteomics played a key rolein the study, which was funded by the Australiangovernment as part of its Cooperative ResearchCenter for Asthma and Airways program, and sug-gests the protein-based techniques may prove vitalin future studies of biomarkers. “Combined withwell-defined clinical groups and advanced statisti-cal analyses, we have shown that proteomics is apowerful tool for the identification of novel diseasebiomarkers,” he said. “The study is a good exampleof how high quality biological science can be trans-lated effectively to a useful result for people withasthma and COPD. Future work is planned tostudy these markers in the lungs of patients withasthma and COPD, and apply the results in differ-ent clinical settings.”

Novel Biomarkers Linked to Asthma and COPD

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MMetabolic profiling of patients with nasopharyn-geal carcinoma (NPC) revealed that four

chemical in their sera were useful as diagnosticmarkers. Serum metabolite levels can be ascer-tained by using both liquid and gas chromatographywith mass spectrometry techniques (LC/GC-MS)and followed in the blood sera of patients sufferingfrom carcinoma before, during, and after therapy.

In a study performed at Jinan University,(Zhuhai, China; www.jnu.edu.cn), scientists evalu-ated 51 serum metabolites in 49 NPC patients, 37throat cancer patients and 40 healthy controls.Nasopharyngeal biopsy tissues were collected from31 patients with NPC and 27 healthy people whowere pathologically diagnosed as nonnasopharyn-geal carcinoma. High metabolites were selectedand confirmed in NPC tissues. Sensitivity andspecificity were appraised for 53 NPC diagnoses.

The LC/GC–MS profiles were significantly dif-ferent among the three groups. In these profiles, 51metabolites were considered endogenous metabo-

lites, which included organic acids, amino acids,and fatty acids involved in multiple biochemicalprocesses. These were studied further for theirpotential to represent the metabolic pattern of thedisease and recovery states.

The results showed that four metabolites,kynurenine, N-acetylglucosaminylamine, N-acetyl-glucosamine and hydroxyphenylpyruvate graduallyincreased from normal nasopharyngeal, atypicalhyperplasia to NPC. Their sensitivity and specifici-ty of the four metabolites were respectively 79%and 71%, 78% and 69%, 83% and 68%, 84% and73% for NPC diagnosis. Three other metabolites,stearic acid, N-acetylgalactosamine and glycine didnot change. This implies that these four metabolitesmay serve as potential markers as after radiothera-py, the four metabolites decreased gradually, tend-ed to a normal level, and were associated with rateof tumor reduction.

The study was published online on March 12,2011, in Clinical Biochemistry.

Biochemical Markers Used in Diagnosis of Nasopharyngeal Cancer




AA sophisticated molecular method has been usedto detect the DNA of the donor in the blood of

heart transplant patients, which will aid in earlyrecognition of rejection. An increase in the amountof the donor’s DNA in the recipient’s blood is oneof the earliest detectable signs of organ rejectionand can be evaluated using a microfluidic digitalpolymerase chain reaction (PCR).

Scientists at Stanford University School ofMedicine (Stanford, CA, USA; www.stanfordmedi-cine.org) developed advanced genome-sequencingtechnology to measure levels of donor DNA releasedwhen cells in the transplanted heart are damaged asoccurs early in the rejection process. A study of 39samples from women with male hearts showed thatthe prevalence of the Y chromosome in the recipi-ent’s blood increased significantly, from a norm ofabout 0.5% of the total, up to 8%, during episodes ofrejection. They also used an existing blood test thatrelies on the expression profile of 20 genes in apatient’s blood sample to determine whether thebody has launched an attack on the donated organ.

The original Allomap blood test is produced by XDXDiagnostics, (Brisbane, CA, USA; www.xdx.com).The two methods in tandem will allow the noninva-sive monitoring of the health of many transplantedorgans, including hearts, lungs and kidneys.

The analysis of the cell-free DNA circulating inthe blood of heart transplant recipients showed sig-nificantly increased levels of cell-free DNA from thedonor genome at times when an endomyocardialbiopsy independently established the presence ofacute cellular rejection in the heart transplantrecipients. Rejection episodes corresponded to lev-els of donor DNA approaching 3% to 4%, so whenthe patients were successfully treated withimmunosuppressants, the amount of the donorDNA in the blood decreased to less than 1% of totalfree DNA. The high throughput shotgun sequenc-ing method that was developed leads to a universalnoninvasive approach to monitoring organ health.

The study was published online on March 28,2011, in the Proceedings of the National Academyof Sciences of the Unites States of America (PNAS).

Blood Test for Donor DNA Improves Detection of Rejection

II ncreased levels of amino acids in the bloodcan identify individuals at risk of developing

diabetes mellitus type 2. Amino acids, amines and other polar metabo-

lites can be profiled in baseline blood specimensby liquid chromatography–tandem mass spec-trometry (LC-MS), and correlated with diseaseprogression.

A team led by scientists at MassachusettsGeneral Hospital (MGH; Boston, MA, USA;www.massgeneral.org) recently found that thelevels of five amino acids, identified by LC-MS,indicated increased diabetes risk in a generalpopulation. Out of 2,400 normoglycemic partic-ipants who entered the study in 1991 and 1995,201 developed type 2 diabetes during the subse-quent 12 years. Using the baseline blood sam-

ples, the research team measured levels of 61metabolites in 189 participants who later devel-oped diabetes and 189 diabetes free individuals,who were matched for age, sex, and diabetesrisk factors.

The analysis found that elevations in fiveamino acids: isoleucine, leucine, valine, tyrosine,and phenylalanine, were significantly associatedwith the later development of type 2 diabetes andcould also differentiate, among individuals withtraditional risk factors such as obesity, and thosemost likely to actually develop diabetes. Theinvestigators found that measuring combinationsof several metabolites, as opposed to a singleamino acid, improved risk prediction. Overall, inindividuals closely matched for traditional riskfactors for type 2 diabetes, those with the highest

levels of the three most predictive amino acidshad a four to five times greater risk of developingdiabetes than did those with the lowest levels.These findings underscore the potential key roleof amino acid metabolism early in the pathogen-esis of diabetes and suggest that amino acid pro-files could aid in diabetes risk assessment.

Thomas J. Wang, MD, the lead author of thestudy, said, “These findings could provide insightinto metabolic pathways that are altered veryearly in the process leading to diabetes. They alsoraise the possibility that, in selected individuals,these measurements could identify those at high-est risk of developing diabetes so that early pre-ventive measures could be instituted.” The studywas published online on March 20, 2011, inNature Medicine.

Elevated Metabolites Signal Diabetes Risk


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AAcardiovascular disease (CVD) risk assay willenhance cardiologists’ ability to assess heart

attack and stroke risk.The laboratory-developed assay is based on

gamma prime fibrinogen, a naturally occurringclotting protein in human blood. This biomarkeris strongly associated with cardiovascular disease.

Developed by Gamma Therapeutics (Portland,OR, USA; www.gamma-therapeutics.com), theCVD assay will be marketed exclusively by HealthDiagnostic Laboratory Inc. (HDL; Albuquerque,NM, USA; www.hdl.com), which also will leadthe BETA testing of the assay for the US Food andDrug Administration (FDA; Silver Springs, MD,USA; www.fda.gov) approval.

Despite current diagnostic tests to assessheart disease or stroke risk, millions die each

year from fatal heart attacks – 500,000 in the USalone in 2009 – many of which were preventa-ble with more predictive testing methods.Launch of the partnership between HDL, Inc.and Gamma Therapeutics represents a combinedeffort to advance the preventative model forchronic disease management, based on therecent shift in the way physicians test for life-threatening conditions.

“The results are simple,” said Tonya Mallory,CEO and cofounder of HDL, Inc. “Thanks toadvanced testing, it [is] now possible to reveal riskfactors and biomarkers for cardiovascular andrelated diseases. The partnership with GammaTherapeutics demonstrates HDL, Inc.’s ongoinggoal to provide best of breed biomarkers, such asthis new assay.”

Image: False color scanning electron micrograph ofhuman red blood cells with normal fibrinogenthreads (Photo courtesy of Manfred Kage / SciencePhoto Library).

Diagnostic for Heart Attack and Stroke Risk Launched



IMMUNOASSAY TEST KITAwareness Technology

The ReQuest kit offers enhancedsensitivity, specificity, accuracy, andprecision. The kit provides reliable,user-friendly, and cost-effectivediagnostic test methods for TORCH,autoimmune panels, and infectiousdisease markers, among others.

PROTEIN ANALYZERBinding Site

The SPAPlus is a dedicated special-ist protein analyzer for serum, plas-ma, and urine assays includingFreelite and Hevylite. The system’scompact design allows for an easy fitin any lab, and it can be run beside achemistry or electrophoresis plat-form.

DIRECT RENIN ELISADIASource ImmunoAssays

The automated Renin ELISA isdesigned for the direct determinationof Renin in human plasma by use ofa monoclonal antibody pair. Alsoavailable is the Aldosterone ELISA,which along with the Renin ELISA,has been validated on the openAutomate Stratec Gemini.

CHEMISTRY ANALYZEREmperor Electronic Technology

The EMP-168 is a compact, stand-alone, user-friendly chemistry ana-lyzer that provides rapid and accu-rate analysis. Key features includetouch screen interface, on-boardcurve-fitting software, and built-inprinter to meet the needs of mostmodern labs.

CC lass II style clean air and biocon-tainment enclosures, designed for

high-volume robotic and automatedequipment applications, have a flexiblemodular design.

BioPROtect enclosures are designedfor aseptic product preparation andbiologic investigation involving agentsof low to moderate risk. TheBioPROtect III may be exhausted backinto the laboratory or connected to anin-house exhaust system.

The BioPROtect III (BPIII) andBioPROtect Jr (BPJr) air containmentunits accommodate high-throughputrobotic systems (including ancillarydevices), ultracentrifuges, flow cytome-ters, aerosol generators, and other largelaboratory equipment. Both models areideal for high-throughput screening,combinatorial chemistry, immunology,tissue culture, clinical research, drugdiscovery, molecular biology, and quali-ty control assays.

While offering clean air and biocon-tainment, the BioPROtect III modelallows total access to the 4.64 m3 inte-rior work area with combination dou-ble doors. BioPROtect III Jr. has a sin-gle door access with a 2.2 m3 interiorvolume.

The Baker Company (Sanford, ME,USA; www.bakerco.com) is offering theClass II biosafety cabinets BPIII/BPJr.The air inflow rate is 30 m/minute;recirculated/exhausted air: 70%/30%;and internal dimensions 259 cm (or124.4 cm) x 92.7 cm x 193 cm.

The cabinets’ high-performance air-flow system provides optimum protec-tion against airborne particulates andaerosols for personnel, product, and

the environment. HEPA-filtered, partic-ulate-free airflow throughout the workarea provides an aseptic environmentand minimizes cross-contamination.

The modular construction of theenclosures allows disassembly for ship-ping, delivery, and placement; cabinetdesign simplifies assembly and installa-tion prior to certification.

Image: The BioPROtect III clean airequipment containment enclosure (Photocourtesy of The Baker Company).

Class II Biosafety Cabinets Have Flexible Modular Design


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TThe latest addition to a series of clinical chemicalanalyzers provides increased efficiency and pro-

ductivity. The RX series of four clinical chemistryanalyzers provide quality results at every phase ofclinical development. The analyzers offer an exten-sive test menu enabling laboratories to avoid thecostly outsourcing of routine safety testing.

The latest addition to the series is the RX suzu-ka, a fully automated random access analyzercapable of carrying out up to 1200 tests per hourincluding ISEs. The RX monza is the smallest ofthe series; it is a semi-automated clinical analyzerideal for low throughput testing in clinical,research laboratories, and specialized clinics. TheRX daytona is a compact benchtop fully automat-ed clinical analyzer with a throughput of 180 pho-tometric tests and 270 ISE tests per hour. The RX

imola is a fully automated and random accessbenchtop analyzer capable of performing 400photometric tests and 240 ISE tests per hour.

Each system requires only a small sample vol-ume. Reagent volume required is also low, reducingcost per test. The RX Series require no extra con-sumables – for example, permanent pyrex cuvettesare used, providing considerable cost savings.

Randox Pharma Services (Crumlin , UK; www.randoxpharmaservices.com) markets the RX series ofanalyzers. The company also offers an extensive testmenu consisting of over 120 enzymatic, substrate, andimmunoturbidimetric assays.

In addition to the analyzers, a Quality Control(QC) package is provided. Randox quality controlscover over 170 parameters and are of high quali-ty, accurate, and stable ensuring valid clinical

results. Customized QC is also available in addi-tion to RIQAS, the largest global EQA scheme.

Image: The RX imola random access benchtop ana-lyzer (Photo courtesy of Randox).

Clinical Chemistry Analyzer Offers Increased Efficiency and Productivity


AAn assay, designed to detect and distinguish 17different biothreat pathogens, enables rapid

and accurate detection of potentially dangerousmicroorganisms that could pose serious threats tohuman health.

The PLEX-ID Biothreat Assay permits analysis ofdirect specimens, such as blood, water, food, andair filter samples, and provides results in less thaneight hours. The seventeen bioagents targeted inthe new test, include Bacillus anthracis, Esche-richia coli, Salmonella, Ebolavirus, and avianinfluenza viruses. PLEX-ID offers the unique capa-bility to detect and identify these, and other, bac-terial and viral biothreat agents while also differ-entiating similar organisms.

A high-throughput technology introduced byAbbott (Abbott Park, IL, USA; www.abbott.com)PLEX-ID offers rapid and broad identification,detailed genotyping and characterization, and recog-nition of emerging organisms. The system employs acombination of molecular technologies, including

polymerase chain reaction (PCR) for gene amplifica-tion and mass spectrometry analysis to characterizeknown and unknown organisms rapidly.

The assay, in addition to identifying a broadrange of bacteria, viruses, fungi, and parasites, alsoprovides information about drug resistance, viru-lence, and strain type. Anticipated public healthand biodefense applications include epidemiologicresearch and identification of emerging or previ-ously unknown agents. In addition, the system isbeing used for forensic characterization of humansamples.

At the American Society for MicrobiologyConference on Biodefense and Emerging Diseasesheld in Washington DC (USA) from February 6-9,2011, Abbott and the Midwest Research Institute(Kansas City, MO, USA; www.mriresearch.org) reported that an independent evaluation of thePLEX-ID Biothreat assay showed that it provideshighly sensitive and specific results for biothreatdetection in environmental air sample analysis.

Biothreat Assay Offers Rapid Detection of Dangerous Microorganisms

AAconsortium has been formed todevelop an immunoassay detection

device for the diagnosis of cerebrovascu-lar disease.

The device has to be standalone sothat it may be used for emergencies suchas when diagnosis is required in anambulance, emergency room, or as partof a rapid near-patient laboratory test ina hospital environment. Therefore, anumber of key processes must be com-pleted automatically within the sys-tem. The biosensor platform needs tobe able to manipulate liquid samplesand deliver any biomarkers that arepresent to the surface of the sensor ina manner that ensures accurate andreliable detection.

The EUR 3.6-million P3SENS consor-tium project (www.p3sens-project.eu),which is being coordinated by Multitel(Mons, Belgium; www.multitel.be), hasbeen making good progress. The aim ofthe project is to design, develop, andmanufacture robust microfluidic systemsthat can be used for fast and cost-effec-tive sample transport and that also con-tain simple sample preparation func-tions. Preliminary microfluidic struc-tures have been designed taking intoconsideration the proposed layout ofthe sensor chip and the materialrequirements. The microfluidics systemis to contain six parallel individualchannels with different componentssupplying the integrated functions ofwashing and mixing.

Members of the consortiuminclude: The Research Institute forTechnical Physics and MaterialsScience (MFA; Budapest Hungary;www.mfa.kfki.hu), which is mainlyresponsible for the immobilization andoptical characterization of receptor pro-tein layers using label-free opticalwaveguide based sensors, and for themanufacture of the microfluidic polymer structure; and Micronova, a center for micro- and nano-technology located in Espoo, Finland (www.micronova.fi) and run jointly by VTTTechnical Research Center of Finland(VTT; Finland; www.vtt.fi) and AaltoUniversity (Finland; www.aalto.fi/en).VTT’s main responsibilities in the proj-ect are the development of nanoim-print lithography (NIL) for patterningwaveguides and photonic crystals intothe polymer, the design and fabricationof NIL-based photonic chips, and theintegration of photonic and fluidicfunctions in a single chip. Other insti-tutes in the consortium include The

Biomedical Proteomics Research Group(BPRG) at Geneva University (Switzer-land; www.unige.ch); The James WattNanofabrication Center (JWNC) in Glas-gow University (Scotland; www.jwnc.gla.ac.uk); Bayer Technology Services GmbH(Leverkusen, Germany; www.bayertech-nology.com); and Stratophase, a VC-fund-ed spin-out from the University ofSouthampton in UK (www.stratophase.com).

Biosensor Platform Developed for POC Diagnosis of Cerebrovascular Disease



Image: The mixing of fluorescent human serum albumin [0,1mMol/mL] and buffer solutions in the Herring-Bone type microfluidicmixer (Photo courtesy of the P3SENS consortium).


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AAn important milestone wasachieved in the development of

fully automated, handheld, rapiddiagnostic test solutions for use at thepoint-of-care (POC).

One important target application

for the technology is the measure-ment of cardiac Troponin-I levels inblood to assist in the rapid diagnosisof myocardial infarction. Troponin-I istypically found at elevated levels inpatients who have suffered a heart

attack. However, it is only present inthe patient’s blood in picomolar con-centrations. In the past, detectingthese extremely low concentrationshas required costly time-consuminglaboratory-based testing.

The milestone was the result of theintegration of bioMérieux’s (Marcyl’Etoile, France; www.biomerieux.com) assay technology and Philips’(Eindhoven, The Netherlands; www.philips.nl) Magnotech rapid diagnostictesting technology, into a disposablecartridge and handheld reader combi-nation that achieves speed, sensitivity,and precision. The success representsone of the first POC multiassay solu-tions with the potential to achieve lab

quality performance.The achievement was realized

within a year of the two companiessigning a joint development agree-ment in January 2010 to develophandheld diagnostic solutions, andmeans that both companies will nowgo ahead with the development pro-gram.

Philips will further develop its pro-totype handheld reader into a fullyengineered, rugged unit, whilebioMérieux will continue the assaydevelopment. In addition, Philips willset up manufacturing facilities to beready to produce the disposable car-tridges for the 2013 commerciallaunch of the new solution.

Handheld Diagnostic Solutions Achieve Performance Requirements in POC Applications

AAnovel biomarker for diagnosingacute kidney injury (AKI)

responds earlier than other renal sta-tus markers such as serum creati-nine, and shows a proportionateresponse to injury.

Using only a few drops of plasmaor urine the new, rapid NGAL testgives results in just 10 minutes andthus addresses the widespreaddemand for urgent determination ofkidney damage. The test provides anew way to identify patients at riskof developing potentially severeacute kidney injury (AKI) - 24-72hours before the problem wouldotherwise be detected.

The NGAL test is designed to runon open channels of chemistry ana-

lyzers from various manufacturers,effectively giving most laboratories aconvenient and easy way to estab-lish kidney damage. NGAL levelsrise rapidly after renal injury andhave been used in a variety of clini-cal situations including intensivecare, emergency medicine, renaltransplantation, and proceduresinvolving the use of intravenous(I/V) contrast media and othernephrotoxic agents.

BioPorto Diagnostics (Gentofte,Denmark; www.bioporto.com) isnow launching the CE-markedNGAL test for diagnostic use inEurope. This means that the compa-ny is starting to sell the test toEuropean hospitals, where the

physicians will utilize the tool forcombating the harmful effects ofacute kidney injury.

In November 2010, BioPortoprelaunched the NGAL test forresearch use, and since then the test

has been successfully tested inselected hospitals in Europe, theUnited States, and Southeast Asia.

Image: The NGAL rapid ELISA kit fordetecting AKI (Photo courtesy ofBioPorto Diagnostics).

Biomarker for AKI Responds Before Other Status Markers

TTwo new agreements have beenmade for the development and

validation of microRNA-based diag-nostics for various indications.

The Gen 3 tests will focus on car-diovascular indications, neurodegen-erative diseases, women’s health, andearly detection of certain cancers,and are designed to leveragemicroRNA biomarkers extractedfrom body fluids.

A leading developer and providerof microRNA-based molecular diag-nostics, Rosetta Genomics (Rehovot,Israel; www.rosettagenomics.com)has entered into agreements with TelHashomer Medical Research Infra-structure and Services Ltd (Tel Aviv,Israel; http://eng.sheba.co.il) andCarmel Medical Center (Haifa, Israel;www.clalit.org.il/carmel).

The collaborations are an integralpart of Rosetta Genomics’ Gen 3product development process as theyutilize the capabilities and samples atthese specialized centers to identifyinitial microRNA candidate biomark-ers for the company’s discovery-stageprojects.

MicroRNAs (miRNAs) are smallRNAs that act as master regulators ofprotein synthesis, and have beenshown to be highly effective biomark-ers. The unique advantage ofmicroRNAs as biomarkers lies in theirhigh tissue specificity, and theirexceptional stability in the most rou-tine preservation methods for biop-sies, including Formalin FixedParaffin Embedded (FFPE) block tis-sue and fine needle aspirate (FNA)cell blocks.

Body Fluids-Based Diagnostics to Be Developed and Validated





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AAmolecular test that detects and differentiatesamong the DNA of Herpes Simplex Virus

(HSV) types is available for use with clinician-col-lected external anogenital lesions.

The fully automated system, which uses StrandDisplacement Amplification technology to identifythe viral DNA qualitatively, will aid clinicians todiagnose symptomatic patients with HSV1 andHSV2.

The ProbeTec HSV-1 and HSV-2 Qx Assays willsignificantly improve accuracy and time to resultsover culture methods, which often take 2-10 daysfor results. The new automated HSV assays willprovide laboratories with the capability to read upto 96 positive or negative results in a little overtwo hours. When utilizing the Viper System withXTR Technology, clinical laboratories also will beable to run tests for Chlamydia and gonorrhea,

along with HSV-1 and HSV-2, on asingle automated run.

Both the ProbeTec assays and theViper System are products of BDDiagnostics (Franklin Lakes, NJ, USA;www.bd.com). The ProbeTec assayshave received US Food and DrugAdministration (FDA, Silver Springs,MD, USA, www.fda.gov) 510(k)clearance for the first fully automatedmolecular tests to detect and differentiate HSV types1 and 2 in external anogenital samples collected bythe physicians. The assays are not FDA cleared foruse with cerebrospinal fluid (CSF) or any lesionsother than anogenital lesions. The assays are notintended to be used for prenatal screening or forindividuals under the age of 17 years.

Herpes virus infections are found worldwide,

and without seasonal variation. It is estimatedthat worldwide 314.8 million females and 220.7million males, ages 15 to 49, were living withHSV-2 infection. The global number of new infec-tions annually is estimated at 23.6 million.

Image: The ProbeTec Herpes Simplex Viruses Qxamplified assays (Photo courtesy of BD Diagnostics).

Automated Tests Differentiate Sexually Transmitted Infections


Automated Cholesterol TestShowcased for Cardiologists

AAn expanded lipid profile assay performed onwhole blood has been demonstrated to heart

specialist at a conference using qualified attendeesown samples.

The blood test directly measures low-densitylipoprotein (LDL) cholesterol (LDLc), without thepatient having to fast, as well as 22 other cholesterolcomponents.

The Vertical Auto Profile (VAP) Cholesterol Testcomponents include lipoprotein A, (Lp(a)), apo-lipoprotein B, (apoB), apolipoprotein A1, (ApoA1),and the apoB/apoA1 ratio, making the VAP Test theonly lipid profile that routinely reports all three lipidparameters, LDL, non-high-density lipoprotein(HDL) and apoB. These three lipid parameters areconsidered essential diagnostic parameters by theAmerican College of Cardiology (ACC, WashingtonDC, USA; www.cardiosource.org), and the Ameri-can Diabetes Association (Alexandria, VA, USA;www.diabetes.org).

The comprehensive lipid profile also identifiesmarkers of metabolic syndrome, often associatedwith early diabetes. The VAP Cholesterol Test is pro-duced by Atherotech Diagnostics Lab (Birmingham,AL, USA; www.atherotech.com), and provides clini-cians with a single source for more than a dozen car-diovascular and metabolic tests. These include: highsensitivity C-reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (LpPLA2), apolipopro-tein E (apoE) genotype, the N-terminal prohormoneof brain natriuretic peptide (NT-proBNP), cystatin C,triiodothyronine (T3) and thyroxine (T4) when thethyroid-stimulating hormone (TSH) is abnormal, andgamma-glutamyl transferase (GGT), a recognizedcardiovascular risk biomarker.

The VAP Cholesterol Test was exhibited to partici-pants at the American College of Cardiology’s 60thAnnual Scientific Sessions held April 2-5, 2011, inNew Orleans, LA, USA. Michael V. Mullen, presidentand chief executive officer of Atherotech, said,“Atherotech invited ACC attendees to learn about ourbattery of cardiodiagnostic tests and learn firsthand thepredictive power of the VAP Test.”

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AAn automatic blood gas system simplifies bloodsampling and data capture, from the initial

ordering of blood gas tests through to receivingresults at the point of patient care.

The system offers faster testing and throughput,meaning that time previously spent in front of ananalyzer is now available for direct patient care.

The analyzer, called Radiometer (Brønshøj,Denmark; www.radiometer.com) 1st Automatic,reduces errors, improving safety for patient andoperator. The patient and sample IDs are scannedand linked together as the whole blood sample isdrawn at the patient’s bedside, and thedata is automatically sent to the analyzer,ensuring a correct patient-to-samplematch throughout the test.

The operator identifies the patientand then draws a blood gas sample usinga one-hand device called a safe PICOsampler. The needle removal deviceallows optimal protection for the nurse.A safe tip cap is fitted onto the sampler,

which removes air bubbles when the plunger ispressed.

Once the blood sample has been taken to theanalyzer, it is automatically identified, mixed, andmeasured; the results are sent directly to a bedsidemonitor as well as the hospital information manage-ment system. Results are then transferred to patientrecords, and full documentation is available for reg-ulatory requirement.

Image: The ABL80 FLEX, part of 1st Automatic, theworld’s first automatic blood gas analysis system(Photo courtesy of Radiometer).

Automatic Blood Gas System SimplifiesBlood Sampling and Data Capture



Genetic Biomarkers in Feces Predict Colon Cancer

BB iomarkers that predicted inflamma-tion-associated colon cancer were

found in mouse feces. This is the sametype of cancer associated with some com-mon human inflammatory bowel diseasessuch as ulcerative colitis and Crohn’sDisease.

Scientists found that the bacteriumthat leads to inflammation-associatedcolon cancer in mice first results ininflammation that can be detected byscreening feces for messenger RNA ofgenes.

Craig Franklin, associate professor ofveterinary pathobiology in the Universityof Missouri (MU) College of VeterinaryMedicine (Columbia, MO, USA; www.cvm.missouri.edu), believes that this dis-covery could lead to tests for similargenes present in humans with earlyinflammation-associated colon cancer.The study was published in theDecember 2010 edition of the journalNeoplasia.

“The assumption was that the geneexpression couldn’t be detected in fecalmatter because RNA breaks down veryrapidly. Historically, this was somethingthat a lot of scientists, including us, had-n’t considered,” Prof. Franklin said. “Buttechnology has evolved, and we nowhave the means of preserving RNA muchbetter than we did 15 years ago.”

The new testing method shoulddecrease the number of animals neededfor research and could lead to a test forhumans that will replace colonoscopies.


PP rotein expression levels revealedby immunohistochemistry and

molecular methods have been report-ed from patients with hepatocellularcarcinoma (HCC).

The protein expression level of thetranscription factor E2F5 can be esti-mated in formalin-fixed, paraffin-

embedded tissue blocks by microarraytechnology. This transcription factor isencoded by the gene E2F5, which ispart of a family that plays a crucialrole in the control of cell cycle andaction of tumor suppressor proteinsand is also a target of the transformingproteins of small DNA tumor viruses.

Scientists at The Catholic Univer-sity of Korea (Seoul; www.catholic.ac.kr), analyzed 120 tissue samplesfrom primary HCC patients and 29normal liver tissues by immunohisto-chemistry (IHC) analysis. The E2F5-small interfering ribonucleic acid(RNA) was transfected into HepG2,an E2F5-overexpressed HCC cellline. They also explored the biologi-cal effects of E2F5 overexpression byknockdown of the gene and exam-ined cell growth capacity and migrat-ing potential. The investigators,using the tissue microarray-basedIHC, found that E2F5 expressionwas mostly localized in the cyto-plasm with occasional nuclear stain-ing, and therefore cytoplasmic stain-ing was considered a positive result.

They found that 18.3% of thepatients with HCCs were positive,while none of the normal liver tis-sues was positive.

The authors concluded that E2F5is commonly overexpressed in pri-mary human HCC and that E2F5knockdown profoundly repressed thegrowth of HCC cells. The overexpres-sion of E2F5 may induce uncontrol-lable cell cycle progression in livercells and eventually contribute to can-cer transformation by working togeth-er with other carcinogenic factors.This study will help to understandhepatocarcinogenesis mechanismsand to define therapeutic targets ofearly HCC. The study was publishedon January 28, 2011, in the WorldJournal of Gastroenterology

AAgene signature has been discovered that canaccurately predict which breast cancer

patients are at risk of relapse, thereby sparingthose who are not at risk from the burdens associ-ated with unnecessary treatment.

The test analyzes two sets of 29 genes frombreast cancer-tumor samples. One set of genes isresponsible for rampant neoplasia, which is the veryfundamental nature of cancer, and the second setinvolves genetic instability. When the test resultsshow high expressions of both sets of these genes,the patient would be at a high risk of a relapse.

Scientists at McGill University (Montreal, QC,Canada; www.mcgill.ca) and their US colleagues,used a variety of molecular biology techniques toexamine in 12 publicly available gene expressiondatasets comprising a total of 2,481 patients withbreast cancer. The test is reported to be superiorto an existing test, and has the potential to spare

women at a very low risk of relapse of breast can-cer from undergoing toxic chemotherapy.

Clinicians have been faced with the problemthat breast cancer cannot be treated with a one-size-fits-all approach. Some cancers respond tospecific treatments while others do not. Close to50% of breast cancer patients belong to a groupdefined as “estrogen receptor positive/lymphnode negative (ER+/LR-)”, who are at low risk ofrelapse. The majority of patients in this group maynot require any treatment beyond the surgicalremoval of their tumor, while a small minorityshould receive additional treatment.

The study was published on February 1, 2011,in the Proceedings of the National Academy ofSciences of the United States of America (PNAS).

Image: Colored scanning electron micrograph (SEM)of breast cancer cells (Photo courtesy of SteveGschmeissner / Science Photo Library).

Genetic Test Predicts Breast Cancer Relapse




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Gene Expression Profile Linked to Liver Cancer

MMolecular methods have been used to identifymicro ribonucleic acids (miRNAs) in serum,

which can serve as biomarkers for prostate cancer.Noncoding miRNAs in the serum and plasma

have been shown to have potential as noninvasivemarkers for physiological and pathological condi-tions including malignancy.

Scientists at the University of California SanFrancisco (UCSF; San Francisco, CA, USA;www.ucsf.edu), have developed a multiplex quan-titative reverse transcription polymerase chain reac-tion (qRT-PCR) method involving purification ofmultiplex PCR products followed by uniplex analy-sis to identify miRNAs. They used a microfluidicschip to evaluate 384 human miRNAs using smallRNA deficient knockout mouse cells as the bench-mark. The investigators confirmed the validity oftheir technique, while uncovering a significant lackof accuracy in previously published methods.

The scientists profiled 48 sera from healthymen and untreated prostate cancer patients withdiffering Cancer of the Prostate Risk Assessmentscores. They identified miRNA signatures thatallowed them to diagnose cancer patients and cor-relate with prognosis. These serum signaturesincluded oncogenic and tumor suppressive

miRNAs suggesting functional roles in prostatecancer progression. The uniplex analysis was per-formed on the microfluidics chip produced byFluidigm Corporation (South San Francisco, CA,USA; www.fluidigm.com).

The Fluidigm BioMark System transforms theway that scientists can perform high-throughputreal-time quantitative PCR (qPCR) studies. TheBioMark System uses microfluidic chips and fea-tures low input requirements providing the sensi-tivity and assay throughput necessary for qPCR.Fluidigm’s proprietary Integrated Fluidic Circuittechnology enables single-cell discovery with theability to screen hundreds of genes from single cellsusing standard TaqMan and DNA binding dyeassays.

The authors concluded that the modified qRT-PCR demonstrated that primer carry-over from themultiplex PCR has detrimental effects on miRNA

quantification. This technique used on a nanoliterscale on a microfluidic chip allows for high-throughput multiplex qRT-PCR in a timely andcost-effective manner. The study was published onJanuary 15, 2011, in Cancer Research.

Image: Confocal light micrograph of metastasizingprostate cancer cells (Photo courtesy of NancyKedersha / Science Photo Library).

Serum Biomarker Identified for Prostate Cancer

Test Aids in Identifying and Containing Norovirus

Outbreaks

AA test for the most common cause of gastroenteri-tis will aid in identifying and containing

Norovirus outbreaks.The Ridascreen Norovirus 3rd Generation

enzyme immunoassay (EIA) is meant to be usedwhen a number of people have simultaneously con-tracted gastroenteritis and there is a clear avenue forvirus transmission, such as a shared location or food.

The US Food and Drug Administration (FDA;Silver Springs, MD, USA; www.fda.gov) allowedmarketing of this first test for the preliminary identi-fication of Norovirus. The FDA reviewed data forRidascreen via the de novo pathway, an alternativepath to market for devices that are lower risk andmay not require premarket approval (PMA), but areof a new type, and therefore may not be able to becleared in a “510(k)” premarket notification.

“This test provides an avenue for early identifica-tion of Norovirus,” said Jeffrey Shuren, MD, JD,director of the FDA’s Center for Devices andRadiological Health. “Early intervention can halt thespread of an outbreak.”

Norovirus is a leading cause of food-borne diseaseoutbreaks in the United States. Contamination usual-ly occurs in settings where there is close group con-tact, such as cruise ships, hospitals, long-term carefacilities, and schools or child-care centers. It is ahighly contagious virus that spreads rapidly throughdirect person-to-person contact, contaminated food,or water, or by touching contaminated surfaces.

The test is not sensitive enough for use when onlya single person has symptoms and should not beused for diagnosing individual patients.

Ridascreen is made by R-Biopharm AG(Darmstadt, Germany; www.r-biopharm.com).



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AAnewly developed molecular diagnostic testidentifies genomic sequences of Hepatitis B

virus (HBV). Capable of identifying the DNAsequence of the HBV polymerase gene includingall clinically relevant HBV drug resistant muta-tions, the test will help physicians monitor HBVinfections, guide treatment decisions, and predictor reveal drug resistance.

Abbott Molecular (Wiesbaden, Germany;www.abbottmolecular.com) received CE markingto market the HBV Sequencing test in theEuropean Union. It is the first DNA sequencingassay developed and introduced by AbbottMolecular. The assay was developed for use onthe Life Technologies (Carlsbad, CA, USA;www.lifetechnologies.com) ABI 3130 DNAsequencing system.

HBV is classified into eight separategenotypes (labeled A-H). HBV genotype isa prognostic indicator because it corre-lates with disease severity and responseto interferon therapy. For example,patients with HBV genotypes A and Bseem to respond better to interferon ther-apy than those with genotypes C and D.

The test is not intended for screeningblood donors, plasma or tissue donors forHBV, or to be used as a diagnostic test toconfirm the presence of HBV infection.

Abbott Molecular analyzes DNA, RNA, andproteins at the molecular level. Some of AbbottMolecular’s tests are designed to detect subtle butkey changes in human genes and chromosomes.The results of these tests may aid in the earlier

detection or diagnosis of disease, may influencethe selection of appropriate therapies, and mayimprove monitoring of disease progression.

Image: The ABI 3130 DNA analyzer (Photo courtesyof Life Technologies).

New Hepatitis B Sequencing Test Available in Europe

Dipstick Assay IdentifiesFungal Disease Antigen

AA rapid point-of-care assay is under developmentthat could lead to early diagnosis and potential-

ly save the lives of people stricken with fungalmeningitis.

The assay detects cryptococcal antigen and willuse a drop of blood from a finger-stick or a urine sam-ple to identify immediately the presence of the dis-ease so treatment can begin instantly, rather than hav-ing to wait for results to be processed at a laboratory.

The Lateral Flow Assay is an immunochromato-graphic test system for the qualitative or semiquanti-tative detection of Cryptococcus species capsularpolysaccharide antigens (CrAg) of both Cryptococcusneoformans and C. gattii in serum and cerebrospinalfluid (CSF). The test is the CrAg Lateral Flow Assay,which is a dipstick sandwich-immunochromatograph-ic assay. Specimens and specimen diluent are addedinto an appropriate reservoir, such as a test tube, andthe lateral flow device is placed into the reservoir.The test uses specimen wicking to capture gold-con-jugated, anti-CrAg monoclonal antibodies and gold-conjugated control antibodies deposited on the testmembrane.

The assay is being developed in a joint collabora-tion between scientists at the University of NevadaSchool of Medicine (Reno, NV, USA; www.medicine.nevada.edu) and Immuno-Mycologics,(IMMY; Norman, OK, USA; www.immy.com), whohave licensed the CrAg Lateral Flow Assay. Theassay has received the conformance marking (CE) ofthe European Community, and is being field testedin Africa.

Thomas Kozel, PhD, professor of microbiology atthe University of Nevada School of Medicine, said,“The ability to quickly identify mycosis in patients isexpected to help in significantly reducing cryptococ-cal meningitis deaths in resource-limited countriessuch as those in sub-Saharan Africa. Cryptococcosis isa rare form of meningitis among otherwise healthyindividuals, but an estimated 600,000 lives are lost tothis infection each year in patients with acquiredimmunodeficiency syndrome (AIDS). Many of theselives could be saved through early diagnosis.”




AAnovel cancer gene has been discovered that,when overactive, triggers a particularly aggres-

sive type of breast cancer to develop. The oncogenewas discovered using microarray technology, whichallows large numbers of tissue samples to be testedsimultaneously, picking up subtle differences ingene activity between normal cells and cancer cells.

Scientists, based at the Cambridge ResearchInstitute, (Cambridge, UK; www.cambridgecancer.org.uk), and at the British Columbia Cancer Agency(Vancouver, BC, Canada; www.bccancer.bc.ca),tested patients tumors to see if the gene, called zincfinger protein 703 (ZNF703), is overactive couldhelp identify patients with more aggressive tumors,so their treatment can be tailored accordingly. Theystudied the patterns of gene activity in 1,172 breasttumors, as well as breast cancer cells grown in the

laboratory. This allowed them to eliminate onegene at a time until there was only one gene leftwithin that region that was overactive in all thesamples tested.

It is thought that up to a third of more aggres-sive estrogen positive breast cancers could havemultiple copies of the ZNF703 gene. In the study,there were two patients in which ZNF703 was theonly gene shown to be overactive, which providedfurther evidence that it was the driving force in thedevelopment of the cancer. An important observa-tion that arises from the data is that amplificationof the genes ZNF703 and erythroblastic leukemiaviral oncogene homolog 2,(ERBB2), which arealmost completely mutually exclusive, jointlyaccount for around two-thirds of all breast cancersof the Luminal B subtype. This has potential for

clinical application since a combination ofimmunohistochemistry and fluorescence in situhybridization for these two genes/proteins(ZNF703 and ERBB2) can now be used to identifythese more aggressive estrogen receptor positive(ER+) cancers in the clinic.

Dr. Lesley Walker, director of cancer informationat Cancer Research UK, said, “This is the first geneof its kind to be discovered in breast cancer for fiveyears. This is exciting because it is a prime candidatefor the development of new breast cancer drugsdesigned specifically to target tumors in which thisgene is overactive. Hopefully this will lead to moreeffective cancer treatments in the future.” The studywas published online on February 18, 2011, in theEuropean Molecular Biology Organization (EMBO)Molecular Medicine.

Prognostic Biomarker Discovered for Aggressive Breast Cancer

PPolymerase chain reaction (PCR) assays forintestinal parasites can be used on fecal DNA

samples for enhanced detection of pathogenicorganisms.

A multiplex PCR-based assay for the ova andparasite stool examination is now available andthe molecular technology is comparable withmicroscopy and copro-antigen detection systems.

Scientists at the University of Virginia(Charlottesville, VA, USA; www.virginia.edu),adapted several existing real time PCR assays intoa high throughput protocol for the major intestin-al parasites. Fecal DNA specimens were obtainedfrom 192 preschool-age or younger children fromBangladesh and 190 DNA specimens wereobtained from the Leiden University MedicalCenter (Leiden, Netherlands; www.lumc.nl).Positive control materials were included in thisstudy. The assay involves two multiplex PCR reac-tions, one with specific primers for the protozoaand one with specific primers for the helminths,after which PCR products are hybridized to beads

linked to internal oligonucleotide probesand detected on a Luminex platform(Luminex Corporation, Austin, TX, USA;www.luminexcorp.com).

The Luminex protozoa assay showed alow limit of detection of 1,000 Giardialamblia cysts, 100 Cryptosporidiumparvum oocysts, and 10 Entamoeba his-tolytica trophozoites in 200 mg of a stoolspecimen. The Luminex helminth assaycould detect Ancylostoma duodenale,Ascaris lumbricoides, Necator ameri-canus, and Strongyloides stericoralis invery low concentrations. When compared withthe parent multiplex real-time PCR assays, thismultiplex PCR-bead assay afforded between 83%and 100% sensitivity and specificity on 319 clini-cal specimens.

The authors concluded that the multiplexPCR-bead protocol provides an alternative highthroughput molecular diagnostic platform for spe-cific and sensitive detection of several major intes-

tinal parasites and is a potential alternative tomicroscopy for equipped laboratories. The studywas published in February 2011, in the AmericanJournal of Tropical Medicine and Hygiene.

Image: Colored scanning electron micrograph (SEM)of a Giardia lamblia protozoan, a single-celled para-site of the intestinal tract most common in tropicalregions (Photo courtesy of Dr. Tony Brain / SciencePhoto Library).

Multiplex Molecular Tests Detect Seven Intestinal Parasites

135LMI-07-11LINKXPRESS COM 136LMI-07-11LINKXPRESS COM


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AA technique for the automatic cell viabilitymeasurement with a microscopic cell count-

er and microchip has been evaluated. An appraisal has been made of different meth-

ods of cell viability testing, an essential tool forperforming cell-based studies and clinical labora-tory tests.

Scientists at Korea University Guro Hospital(Seoul, Korea; http://guro.kumc.or.kr) compared

three different methods to test the viability ofblood cells. Blood was drawn from 11 healthy vol-unteers and mononuclear cells were separatedimmediately from the heparinized whole blood,and the viable cells were diluted subsequentlydown from 100% to, 75%, 50%, 25%, and 1%.The cell viability tests were performed simultane-ously with the following three methods: the con-ventional manual trypan blue exclusion method;the flow cytometry measurement with propidiumiodide stain; and the newly developed automatedfluorescence microscopic cell counter withmicrochip.

The linearity, precision, and correlations fromthree methods were analyzed and compared.The correlations data from the microscopic cellcounter were in good agreement with both theconventional trypan blue method and the flowcytometry. The precision and linearity from themicroscopic cell counter method with microchip

were superior in comparison with the conven-tional method. The new microscopic cell count-er with microchip, known as Adam (NanoenTek,Inc.; Seoul, Korea; www.nanoentek.com), wasfurther developed and improved to produce theresults within five minutes, including all proce-dural steps.

In the manual trypan blue stain, only 200cells were counted to measure their viability,but in Adam, larger number of cells, approxi-mately between 1,000 and 3,000 cells, werecounted. Greater number of counted cells andthe repetitions of the experiments by the micro-scopic cell counter and microchip for the analy-ses provided the better statistical significance.The real-time cellular images and archived datacould also be used for analyzing other parame-ters. The study was published online on March15, 2011, in the Journal of Clinical LaboratoryAnalysis.

Cell Viability Tests Compared with Microchip Method



Antibody BiomarkersIdentified for Alzheimer’s

AAnovel technique has been used in to discoverantibody biomarkers that avoid the need for

antigen identification in patients suffering fromAlzheimer’s Disease.

This new approach for the discovery of anti-body biomarkers required no knowledge of thespecificity of the immune response. An array ofrandom synthetic molecules to pinpoint disease-associated antibodies was used instead of putativeantigens.

Scientists at the Scripps Research Institute(Jupiter, FL, USA; www.scripps.edu) used combina-torial library of unnatural, synthetic molecules thatmight serendipitously mimic the antibody-bindingsite of the primary antigen. The premise is that thesesynthetic molecules, termed peptoids, can formshapes that cannot be formed by unmodified biomol-ecules. Through mimicry, then, peptoids might beable to pinpoint antibodies that are important to thedisease process and thus aid in the discovery of bio-markers.

The team first used comparative screening ofcombination libraries of thee synthetic peptoidsagainst serum samples from mice with multiple scle-rosis (MS) like symptoms, as well as healthy mice.The peptoids that retained more immunoglobulin(IgG) from the blood samples of the sick animalswere identified as potential agents for capturing diag-nostically useful molecules. The team says thisworked well.

The investigators then examined serum samplesfrom 18 humans, 6 with Alzheimer’s, 6 individualswith Parkinson’s disease, and 6 healthy participants.They identified three peptoids that captured threetimes the IgG antibody levels in all the Alzheimer’spatients than the controls or Parkinson’s patients.Two of the peptoids were found to bind the sameIgG antibodies, while the third binds different anti-bodies, suggesting that there are at least two candi-date biomarkers for Alzheimer’s.

Thomas Kodadek, PhD, a professor at Scripps,said, “The plan is to test the method now in thecontext of diseases, such as pancreatic cancer,where it is clear that early diagnosis could have sig-nificant implications for patient survival. It is possi-ble that antibody-based tests might identify suchcancers years before they could be detected other-wise. If those antibodies and the natural antigensthat they recognize could be found using the newtechnology, it might even aid the development ofnew and more effective cancer vaccines designed tobolster the body’s natural defenses against the dis-ease.” The study was published in January 2011 inthe journal Cell.

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IImmunohistochemistry has been used to detectthe expression of a biomarker for metastatic pro-

static adenocarcinomas.Tissue microarrays made from cores were taken

from the appropriate case specific paraffin-embed-ded tissue blocks were immunohistochemicallystained for the protein biomarker claudin-3.

A study performed at University of PittsburghSchool of Medicine, (Pittsburgh, PA, USA;www.medschool.pitt.edu), tested microarraysfrom 17 cases of benign prostatic hyperplasia(BPH), 35 with prostatic intraepithelial neoplasia(PIN), 53 patients with normal tissue adjacent toprostatic adenocarcinoma (NAC), 107 cases withprimary prostatic adenocarcinoma (PCa), and 55

cases of metastatic prostatic adenocarcinoma(Mets). The tissue microarrays were stained witha rabbit polyclonal antibody anti-claudin-3 fromThermo Scientific, (Waltham, MA, USA;www.thermo.com).

In the claudin-3 stained specimens, the averagestaining scores were highest in PCa and Mets. PINhad a lower absolute staining score than PCa andMets, although the differences were not signifi-cant. Both BPH and NAC had significantly lessstaining than PCa and Mets. As claudin-3 is a tightjunction protein, it is interesting to note that inaddition to membranous staining, cytoplasmicstaining was also seen in select cores, most promi-nently in cases of PCa and Mets.

The authors concluded that this study representsone of the first comparing the immunohistochemi-cal profiles of claudin-3 in PCa and NAC to speci-mens of PIN, BPH, and Mets. These findings pro-vide further evidence that claudin-3 may serve asan important biomarker for prostate cancer, bothprimary and metastatic, but does not provide evi-dence that claudin-3 can be used to predict risk ofmetastasis.

Claudins are integral membrane proteins thatare involved in forming cellular tight junctions, andclaudin-3, has been shown to be overexpressed inbreast, ovarian, and pancreatic cancer. The studywas published on January 21, 2011, in DiagnosticPathology.

Tissue Microarrays Identify Biomarker for Prostate Cancer

TThirty-two new clinical flow cytometry reagentshave been developed for immunophenotyping

of hematologic malignancies.A provider of reagents for multicolor flow

cytometry has expanded its portfolio of antibodies,fluorochromes, and reagents for diagnostics,immunology, oncology, cell biology, and stem cellbiology. eBioscience (San Diego, CA, USA;(www.ebioscience.com) manufactures the clinicalreagents under The Good Manufacturing Practice(GMP) environment. The company assures goodsignal to noise and more than 90% purity.

The Clinical Flow Cytometry Reagent productline was developed and optimized by eBiosciencefor the clinical laboratory user. The antibodies arepackaged in flexible sizes to help manage precisebudgets. All sizes are formulated at 5 µL/test toensure efficient multicolor immunophenotyping byreducing the ratio of reagent solution to sample vol-ume – critical for conserving precious samples. Thewide selection of fluorochrome formats are neededfor the variety of cytometers now found in clinicallaboratories.

The American Association for Cancer Research(AACR) 102nd Annual Meeting, (April 2–6, 2011)in Orlando (FL, USA) and the XXVI Congress of theInternational Society for Advancement ofCytometry (CYTO2011), May 2011 in Baltimore,(MD, USA) are showcasing eBioscience’s expand-ing portfolio of clinical reagents.

Thirty-Two Products Developed for Immunophenotyping of Hematologic Malignancies




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FLU A/B & RSV KITFocus Diagnostics

The Simplexa kit real-time RT-PCRassay is designed for use on the 3MIntegrated Cycler, a compact andportable platform that can provideresults in 60 minutes after sampleextraction. The kit aids in the detec-tion of influenza A and B, as well asrespiratory syncytial virus RNA.

SAMPLE PREPARATION SYSTEM

Hitachi Aloka MedicalThe LabFLEX 2500 features an auto-mated opening system and dispens-ing system, to enhance efficacy whilepreventing contamination. Otherbenefits include a labeling system, aliquid volume monitor, and compati-bility with standard five-tube racks.

DIPSTICK IMMUNOASSAYQuidel

The QuickVue Dipstick Strep A testis designed for the rapid qualitativedetection of Group A Strepococcalantigen from throat swab speci-mens. The 50-test kit featuresinclude high sensitivity at low levelsof colony count, along with resultsavailable in five minutes or less.

REPLACEMENT PROBESPeripheral Visions

The two available replacementprobes are designed for use on theKonelab analyzers, and are con-structed of stainless steel and Teflontubing. The cost-effective probes areavailable at less than half the cost ofcompetitor probes, and carry a six-month manufacturer defect warranty.


CCapillary electrophoresis can be used as detec-tion platform in a multiplex assay for viral and

bacterial respiratory pathogens.The multiplex polymerase chain reaction (PCR)

assay has been compared to other PCR assays forthe detection of Influenza A virus, Influenza Bvirus, and respiratory syncytial virus (RSV).

In a study carried out at the Institute for Clinicaland Experimental Pathology, (Salt Lake City, Utah,USA; www.path.utah.edu), scientists evaluated thecapillary electrophoresis-based multiplex assay forthree viral targets. Thirty respiratory samples werecollected that had previously tested positive for arespiratory virus. There were ten samples fromeach of the following viruses: Influenza A virus,

Influenza B virus, and respiratory syncytial virus. The multiplex PCR test, called the Seeplex assay

was manufactured by Seegene (Rockville, MD,USA; www.seegene.com). The assay detected nineof the ten influenza A samples; nine out of teninfluenza B samples, and all ten RSV samples. Theoverall total detection rate was 93%. The two sam-ples that were undetected by the Seegene assayboth generated late-crossing thresholds on the real-time platform, consistent with low viral loads. Theauthors concluded that the Seeplex assay providesa promising alternative for multiplex respiratorytesting.

The importance of differentiating between respi-ratory pathogenic organisms is while those infected

with the 2009 H1N1 Flu strain, seasonal influenzaA and B have similar symptoms, the correct antivi-ral drug must be prescribed for efficacious treat-ment. The 2009 H1N1 Flu, seasonal influenza A(H3N2), and seasonal influenza B viruses are sus-ceptible to the neuraminidase inhibitors, while sea-sonal influenza A (H1N1) is resistant to thesedrugs. The Influenza B virus is easier to catch infall/winter and symptoms are similar to those ofInfluenza A virus. Therefore, it is essential to differ-entiate between 2009 H1N1 Flu and other season-al influenza viruses for administration of the appro-priate therapy and prevention of drug resistance.The study was published in January 2011, inAnnals of Clinical and Laboratory Science.

Capillary Electrophoresis-Based Assay Differentiates Respiratory Viruses

AAtest uses the science of mitochondrial DNA(mtDNA) to determine accurately the absence or

presence of cancerous cells in prostate biopsy tissue.Called the Prostate Core Mitomic Test (PCMT),

it offers accurate, reliable results from existingprostate biopsy tissue. The PCMT can determinethe presence of malignant cells via a “canceriza-tion” field effect by detecting underlying molecular

alterations in normal appearing tissue. This is allperformed quickly and easily with a simple lab test.Molecular changes are identified that enable detec-tion of missed tumors; PCMT has demonstratedsensitivity of 84% and has also been shown to accu-rately rule out prostate cancer with a negative pre-dictive value of 91%. Mitomics (Thunder Bay,Canada; www.mitomicsinc.com) is a companyworking on mitochondrial genome-based productsto improve clinical insight and therapeutic deci-sions. It developed and launched the PCMT, whichis available through the company’s PCMT ClinicalLaboratory Improvement Amendments (CLIA) lab-oratory in Aurora (CO, USA).

“With the high rate of false negatives, uncertain-ty associated with traditional diagnostic tools,whether biochemical or histopathology, and ongo-ing controversy regarding treatment paradigms,men at risk for prostate cancer are in need of newoptions,” said Raoul Concepcion, MD, FACS, direc-tor of clinical research, Urology Associates P.C. inNashville (TN, USA; www.urologynashville.com).“The ability of PCMT to use mtDNA to potentiallyidentify malignancy by detecting underlying molec-ular alterations in normal-appearing tissue is animportant advance for managing patients whom theurologist feels may be at increased risk.”

Mitomics Test Determines Presence of Prostate Cancer




MICROSCOPE ATTACHMENTQBC Diagnostics

The ParaLens Advance is designedto upgrade any compound lightmicroscope for LED fluorescencemicroscopy. The ParaLens Advancefeatures a powerful light source, anda removable filter set arm that allowsusers to quickly change betweenobjectives whenever necessary.

SED-RATE ANALYZERStreck

The ESR-Auto Plus 10-positionautomated analyzer is designed toaccurately analyze the sedimenta-tion rate of erythrocytes in 1.2 mLESR-vacuum tubes. Key featuresinclude barcode scanner, patientresult log, automated QC file, built-inprinter, and results in 30 minutes.

CLINICAL ANALYZERToyko Boeki Medical System

The Biolis 50i Superior is a fullyautomated, random access analyzerdesigned for clinical analysis. Thesystem is the largest of the Biolisseries, and features a throughput of580 tests per hour with ISE, alongwith a wide range of functions forclinical labs.

BLOOD ANALYSIS SYSTEMWest Medica

The Vision Hema automatic digitalblood-smear analysis system is spe-cially designed for hematologists.Key features include preparing andsorting blood-cell galleries, automat-ic choice of motion path, slide andanalysis result database, and reportgeneration.


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TThe tests for the Human Epidermalgrowth factor Receptor 2 (HER2)

proteins and genes in tissue samplesgive equivocal results when morethan one sample is tested. The relia-bility of immunohistochemistry testsfor the HER2 protein and fluores-cence in situ hybridization, or FISHtests for the HER2 gene have beenstudied since 2001 and their appearsto be some variation in the overallresults.

Scientists from the Mayo CancerClinic Center, (Jackson, FL, USA;http://mayoresearch.mayo.edu)have studies whether teams ofpathologists are in concordancewhen examining the results fromthese tests. Three teams of patholo-gists conducted a blinded review ofsamples from 389 patients who had

been enrolled in three adjuvant clini-cal trials in which HER2 testing wasperformed by local and central labo-ratories to determine if patients werecandidates for these studies. Each ofthe three central laboratoriesreceived at least six slides from apatient’s tumor block that the labora-tory used to retest HER2 gene andprotein levels.

The pathologists were from centrallaboratories at the Mayo Clinic, theUniversity of Southern California, (LosAngeles, CA, USA; www.usc.edu),and the University of Pittsburgh,(Pittsburgh, PA, USA; www.pitt.edu).They found significant heterogeneity,or variability, between two tumorblocks taken from the same patient in5% to 10% of cases. Most often, onetumor block showed a normal HER2

expression, while the second piece oftumor tested HER2 positive. Theyfound that there was 92% agreementbetween the immunoassay and theFISH test. In 125 patients from thegroup of 389, who had more than onetumor block available for analysis theyfound that 5% to 10% of these sampleshad dissimilar protein and gene testresults. Edith Perez, MD, deputydirector of Mayo Clinic Cancer

Center, said, “It is necessary for oncol-ogists to continue to refine these testsand their analysis. That may meansome tests may be needed for multipletumor blocks, or that pathologists mayneed to discuss borderline results forsome patients.” The findings were pre-sented at the 33rd Annual SanAntonio Breast Cancer Symposiumheld December 8-12, 2010, in SanAntonio, TX, USA

Breast Tumor Biomarker Tests Reveal Different Results

TThe new vitamin D assay is a fullyautomated immunoassay, which

can help laboratories manage theexpected increase in vitamin D test-ing volumes.

The assay is intended for quantita-tive determination of 25-hydroxy(25-OH) vitamin D in human serumand plasma to aid in the assessmentof vitamin D sufficiency. The 25-OHvitamin D test provides an accurategauge of vitamin D status, and itsmeasurement in patients providesopportunities for preventive and ther-apeutic interventions.

The Abbott (Abbott Park IL, USA;www.abbott.com) diagnostic 25-OHvitamin D assay has received CE mark-ing. The assay will measure levels ofvitamin D in blood on the company’sARCHITECT automated instrumentsystem. According to the Internation-al Osteoporosis Foundation, vitaminD deficiency is a global health issue.The percentage of the European pop-ulation that is vitamin D insufficientis high, in some countries exceeding75 %. Global demand for patient test-ing is estimated to be growing at 50

% per year due to increasing medicalknowledge of the adverse healthimplications associated with vitaminD deficiency.

Determination of the serum vita-min D concentration and supplemen-tation according to the measuredlevel is important for patients withosteoporosis, chronic kidney disease,abnormalities in absorbing food nutri-ents, and more generally, in thosewith a disease or a treatment thatmay impair bone health.

“As a major diagnostic lab, serum25-OH vitamin D has become anincreasingly important diagnosticmarker to us,” said Dr. Frans AL vander Horst, Reinier de Graaf Group,Diagnostic Center SSDZ (Delft, TheNetherlands; www.rdgg.nl). “Therehas been a great need for a reliableand cost effective assay. With theintroduction of the Abbott test, wecan fulfill these needs and significant-ly improve the efficiency of the work-flow in our routine lab.”

The ARCHITECT 25-OH VitaminD assay is not yet approved for use inthe United States.

Vitamin D Test Available for Use in EU





MICROPLATE/SLIDEPROCESSOR

A. Menarini DiagnosticsThe Zenit UP is an all-in-one solutiondesigned for automation of ELISAand IFA methods. The accurate andreliable system offers a wide rangeof features, all allowing for an effi-cient and flexible workflow, that max-imizes productivity and throughput.

HEMOSTASIS ANALYZERAnalyticon Biotechnologies

The Coagulyzer 100 is a compact,stand-alone lab solution designedwith a focus on being user-friendly,reliable, and cost-effective. Theeasy-to-use analyzer is intended tomeet the needs of low- to mid-vol-ume hemostasis laboratories.

AUTOMATED CHEMISTRY SYSTEM

Beckman CoulterThe AU5800 series featuresenhanced speed to improve pro-cessing time, compared to currentsystems. The models are availablein one- to four-module configura-tions, and are designed for high- andultra-high-volume clinical labs.

ASSAY SYSTEMBoditech Med

The i-CHROMA reader is a portablesystem designed to quantify singleor multiple analytes simultaneouslymeasuring the laser-induced epifluo-rescence of the test cartridge. ThePOCT system screens for a range ofdiseases, and provides results in assoon as three to 15 minutes.


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TThe unregulated growth of genetic tests market-ed directly to consumers will have a significant

adverse impact on consumers and undermine thephysician-patient relationship. In many cases, it alsorepresents the unauthorized practice of medicine.

In a letter to the Food and Drug Administration(FDA; Rockville, MD, USA; www.fda.gov), theAmerican Medical Association (AMA; Chicago, IL,USA; www.ama-assn.org) called for genetic testingto be conducted under the guidance of a physician,genetic counselor, or other genetics specialist. Theletter was sent to the Molecular and ClinicalGenetics Panel of the FDA’s Medical DevicesAdvisory Committee regarding direct to consumergenetic tests prior to the panel’s hearings on thetopic, scheduled for March 8-9, 2011.

Direct to consumer (DTC) genetic tests mayoffer some benefits, such as promoting awarenessof the genetic basis of disease and increasing atten-tion to healthy behaviors that prevent the onset of

disease. However, the AMA is concerned about thepotential of DTC genetic tests to cause harm to con-sumers and over time increase health care costs.

Without the guidance of a physician, geneticcounselor, or other genetics specialist, test resultscould be misinterpreted, risks miscalculated, andincorrect health and lifestyle changes pursued. Atthe very least, consumers will waste money pur-chasing tests with little value.

Patients could make important reproductivedecisions based on the results of carrier screeningfor hereditary diseases. These decisions requirecareful consideration of both the screening resultsand other factors, and it is essential that a physi-cian or other genetics professional ensure thatpatients are well informed before making suchdecisions.

Genetic tests often require a complete clinicalcontext to be meaningful. A positive result doesnot necessarily indicate a clinical diagnosis;

instead, it may indicate an increased risk for devel-oping a disease or condition, the phenotypic mani-festations of which are variable in individuals.Conversely, since only a fraction of testable muta-tions are identified for genetically based diseases, agenetic test with a negative result is not indicativeof the absence of disease risk.

“Without the benefit of proper medical counsel-ing, patients may spend money on direct to con-sumer genetic tests needlessly or misinterpret theresults of the tests, causing them to make unneces-sary or unhealthy lifestyle changes,” said AMAchair Ardis D. Hoven, MD. “While genetic testingcan be a valuable tool to aid in diagnostic and ther-apeutic decisions, it should be done under theguidance of a physician, genetic counselor, or othergenetics specialist. These health professionals arebest prepared to help patients understand theresults and the limitations of the tests, and whattype of action should occur based on the results.”

Genetic Testing Should Be Conducted By Qualified Health Professionals

AAmajor milestone in microfluidics could soonlead to standalone, self-powered chips that can

diagnose diseases within minutes.The novel biochip uses trenches patterned

underneath microfluidic channels that are aboutthe width of a human hair. When whole blood isdropped onto the chip’s inlets, the relatively heavyred and white blood cells settle down into thetrenches, separating from the clear blood plasma.

The Self-powered Integrated Microfluidic BloodAnalysis System (SIMBAS) was developed by aninternational team, led by scientists at theUniversity of California Berkeley (USA;www.berkeley.edu) and is able to process wholeblood samples without the use of external tubingand extra components. The blood moves throughthe chip in a process called degas-driven flow,where air molecules inside the porous polymeric

device are removed by placing the device in a vac-uum-sealed package. When the seal is broken, thedevice is brought to atmospheric conditions, andair molecules are reabsorbed into the device mate-rial. This generates a pressure difference, whichdrives the blood fluid flow in the chip.

For the new SIMBAS biochip, the scientists tookadvantage of the laws of microscale physics tospeed up processes that may take hours or days ina traditional laboratory. In experiments, they wereable to capture more than 99% of the blood cells inthe trenches and selectively separate plasma usingthis method. The team demonstrated the proof-of-concept of SIMBAS by placing into the chip’s inleta 5 µL sample of whole blood that contained biotinat a concentration of about one part per 40 billion.The biodetectors in the SIMBAS chip provided thereadout of the biotin levels in 10 minutes and the

limit of detection was 1.5 picomoles. Luke P. Lee, PhD, the principal investigator of

the study, said, “Field workers would be able to usethis device to detect diseases such as humanimmunodeficiency virus (HIV) or tuberculosis in amatter of minutes. The fact that we reduced thecomplexity of the biochip and used plastic compo-nents makes it much easier to manufacture in highvolume at low cost.” The study was publishedonline in March 17, 2011, in Lab on a Chip.

Image: The SIMBAS biochip (Photo courtesy of theUniversity of California Berkeley).

Autonomous Biochip Leads to Rapid Diagnostic Capability

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TThe detection performance of automated high-pressure liquid chromatography (HPLC) sys-

tems for variant hemoglobins has been compared.The HPLC systems have become the method

of choice for the evaluation of patients suspectedwith hemoglobinopathies, but they vary in theirperformance and ability to discriminate varianthemoglobins.

Scientists at the University of California DavisHealth System, (Sacramento, CA, USA;www.ucdmc.ucdavis.edu), evaluated the per-formance of two HPLC methods used in thedetection of common hemoglobin (Hb)variants. They tested 377 samples, ofwhich 99 were from patents with HbS,32 with HbC, 78 with other hemoglo-bin variants or thalassemia, and 11with increased hemoglobin A1c. Theinterpretations of each chromatographproduced by the HPLC systems werecompared.

The two systems were the Variant,(Bio-Rad Laboratories, Hercules, CA,USA; www.bio-rad.com), and theUltra2, (Trinity Biotech, Kansas City,MO, USA; www.trinityusa.com). Boththe Variant and Ultra2 methods use arelatively short program that measuresthe separation process over approxi-mately 4–6 minutes. The Ultra2 has asecondary feature that will reflexrepeat test samples with abnormalpeaks or unusual findings using a high-resolution method that observes theseparation process over 6-8 minutes,allowing for better separation of thehemoglobin peaks.

There were no differences noted forhemoglobins A0, S, or C. There weresignificant differences between theHPLC methods for hemoglobins F, A2,and A1c. However, there was goodconcordance between normal andabnormal interpretations (97.9% and96.2%, respectively). The authors con-cluded that both the Variant andUltra2 HPLC methods were able todetect most common hemoglobin vari-ants. There was better discriminationfor fast hemoglobins, between hemo-globins E and A2, and between hemo-globins S and F using the Ultra2 HPLCmethod.

Hemoglobin variants are a result ofgenetic changes resulting in abnormalor dys-synchronous hemoglobin chainproduction, as in thalassemia or thegeneration of hemoglobin chain vari-ants such as hemoglobin S, as seen insickle cell anemia.

Automated high-pressure liquidchromatography (HPLC) systems havebecome the method of choice for theevaluation of hemoglobinopathies.With this method, samples are mixed

with buffers and salts and injected through an ionexchange column where physical properties ofthe hemoglobin such as surface charge andhydrophilic group, are separated during migra-tion. HPLC methods allow for better isolation ofhemoglobin variants and are less subjective thanelectrophoretic methods.

The study was published in the April 2011edition of the International Journal of LaboratoryHematology.

Image: The Variant II Turbo hemoglobin testing sys-tem (Photo courtesy of Bio-Rad Laboratories).

Automated Systems Detect Variant Hemoglobins



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AAgenotyping test kit has beenevaluated for identifying human

papilloma virus (HPV) in histologicaltissue samples.

A Linear Array HPV test kit identi-fies, and then specifically genotypesthe virus in formalin-fixed, paraffin-embedded (FFPE) tissues from headand neck cancer patients.

In a study performed at Dart-mouth Medical School, (Lebanon,NH, USA; http://dms.dartmouth.edu), scientists evaluated the per-formance of Roche Linear Array HPVGenotyping test kit assay (F. Hoff-mann-La Roche AG, Basel, Switzer-land; www.roche.ch), for accuracy,for intra-assay and interassay preci-sion, and for its limit of detection,using materials with known HPV sta-tus. DNA from formalin-fixed, paraf-

fin-embedded tumor sections was iso-lated and amplified in duplicate, withpositive and negative controls, usingprimers specific to the polymorphicL1 region of the HPV genome.

Thirty-seven genotypes were test-ed using the linear array. The ampli-fied product (450 base pairs) wasvisualized by gel electrophoresis and,if positive, reflexed to HPV genotyp-ing. Of these cases, all were deter-mined to have suitable DNA forgenotyping based on an internal con-trol gene reaction. The Linear ArrayHPV Genotyping kit contains posi-tive β-globin high-control and β-glo-bin low-control bands for determin-ing whether the DNA from FFPE tis-sue is suitable for HPV genotypingusing this assay. Nine of the 16tumors analyzed were HPV positive.

The detected genotypes includedHPV 6, 16, and 69.

Head and neck tumors commonlyarise from the squamous and respira-tory mucosa that lines the nasal andoral cavity, sinuses, pharynx, and lar-ynx. The rate of oropharyngeal can-cers diagnosed among Americansyounger than 50 years is increasing.Infection of the oropharynx and ton-sils by the human papillomavirus(HPV) has been linked to preneopla-

sia and cancer. The Roche Linear Array HPV

Genotyping test was found to be aneasy-to-use method for determiningHPV genotype in the routine analysisof formalin-fixed, paraffin-embeddedtumors. According to the authors,this assay was robust and can be per-formed routinely in a clinical labora-tory setting. The study was publishedin December 2010, in the Archivesof Pathology & Laboratory Medicine.

Genotyping Test Evaluated for HPV

AAn enzyme-linked immunosor-bent assay (ELISA) that meas-

ures galectin-3 in human plasma hasbeen used to calculate the risk ofheart failure (HF). This ELISA assayquantitatively measures the concen-tration of human galectin-3 levels inEDTA plasma. This assay has highsensitivity with a lower limit of detec-tion of 1.13 ng/mL) and exhibits nocross-reactivity with collagens orother members of the galectin family.

In a study carried out at theUniversity Medical Center Gronin-gen, (UMCG; Groningen, TheNetherlands; www.umcg.nl), bloodsamples were available from 592heart failure patients during theirindex admission. Samples were alsocollected just before discharge whenpatients were stabilized and there wasa mean follow-up of 18 months.Galectin-3 was measured by theELISA method developed by BGMedicine (Waltham, MA, USA;www.bg-medicine.com). Levels ofcytokines vascular endothelial growthfactor (VEGF), interleukin-6 (IL-6), C-reactive protein (CRP), and transform-

ing growth factor-β 1 (TGF-β 1) weremeasured in the same plasma samplesusing Search-Light Proteome Arrays(Aushon BioSystems, Billerica, MA,USA; www.aushon.com).

The investigators reported that theinflammatory markers were positive-ly correlated to galectin-3 levels andthe study confirmed that galectin-3 isa strong and independent predictor ofadverse outcomes. The prognosticvalue of the galectin-3 biomarkerremained even after adjustment forestablished risk factors for poor out-comes in HF, including age, sex,brain natriuretic peptide, renal func-tion, and diabetes mellitus. The pre-dictive power of plasma galectin-3appears to be predominantly strongin heart failure patients with pre-served left ventricular ejection frac-tion, which nowadays compriseabout half of all HF patients. Serialmeasurements of galectin-3 do notappear to add to the prognosticpower of single measurements. Thedetails of the study were published inJanuary 2011, in the journal Annalsof Medicine.

Immunoassay for Biomarker Predicts Risk of Heart Failure



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CHEMISTRY ANALYZERCaretium Medical Instruments

The NB-201 semiautomated analyz-er features a large LCD and touchscreen, as well as seven filters andone free position. Other benefitsinclude temperature control, a QCgraph print out, programmability for112 test profiles, and memory for3,200 sample results.

IMMUNOASSAY SYSTEMSiemens Healthcare Diagnostics

The IMMULITE 2000 XPi offers alarge menu of automated tests,along with hardware and softwaresolutions to enhance productivityand efficiency in medium- to high-volume labs. A user-friendly touchscreen interface and remote moni-toring add to the system’s benefits.

SPECIMEN PROCESSORCopan Diagnostics

The WASP walk-away system isdesigned to manage all aspects ofspecimen processing, planting andstreaking, gram slide preparation,and enrichment broth inoculation.The WASP streamlines operations,and offers a throughput equal tothree full-time equivalent units.

ARRAY TEST KITDiagCor Bioscience

The GenoFlow DR-MTB is designedfor the detection of wild-type MTBand drug-resistant MTB for manage-ment of active tuberculosis. The testis user-friendly, requires only fourhours from DNA extraction to datainterpretation, and allows 24 sam-ples to run simultaneously.

AApoint-of-care (POC) immunoassay ana-lyzer for diabetes management pro-

vides enhanced operator management andconnectivity capabilities to meet the grow-ing demands in POC testing for improvedcompliance management and data captureinto patient records.

The DCA Vantage Analyzer ensures thatall analyzers are running the same qualitycontrol regimen required by their institutionand that only authorized operators are run-ning the devices according to their specifiedaccess level.

The operator management capabili-ty has been expanded to support up to1,000 operators, each with theirunique access level as defined by theirsupervisor. Another enhancement tothe analyzer is the ability to display,print, and transmit the HbA1c refer-ence ranges with the patient results,aiding in improved results interpreta-tion.

POC managers are demanding bet-ter connectivity between their POCanalyzers and the associated healthcareorganization so that test results can beautomatically transmitted to the labora-tory and hospital information systems,and eventually to the patient’s electron-ic medical record.

Siemens Healthcare Diagnostics(Erlangen, Germany; www.medical.siemens.com) launched the DCAVantage Analyzer with Version 3.0 soft-ware. It has the capacity to manage alarger number of operators while pro-viding the required security accessmodes to prevent unauthorized use. Inaddition, the analyzer is one of the firsthemoglobin A1c (HbA1c) POC analyz-ers in the industry to include thePOCT1-A2 communication protocol.Use of this standard interface simplifiesthe connection to POC data manage-ment systems, enabling results to beautomatically transmitted to thepatient electronic medical record.

“We are focused on providing ourcustomers with a trusted, clinicallyproven, point-of-care analyzer to bettermanage diabetes patients at the time ofvisit,” said Dr. David Stein, CEO, POC

business unit, Siemens Healthcare Diag-nostics. “At the same time, we are continu-ally looking at ways to enhance our productsto meet the changing needs of our cus-tomers. These newly added features areimportant to point-of-care managers who areresponsible for tests conducted at remotesites with multiple operators and devices inorder to drive testing compliance.”

Image: The DCA Vantage point-of-careimmunoassay analyzer (Photo courtesy ofSiemens Healthcare Diagnostics).

Point-Of-Care HbA1c Analyzer Enhanced





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MMethicillin-resistant Staphylococ-cus aureus (MRSA) can be de-

tected in asymptomatic patients in anemergency department (ED) setting.

The prevalence of asymptomaticMRSA colonization in ED patients ispoorly described, particularly in theabsence of skin and soft tissue infec-tion-related complaints.

A study to assess the prevalence ofnasal and extranasal staphylococcalcolonization in ED patients was car-ried out at the Boston UniversitySchool of Medicine (Boston, MA,USA; www.bumc.bu.edu). The scien-tists evaluated the risk factors, andcharacterized the strains by molecu-lar techniques. They actively sur-veyed 400 patients presenting to theED. Testing was conducted on anteri-or nares, oropharynx, palms, groin,perirectal area, wounds, and catheterinsertion sites. Swabs taken from thevarious sites were cultured and anyS. aureus, whether sensitive (MSSA)or resistant (MRSA) to methicillin,were characterized by a multiplexpolymerase chain reaction assay.

The prevalence of colonization withMSSA was 39%, and prevalence of col-onization with MRSA was 5%. AmongMRSA-colonized subjects, an extra-nasal site tested positive in 80% of sub-jects, and 45% had exclusive extranasalcolonization. Human immunodeficien-cy virus (HIV) infection showed thestrongest association with MRSA colo-nization, with a nearly 14-fold in-creased risk. Among factors at leasttripling the risk was a history of dia-betes, presenting from a nursing home,and playing contact sports. However,among those who were colonized, 20%

had no risk factors for colonization and45% were colonized only at sites otherthan the nose. Of those colonized withMRSA, 55% were infected with theUSA300 strain which often carries thePanton-Valentine leukocidin virulencefactor and is responsible for invasiveskin and soft tissue infections, necrotiz-ing pneumonia, necrotizing fasciitis,and other serious infections in other-wise healthy hosts.

Elissa M. Schechter-Perkins, MD,M.P.H., the lead author of the study,said, “These findings suggest that cur-rent programs that screen for MRSA,which typically screen for nasal MRSAcolonization among patients perceivedto be at high-risk, may actually bemissing a large number of patientsactually colonized with MRSA. Thishas implications for spread of MRSAcolonization and subsequent infec-tions that nasal screening programsaim to prevent.” The study was pub-lished online on January 15, 2011, inAnnals of Emergency Medicine.

Image: Colored scanning electronmicrograph (SEM) of Methicillin-resist-ant Staphylococcus aureus (MRSA)(Photo courtesy of Paul Gunning /Science Photo Library).

Asymptomatic Drug ResistantStaphylococcus Detected




GLUCOSE MONITORING SYSTEM

DIALABThe DiaCheck monitoring systemfeatures an enhanced plasma equiv-alent calibration, and requires only aminimal amount of capillary blood forprocessing. The blood glucose levelis displayed only five seconds afterapplying the blood sample.

SINGLE-CHANNEL PIPETTEHTL Lab Solutions

The Labmate Soft combines tradi-tional design with a thumb-friendlyspring system and an improved vol-ume setting push button for effort-less daily pipetting. Each LabmateSoft is equipped with a dual adjust-ment to meet the preferences of allusers.

URINALYSIS REAGENT STRIPS

Dirui IndustrialThe H13-Cr strips offer high sensitiv-ity and accurate results for in vitrodiagnostics. The test strips are easy-to-read for both visual and instru-ment reading, match the color chartfor fast results, and are convenientlypackaged 100 strips per bottle.

RANDOM ACCESS ANALYZER

DRGThe HYBRiD XL allows for the simul-taneous measurement of immuno-assays and clinical chemistry para-meters in one sample. Efficiencyfeatures include results in 10 min-utes and a throughput of 80 tests perhour.



AAn improved and more sensitivetest should be included in the

screening of vaginal swabs forwomen suspected of having sexuallytransmitted diseases (STD).

A molecular diagnostic assay thatuses transcription-mediated amplifi-cation (TMA) for the detection ofTrichomonas vaginalis augments thelaboratory diagnosis of venereal dis-eases.

Scientists at Rhode Island Hospital(Providence, RI, USA; www.rhodeis-landhospital.org), compared a TMAassay with a direct-specimen, ribonu-cleic acid (RNA) probe-based diag-nostic test designed to differentiateand identify pathogens associatedwith bacterial vaginosis (Gardnerellavaginalis) and vaginitis (T. vaginalisand Candida species). A total of 781consecutive specimen pairs, consist-ing of one vaginal specimen and onecervical or urine specimen, were col-lected from 766 women from July2009 to August 2010.

The study revealed that the APTI-MA assay (Gen-Probe, San Diego,CA, USA; www.gen-probe.com)detected 36% more women infectedwith T. vaginalis, yielding a sensitivi-ty of 100% and no false positives.The authors noted a high prevalenceof trichomoniasis in women in the36 to 45 year-old age group, who arenot normally included in the recom-mended STD screening criteria. TheAFFIRM Vaginitis three pathogens(VPIII) RNA assay, (BD; FranklinLakes, NJ, USA; www.bd.com),which is commonly used in obstet-rics and gynecological patients, pro-duced one false positive and 15 falsenegative results in symptomaticpatients.

Trichomoniasis can affect bothmen and women and the true preva-lence and clinical impact isunknown because current methodsof detection exhibit poor sensitivitywhen compared to molecular ampli-fication methods. Kimberle Chapin,

MD, lead author of the study, said,“Despite a worldwide prevalencerate likely to be double that of gon-orrhea or Chlamydia infectionscombined, trichomoniasis is not cur-rently a reportable disease in theUnited States. We also found thedisease was most prevalent inwomen ages 36 to 45 and inwomen ages 51 to 60. This was def-

initely surprising and a new findingin these age groups.” The study waspublished in March 2011, in theJournal of Clinical Microbiology.

Image: Colored scanning electronmicrograph (SEM) of the parasiticprotozoan Trichomonas vaginalis, thecause of sexually transmitted vaginitis(Photo courtesy of Moredun AnimalHealth).

Routine ScreeningRecommended for SexuallyTransmitted Diseases


AA device, based on chip technol-ogy, has been developed that

will enable the diagnosis of eight ormore different diseases on blood orcell samples. The integrated systembased on microtechnology andbiotechnology, will enable a num-ber of conditions to be diagnosedautomatically in the doctor’s ownoffice. The chip looks like a creditcard and contains a complete labo-ratory.

The chip is engraved with anumber of very narrow channelsthat contain chemicals and enzymesin the correct proportions for eachindividual analysis. When thepatient’s sample has been drawninto the channels, these reagentsare mixed. The card is then put intoa machine than can read the bio-markers, such as DNA or enzymes,to produce a diagnosis. The projectto develop the chip is being coordi-nated by SINTEF (Trondheim,Norway; www.sintef.no), thelargest independent research organ-ization in Scandinavia.

Scientists at SINTEF’s micro andnanotechnology laboratory havedeveloped a number of techniquesfor interpreting the results when thebiomarkers have been found. For

example, they can read them off ina spectrophotometer, an opticalinstrument in which the ribonucleicacid (RNA) molecules in differentmarkers emit specific fluorescentsignals. The project has used cellstaken to diagnose cervical cancer asa case study, but in principle, thechip can check out a number of dif-ferent diseases caused by bacteria orviruses, as well as various types ofcancer.

NorChip (Klokkarstua, Norway;www.norchip.com), the companythat had the original idea, has juststarted a new two-year EU projectthat aims to industrialize the diag-nostic chip to the mass-productionstage while the company will alsoevaluate market potential andindustrial partners. Frank Karlsen,PhD, the chief scientist at Nor-Chip, said, “The ways in which thechip can be used can be extended toenable patients themselves to takesamples at home,” and he expectsthat such special sampling systemswill be ready for testing within afew years. The venture is part of theEuropean Commission’s (Brussels,Belgium; http://ec.europa.eu) proj-ect Microactive, which develops in-office health test system.”

Integrated Chip System Developed as Complete Laboratory

UU rine samples from pregnantwomen have been successfully

screened to identify those infectedwith Chlamydia trachomatis.

The urine screening was con-ducted using a commercial molecu-lar assay utilizing target capture forthe in vitro qualitative detection anddifferentiation of ribosomal RNA(rRNA) of C. trachomatis andNeisseria gonorrhoeae.

Scientists at University of TexasSouthwestern Medical Center,(Dallas, TX, USA; www.utsouthwestern.edu), tested a total of 2,018pregnant women whose mean agewas 26.9 years old, and of whom84% were Hispanic. For fourmonths, all women who were seen

at a group of family planning andobstetric complication clinics in thearea and who were between 35 and37 weeks pregnant were tested.Both urine samples and endocervi-cal secretions were assayed.

All samples were analyzed usingthe Aptima Combo 2 Assay, whichis a target amplification nucleicacid probe test. The prevalence ofChlamydia according to tests ofcervical secretions was 4.3% com-pared to 4.1% using urine sam-pling. The results from the twosamplings were considered to bealmost perfectly concordant.Sensitivity of urine screening was96.5% relative to endocervicalscreening where the 95% confi-

dence interval (CI) was 90.1% to99.3%, with a relative specificity of100%.

Urine screening for Chlamydiahas shown to be accurate in maleand nonpregnant female populationsusing Aptima Combo 2 Assay (Gen-Probe Inc.; San Diego, CA, USA;www.gen-probe.com). However, thescientists were uncertain that wouldtranslate to effectiveness in pregnantwomen. Their concern was thatpregnant women might have ampli-fication inhibitors not present in thenonpregnant population leading tonucleic acid amplification tests beingless sensitive when performed onurine as compared with cervicalspecimens. However, this proved notto be the case.

Scott W. Roberts, MD, leadauthor of the study, said,“Removing the need for a specu-lum examination with its potential

benefits in costs and respect forpatients’ desires has led us to useurine nucleic acid amplificationtesting for our C. trachomatisscreening in all pregnant women.”Urine sampling is also considerablycheaper than endocervical sam-pling, and scores points withpatients who would rather notundergo an invasive exam.Chlamydia trachomatis is the mostcommon bacterial sexually trans-mitted infection in the US. Thisdisease disproportionately affectsadolescent minority women, anduntreated infection can lead tolasting reproductive tract morbidi-ty. The study was published in theApril 2011, edition of Obstetrics &Gynecology.

Image: Color enhanced scanningelectron micrograph (SEM) of chlamy-dia (Photo courtesy of David M.Phillips / Science Photo Library).

Antenatal Urine SamplesScreened for Chlamydia




RANDOM ACCESS ANALYZERThermo Fisher Scientific

The Indiko benchtop system isdesigned for load-up and walk-awayconvenience. The self-containedsystem offers an intuitive user inter-face, along with a wide range ofautomated features to manage andstreamline daily lab workloads.

HEMATOLOGY SYSTEMDiatron

The Abacus Junior 30 provides acomplete 18-parameter report withthree-part WBC differential for vari-ous profiles in about two minutes.The reliable and efficient system isuser-friendly, and features a lowweight, small size, and a color touchscreen for added convenience.

RESPIRATORY PANELIdaho Technology

The FilmArray tests for a compre-hensive panel of respiratorypathogens which cause URTIs. Thepanel integrates sample preparation,amplification, detection, and analy-sis into one simple system thatrequires two minutes of hands-ontime, and has a run time of one hour.

CLINICALCHEMISTRY ANALYZER

Kehua Laboratory SystemThe ZY-1200 is a fully automatic,open system that offers enhancedmicropipette and fluid controllingtechnology. The system has athroughput of 800 photometric testsper hour, and 1,200 tests per hourwith ISE, with accurate tests results.



AApoint-of-care hand-held analyzer allows realtime transmission of diagnostic test results

generated directly from the patient bedside.The handheld analyzer can potentially save pre-

cious time by allowing caregivers to perform criticaltests at the bedside and then transmit test resultsimmediately so they can be reviewed by physiciansanywhere they have access to electronic records.

The device, called the i-STAT 1 Wireless, elimi-nates the back-and-forth movement from the bed-side to a desktop transmission terminal somewherein the department giving staff the ability to focus onthe patient better. For example, with the 10-minutei-STAT cardiac troponin test cartridge, emergencydepartment staffs can test, transmit, and treat fromthe bedside. By sharing these test results via a hos-pital’s existing wireless network, caregivers haverapid access to information that can help determineif a patient is having a heart attack.

The i-STAT 1 Wireless is the latest version of the

device from Abbott Laboratories, (Abbott Park, IL,USA; www.abbott.com). Lightweight, portable,and easy to use, the i-STAT System features single-use disposable cartridges that perform a broadmenu of the most commonly performed diagnostictests, including cardiac markers, blood gases,chemistries and electrolytes, lactate, coagulation,and hematology. Abbott announced it has receivedclearance from the US Food and DrugAdministration (FDA; Silver Springs, MD, USA;www.fda.gov), to begin marketing the i-STAT 1Wireless.

The i-STAT System is used in nearly 2,000 hos-pitals and in nearly 1,000 emergency departmentsin the US. Some 50,000 i-STAT analyzers are usedworldwide and they process about 100 million testcartridges a year.

Image: The i-STAT 1 wireless, point-of-care analyzer(Photo courtesy of Abbott Laboratories).

Agreement to Develop,Market Integrated Digital

Pathology Solutions

RRoyal Philips Electronics (Eindhoven, TheNetherlands; www.philips.com) and NEC

Corporation (Tokyo, Japan; www.nec.com) havesigned an agreement under which the two companieswill jointly develop and market highly integrated dig-ital pathology solutions.

Initially targeted to assist in the grading of breastcancer and prostate cancer, the solutions will bebased around Philips’ new high-throughput pathologyslide scanner and NEC’s e-Pathologist CancerDiagnosis Assistance System. They will be designedto use advanced digital techniques to add quantitativeanalysis to the qualitative information derived fromthe visual inspection of pathology slides, which is cur-rently the standard procedure.

When a lesion is suspected to be cancerous or pre-cancerous, the normal procedure is to remove a sam-ple of tissue from it and send it to a pathology lab forexamination. A thin section of the tissue is mountedon a glass slide, stained to highlight various struc-tures, and visually examined under a microscope.

Philips’ ultra-fast slide scanner, which is alreadycommercially available in Europe for research pur-poses only, employs a unique “continuous autofo-cus” technology that accurately follows height vari-ations in the tissue surface over horizontal distancesas short as 30 µm, allowing extremely high defini-tion full-slide images to be captured in less than oneminute per slide.

NEC’s e-Pathologist system will detect tissue andcell features within these images in order to identifyregions of interest and make quantitative measure-ments of key structures in conventionally stained(hematoxylin and eosin) tissue samples, or samplesstained with immunohistochemistry reagents. Thesequantitative measurements should assist pathologistsin making decisions relating to the clinical treatmentof cancer in individual patients.

Philips and NEC aim to produce initial develop-ment results from their joint development in digitalpathology within the current year.

Blood Analyzer Goes Wireless


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LabMedicaLabMedica

Molecular TechnologyDiscriminates BetweenCancer and Noncancer

Patients

AA new molecular technology has been devel-oped to detect distinct genetic changes differ-

entiating cancer patients from healthy individualsand could serve as a future cancer-predispositiontest.

A DNA microarray has been designed thatallows the measurement of the two millionmicrosatellites found within the human genomeusing 300,000 probes and evaluation of globalchanges in the genome. This can determinewhether pattern change alludes to a new mecha-nism disrupting the genome in cancer patientsand may represent a new breast cancer-risk bio-marker.

Scientists from the Virginia BioinformaticsInstitute (VBI) at Virginia Tech (Blacksburg, VA,USA; www.vbi.vt.edu), used a custom CGH-likeoligonucleotide array to measure the globalmicrosatellite content in the genomes of 72 can-cer, cancer-free, and high risk patient and cell linesamples and 56 germline DNA and 16 in tumor ortumor cell line DNA. They found a unique, repro-ducible, and statistically significant pattern of 18motif-specific microsatellite families out of 962possible 1-6 mer repeats in breast cancer patientgermline and tumor DNA but not in germlineDNA of cancer-free volunteer controls or in breastcancer (BRCA) patients with BRCA1/2 genemutations.

Microsatellites are short, repetitive DNAsequences that tend to vary greatly among individ-uals are used to uncover information related to anumber of other genetic diseases such as Fragile-X or Huntington’s disease. Only a small percent-age of microsatellites have been linked to cancerand other diseases because there has not been aneffective method available for evaluating largenumbers of these sequences. This technology isenabling scientists to understand the role of theseunderstudied parts of the human genome for thefirst time and may help explain the differencebetween the known genetic components in dis-ease and those that have been explained bygenomic studies. This tool can be used to identifyand better understand genetic changes in manydifferent types of cancer with the potential toserve as a universal cancer biomarker. It hasalready been instrumental in the discovery of anew biomarker in the estrogen-related receptorgamma (ERR-γ) gene, which indicates an individ-ual’s increased risk for breast cancer.

Harold Garner, PhD, a professor at VBI, said,“We have now arrived at a new biomarker, anindicator that could be used to evaluate theamount of risk that you have for developing can-cer in the future. The description of the technolo-gy allows us to very quickly and efficiently andinexpensively measure these two million placesusing a uniquely designed microarray. It is the pat-tern on that microarray that provides us the infor-mation we need.” The study was published onlineon January 14, 2011 in Genes, Chromosomes,and Cancer

AAn enzyme-linked immunosor-bent assay (ELISA) is now avail-

able to test blood samples for the pres-ence of antibodies to the denguevirus.

The ELISA test is designed for thequalitative detection of Immunoglob-ulin M (IgM) antibodies to denguerecombinant antigens (DENRA) inserum for the presumptive clinicallaboratory diagnosis of dengue virusinfection in patients with clinicalsymptoms consistent with denguefever or dengue hemorrhagic fever.

The complete kit includes one 96well strippable plate with all neces-sary reagents and controls. The ELISAis easy to use and accurate and per-formance was thoroughly evaluatedin prospective studies and with clini-cally confirmed cases of dengue 1-4serotypes. It was developed with anew generation of US Centers ofDisease Control and Prevention(CDC; Atlanta, GA, USA; www.cdc.gov), licensed recombinantsexpressed in mammalian cells. Theaccuracy was improved by monitor-ing background reactivity withNormal Cell Antigen and employs asimple, one-step ratio method of inter-pretation.

Diagnostic testing for dengue iscomplicated by the fact that an IgMantibody response to the dengue virusinfection is not detectable until 3-5days after the onset of fever, whichcan produce a negative test resulteven though a person has dengue.During this IgM negative window,the dengue virus is present in thebloodstream. The DENV Detect IgMCapture ELISA test is based on tech-nology patented by the CDC andmanufactured by Inbios Inc, (Seattle,WA, USA; www.inbios.com). Thisnew test shows cross-reaction withother closely related viruses such asthose that cause West Nile disease.However, in most patient testing situ-ations found in the US, a positive testresult in a patient with signs or symp-toms consistent with dengue shouldbe considered presumptive evidenceof dengue.

This is the first in vitro assay fordengue, where the US Food and DrugAdministration, (FDA; Silver Springs,MD, USA; www.fda.gov), revieweddata for the test via the “de novo”pathway, an alternative path to mar-ket for devices that are low to moder-ate risk and may not require premar-ket approval. Alberto Gutierrez, PhD,

director of the Office of In VitroDiagnostics Device Evaluation andSafety in FDA’s Center for Devicesand Radiological Health, said, “Casesof dengue fever or dengue hemor-rhagic fever can be potentially fatalfor people who do not recognize thesymptoms. This test will now aidhealthcare professionals in their effortto more effectively diagnose dengue.”

Image: The DENV Detect IgM CaptureELISA test (Photo courtesy of Inbios).

Immunoassay Approved for Detecting Dengue Fever Virus



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MMalaria rapid diagnostictests (RDTs) can be used

as a resource for extractingmalaria DNA for use withmolecular confirmative technol-ogy. RDTs are frequently usedas an adjunct to microscopy inthe diagnosis of malaria and insettings where high qualitymicroscopy is not available; thedetection of Plasmodium infec-tions is often based on RDTs alone.

At present, there is no widelyaccepted way of assessing the qualityof RDTs at the end-user level andboth microscopy and real time poly-merase chain reactions (RT-PCR)could be used as reference methods.Scientists at the Institute of TropicalMedicine (Antwerp, Belgium;www.itg.be) investigated the bestmethod of extracting DNA fromRDTs that would be used in a RT-PCRmethod. DNA extraction methodwas assessed on 12 different RDTbrands and two RDT brands werecomprehensively evaluated on apanel of clinical samples submittedfor routine malaria diagnosis.

The DNA amplification was donewith the 18S ribosomal ribonucleicacid (rRNA) real-time PCR targetingthe four malaria species. The results ofthe PCR from RDT samples were com-pared to those obtained by PCR onwhole blood samples. The PCR onRDT DNA showed a detection limit of0.02 asexual parasites/µL, which wasidentical to the same PCR on wholeblood. PCR analysis on clinical RDTsamples demonstrated correct identifi-cation for single species infections forall RDT samples with asexual parasites

of 60 Plasmodium falciparum samplesand 10 samples each of P. vivax, P.ovale, and P. malariae. Samples withonly gametocytes were detected in allOptiMAL Rapid Malaria Test (DiamedAG, Cressier, Switzerland; www.diamed.com), and in 10 of the 11SDFK60 malaria Antigen Plasmodiumfalciparum/Pan tests (Standard Diag-nostics Inc, Suwon, Korea; www.standardia.com).

The authors concluded that in ref-erence settings, PCR on RDT couldbe applied for confirmation of malar-ia infection when the whole bloodsample is not available. Real-timePCR is of added value as it can distin-guish between non-falciparumspecies and differentiate between sin-gle and mixed infections. Anotherapplication is post-travel quality con-trol by PCR on for travelers returninghome that used a RDT marketed forself-use during their travel. The studywas published on March 24, 2011 inthe Malaria Journal.

Image: Colored scanning electronmicrograph (SEM) of a freeze-fracturedred blood cell (erythrocyte, brown)infected with a Plasmodium falciparumprotozoan (red) (Photo courtesy of theNIBSC).

Rapid Diagnostic Tests Used as Source for Malaria DNA


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GGenetic material extracted fromwhite blood cells can be used as

biomarkers for the early detection ofcolon cancer.

The white blood cells, the mono-cytes, contain genetic material thatwhen analyzed by a novel method, willenhance the monitoring of the develop-ment of the colon cancer in patients.

White blood cells play a significantrole in the growth of tumors, the metas-tasis of cancer cells and the formation ofblood vessels in and around tumors. Inaddition, they serve a crucial function incombating malignant cells. They formthe core of the defense mechanism,which the body musters against cancercells. The scientists will link changes inthe genetic material of monocytes to thepresence and progression of colon can-cer. The advantage of this approach isthat monocytes are easy to extract fromthe patient’s blood sample.

Massimiliano Mazzone, PhD, whoheads a laboratory at the KatholiekeUniversiteit Leuven (Leuven, Belgium;www.kuleuven.be), has just beenawarded a substantial grant over a threeyear period to refine the technique. Hehas specialized in blood vessel formationin tumors. His most important discoveryis the “phalanx cells,” highly stream-lined cells on the inside of blood vesselsthat are needed for improved supply ofoxygen. These more quiescent endothe-lial cell types in nongrowing vessels sur-vive for many years and maintain lumenpatency. These cells form a tightlyaligned, orderly shaped, smooth layerwith a typical cobblestone appearance,comparable to the “phalanx” formationof Greek Spartan soldiers.

The grant was awarded by The

Fournier-Majoie Foundation for Inno-vation (FFMI; Brussels, Belgium; www.ffmi.eu). In close collaboration withoncology specialists at the UniversityHospital of Leuven (Leuven, Belgium;www.uzleuven.be), the grant recipientshope to go from the bench to the bed-side in a very short time.

Image: Immunofluorescent light micro-graph of human colon cancer cells (Photocourtesy of Nancy Kedersha / SciencePhoto Library).

Leukocyte Biomarker Applied to Early Detection of Colon Cancer



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AA capillary electrophoresis systemhas been used to identify and

characterize different proteins. The system uses capillary isoelec-

tric focusing (cIEF) with laser-induced fluorescence detection. Theapparatus has been set up as a mul-tiplexed array and has proved to bewell suited to high-throughputanalysis. The multiplexed capillaryelectrophoresis system employs anarray of 32 capillaries with a micro-machined sheath-flow cuvette as thedetection chamber. The samplestreams were simultaneously excitedwith a 473-nm laser beam, and thefluorescence emission was imagedon a charge-coupled device (CCD)camera with a pair of doublet achro-mat lens.

The performance of the technolo-gy was excellent as it provided thehighest throughput isoelectric focus-ing analysis ever reported. Therewas a very high sensitivity for ahigh-throughput instrument, andexcellent resolution separation forcapillary isoelectric focusing. Thecapillary array electrophoresis sys-tem produced over six orders ofmagnitude superior detection limitscompared to other systems. Thetechnology will find wide applica-tion, including characterization ofrecombinant and therapeutic pro-teins, the diagnosis of disease, andthe study of systems biology.

Oluwatosin O. Dada, PhD, leadauthor of the study and a researchassistant professor at the University

of Notre Dame, (South Bend, IN,USA; www.nd.edu) was awarded aprize for the best paper published in2010 in Analytical and BioanalyticalChemistry, (ABC). The editor of thejournal, Prof. Aldo Roda, PhD, said,“There is a highly competitive effortunderway in the scientific communi-ty to improve the analytical perform-ance of isoelectric focusing (IEF) as a

tool for protein separation and con-centration. Several groups haveinvestigated the miniaturization ofcIEF and the integration of cIEF to amicrochip format. This new analyti-cal approach may resolve the ongo-ing problem of time-consuming pro-cedures.” The paper was originallypublished on line in ABC on March25, 2010.

Systems Array Developed to Detect Minute Amounts of Proteins

TThe blood clotting properties ofrefrigerated whole blood may

have a shelf life well beyond the cur-rent standard of 24 to 48 hours.

The majority of patients receivingblood transfusions only require spe-cific components of whole blood,such as red blood cells, plasma andplatelets and the coagulation proper-ties are thought to decline rapidly.

A study carried out at TheChildren’s Hospital of Philadelphia,(Philadelphia, PA, USA; www.chop.edu), examined the freshnessof whole blood with respect to itsclotting properties in 21 units ofblood from healthy volunteerdonors. The units of blood werestored under standard conditions as mandated by the AmericanAssociation of Blood Banks, (AABB;Bethesda, MD, USA; www.aabb.org). Samples were obtained on theday after donation and again on days2, 4, 7, 11, 14, 17, 21, 24, and 31.Tests included complete bloodcount, pH, partial pressures of oxy-gen and carbon dioxide (pO2,pCO2), glucose, lactate, thromboe-lastography (TEG), and platelet func-

tion by light transmission aggregom-etry (LTA).

The current practice at TheChildren’s Hospital of Philadelphiaassumes a fresh whole blood shelflife of 48 hours when refrigerated.After that point, the erythrocytesmay be recovered from the wholeblood, but the other components,such as plasma and platelets must bediscarded. However, the scientistsfound that TEG and platelet aggrega-tion levels, which measure the effi-ciency of blood coagulation, remainnormal at least 11 days under stan-dard refrigerated conditions.

David Jobes, MD, a cardiotho-racic anesthesiologist at the hospital,said, “Trauma patients could poten-tially benefit, as well as others need-ing a large volume of blood replace-ment, such as patients undergoingliver transplant or children who needcraniofacial reconstruction. Theresults of the study strongly suggestthat clinical trials should proceed totest the value of whole blood beyonda 48-hour period.” The study waspublished in January 2011, in thejournal Transfusion.

Coagulation Properties of Fresh Blood Lasts Longer Than Assumed


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PROTEIN ASSAY SYSTEM

QuantimetrixThe QuanTtest Redsystem is designed forthe qualitative determi-nation of protein incerebrospinal fluid andurine for manual andautomated systems.

AUTOMATEDASSAY

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BLOOD GASANALYZERS

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The RAPIDPoint 340/350 analyzers aredesigned as an easy-to-use solution for reli-able blood gas resultsin low- to medium-vol-ume testing sites.

Edited by Edgard Delvin, Ph.D., FCACBIFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5Tel: (1) 514-345-4831 (ext. 5635); E-mail: [email protected] NEWS

T he 21st International Congress of Clinical Chemistry and Laboratory Medicine(CCLM) and 19th IFCC-EFCC congress of CCLM in Berlin have just ended. The con-

gress marked a great success with over 4500 delegates and speakers from more than100 countries, with over 12 plenary lectures in 4 sessions, 22 symposia, interactive ses-sions, 14 workshops, and more than 40 industry sponsored workshops. Total attendancewas over 8500 people. This four-day academic program provided the participants oppor-tunities to communicate, to exchange ideas, and to make friends. We remember howmany conference rooms were still packed during the last minute of the congress. Theorganizers built on the previous experience and implemented innovations – positivelyreceived for the most part – as were the poster walk, the Year in Review sessions – andthough overcrowded at times--the high number of young scientists and the involvementof the leading journals.

This IFCC/EFCC congress acted as a perma-nent platform for framing future considerations ofglobal laboratory medicine developments andhealth challenges promoting the translation ofresearch progress from the laboratory to thebeside and to populations. It is the IFCC/EFCCvision to harness academic excellence to improvehealth. In addition to science, it was possible toenjoy Berlin as a modern metropolis strategicallyplaced at the crossroads where East meets Westin the heart of Europe. Berlin has undergone morechanges than other European capital and is stillchanging today. Berlin has offered to theIFCC/EFCC delegates a rich, diverse, and livelycultural environment with outstanding architecturewith the Reichstag by Sir Norman Foster, the all-new Potsdamer platz featuring buildings byfamous architects such as Renzo Piano, ArataIsozaki, and others.

Thank you to Harald, Rudy, Karl, the Germanorganizers, and the Emmezeta team that alsogave us the exclusive opportunity to visit theMuseum island, a UNESCO World heritage site, tomeet the queen Nefertiti at the new museum andto enjoy the buffet at the colonnades. The Berlinmeeting was one of the world’s foremost gather-ings of leaders from academia, public and privatesectors, in vitro diagnostic industry, stakeholders,civil society to jointly develop strategies and act toaddress key challenges in lab medicine practicesand research with the aim to develop answers tolab medicine challenges.

The 21st IFCC/EFCC Euromedlab will takeplace in Paris in 2015. The theme is “R”evolutionin Laboratory Medicine, linking scientific andother evidence to shape tomorrow’s developmentin the field of Laboratory medicine and globalhealth. It is a big challenge to organize such asustainable high level and dynamic forum afterBerlin 2011 and Milan 2013; on behalf the Frenchsociety, we sincerely hope you could participateand contribute your invaluable experience andknowledge to organize this important IFCC/EFCCcongress. By close collaboration between lead-ing representatives in lab medicine from,research; health related industry and technologysector, international institutions, governmentaland non-governmental institutions in analyzingtoday’s science and by extensively sharing expe-rience and debate, we will be able to structuretomorrow’s laboratory medicine.

In Berlin, in the Spirit of Friendship and Global Identity

Paris Chosen for EuroMedLab 2015

by Dr. Bernard GougetIFCC Executive Board Member and Treasurer-Elect 2012-2014

Secretary General, International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML)



VISIT US AT

Booth: 2109

2011ANNUAL

MEETING

Dr. Graham Beastall,President, IFCC

Nowadays important organization like WorldHealth Organization - WHO and International

Federation of Clinical Chemistry and LaboratoryMedicine - IFFC are intensively working to decreaselaboratory error thus guaranteeing patient safety.

Many laboratory professionals think that to elimi-nate laboratory error is enough to make internalquality controls and proficiency tests. The problem isthat most frequently errors in laboratory occur inextra-analytical phases (i.e., pre- and post-analyti-cal). Moreover, there are only few routine proce-dures for the detection of nonconformities in thisfield of activity. In the preanalytical phase, the proce-dures involving phlebotomy, critical to obtaining ofdiagnostic blood specimens, are poorly studied asregards the major sources of errors and the proce-

dures related to the quality control process.Personally, I did study during my master's degreethe impact of tourniquet application time during diag-nostic blood specimen collection and was able tofind a new way to eliminate this problem by transillu-mination.

From a practical point of view, the tourniquet-induced venous stasis promotes the exit of water,diffusible ions, and low molecular weight substancesfrom the vessel thereby increasing the concentrationof various blood analytes at the punctured site thuspotentially influencing the interpretation of laborato-ry results. More so, when the vascular microenviron-ment is subjected to both hypoxia and concurrentstasis, accumulation of some bioproducts ensuessuch as the protons that have the potential to pro-

mote changes in laboratory parameters. Thus, the use of tourniquet has the potential to

generate false positive results and prospectivelyinduce the caring physicians to adopt undue treat-ments. On the other hand, transillumination is ableto eliminate or greatly reduce these risks on hema-tological, biochemistry and coagulation laboratorytests. The use of transillumination device is basedon cold near-infrared light-emitting diodes (LEDs)whose light is absorbed by intraerythrocyte hemo-globin flowing along the veins. In the course of myPhD program, I am presently dealing with the prean-alytical issues both at Verona University (Italy) andat Federal University of Parana (Brazil). The workinggroup, which consists of Prof. Gian Cesare Guidiand Prof. Giuseppe Lippi, Prof. Martina Montagnanaand Dr. Gian Luca Salvagno, is helping me to iden-tify the new source of errors to guarantee the patientsafety.

I am very lucky because I am a young scientistand this very important working group has openeddoors to me. With this working group, I learn,work, and help improve patient safety. If Labs arevital then young scientist are essential to studysources of laboratory errors both to guaranteepatient safety and to improve the future of labora-tory medicine.

The Future of Laboratory Medicine:

Researchers Look for New Possible Sources of Error in Order

to Guarantee Patient Safetyby Gabriel Lima-Oliveira Brazilian Society of Clinical Analyses

in Sao Paulo State, Brazil & MERCOSUL: Sector Committee of Clinical Analyses and in Vitro Diagnostics

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine

Visit www.ifcc.org for more informationNEWS

58LabMedica InternationalJune-July/2011159LMI-07-11LINKXPRESS COM

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2011ANNUAL

MEETING

Elections in BerlinNew IFCC and EFCC Executive Boards Elected

At the General Assembly held onSunday May 15, the new EFCCExecutive board was elected for theterm July 1, 2011- 2013. It is as follows:

President: Dr. Ian WATSON(United Kingdom); Past President:Prof. Andrea Rita Horvath (Hungary);President-Elect: Prof. Mauro Pan-teghini (Italy); Secretary: Dr. Ana-Maria Simundic (Croatia); Treasurer:Prof. Dr. Peter Schuff-Werner (Ger-many); Members-At-Large: Dr. HuibStorm (The Netherlands), Prof. TomasZima (Czech Republic).

At the Council Meeting held recentlyin Berlin the IFCC Executive Boardwas elected to serve for the periodJanuary 1, 2012, to December 31,2014. It is as follows:

President: Graham Beastall (UK);Past President: Jocelyn Hicks (US);Vice President: Howard Morris (AU);Secretary: Sergio Bernardini (IT);Treasurer: Bernard Gouget (FR);Member: Vanessa Steenkamp (ZA);Member: Larry Kricka (US); Member:Ulisses Tuma (BR); Corporate Mem-ber: Thomas Brinkmann (Unilabs).

News from the Corporate Members:New Layout for Lab Tests Online Entry Point

Brussels, 5 May 2011 – EDMA is proud to announce that www.labtestsonline.infois now online with a new layout. Aiming at providing a better entry point for

patients looking for accurate information on laboratory testing, the new pageemphasizes the international scale of the project (14 countries worldwide, 10 ofwhich in continental Europe coordinated by EDMA).

Lab Tests Online offers a clear and easy way to understand information to cit-izens and physicians about the diverse and advantageous contributions of labo-ratory medicine to health protection and care. Thus, users can inform themselvesabout the tests they have been prescribed, the conditions usually related to theassays, and how the success of the treatment is evaluated. To get a better under-standing of the project please visit: www.LabTestsOnline.info where you canaccess all national sites. For more information, please visit the EDMA website orcontact: Daniele Dosi, EDMA Communications Officer (Tel. +32 2 777 02 78).

Clinical Chemistry Trainee Council: A New Initiative

During the IFCC WorldLab-EuroMedLab meeting in Berlin, the journal ClinicalChemistry launched a new initiative entitled Clinical Chemistry Trainee Council.

This initiative is an extension of the educational program of the journal that is meantto reach trainees in clinical chemistry and laboratory medicine throughout the world.The journal currently publishes a variety of educational materials including ClinicalCase Studies, Q&A (a virtual roundtable discussion among a group of experts abouta hot topic), and the Guide to Scientific Writing (a series of 14 articles). In addition,the journal periodically publishes interviews with world scientific leaders and articlesabout prominent clinical chemists (Inspiring Minds) that can be of great interest andserve as an inspiration to young scientists. Through the Council, the journal will makethese materials available to trainees free of charge. The materials can be accessedvia a special website that has been specifically designed for this purpose. The web-site will also enable the journal to provide the trainees with Webcasts (lectures byleading international scientists), Pearls of Laboratory Medicine (10-15 minute presen-tations about a laboratory test), and Council Chat (a chat room directed by 6 juniorfaculty members from around the world). In addition, the trainees will have access toour more than 70 popular podcasts, which have been downloaded over 230,000times in the last 2 years. To access the website go to www.traineecouncil.org

The recently launched English version of this program targeted over 7,000MD/PhD trainees and future leaders in clinical chemistry and laboratory medicine in25 countries. In November of 2011, this initiative will be launched in Spanish duringCOLABIOCLI in the Dominican Republic, and in 2012 in Russian, Arabic, andChinese. In the near future, we hope to produce a Portuguese version of the program.

by Nader Rifai, Editor in Chief, Clinical Chemistry

News from the World of the International Federation of Clinical Chemistry and Laboratory MedicineVisit www.ifcc.org for more information NEWS

The first International Meeting on Quality inClinical Laboratories was held in Mexico

City in November 2010. This meeting, organ-ized by the National University of Mexico(UNAM) and the Program for the Quality ofClinical Laboratories (PACAL), gathered labprofessionals to present and discuss experi-ences in establishing and maintainingquality in clinical laboratories. I waspleased to represent the CSCC at the invi-tation of Dr. Andres Romero Rojos, Headof the University Diagnostic Center.

The conference was held in the lovelyCentro Cultural Universitario Tlatelolco. Tomy delight, this building was built immedi-ately adjacent to an expanse of Aztecruins, which could be viewed from anoverlooking balcony. This was the site ofthe last stand of the Aztecs in the waragainst their Spanish conquistadors in the1500s. While this was fascinating for a firsttimer like me, it seemed to attract littleattention from others attending the confer-ence, presumably since it was simply partof everyday life in Mexico City.

The meeting started with an assemblyof some 800 participants. The speakerswere paraded in to welcoming applause.There were eight of us from countries out-side of Mexico, representing Canada,Chile, Cuba, El Salvador, Spain, USA, andVenezuela. As the proceedings were inSpanish, I was always unsure what toexpect next. After a few speeches, awardpresentations to honored individuals andspeaker introductions, a video was pre-sented featuring Pacalito, a Mayan God asprotagonist (this video can be viewed onYouTube pacalito 2.mp4). While the signif-icance of this animated God escapes me,it was clear from audience reaction that herepresents an important symbol to the lab-oratory community in Latin America.

After opening ceremonies, participantsscattered throughout the center andspeakers were ushered to different pres-entation rooms. Vincent Gallicchio fromSouth Carolina and me were the onlyones who gave presentations in English(with simultaneous translation intoSpanish). We each gave two presenta-tions, the titles of which are shown belowto give you a sense of overall content. • Promotion of Laboratory Best Pract-ices World-Wide: Focus on Publica-tions and Educational Programs; andImproving Quality in Laboratory Medi-cine by Vincent Gallichio.• Our Experience with Using an ExternalQuality Assessment Program for Mo-nitoring and Improving Quality; andExploring Use of Standardized ControlCharts and Procedures in a CanadianLab by David Parry.

Our presentations spanned the entireday and after each talk and questions, ahalf hour session was devoted to hand-

ing out awards to individuals who had suc-cessfully completed some earlier training.Hence, following my talks, my role changed

A Quality Meeting in Mexico City: CSCC Links with Latin America

by Dr. David M Parry, Department of Clinical Biochemistry, St-Boniface hospital, Manitoba, Canada



Photo: Dr. David Parry and his Mexican hostsArmando Esparza, Alfredo Aranda andAndres Rojos posing with Pacalito

con’t on page 60

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine

Visit www.ifcc.org for more informationNEWS



The standard ISO 151891, conceivedto be applicable world-wide, states

more or less explicitly that the clinicallaboratory is a laboratory where exami-nations related to biology, microbiology,immunology, chemistry, immunohema-tology, hematology, biophysics, cytol-ogy, pathology, or other, are done inmaterials derived from the human bodyfor purposes related to healthcare.

One issue is scientific approach toa fact, and the other is the political orcorporate approach to the same fact.From an epistemological point of view,there are two main sets of knowledgeobtained by applying the scientificmethod: science and technology(technique, according some authors).Science and technology may be con-sidered as the trunk of a tree thatgrows by means of the scientificmethod; and all the scientific and tech-nological disciplines (academic view)or specialties (professional view) arebranches, more or less distant of thetrunk, of this unique tree. Defining therelations between branches devel-oped by different ways is not a trivialissue. Thus, in many countries there isa controversy about the classificationof the above disciplines or specialties.

Recently, the Spanish Governmenthas answered and clarified the oldquestion: is, for example, clinical (bio)chemistry a medical specialty, or it is an

independent specialty of health sci-ences, as pharmacy, dentistry, or nurs-ing are (in Spain as well as in othercountries in the world)? Obviously, thesame question applies for the rest ofspecialties forming the clinical laborato-ry sciences. This response has beenmade by means a Royal Decree (anOrder in Council)2. The aim of thisOrder, among other issues, is to estab-lish and classify the specialties in thebroad field of health sciences.

The Order divides the specialties ofhealth sciences in five groups: Medicalspecialties, Multidisciplinary special-ties, Nursing specialties, Pharmacyspecialties, Psychology specialties.

Regarding those specialties thatmay be considered related with theclinical laboratory, the Order classifiesthe following specialties of health sci-ences as multidisciplinary specialties[The “neutral” English nomenclatureused in the European Parliament3 isfollowed by the literary word-by-wordtranslation of the Spanish terms]:• Clinical Biology (Clinical Analyses)• Biological Chemistry (Clinical Bio-

chemistry)• Immunology (Immunology)• Microbiology-Bacteriology (Micro-

biology and Parasitology)Pathological Anatomy (Anatomic

Pathology) and Hematology-Hemo-therapy (in part Biological Hematol-

ogy), the other two specialties ofhealth sciences directly related withthe clinical laboratory, are classified asmedical specialties.

As the above classification ismore or less the same in many coun-tries around the world, when talkingor writing internationally (not for aspecific country), it would be respect-ful to the clinical laboratory profes-sional community to avoid the nounsor adjectives biology/biological, che-mistry/chemical, medicine/medical,and pharmacy/pharmaceutical in theclassification of the different special-ties of the clinical laboratory sci-ences.

References1. International Organization for Standardiza-

tion. Medical laboratories - particularrequirements for quality and competence.ISO 15189:2007. Geneva: ISO; 2007.

2. Gobierno de España. Real Decreto183/2008, de 8 de febrero, por el que sedeterminan y clasifican las especiali-dades en Ciencias de la Salud y sedesarrollan determinados aspectos delsistema de formación sanitaria especial-izada. Boletín Oficial del Estado 2008-02-21;(45):10020-35.

3. European Parliament, Council of Euro-pean Union. Council Directive 93/16/EECof 5 April 1993 to facilitate the free move-ment of doctors and the mutual recognitionof their diplomas, certificates and other evi-dence of formal qualifications. EurLex -Access to the Uropean Union law.

Spanish Royal Decree:Classification of Health

Sciences Specialties

by Xavier Fuentes-Arderiu, ACCLC past-president,

IFCC News Working Group

to handing out Quality Tree Statues torecipients. There were many dozens ofthese awards handed out over thecourse of the day and these interludeswere a pleasant break between talks.

While our talks were translated intoSpanish, our presentation slides were,of course, in English. Based on ques-tions from the audience however, it wasapparent that our messages reachedreceptive ears. After one of my talks, I

was besieged by a group seeking moreinformation about Canadian laboratorypractices. Most of their queries though,were not in English and communicationrequired the help of a translator.

My hosts, Alfredo and Armandomade sure I was well fed, and alreadystarted talking about organizing theirnext conference in a couple of years.They were definitely pleased with theoutcome of this conference and Iassured them the CSCC would bepleased to participate in future eventslike this one. I can honestly say this con-ference was very well organized andattended and judging from the hustleand bustle of participants, it was anexciting event. I was hoping to learnmore about what was happening in lab-oratories in Mexico by attending otherpresentations, but the opportunity for thiswas minimal. My time there was limitedand my hosts were intent on assuringmy visit was full. During a tour of MexicoCity on a double-decker bus, open to the

cool evening air, I learned about thecomplex history of Mexican independ-ence and revolution. Traffic was mind-boggling: it never seemed to let up.

We had a very enjoyable eveningdinner and shared stories about our dif-ferent worlds of work and play. Perhapsthe tequilas and enticing Mexican foodplatters we also shared helped liven itup a little. I found this to be the highlightof my trip, since it gave me a glimpseinto what life in Mexico was really like.

On the next day, I was taken towhere there was a fascinating streetdisplay of huge papier-mâché sculp-tures, hundreds of them lining bothsides of the boulevard. These werecreated by artists in celebration of 200years of independence and 100 yearssince revolution. After a heartfelt good-bye at the airport, I left Mexico, contentwith my contribution to the conference,happy to have shared a fun time withmy new Mexican friends, and pleasedto have had a chance to visit thisdelightful city. I feel confident that Ihelped reinforce links between theCSCC and the laboratory community inLatin America. My thanks to the CSCCand PACAL for this opportunity.

con’t from page 59

A Quality Meeting in Mexico City: CSCC Links with Latin America

Photo: Dr. David Parry helping handing out awards.

IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALYTel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846E-mail: [email protected] • Web: www.ifcc.orgOffice Hours: 9.00-13.00 and 14.00-18.00Staff Members: Paola Bramati, Silvia Cattaneo,Silvia Colli-Lanzi

Romania first acknowledged theneed to implement a quality man-

agement system according to interna-tional standards of medical laborato-ries in the late 1990s. Between 1998and 2001, the Romanian AccreditationBody organized the first coursesregarding the subject. The legislationregulating the standard of quality dur-ing that time was ISO/EN 17025.However, it was not adapted to themedical laboratory field. Moreover, thelecturers were engineers or chemistswho did not use the proper medicallanguage. The medical staff ques-tioned the applicability of the rules withregard to the needs of a medical labo-ratory. Nevertheless, the RomanianAccreditation Body began the processof accreditation and an increasingnumber of laboratory professionalsbecame interested in the field andreceived medical auditor licenses.

ISO/EN 15189, introduced in 2005,resolved the shortfalls of the previouslegislation. It implemented standardsadapted to the medical language andneeds. More and more laboratorieswanted to provide evidence of thequality of their work and began imple-menting the new standards.

In 2007, the Romanian Ministry ofHealth issued Order 1301/2007, pro-viding, “Starting 1 January 2008, it is

compulsory for all medical laboratoriesin relation with the National HealthInsurance House to implement a qual-ity management system according toISO/EN 15189.” Medical laboratorieswere required to have at least 10 testsaccredited.

It proved to be an efficient way ofselecting laboratories that were com-peting for funds, as well as have labo-ratories resolve to fulfill the standardsand improve their quality managementsystem. The legislation was amendedagain in April 2009 when the NationalHealth Insurance House announced,“Starting 1 January 2010, it is compul-sory for all medical laboratories in rela-tion with the National Health InsuranceHouse to be accredited according toISO/EN 15189 for 50% of the tests.”

Were Romanian MedicalLaboratories Prepared forAccreditation?Romania did not have national guide-lines regarding Good LaboratoryPractices. Hospital laboratories usedoutdated equipment, there was nomodern IT system in place, but themost pressing issue was the lack offunds to fulfill standard demands. Onthe other hand, laboratories operatingin the private sector had access to newequipment and were able to engage

human resources and funds to fulfill EUstandards. This led to an increase incompetition between public and privatelaboratories for available funding, withprivate laboratories taking the lead indevelopment. Because public hospitalsdid not have sufficient resources to

develop their capacities, a significantnumber of hospital labs were out-sourced and private laboratoriesbecame dominant on the market.

Beginning with 2008, accreditationbecame a key objective for medicallaboratories. In 2008, only around 20laboratories received accreditationaccording to ISO/EN 17025 stan-dards. During 2009 and 2010, anincreasing number made efforts to ful-fill the requirements, and in March

As part of the 2011 EuropeanCervical Cancer Week, EDMA,

the European Diagnostic Manu-facturers Association, and the ECCA,the European Cervical CancerAssociation jointly organized the“Better Health Literacy for BetterHealth in Europe” dinner debate inpresence of Vic Blaton, EFCC pastpresident, and some EFCC repre-sentatives.

ECCA and EDMA made a timelycontribution to the debate on HealthLiteracy at a lively dinner debate heldin the Members Salon of theEuropean Parliament on the eveningof 25 January. Hosted by Irish MEPMarian Harkin, the event gatherednumerous stakeholders from patientorganizations, medical associations,the corporate world and the NGOcommunity to debate how health liter-acy can be improved in the EU.

Mrs. Harkin opened the debate byhighlighting the fact that poor healthliteracy in Europe is a significant bar-rier to both EU and national goals forimproving the health of Europeans.

She also noted that poor health liter-acy has serious economic conse-quences for Europe, because it isassociated with increased medicalinterventions that run up unneces-sary costs for the European health-care systems.

Dr. Philip Davies of the EuropeanCervical Cancer Association focusedon the fact that health literacy isassociated with increased participa-tion in disease prevention programssuch as cervical cancer screening.Unfortunately, low health literacyaccompanies social deprivation so itis therefore mainly lower socioeco-nomic groups across Europe that failto take advantage of these prog-rams, and consequently bear aninequitable burden of disease.

Dr. Isabel de la Mata, principalpublic health advisor at DG SANCOof the European Commission, pre-sented an overview of the efforts andthe future steps the EU executive willmake to foster health literacy andtherefore have healthier citizens.

Dr. Jürgen Schulze, president of

EDMA, noted that the IVD industry isvery concerned about health literacyin Europe and very interested tomake a positive contribution to thedebate. Moreover, he pledged a clos-er collaboration between all theinvolved stakeholders to bypasscommon prejudices and ultimately toachieve the objectives of having sus-tainable public finances and better

empowered patients. To this end, EDMA has delivered

on a long-standing commitment bylaunching Lab Tests Online (www.labtestsonline.info): a global, multilin-gual, peer-reviewed, patient-centeredinformation portal on laboratory test-ing organized by the AmericanAssociation for Clinical Chemistry andcoordinated by EDMA in Europe.

ECCA and EDMA Advance the EU Health Literacy Debate

Mandatory Accreditation for Medical Laboratories in Romania

by Camelia Grigore, RSLM-EFCC representative


European Federation of Clinical Chemistry and Laboratory Medicine

EFCC CORNER

Photo: Mariam Harkin, MEP; Dr. Silvia De San José Longueras, Dr. Isabel dela Mata, DG Sanco.


VISIT US ATBooth: 32432011

ANNUAL MEETING

con’t on page 62

2011, the number of accredited labora-tories reached 736. Private laborato-ries dominate the total number ofaccredited laboratories (92.5% or 679medical labs), with public laboratorieslagging far behind (7.4% or 55 labora-tories). There are currently only 19 bigprivate laboratories (with more than 3laboratories) and only 4 are part of aforeign network, the remaining 660 lab-oratories are small with only 1-2 labs. Itis obvious that funding was an impor-tant aspect in the accreditation processand public laboratories, receiving fewerfunds, were unable to close the gap,despite the availability of very compe-tent professionals working in the publichealthcare sector.

Accreditation Process IsComplex and Standards Difficult to AchieveLooking at the distribution of accredita-tion by field, 100% of labs receivedaccreditation on hematology tests, 95%on biochemistry, 70% on immunology,and only 45% on microbiology. Because,

the National Health Insurance Houserequires laboratories to receive accredi-tation on all reimbursed tests, the labstaff is faced with the difficult task of ful-filling standards given the constraints ofthe current working environment andavailable funding. The advantages ofaccreditation for Romanian laboratoriesinclude harmonization of laboratorywork, suitable laboratory circuits, up-to-date equipment with maintenance con-tracts, protocols for each lab test, mod-ern IT systems, accurate lab reports, evi-dence of staff continuous medical edu-cation, increased client confidence.

Conclusion Making accreditation of medical labora-tories mandatory has been an impor-tant and beneficial step in the develop-ment of Romanian medical laborato-ries. The process has contributed tothe increase in transparency and effi-ciency of medical laboratories, all tothe benefit of the Romanian patient.Accreditation is not proof of whichmedical laboratory is best, but which isbest at obeying the rules.

Mandatory Accreditation for Medical Laboratories in Romania

con’t from page 61

On April 8-9, 2011, the FrenchSociety of Clinical Biology gath-

ered some 20 national EFCC repre-sentatives from European societies inParis for an interesting symposium,“Laboratory Management in Europe,”and, noblesse oblige, the French cre-ated the right atmosphere for a fruitfuland inspiring discussion about the cru-cial elements of our LaboratoryMedicine profession.

The lecture by Bernard Gougetabout the French reform of the medicallabs set the tune. A new French law

reorganizing the health care systemincludes the definition of medical biolo-gy as a medical specialty and theresponsibility of the medical biologist,or as we should say now the Specialistin Laboratory Medicine, for the entiremedical laboratory test procedure. Thislaboratory professional in France iseither a medical doctor or a pharmacistspecialized in medical biology. Since anumber of countries are still strugglingwith official government regulation andrecognition this French law may pro-vide a lever for the development of national regulation. The law also brings

into line the public and private medicallaboratories, which will also enforceaccreditation of laboratories. It will beinteresting to see whether the numberof laboratories in France will decreasein the near future as a result of this newlaw. Why is this development so impor-tant and interesting? I think because itwill stimulate the harmonizationprocess throughout Europe with regardto patient service, best practices, EC4register, and training.

The importance of these issueswas nicely illustrated by Gabriel Ko (ofFrance, representing the angry youngcolleagues), Gheorge Benga (Roma-nia), Jean-Philippe Brochet (France),Alexander Haliassos (Greece), To-masz Anyszek (Poland), Sanja Stan-kovic (Serbia), Yahya Laleli (Turkey),and Camelia Grigore (Romania).

Differences between countries arenicely illustrated by comparing thenumber of laboratories in relation tothe number of inhabitants: rangingfrom approx one lab per 4,000 inhabi-tants to one lab per 200,000 inhabi-tants. Also, the number of private lab-oratories and the number of special-ists in lab medicine vary wildly, asdoes the activity of the leading privatelaboratory chains in the different coun-tries. Clearly, a great challenge liesahead of us.

The symposium included a clearlecture by Mariam Klouche showingthe ever-increasing role of Lab TestsOnline in providing information to thepatient. With inspiring thoughts ofYahya Laleli and Joseph Watine oncollaboration in Europe for establish-ing better and evidence-based prac-tices, the symposium was closed.

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Photo: (From left to right) Dr Huib Storm, EFCC NVKC Representative, and Pr PhilippeGambert, SFBC President

Impressions of SFBC Symposium in Paris on Laboratory

Management in Europeby Dr. Huib Storm, National Representative The Netherlands

EFCC CORNER European Federation of Clinical Chemistry and Laboratory Medicine

EFCC CORNER

T he Cyprus Association of ClinicalLaboratory Directors, Biomedical

and Clinical Laboratory Scientists is ina position to say that the 5th Congressof Clinical Chemistry and LaboratoryMedicine held under the auspices ofthe Cyprus Minister of Health, the

Honorable Mr. Christos Patsalides,and the EFCC during March 18-20,2011, at the Amathus Beach HotelLimassol, ended with the best ofimpressions. The Scientific andOrganizing Committee worked hardfor the past 14 months so that ourspeakers and delegates would feelthat it was a Congress of high qualityand standards covering all LaboratoryDisciplines, Hematology, ClinicalChemistry, Molecular Genetics, Cyto-genetics, and Microbiology.

Our keynote Speaker HematologyProf. Ioannis Meletis gave a very inter-esting opening lecture "The peripheralblood film in the diagnostic approachof common and rare diseases.”Distinguished Scientists from Cyprus(Institute of Neurology and Genetics,The Bone Marrow Donor Foundation,Cyprus University) Greece and otherEuropean countries were invited tospeak at our Congress.

Dr. Thomas Zima addressed theCongress on behalf of the EFCCPresident Dr. Rita Horvath and gave avery interesting lecture for the NewTrends in Laboratory Diagnosis. The

EC4 Registration Commission ChairMrs. Simone Zerah and the EC4Registration Commission Secretarywere also there. They introduced tothe audience the role and the imple-mentation of the EC4 Register forSpecialists in Clinical Chemistry andLaboratory Medicine. The Minister ofHealth and the European MP Dr. EleniTheocharous, both addressed theCongress during the opening ceremo-ny. The many interesting lectures com-bined with an absolutely lovely weath-er, made the three day Congress agreat success. The President of the

Association and President of the 5thCongress Mr. Charis Charilaou wasvery moved during his farewell speechon Closing Ceremony because thecomments he received during theCongress overcame his expectations.Mr. Charilaou called to the podium hisassociates, the President of theScientific Committee Mr. Elias Ziras,the President of the OrganizingCommittee Ms. Spyroula Christou andall the members of both Committeesand gave his many thanks. PosterPresentation Awards were given dur-ing the closing ceremony.

Cyprus Congress of ClinicalChemistry and Laboratory Medicine

by Spyroula Christou, EurClinChem, president of the Organising Committee

Photo: General view of the lecture hall at the Amathus Beach Hotel Limassol.

Photo: Introduction of the EC4 Regis-tration Commission Chair Mrs. Zerahwith Dr. Eleni Theocharous, memberof the European Parliament, andmember of the European Health andEnvironment Committee.

As a result of ongoing strong collabo-ration between the European coop-

eration for Accreditation (EA)* and theEuropean Federation of ClinicalChemistry and Laboratory Medicine(EFCC), EFCC has been admitted toRecognized Stakeholder Status in theEA on 13 December 2010. RecognizedStakeholders of EA are organizationswith significant membership from the EUand EFTA Member States, which have adistinct international role and predomi-nantly a proactive contribution toEuropean social and economic matters,and bear a clear interest in and commit-ment towards accreditation activities.

In the Recognized StakeholderAgreement, signed by EA ChairmanGraham Talbot and EFCC PresidentAndrea Rita Horvath, both partiesagreed to cooperate with the intentionto further high standards in medicallaboratory practice by stimulatingaccreditation in Europe. Due to theAgreement representatives of EFCCwill be entitled to formally participate inthe work of technical committees,working groups, and task forces of EAand will be informed and consultedabout relevant policy and technicaldocuments to provide inputs and com-ments representing the views of the

medical laboratory profession.EA and EFCC may arrange joint

cultural/educational initiatives, suchas conferences, seminars, work-shops, training courses for the dis-semination of activities related toaccreditation. EFCC delegated WimHuisman, chairman of EFCC'sWorking Group on Accreditation andISO/CEN Standards, and SimoneZerah, chair of EFCC's ProfessionCommittee as official representativesin EA. Both EFCC officers have beenhaving long professional relationshipswith EA and their valuable contributionover the years has resulted in thisinternational recognition.

The "European cooperation forAccreditation" is the association ofnationally recognized AccreditationBodies of the Member States of theEuropean Union (EU) and of theEuropean Free Trade Association(EFTA) and of countries that have beenformally identified as candidates formembership of EU and EFTA. EA's mis-sion is to provide, through its members,effective and reliable accreditation serv-ices fulfilling at best the needs of theEuropean economy and society. Furtherinformation about EA can be found atwww.european-accreditation.org.

EFCC Granted “RecognizedStakeholder” Status in EA

by Wim Huisman and Andrea Rita Horváth


European Federation of Clinical Chemistry and Laboratory Medicine

cont’d from cover

The company develops, manufac-tures, and markets complete blood-test systems to support the clinicaldiagnosis and monitoring of allergy

and autoimmune diseases. Phadiaoperates through two leading brands:ImmunoCAP for allergy tests andEliA for autoimmunity tests.

Allergy testing is high-growth mar-

ket, with in vitro allergy testing grow-ing 9% a year globally. About one infive people in North America andEurope suffers from allergies. The invitro allergy testing market has signif-

icant untapped potential forgrowth, particularly in theUnited States, where there islow prevalence of allergy test-ing today.

Autoimmunity is also agrowing segment of healthcare,with more than 100 millionpeople worldwide sufferingfrom autoimmune disorders,including celiac disease,rheumatoid arthritis, and con-nective tissue diseases. “Theacquisition of Phadia is a majorstep forward in our strategy toenhance Thermo Fisher’s globalpresence in specialty diagnos-tics, one of our key growth plat-forms,” said Marc N. Casper,president and CEO of ThermoFisher Scientific (Waltham,MA, USA; www.thermofisher.com). “From a market perspec-tive, Phadia (Uppsala, Sweden;www.phadia.com) offers signif-icant growth opportunities inthe large, underpenetrated USmarket, and can leverage ourstrong presence in emerginggeographies to further acceler-ate growth.”

Thermo Fisher BuysSterilin, Expands inDisposablesIn a related development, Ther-mo Fisher announced the ac-quisition of Sterilin Ltd. (South

Wales, UK; www.sterilin.co.uk), aprovider of single-use plastic productsserving the microbiology, life sci-ences, and clinical markets. Financialdetails were not disclosed.

The acquisition will provideThermo Fisher with a broad portfolioof single-use laboratory productsused in sample collection, storage,and analysis, including Petri dishes,specimen containers, packaging bot-tles, silicone tubing and fittings, andserological pipettes. Thermo Fisherwill leverage its global sales and sup-port organization to make theseproducts more accessible to cus-tomers across Europe, Asia Pacific,and North America.

The two premier brands ofThermo Fisher Scientific, ThermoScientific and Fisher Scientific, offer acombination of continuous technolo-gy development and convenient pur-chasing options. The company's prod-ucts and services help accelerate thepace of scientific discovery, and solveanalytical challenges ranging fromcomplex research to routine testingto field applications.

Chuck Kummeth, president ofthe Thermo Fisher Scientific labora-tory consumables business, said,“We continue to invest in the mostup-to-date manufacturing sites andexpertise throughout the globe. Theacquisition of Sterilin’s recentlyexpanded facilities in the UK, outfit-ted with the latest advanced manu-facturing equipment, further under-lines our strong commitment to sup-plying the very best laboratory con-sumables to meet demand at a localand global level.”

Thermo Fisher to Acquire Phadia for $3.5 Billion



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INDUSTRY NEWSINDUSTRY NEWS

HDL Acquisition ExpandsFatty Acid Panel

HHealth Diagnostic Laboratory Inc. (HDL, Inc.;Richmond, VA, USA; www.myhdl.com), a

College of American Pathologists (CAP) accreditedlaboratory specializing in health management,announced that it will expand its comprehensivetest menu of risk factors and biomarkers for cardio-vascular and related diseases through the acquisi-tion of Harris Scientific, Inc., a company providingomega-3 fatty acid testing.

Dr. William Harris (of Harris Scientific) will joinHDL to expand his work in fatty acid analysis, andto enhance HDL's fatty acid panel of tests. Thispanel includes measurement of the level of omega-3, omega-6, cis-monounsaturated, saturated andtransfatty acids in erythrocyte membranes. Byreducing inflammation, blood clotting, and improv-ing membrane function, omega-3's can reduce riskof heart disease–including fatal heart attacks andheart failure–both in persons with a history of car-diovascular disease and in healthy individuals.

Lab21 Buys MolecularDiagnostics Concern

LL ab21 Ltd. (Cambridge, UK; USA;www.lab21.com) announced that it

has acquired Myconostica Ltd. (Greenville,SC, USA; www.myconostica.com), amolecular diagnostic company focusing onthe diagnosis of fungal infections of clinicalimportance. The financial terms of the dealwere not disclosed.

The Myconostica acquisition will pro-vide Lab21 with its first set of nucleic acid-based assays. It will also provide manufac-turing capabilities for Lab21 from which itwill be able to develop and produce a rangeof new biomarker assays. The transactionadds new diagnostic products to Lab21'sinfectious disease portfolio and representsits sixth acquisition over the past two years.

In addition to developing global sales ofMyconostica products, Lab21 will belaunching the Myconostica fungal testingservices from its new reference laboratoryin South Carolina (USA) as well as its labo-ratory in Cambridge, UK.

Speaking about the transaction, Prof.David Denning of the University Hospitalof South Manchester (United Kingdom)CMO of Myconostica said, "We havedeveloped fast and sensitive moleculardiagnostics for life threatening fungalinfections such as aspergillosis andPneumocystis pneumonia that will trans-form patient care for these infections.Fungal infections are frequently under-diagnosed using current diagnostic meth-ods and are much more common thanrealized."

A UK-based medical diagnostic compa-ny, Myconostica Ltd. is a spinout from theUniversity of Manchester. Traditionalmethods of the detection of fungal infec-tions are relatively insensitive and slow.

Myconostica is developing and commer-cializing a portfolio of real-time moleculardiagnostic tests for life-threatening fungalinfections. Over 10 million people are atrisk of these infections each year in Europeand North America alone. Aspergillosisaffects leukemia, transplant, and corticos-teroid-treated patients, including asthmaand chronic obstructive pulmonary disease(COPD). Pneumocystis affects humanimmunodeficiency virus (HIV)-infected andAIDS patients as well as many others withsuboptimal immune symptoms.

Myconostica has three CE-marked prod-ucts on the market in Europe, Canada, andSouthern Africa, launched in 2010, capableof running on a wide range of testing plat-forms. These include a product for extract-ing fungal DNA from human samples andtests for the detection of Aspergillus andPneumocystis jirove. The global market forfast and reliable invasive fungal infectiondiagnosis is substantial, with more than 10million patients each year at risk of lifethreatening fungal infections.

PPerkinElmer's (Waltham, MA, USA; www.perkinelmer.com) software company has bought

the electronic laboratory notebook provider Labtronics(Guelph, Canada; www.labtronics.com). Labtronicsprovides procedure-based electronic laboratory note-book (ELN) solutions for laboratories performing rou-tine analysis in multiple industries. Financial details ofthe deal were not disclosed.

The Labtronics acquisition follows the purchase ofinformatics companies CambridgeSoft and ArtusLabs byPerkinElmer in March 2011 for US$220 million.CambridgeSoft and ArtusLabs anticipate combined rev-enues of about $65 million, according to PerkinElmer,which finished 2010 with about $1.7 billion in revenue.

The addition of Labtronics’ solutions extends

PerkinElmer’s ELN and data-integration software offer-ings into laboratories following strict routine proce-dures such as regulated and nonregulated quality assur-ance/quality control (QA/QC), late-stage product ormethod development laboratories, and environmentaland food testing labs. Labtronics' tools can be applied toany procedure-based problem including laboratoryanalysis, equipment calibration, and validation, andcleaning validation, notes PerkinElmer.

Dusty Tenney, president, analytical sciences and lab-oratory services, PerkinElmer said, “This acquisitionsuccessfully positions PerkinElmer as the only technol-ogy provider able to deploy an optimized ELN solutionacross a global customer’s entire value chain, fromresearch to manufacturing.”

PerkinElmer Buys Provider of Lab Notebook Solutions


INDUSTRY NEWSINDUSTRY NEWS

AUGUST 2011FIME 2011. August 10-12; Miami Beach, FL,USA; Web: www.fimeshow.com

24th Annual Meeting of the Association ofMedical Laboratory Immunologists (AMLI).August 13-16; San Diego, CA, USA; Web:www.amli.org

45th Brazilian Congress of Clinical Pathology -Laboratory Medicine. Aug 16-19; Florianópolis,Brazil; Web: www.cbpcml.org.br/2011

40th Annual Scientific Meeting of the Societyfor Hematology and Stem Cells. August 25-28;Vancouver, BC, Canada; Web: www.iseh.org

SEPTEMBER 2011RNAi and miRNA Europe. September 8-9;Munich, Germany; Web: www.selectbiosciences.com

qPCR Europe. Sep 8-9; Munich, Germany;Web: www.selectbiosciences.com

Epigenetics Europe September 8-9; Munich,Germany; Web: www.selectbiosciences.com

CAP 2011 – The Pathologists’ Meeting.September 11-14; Grapevine, TX, USA; Web:www.cap.org

7th European Course on Clinical Cytometryand 11th Euroconference on Clinical CellAnalysis. September 13-17; Dublin, Ireland;Web: www.cytometry2011.eu

19th ECDO Euroconference on Apoptosis –

European Cell Death Organization. Sep 14-17; Stockholm, Sweden; Web: www.ecdo.eu

11th Analytica Latin America. September 20-22;Sao Paulo, Brazil; Web: www.analiticanet.com.br

14th Annual Meeting of the European Societyfor Clinical Virology. Sep 21-24; Funchal,Portugal; Web: www.escv.org

BCLF 2011 - 19th Annual Meeting of theBalkan Clinical Laboratory Federation.September 21-23; Bucharest, Romania; Web:www.bclf.info

36th European Congress of Cytology.September 22-25; Istanbul, Turkey; Web:www.cytologyistanbul2011.com

10th Czech National Congress of ClinicalBiochemistry. September 25-27; Pilsen, CzechRepublic; Web: www.sjezdcskb2011.cz

50th Annual ESPE Meeting – EuropeanSociety of Paediatric Endocrinology. Sept 25-28; Glasgow, UK; Web: www.espe2011.org

OCTOBER 201112th International Congress of TherapeuticDrug Monitoring & Clinical Toxicology.October 2-6; Stuttgart, Germany; Web: www.iatdmct2011.de

Biotechnica 2011. October 11-13; Hannover,Germany; Web: www.biotechnica.de

12th International Congress of HumanGenetics. October 11-15; Montreal, Quebec,Canada; Web: www.ichg2011.org

Analytica Anacon India. October 12-14;Mumbai, India; Web: www.analyticaindia.com

ASHG 2011 - Annual Meeting of theAmerican Society of Human Genetics.October 13-15; Montreal, QC, Canada; e-mail:[email protected]; Web: www.ashg.org

67th Annual Meeting of the American Societyfor Reproductive Medicine. October 15-19;Orlando, FL, USA; www.asrm.org

37th Annual Meeting of the American Societyfor Histocompatibility and Immunogenetics(ASHI). October 17-21; New Orleans, LA, USA;

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e-mail: [email protected]; Web: www.ashi-hla.org

26th WASPaLM – World Association ofPathology and Laboratory Medicine. October19-23; Las Vegas, NV, USA; Web: www.waspalm.org

NOVEMBER 2011Annual Assembly of the Swiss Society ofClinical Chemistry & Tri-National Congressof Laboratory Medicine. November 2-4;Zurich, Switzerland Web: www.congress-info.ch/sscc2011/p1.html

58th Annual Scientific Meeting of theAmerican Society of Cytopathology. Nov 4-8;Baltimore, MD, USA; Web: http://cytopatholo-gymeeting.org/2011

JIB 2011 - Journées Internationales deBiologie. November 7-10; Paris, France; Web:www.jib-sdbio.fr

Mass Spec Europe. Nov 8-9; Dublin, Ireland;Web: www.selectbiosciences.com

Advances in Metabolic Profiling. Nov 8-9;Dublin, Ireland; Web: www.selectbiosciences.com

Medica 2011. November 16-19; Düsseldorf,Germany; Web: www.medica.de

Association for Molecular Pathology (AMP).Nov 17-19; Grapevine, TX, USA; Web:www.amp.org/meetings/2011

22nd Asian Regional Congress of the ISBT –International Society for Blood Transfusion.November 20-23; Taipei, Taiwan; Web:www.isbtweb.org

RNAi Asia.. Nov 22-23; Singapore; Web:www.selectbiosciences.com

Screening Asia. Nov 22-23; Singapore; Web:www.selectbiosciences.com

COLABIOCLI 2011 - 30th Latin AmericanCongress of Clinical Biochemistry. November26-28; Punta Cana, Dominican Republic; Web:www.colabiocli.org

23rd National Congress of Biochemistry ofthe Turkish Biochemical Society (TBD). Nov

29-Dec 2; Adana, Turkey; Web: www.biyokimyakongresi.org

California Society of Pathologists 63rd AnnualConvention. Nov 29-Dec 3; San Francisco, CA,USA; Web: www.calpath.org/events.php

DECEMBER 201138th National Conference of "Association ofClinical Biochemists of India". Dec 2-6;Gwalior, India; Web: acbicon2011.com

Annual Meeting of the American Society forCell Biology. Dec 3-7; Denver, CL, USA; Web:www.ascb.org/meetings/index.cfm

22nd World Allergy Congress. December 4-8;Cancun, Mexico; Web: www.worldallergy.org

53rd Annual American Society of Hematology(ASH) Meeting and Expositio. Dec 10-13; SanDiego, CA, USA; Web: www.hematology.org/Meetings/Annual-Meeting

41st Annual Scientific Meeting for theAustralasian Society for Immunology. Dec11-15; Adelaide, SA, Australia; Web:www.asi2011.org

APRIL 2012Analytica 2012. Apr 17-20; Munich, Germany;Web: www.analytica.de/en/Home

MAY 2012ArabMedLab 2012 – 13th Arab Congress ofClinical Biology (AFCB) and 12th MoroccanCongress of Clinical Chemistry andLaboratory Medicine. May 2-5; Marrakech,Morocco; Web: www.smccbm.org

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