iso 15189 made easier
TRANSCRIPT
ISO 15189
HELPING YOU TO MEET THE STANDARD
Controls
Calibrators
Reference Plasmas
Pipette Service and Calibration
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ISO 15189 Made Easier
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Both NHS and private practices rely heavily on the quality of the diagnostic testing provided by medical laboratory services and pathology laboratories. The provision of accurate and consistent examination, result validation and authorisation interpretation and reporting is essential for many patient pathways.
Assessments such as the 2014 NHS England Pathology Quality Assurance Review, chaired by Dr Ian Barnes, have highlighted the importance of accreditation of medical laboratories to assure the quality of the services being provided.
The United Kingdom Accreditation Service (UKAS) is moving to accredit pathology services against the internationally recognised standard: ISO 15189.
Regarding accreditation, the Barnes review recommended:
Adopting the new ISO 15189 standards will increase confidence in the results produced by elimination, wherever possible, of all causes of variability in test protocols and procedures. Significant focus should be on those sections relating to method validation, system calibration, internal quality control and assurance and result consistency. ISO 15189 Quality Management System criteria encompass:
■ 5.3.1.4 equipment calibration and metrological traceability
■ 5.3.2.3 reagents and consumables acceptance testing
■ 5.5.1.2 verification of examination procedures
■ 5.5.1.3 validation of examination procedures
■ 5.5.1.4 measurement uncertainty of measured values
■ 5.6.2.2 quality control materials
Alpha Laboratories can provide help and support for laboratories implementing ISO 15189 through its many products and services.
“In order that patients and clinicians can rely on accreditation status as shorthand for a quality assured service, the accreditation of pathology services must be updated showing clearly which laboratories are meeting minimum requirements, and which are excelling to provide first-rate service quality. UKAS has agreed to undertake this work.”
ISO 15189 Made Easier
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If your laboratory is aiming for ISO 15189 accreditation you need to demonstrate that your testing service follows defined quality assurance levels, performing with competence and consistency.
Commercially available control, calibrator and reference materials provide third party verification of your system.
Those that follow the patient pathway provide greater confidence in test system results, over controls that use artificial materials, or that do not enumerate accurately over a number of parameters.
Together with regularly validated and calibrated equipment they help you to achieve and maintain accreditation.
Supporting ISO 15189 Compliance
Contents Page/sClinical Chemistry Calibrators & Standards 3
Clinical Chemistry Controls 4
HbA1c Controls 5
Haematology Product Selector Guide 7
Streck STATS® Quality Control Programme
8
Haematology Calibrators 9
Haematology Controls 10-14
Sickle Cell Tests and Controls 15
UA-Cellular™ Urine Controls 16
Temp-Chex Thermometers 16
ESR Testing 17
Light Transmission Aggregometry Performance Validation
18
Flow Cytometry Controls 19-20
Flow Cytometry Product Selector Guide 20
Lupus Anticoagulation Controls 21
Factor Deficient Substrates 22
Reference Plasma 23
Control Plasma 24-25
Blood Grouping Control Reagents 26-27
Fastrak and Laboratree 28
Pipette Service and Calibration, plus Pipetting Academies
29-30
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Clin
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Clinical Chemistry Calibrators and Standards
Clinical Chemistry Calibrator (Sentinel):
ACP (Acid Phosphatase), Albumin, ALP (Alkaline phosphatase), ALT (Alanine Aminotransferase), Amylase, AST (Aspartate aminotransferase), Bile Acids, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Chlorides, Creatinine, Copper, Iron, GGT, GLDH (Glutamate Dehydrogenase), Glucose, HBDH, β-Hydroxybutyrate. Lactate, LDH (Lactate Dehydrogenase), Lipase, Magnesium, Phosphate, Triglycerides, Total Protein, Uric Acid, Urea, Zinc.
Plasma Protein Calibrator (Sentinel): α-2-Macroglobulin, α-1-Antitrypsin, α-1-Acid Glycoprotein, Albumin, Antithrombin III, C3, C4, C1-esterase inhibitor, Ceruloplasmin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Transferrin.
Diacal Auto (Dialab): ALP (Alkaline phosphatase), Albumin, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate aminotransferase), BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Chlorides, Creatinine, Copper, Iron, GGT, Glucose, HBDH. HDL-C,Lactate, LDH (Lactate Dehydrogenase), LDL-C, Lithium, Lipase, Magnesium, Phosphorus, Phospholipids, Triglycerides, Total Protein, Uric Acid, Urea.
Protein Calibrator High/Low (Dialab): α-1-Antitrypsin, α-1-Acid Glycoprotein Albumin, α-2-Macroglobulin, Antithrombin III, C3, C4, C1-esterase inhibitor, Ceruloplasmin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Transferrin.
Multi-Constituent Calibrators
Multi-Constituent Calibrators
Catalogue Number
Description Pack Size
16550 Clin Chem Calibrator 4x3ml
D98485SV Diacal Auto 1x3ml
11200D Plasma Protein Calibrator 3x1ml
A00580 Protein Calibrator High 1x1ml
A00701 Protein Calibrator Low 1x1ml
Single Constituent Calibrators & Standards
Single Constituent Calibrators & Standards
Catalogue Number
Description Pack Size
B-ACK-CA ACE Standard 1x2ml
A00735 β-2-Microglobulin Calibrator 4x1ml
903210 Bile Acids Standard 1x3ml
419-73295 Bilirubin Calibrator 4x3ml
D06520SV Carbon Dioxide Standard 41x3ml
416-51095 HDL Calibrator 4x3ml
419-24032 LDL Calibrator 4x1ml
997-43801 CH50 Calibartor 5x0.5ml
460-25801 CRP Calibrator 5x2ml
11532 CRP Calibrator Set 7x2ml
11533 CRP Ultra-Sensitive Calibrator 1x2ml
16299C CK-MB Calibrator 2x1ml
Z05880 Ethanol Calibrator/Control 4x1ml
11525A Ferritin Calibrator Set 1x19;1x10ml
Y04705SV Haemoglobin Calibrator 1x2ml
993-71115 HA Calibrator 5x2ml
A05746 IgD Calibrator 1x0.5ml
412-73791 Ketone Bodies Calibrator 4x5ml
270-77000 NEFA Standard 2x10ml
910180SV Potassium Standards Set 2x3ml
419-77902 Rheumatoid Factor Calibrator 5x1ml
11523D RF Calibrator Set 5x1ml
A00960 Transferrin Calibrator 5x1ml
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Clinical Chemistry Controls
Multi-Constituent Assayed Control Serum
Single Constituent Controls
Assayed Clinical Chemistry Control 1 & 2 (Sentinel): Acid Phosphatase, Albumin, ALD, Alkaline phosphatase, Alanine Aminotransferase, Amylase, Aspartate aminotransferase, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Creatine Kinase, Chlorides, Creatinine, Copper, Iron, Gamma GT, Glucose, HBDH. HDL-C, Potassium, Lactate, Lactate Dehydrogenase, LDL-C, Lithium, Lipase, Magnesium, Sodium, Phosphorus, Phospholipids, Triglycerides, Total Protein, Uric Acid, UIBC, Urea, Zinc.
Assayed Control Serum I & II (Wako): NEFA, Creatinine, BIL-T, BIL-D, HDL-C, LDL-C, Zinc.
Assayed Diacon N & P (Dialab): Albumin, Alkaline phosphatase, Alanine Aminotransferase, Amylase, Aspartate aminotransferase, Bile Acids, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Creatine Kinase, Chlorides, Creatinine, Copper, Iron, Gamma GT, Glucose, Glutamate Dehydrogenase, HBDH. HDL-C, Lactate, Lactate Dehydrogenase, LDL-C, Lithium, Lipase, Magnesium, Potassium, Phenylalanine, Sodium, Phosphorus, Triglycerides, Total Protein, Uric Acid, Urea, Zinc.
Assayed Immuno Control Set (Sentinel): α-2-Macroglobulin, α-1-Antitrypsin, α-1-Acid Glycoprotein, Albumin, Anti-streptolysin O, Antithrombin III, β2M, C3, C4, C1-esterase inhibitor, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Rheumatoid Factor, Transferrin.
Assayed Protein Control (Dialab): α-1-Antitrypsin, α-1-Acid Glycoprotein Albumin, α-2-Macroglobulin, Anti-streptolysin O, Antithrombin III C3, C4, C1-esterase inhibitor, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Rheumatoid Factor, Transferrin.
Multi-Constituent Controls
Catalogue Number
Description Pack Size
16150 Clin Chem Control Level I 6x5ml
16250 Clin Chem Control Level II 6x5ml
410-00104 Control Serum Level I 4x5ml
416-00204 Control Serum Level II 4x5ml
D98481SV Diacon Normal Control 1x5ml
D98482SV Diacon Pathological Control 1x5ml
11211A Immuno Control Set (2 levels) 2x(2x1)ml
A00590 Protein Control 1x1ml
A08591 Protein Control Low 1x1ml
Single Constituent Controls
Catalogue Number
Description Pack Size
16635 Ammonia Control (3 levels) 3x(1x5)ml
B-ACK-CONSET ACE (2 levels) 2x2ml
A00818 β-2 Microglobulin Control 1x1ml
16002A Bile Acids (2 levels) 2 x (2x3ml)
16299S CK-MB Control 2x1ml
991-43701 CH-50 Control (2 levels) 10x0.5ml Low/10x0.5ml High
11540 CRP Ultra-Sensitive Control 3x2ml
16352 Fructosamine Control Level I 4x1ml
16353 Fructosamine Control Level II 4x1ml
Y04706 Haemoglobin Control Set 6x2ml
16370S Homocysteine Controls 3x(1x1.5)ml
998-71165 HA Control (2 levels) 2x(2x2)ml
125001 Microalbumin Control (2 levels) 2x(5x7)ml
910190SV Potassium Control Set (2 levels) 2x3ml
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HbA1c Controls
A1c-Cellular®
Streck’s A1c-Cellular is a whole blood cellular control for HbA1c and is the only A1c control on the market with intact red blood cells. A1c-Cellular tests the entire HbA1c performance, including the lysing of the red blood cell - a step omitted with other controls. This important step ensures the entire system, instrument and reagents, is working properly and providing accurate patient results.
n Ready to use liquid control
n Open-vial stability of 30 days
n Closed-vial stability of 6 months
Technical information:
A1c-Cellular is available in cap-pierceable plastic vials, which allows autosampling for HbA1c analysers with such capabilities.
It is appropriate for immunoassay and ionic exchange HPLC methodologies and is assayed for:
■ Abbott ARCHITECT® c Systems
■ ARKRAY Menarini ADAMS™ A1c HA-8160
■ Beckman Coulter® Synchron® Systems, UniCel® DxC Systems
■ Bio-Rad® D-10, Variant II™, Variant II™ Turbo
■ Siemens Dimension™ Series
■ Ortho-Clinical Diagnostics VITROS® 5,1 FS; VITROS® 5600
■ Roche Diagnostics Cobas INTEGRA®, Cobas® 6000
■ Tosoh G7, G8, A1c 2.2 Plus
A1c-Cellular is available in two clinically significant levels:
A1c Cellular Control
Catalogue Number
Description Pack Size
211130 A1c-Cellular - Levels 1 & 2 2 x 2.0ml
211124 A1c-Cellular - Levels 1 & 2 6 x 2.0ml
Streck
A1c-Cellular® Linearity
Streck’s A1c-Cellular Linearity evaluates the accuracy and precision of HbA1c procedures over instrument reportable range.
A1c-Cellular Linearity is a 5-level assayed linearity material used to assess instrument accuracy and verify the reportable range of the Haemoglobin A1c (HbA1c) parameter. It is the only commercially-available linearity/calibration verification material containing intact red blood cells. It tests the entire reportable range of the instrument for bias, including the lyse step.
n Ready to use liquid control
n Open-vial stability of 7 days
n Closed-vial stability of 105 days
A1c Cellular Control
Catalogue Number
Description Pack Size
285536 A1c-Cellular Linearity 5 level control 5 x 2.0ml
Streck
Technical information:
A1c-Cellular Linearity is available in cap-pierceable plastic vials, which allows autosampling for HbA1c analysers with such capabilities. Vials also include barcodes.
Instrument specific target values and expected ranges are provided for immediate instrument accuracy verification. Assayed Instruments:
■ Beckman Coulter® Synchron CX®/LX® &, UniCel® DxC 600/800 Synchron®
■ Bio-Rad® Variant II™, Variant II™ Turbo & D-10™
■ Ortho-Clinical Diagnostics VITROS® 5,1 FS & VITROS® 5600
■ Roche COBAS Integra®, Cobas® 6000
■ Siemens Dimension™ Series
■ Tosoh G7, G8AAssay Mean
Level 1 2 - 5% HbA1c
20 - 53 mmol/mol
Level 2 7 - 12% HbA1c
75 - 119 mmol/mol
Typical ranges for A1c-Cellular Linearity
Level 1 0% - 2%
Level 2 4% - 7%
Level 3 9% - 12%
Level 4 14% - 16%
Level 5 17% - 21%
ISO 15189 Made Easier
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Streck, has a long pedigree in developing controls and support products. Their controls are renowned for closely resembling and performing like patient samples.
Together with the STATS® programme, this helps you ensure quality control, confirming the accuracy of your test system and the reliability of patient results.
Streck controls contain true cellular material that undergoes the same procedural conditions as a patient sample. Available for numerous analytes each control provides at least two clinically relevant ranges.
■ Haematology controls
■ Cellular urine control for automated microscopy
■ Flow cytometry controls
The PrecisionBiologic CRYOcheck™ frozen plasma range can enhance your quality procedures compared to traditional lyophilised plasma controls.
■ Ready-to-use buffered, frozen product - consistent vial to vial
■ Prevents reconstitution errors - no pipetting inaccuracy risks
■ Every lot has an assay certificate - fully traceable
■ Saves time, ready to use in just 5 minutes
Cellular Controls Follow the Patient Pathway
Frozen Plasma Products Improve Quality
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Haematology Product Selector Guide
The quickest way to find the right control, calibrator or reticulocyte control:
Simply select your instrument and then the product. If you require additional help, please contact Alpha Laboratories.
I use a…. I am looking for a …
Instrument Control Page Calibrator Page Reticulocytes PageAbbott Laboratories
CELL-DYN 1400 Para 12 Extend 11 Cal-Chex 9
CELL-DYN 1600, 1700 Para 12 Extend 11 Cal-Chex 9
CELL-DYN 1800 Para 12 Extend
CVA for CELL-DYN
11
10
Cal-Chex 9
CELL-DYN 3200 Para 12 Plus
Cell-Chex Auto
CVA for CELL-DYN
11
9
10
Cal-Chex A Plus 9 Retic-Chex Linearity 13
CELL-DYN 3500, 3700 Para 12 Plus
CVA for CELL-DYN
11
10
Cal-Chex A Plus 9 Retic-Chex II
Retic-Chex Linearity
12
13
CELL-DYN Sapphire Cell-Chex Auto
CVA for CELL-DYN
9
10
Cal-Chex A Plus 9 Retic-Chex Linearity 13
CELL-DYN Ruby Cell-Chex Auto
CVA for CELL-DYN
9
10
Cal-Chex A Plus 9 Retic-Chex Linearity 13
CELL-DYN Emerald CVA for CELL-DYN 10
Horiba Medical ABX
Micros 60 Para 12 Extend 11 Cal-Chex 9
Beckman Coulter
AcT™ series, inc. diff and diff 2 Para 12 Extend 11 Cal-Chex 9
LH500 StaK-Chex
StaK-Chex Plus Retics
CVA
13
14
10
Cal-Chex 9 Retic-Chex Linearity for BC 13
LH750/LH755/LH780/LH785 StaK-Chex Plus Retics
CVA
Cell-Chex Auto
LBC-Chex
14
10
9
10
Cal-Chex 9
STKS™, MAXM StaK-Chex 13 Cal-Chex 9 Retic-Chex II 12
HmX. StaK-Chex Plus Retics
CVA
Cell-Chex Auto
14
10
9
Cal-Chex 9 Retic-Chex Linearity 13
DxH™ 800 StaK-Chex Plus Retics
CVA
Cell-Chex Auto
LBC-Chex
14
10
9
10
Cal-Chex 9 Retic-Chex Linearity 13
HemoCue Inc.
B-Haemoglobin Photometer Para 4
CVA
12
10
Hb201+ HQ-Chex
Para 4
CVA
10
12
10
B-Glucose HQ-Chex 10
Glucose 201 HQ-Chex 10
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Stre
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Brand and product names of the instruments are trademarks of their respective holders.
Streck STATS® Programme
All standing order customers qualify for participation in
STATS® which offers you the opportunity to compare the
accuracy of your instrument with a world-wide cohort using
the same lot number and instrument type.
STATS® provides statistical and graphical presentation of
quality control data which includes:
■ Cumulative data
■ Peer group comparisons
■ Levey-Jennings graphs
Data is submitted by mail, fax or e-mail and turnaround time
is fast with reports being produced every month.
In addition to current reports, archived reports are also
available.
Now STATS-Link® offers:
■ Email notification that reports are ready
■ View and download STATS® reports online
■ Access to reports 24 hours a day
■ Manager’s Report providing a summary report for multi-laboratory operations
Enrolment
Once your standing order is established, enrolment is
simple. Please contact Alpha Laboratories for more details.
Free of charge inter-laboratory quality control programme
I use a…. I am looking for a …
Instrument Control Page Calibrator Page Reticulocytes PageSiemens Healthcare Diagnostics
ADVIA 60 Para 12 Extend 11
Sysmex
XE-2100, XE-5000 Cell-Chex
Auto LBC-Chex
9
10
Retic-Chex Linearity 13
XT-1800i, XT-2000i, XT-4000i Cell-Chex Auto 9 Retic-Chex Linearity 13
XN-10, XN-20 LBC-Chex 10 Retic-Chex Linearity 13
Other Analysers
Haemata STAT II Para 4 12
ESR Systems
Ves-Matic ESR-Chex 17
Min-Ves ESR-Chex 17
ESR-Auto Plus ESR-Chex 17
ESR-100 ESR-Chex 17
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A calibrator assayed for Beckman Coulter, Abbott and Horiba
Medical ABX instruments.
Assayed on analysers calibrated with whole blood using
standard reference methods, it ensures accurate and reliable
calibration of haematology analysers.
■ 5-day open-vial stability and 45-day closed-vial stability
■ Supplied with pierceable caps for closed-tube systems
■ System specific values for 9 parameters
Cal-Chex
A calibrator assayed for the Abbott CELL-DYN 1700, 3000,
3200, 3500, 3700, 4000 as well as the Ruby and Sapphire
analysers. Assayed on analysers calibrated with whole blood
using standard reference methods, it ensures accurate and
reliable calibration of haematology analysers.
■ 5-day open-vial stability and 45-day closed-vial stability
■ Supplied with pierceable caps for closed-tube systems
■ System specific values for 9 parameters
Cal-Chex A Plus
The first automated body fluid cell count control, designed to
provide confidence that instrument counts are accurate.
■ 30-day open-vial stability and 75-day closed-vial stability
■ Available in 3 levels
■ All levels are lower than the levels found in abnormal haematology controls and calibrators
■ Free participation in STATS®
Cell-Chex Auto
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 1400, 1600, 1700, 1800 3
Horiba Medical ABX Micros 60 3
Beckman Coulter Ac•T series (exl 5 diff)
LH500/LH750/LH755/LH780/LH785
STKS, MAXM, HMX
DxH™800
3
Cal-ChexCatalogueNumber
Description Pack Size
221101 Cal-Chex 1 x 3ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN Sapphire, Ruby
CELL-DYN 3200, 3500/3700
3
Cal-Chex A PlusCatalogueNumber
Description Pack Size
221106 Cal-Chex A Plus 1 x 3ml
221107 Cal-Chex A Plus 2 x 3ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 3200, Sapphire and Ruby 3
Beckman Coulter LH750/755/780/785 DxH™ 800 3
Sysmex XE-2100, XE-5000, XT-1800i, XT-2000i,
XT-4000i
3
Cell-Chex AutoCatalogueNumber
Description Pack Size
200065 Cell-Chex Auto Level 1 & 2 2 x 3ml
200066 Cell-Chex Auto Level 1, 2 & 3 3 x 3ml
200067 Cell-Chex Auto Level 1 3 x 3ml
200068 Cell-Chex Auto Level 2 3 x 3ml
200069 Cell-Chex Auto Level 3 3 x 3ml
Streck
Haematology Calibrators
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A range of assayed linearity control kits that can be used to
verify calibration and patient reportable range of 3-part and
5-part haematology instruments.
■ 5-day open-vial stability and 120-day closed-vial stability
■ Each kit has customised ranges appropriate for instrument model
■ Kit provides instrument-specific assay values for the WBC, Platelet, RBC and haemoglobin parameters
■ Also measures the linear performance of the analyser
■ Free participation in STATS®
CVA and CVA for CELL-DYN
A whole blood glucose and haemoglobin control to evaluate
the accuracy and precision of point of care instruments.
■ 30-day open-vial stability and 180-day closed-vial stability
■ Available in three clinically significant levels
■ Package in convenient plastic squeeze dropper vials
■ Specially formulated for HemoCue® analysers
■ Free participation in STATS®
HQ-Chex
The first lamellar body count control. Lamellar bodies can be
analysed as an indirect estimate of fetal lung maturity and as
a potential indicator of respiratory distress syndrome.
■ 30-day open-vial stability and 105 day closed-vial stabillity
■ Verifies instrument accuracy by testing the lower platelet limits that standard controls and calibration material fail to assess
■ Provides laboratory scientists with confidence their instrument counts are accurate for patient samples
■ No dilution required
LBC-Chex™
Product Selection Guide
Manufacturer Instrument Compatible
Beckman Coulter LH700 series, UniCel® DxH™ 800 3
Sysmex XE-2100™, XE-5000™, XN-10™, XN-20™ 3
LBC-ChexCatalogueNumber
Description Pack Size
200098 LBC-Chex Level 1, 2 & 3 (RUO) 3 x 3ml
200099 LBC-Chex Level 1 (RUO) 3 x 3ml
200100 LBC-Chex Level 2 (RUO) 3 x 3ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
HemoCue, Inc. B-Glucose Analyzer
B-Hemoglobin Photometer
Hb 201+ Analyzer
Glucose 201 Analyzer
3
HQ-ChexCatalogueNumber
Description Pack Size
232753 HQ-Chex Level 1 6 x 2.5ml
232754 HQ-Chex Level 2 6 x 2.5ml
232755 HQ-Chex Level 3 6 x 2.5ml
232756 HQ-Chex Level 1, 2 & 3 6 x 2.5ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 1800 or lower
CELL-DYN 3200 or higher
3
3
Horiba Medical ABX Micros 60 3
Beckman Coulter LH500, DxH™ 800, HmX
LH500/750/780/785
3
CVA and CVA for CELL-DYNCatalogueNumber
Description Pack Size
291712 CVA for DxH 800, LH500/750/780/785 18 x 3ml
291715 CVA for CELL-DYN 1800 or lower 12 x 3ml
291718 CVA for CELL-DYN 3200 or higher 16 x 3ml
Streck
Haematology Controls
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A three-part differential control with distinct populations of
lymphocytes, mononuclear cells, and granulocytes, but with
extended stability suitable for the smaller laboratory.
n 30-day open-vial stability and 190-day closed-vial stability
n Available in a 2.5ml vial or a 4.5ml pierceable cap vial
n Pierceable cap suitable for instruments with single closed-vial sampling or continuous closed-vial auto-sampling capability
n Varying levels of lymphocytes, mononuclear cells, and granulocytes available at low, normal and high levels
n Free participation in STATS®
Para 12® Extend
The perfectpartnership
for your Sickle Cell testing
SICKLEDEX® Solubility Kits
Sickle-Chex® Whole Blood Control
see page 15 for more details
A five-part whole blood differential control for the Abbott
CELL-DYN 3200, 3500 and 3700.
n 7-day open-vial stability and 75-day closed-vial stability
n Packaged in a 3ml vials pierceable caps and bar-coded labels
n Assay file available for download
n Also provides 3-part differential for CELL-DYN 1600 & 1700
n Stable and reproducible scattergrams assist detection of malfunctions including laser
n Free participation in STATS®
Para 12® Plus
Para 12® PlusCatalogueNumber
Description Pack Size
218924 Para 12 Plus Low 4 x 3ml
218914 Para 12 Plus Normal 4 x 3ml
218934 Para 12 Plus High 4 x 3ml
218913 Para 12 Plus Tri-Level 12 x 3ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 3200, 3500 and 3700 3
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 1400, 1600, 1700, and 1800 3
Horiba Medical ABX Micros 60 3
Beckman Coulter Ac•T/Ac•T diff/Ac•T diff2 3
Siemens Advia 60 3
Para 12® ExtendCatalogueNumber
Description Pack Size
218750 Para 12 Extend Tri-level 18 x 2.5ml
218770 Para 12 Extend Tri-level 18 x 4.5ml
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Hae
mat
olog
y C
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A four-parameter haematology control designed for point
of care testing or the small laboratory performing a limited
number of tests, utilising manual or semi-automated
methods.
■ 14-day open-vial stability and 110-day closed-vial stability
■ Available in glass or plastic squeeze dropper vials
■ Assay parameters are Hgb, WBC, RBC, Hct and platelets
■ Free participation in STATS®
Para 4®
A whole blood control, manufactured with reticulocytes that
resemble the appearance of patient samples for accurate
identifications. Available in three levels which are well
positioned to monitor the haemostatic response.
■ 14-day open-vial stability and 75-day closed-vial stability
■ Available in glass vials for automated methods
■ Packaged in plastic squeeze dropper vials for manual methods
■ Retic-Chex Stain also available
■ Free participation in STATS®
Retic-Chex® II
Product Selection Guide
Manufacturer Instrument Compatible
HemoCue® Inc. B-Haemoglobin Photometer
Hb 201+
3
3
Para 4®
CatalogueNumber
Description Pack Size
215106 Para 4 Low 6 x 1.5ml
215107 Para 4 Normal 6 x 1.5ml
215108 Para 4 High 6 x 1.5ml
215112 Para 4 Tri-Level 12 x 1.5ml
Para 4® Glass VialsCatalogueNumber
Description Pack Size
215426 Para 4 Low 6 x 1.5ml
215416 Para 4 Normal 6 x 1.5ml
215436 Para 4 High 6 x 1.5ml
215412 Para 4 Tri-Level 12 x 1.5ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN 3500 and 3700 3
Beckman Coulter STKS, MAXM, HMX and LH500 3
Manual Methods Miller Ocular
Two Slide
3
3
Retic-Chex® IICatalogueNumber
Description Pack Size
285106 Retic-Chex II Tri-Level (plastic) 6 x 1ml
285104 Retic-Chex II Level 1 (plastic) 4 x 1ml
285204 Retic-Chex II Level 2 (plastic) 4 x 1ml
285304 Retic-Chex II Level 3 (plastic) 4 x 1ml
285410 Retic-Chex Stain 2 x 15
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ISO 15189 Made Easier
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Hae
mat
olog
y C
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A five-part differential control manufactured at clinically
significant low, normal and high levels for all parameters.
■ 14-day open-vial stability and 105-day closed-vial stability
■ Pierceable cap compatible with all cassette systems
■ Bar-coded vials assists daily QC data collection
■ The same lot number can be used for 3 months making trends easier to detect
■ Assay sheets are barcoded for uploading assay values for STKS™, MAXM ™, and HmX
■ Free participation in STATS®
STaK-Chex® Retic-Chex® Linearity
Retic-Chex® Linearity is designed to establish the patient
reportable range and linearity of the system.
■ Available in five-vial sets with instrument-specific assay values
■ The vials have pierceable caps
■ Open-vial stability: 5 days
■ Closed-vial stability: 105 days
Product Selection Guide
Manufacturer Instrument Compatible
Abbott CELL-DYN® 3200, 3500, 3700, Ruby and Sapphire
3
Beckman Coulter STKS™, MAXM™, HmX, GEN•S, DxH™800,LH 500, LH750/755 and LH780/785
3
Sysmex XE-2100™, XE-5000™, XT-2000i™,
XT4000i™, XN-10 and XN-20
3
Retic-Chex® LinearityCatalogueNumber
Description Pack Size
285532 Retic-Chex Linearity for Sysmex 5 x 2.5ml
285535 Retic-Chex Linearity BC/Beckman Coulter 5 x 3ml
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Beckman Coulter STKS™
MAXM™
HmX
LH500
3
3
3
3
STaK-Chex®
CatalogueNumber
Description Pack Size
225512 STaK-Chex Tri-Level 12 x 4ml
225524 STaK-Chex Low 4 x 4ml
225514 STaK-Chex Normal 4 x 4ml
225534 STaK-Chex High 4 x 4ml
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Hae
mat
olog
y C
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A five-part differential control with values for all parameters,
including reticulocytes and nucleated red blood cells.
■ 14-day open-vial stability and 105-day closed-vial stability
■ Assay contains automated/manual reticulocyte values at three clinically significant levels
■ Bar-coded vials to ensure correct data input
■ Pierceable cap vial with unlimited piercing
■ All-in-one controls assists purchase, inventory and QC records
■ The same lot number can be used for 3 months making trends easier to detect
■ Assay values available for upload for all instruments
■ Free participation in STATS®
■ Assayed for LH500, LH750/755, LH780/785, HmX and DxH™800
STaK-Chex® Plus Retics
Typical assay range for STaK-Chex® Plus ReticsWBC (109/L) 2.5 - 22.0
RBC (1012/L) 2.60 - 5.40
MCV (fL) 70 - 100
PLT (109/L) 70 - 625
RETICS (%) 0.1 - 10.0
Product Selection Guide
Manufacturer Instrument Compatible
Beckman Coulter STKS™
MAXM™
HmX
DxH™800
LH500
LH750/755/780/785
3
3
3
3
3
3
STaK-Chex® Plus ReticsCatalogueNumber
Description Pack Size
225480 STaK-Chex Plus Retics Low 4 x 4.5ml
225481 STaK-Chex Plus Retics Normal 4 x 4.5ml
225482 STaK-Chex Plus Retics High 4 x 4.5ml
225483 STaK-Chex Plus Retics Normal 12 x 4.5ml
225485 STaK-Chex Plus Retics Tri-Level 12 x 4.5ml
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ISO 15189 Made Easier
n freephone order 0800 387732 n buy online at www.alphalabs.co.uk15
Sick
le C
ell S
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Tes
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Tests and Controls for Sickle Cell Screening
Designed to detect the presence of Haemoglobin S with just
20µl of sample.
The kit offers:
■ 45-day open-vial stability and 12-month closed-vial stability
■ Superior open-vial stability: three times as long as other products on the market
■ Squeeze bottle (buffer) convenience to minimise waste
■ Only 20µl of patient/control sample required
■ Choice of pack sizes available to suit workload requirements including the 12-test kit which includes all items necessary to perform a sickle cell screening test
■ Ten-place test-tube reading rack is also available
SICKLEDEX®
A positive and negative whole blood control to test for the
presence of Haemoglobin S in solubility tests.
■ 100-day open-vial stability and 6-month closed-vial stability
■ Compatible with most other manufacturers’ sickle cell screening kits
■ Packaged in 2.5ml squeeze dropper vials for easy sample dispensing
■ Vial dispenses accurate sample volume
SICKLEDEX®
CatalogueNumber
Description Pack Size
217661 SICKLEDEX qualitative Solubility Test Kit 12 tests
217660 SICKLEDEX qualitative Solubility Test Kit 50 tests
217657 SICKLEDEX qualitative Solubility Test Kit 100 tests
217659 SICKLEDEX Test Rack 1
Streck
Sickle-Chex®
CatalogueNumber
Description Pack Size
217653 Sickle-Chex Positive and Negative Controls 2 x 2.5ml
217654 Sickle-Chex Positive and Negative Controls 4 x 2.5ml
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Sickle-Chex®
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ISO 15189 Made Easier
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UA
-Cel
lula
r™ C
ellu
lar
Uri
ne C
ontr
ol/T
emp-
Che
x Th
erm
omet
ers
Red Spirit
UA-Cellular™
Cellular Urine Control for Sysmex® UF seriesand Iris iQ200 instruments
Instrumentation controls should represent the same
procedural processes and reflect similar values to those
expected by patient samples.
UA-Cellular for UF and UA-Cellular for IQ is a unique product
that contains components at two clinically significant levels.
The product evaluates an instrument’s ability to identify and
quantify white blood cells, red blood cells, non-squamous
epithelial cells and crystals.
Stability for UA-Cellular for UF and UA-Cellular for iQ
■ Store at 2 - 10C
■ 30 day open-vial stability and 105 day closed-vial stability
Typical RBC, WBC and non-squamous epithelial (NSE) levelsfor UA-Cellular for UF
WBC RBC EC BACT
Level 1 30-50 cells/µl 5-15 cells/µl 10-20 cells/µl 150-250 cells/µl
Level 2 180-220 cells/µl 40-60 cells/µl 20-80 cells/µl 600-800 cells/µl
Level 1 contains crystals, Level 2 contains casts
Typical RBC, WBC and non-squamous epithelial (NSE) levels for UA-Cellular for iQ
WBC RBC NSE
Level 1 30-60 cells/µl 30-60 cells/µl 10-30 cells/µl
Level 2 180-240 cells/µl 180-240 cells/µl 60-120 cells/µl
Level 2 contains casts
UA-Cellular™ for UF and UA-Cellular™ for iQCatalogueNumber
Description Pack Size
213465 Level 1 & 2 (UF) 2 x 120ml
213396 Level 1 & 2 (iQ) 2 x 45ml
Streck
Temp-Chex Thermometers
Streck manufactures a number of quality control devices,
including the Temp-Chex Red Spirit thermometers with scales
in 1/2-degree increments to monitor refrigerators, freezers,
and incubators/room temperatures.
Safe, Reliable, and Accurate Monitoring of Laboratory Temperatures
■ Red Spirit Temp-Chex thermometers monitor refrigerators,
freezers, incubators, and room temperatures.
■ Each thermometer is engraved with a serial number
traceable to NIST/DKD with scales in 1/2º increments*,
allowing the laboratory to meet CAP and CLIA standards.
■ Contained in a vial of propylene glycol, Temp-Chex
thermometers attach to your refrigerator, freezer, or
incubator wall magnetically or adhesively. The Temp-Chex
thermometer and vial are enclosed in a plastic tube to
protect the thermometer and to contain contents in case
of breakage. A temperature wall chart is included with
each Temp-Chex.
■ All Temp-Chex thermometers are mercury-free.
*Ultra-Low thermometer features 1º gradation.
Please note: calibrators, linearity products, PVS, and thermometers are not available as a sample.
Temp-Chex ThermometersCatalogueNumber
Description Pack Size
240043 Temp-Chex Red Spirit -5 ºC to 15 ºC Each
240046 Temp-Chex Red Spirit -30 °C to 1 °C Each
240047 Temp-Chex Red Spirit -90 °C to 25 °C Each
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ISO 15189 Made Easier
n freephone order 0800 387732 n buy online at www.alphalabs.co.uk17
ESR
Test
ing
Con
trol
s
ESR Testing
ESR-Auto Plus®
ESR Vacuum Tubes
The ESR-Auto Plus® is a 10-position automated ESR analyzer.
Results are measured in millimeters per hour (Modified
Westergren Method) and are available in 30 minutes.
The instrument features:
■ Random access
■ Built-in printer
■ Sample ID capability
■ Barcode scanner
■ 15-minute prediction mode
The ESR-Auto Plus incorporates a quality control system for
monitoring the laboratory’s quality control program and data
can be downloaded to a Laboratory Information System.
Collect, transport and analyse the Erythrocyte Sedimentation
Rate (ESR) of whole blood in the clinical laboratory with ESR
tubes. The tubes are specifically designed for use with the
Streck ESR-10 Manual Racks
and ESR-Auto-Plus automated
sedimentation rate analysers.
Stable
ESR tubes preserve the integrity of the patient sample for up to 72 hours from the time of blood collection when transported and stored at 2-10C.
Convenient
Only 1.2ml of whole blood is required to analyse samples in the ESR-Auto Plus.
Safe
ESR tubes are a safe alternative to traditional ESR blood collection systems offering direct-draw blood collection that eliminates unnecessary exposure to patient samples. Patient samples may also be transfrerred from an EDTA blood collection tube into an ESR tube.
Reduces Risk
Safety-coated ESR-Vacuum Tubes are designed with an outer Mylar® coating that contains glass and blood specimen in the event of breakage, reducing the risk of injury and potential exposure to blood-borne pathogens.
Impact Resistant
An independent packaging consultant has reported that ESR-Vacuum Tubes are significantly more impact resistant than glass collection tubes, greatly reducing accidental breakage.
ESR Vacuum Tubes – Safety Coated
Safety Coated ESR-Vacuum Tube struck with metal rod
Crushed tube remains intact
A two-level control used to monitor erythrocyte sedimentation
rates. Manufactured from human red blood cells, ESR-Chex
verifies the precision and accuracy of manual and automated
methods.
■ 95-day open-vial stability and 365-day closed-vial stability
■ Verifies the accuracy of both manual and automated methods
■ Available in two levels
■ Used in the same manner as patient samples
■ Free participation in STATS®
ESR-Chex
ESR-Auto Plus® and ESR-Vacuum TubesCatalogueNumber
Description Pack Size
240207 ESR-Auto Plus Instrument 1 unit
240362 ESR-Vacuum Tubes 1.2ml 12 x 100
240378 ESR-Vacuum Tubes 1.2ml, Safety Coated 12 x 100
Streck
Product Selection Guide
Manufacturer Instrument Compatible
Diesse Ves-Matic
Mini-Ves
3
3
Streck ESR-Auto 3
ESR-ChexCatalogueNumber
Description Pack Size
214102 ESR-Chex Level 1 & 2 2 x 9ml
214104 ESR-Chex Level 1 & 2 4 x 9ml
214108 ESR-Chex Level 1 & 2 8 x 9ml
Streck
ESR Vacuum Tubes – Safety Coated
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ISO 15189 Made Easier
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Ligh
t Tr
ansm
issi
on A
ggre
gom
etry
Per
form
ance
Ver
ifica
tion
The ISO 15189 document states that laboratories should have documentation on the calibration of equipment that directly or indirectly affects examination results (clause 5.3.1.4)
LTA-Check™ is a product that has been specifically designed to verify the performance of the PAP 8 and other Light Transmission Aggregometers, which are multi-channel instruments.
System FunctionalitySystem functionality is determined by the ability of a plasma and ristocetin to induce agglutination of a standardised platelet suspension.
The agglutination is defined by two parameters:
■ Aggregation
■ Slope (rate of reaction)
These results when generated on a regular basis may be used to evaluate the aggregation test system in the laboratory and will generate ongoing information on the functionality of the instrument test system.
Quality ControlRanges and limits for this quality control and system functionality can be documented by the laboratory and may be used to verify the functionality of the system on a “Channel to Channel” and a “Performance to Performance” basis.
Within Specifications?When tested on a periodic basis the specific lot combination of reagents will generate a mean and a deviation that is established by the laboratory. The deviation of a test of less than 10% from established ranges is expected. Deviations greater than 10% may represent problems with the instrument and corrective action is necessary.
■ Verify Aggregometer Function
■ Standardize Instrumentation
■ Ensure Precision and Reliability of Test Results
■ Document Reagent System
■ Comply with Laboratory Regulations
■ Identify & Reduce QC Variables
■ Assure Consistent Results Across Multiple Sites
Light Transmission Aggregometers (LTA) Quality Control
LTA-Check™
Performance Monitoring Test KitCatalogue Number
Description Pack Size
107117 LTA Check™ Kit 18 tests
BioData Corporation
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ISO 15189 Made Easier
n freephone order 0800 387732 n buy online at www.alphalabs.co.uk19
Flow
Cyt
omet
ry C
ontr
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CD-Chex Plus™ is a complete, positive procedure control
manufactured from normal human peripheral blood
leukocytes and erythrocytes.
The range has been extended to match the changing needs
of laboratories and now includes:
n CD-Chex Plus – Screw-Cap Vials
n CD-Chex Plus – Cap-Pierceable Vials
n CD-ChexPlus BC
Each range includes CD4 Low control which offers decreased
levels of CD4 positive cells (~ 200 cells/µl)
n 30-day open-vial stability and 90-day closed-vial stability
n Free participation in STATS®
Benefits of CD-Chex Plus™:
CD-Chex Plus determines the accuracy and reproducibility
of all the steps involved in the process of the
immunophenotyping procedure including:
n Satisfies both CAP and CDC quality control requirements
n Provides two levels of CD4+ T-cells
n Verification of mAb reagents
n Validation of instrument performance
n Validation of operator technique
n Verification of red blood cell lysis
CD-Chex Plus™
CD-Chex Plus is supplied in a format that can be used on any
platform.
n Assayed for 26 of the most common lymphoid and myeloid CD markers
CD-Chex Plus™ – Screw-Cap Vials
CD-Chex Plus™ – Screw-Cap VialsCatalogue Number
Description Pack Size
213326 CD-Chex Plus 2 x 2.5ml
213331 CD-Chex Plus CD4 Low 2 x 2.5ml
213340 CD-Chex Plus CD4 Low, Normal 2 x 2.5ml
213341 CD-Chex Plus CD4 Low, Normal 4 x 2.5ml
213344 CD-Chex Plus CD4 Low, Normal 10 x 2.5ml
Streck
CD-Chex Plus in a new plastic vial with pierceable caps.
n Compatible with BD FACS™ Sample Prep Assistant
n Assayed for 26 of the most common lymphoid and myeloid CD markers
CD-Chex Plus™ – Cap-Pierceable Vials
CD-Chex Plus™ BC
Optimised for Beckman Coulter flow cytometers.
n Compatible with Coulter PrepPlus™ automated sample processing instruments
n Assayed for 22 of the most common lymphoid and myeloid CD markers
CD-Chex Plus™– Cap-Pierceable VialsCatalogue Number
Description Pack Size
213365 CD-Chex Plus 2 x 3ml
213366 CD-Chex Plus, CD4 Low 2 x 3ml
213391 CD-Chex Plus CD4 Low, Normal 2 x 3ml
213369 CD-Chex Plus CD4 Low, Normal 4 x 3ml
213370 CD-Chex Plus CD4 Low, Normal 10 x 3ml
Streck
CD-Chex Plus BC™Catalogue Number
Description Pack Size
213373 CD-Chex Plus BC 1 x 3ml
213374 CD-Chex Plus BC 2 x 3ml
213371 CD-Chex Plus BC CD4 Low 1 x 3ml
213372 CD-Chex Plus BC CD4 Low 2 x 3ml
213375 CD-Chex Plus CD4 Low, Normal 4 x 3ml
Streck
Flow Cytometry Controls
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ISO 15189 Made Easier
n email order [email protected] n freefax order 0800 614249 20
Flow
Cyt
omet
ry C
ontr
ols
A whole blood control
for enumerating CD34
positive cells by flow
cytometry.
n 30-day open-vial stability and 90-day closed-vial stability
n Compatible with both ISHAGE, Stem-Kit and ProCOUNT gating strategies
n Represents samples containing CD34 positive cells having characteristics similar to progenitor cells
n The product can be used with a variety of systems, reagents and Class III antibodies
CD-Chex CD34™ CD-Chex CD117™ Plus
Flow Cytometry Product Selector Guide
The quickest way to find the control is to simply select your instrument and then the product.
If you require additional help, please contact Alpha Laboratories.
I use a…. I am looking for a …
Typical Assay Value Ranges:Level 1: 0.05% (3-5 cells/µl)
Level 2: 0.5% (30-50 cells/µl)
Level 3: 1.75% (90-150 cells/µl)
CD-Chex Select™
CD-Chex CD117™Plus eliminates the need for labs to hold
and validate patient samples to use as a control for CD117,
CD25 and CD71.
n Save lab time and money
n Compatible with BD Biosciences and Beckman Coulterflow cytometry systems
CD-Chex Select™, the first and only commercially available
control with selected group of CD Markers.
- Sample 1 provides % positive vales for CD26, CD41, CD57,
CD64, FMC7, TCR α/β, TCR γ/δ.
- Sample 2 provides % positive values for CD58, CD61,
intracellular CD79a and intracellular MPO.
n Assayed positive procedural control that can be handled like a patient sample.
n Established means and ranges provide the user confidence in instrument results
CD-Chex CD34™Catalogue Number
Description Level Pack Size
213336 CD-Chex CD34 1 1 x 1ml
213337 CD-Chex CD34 1 2 x 1ml
213346 CD-Chex CD34 2 1 x 1ml
213347 CD-Chex CD34 2 2 x 1ml
213382 CD-Chex CD34 3 1 x 1ml
213383 CD-Chex CD34 3 2 x 2ml
213338 CD-Chex CD34 1 & 2 2 x 1ml
213339 CD-Chex CD34 1 & 2 4 x 1ml
Streck
CD-Chex CD117™ PlusCatalogue Number
Description Pack Size
213557 CD-Chex CD117 1 x 1ml
213558 CD-Chex CD117 2 x 1ml
Streck
CD-Chex™ SelectCatalogue Number
Description Pack Size
213554 CD-Chex Select (Sample 1, Sample 2) 2 x 3ml
213555 CD-Chex Select (Sample 1, Sample 2) 4 x 3ml
Streck Sample 1 and 2 are not sold separately.
Instrument Control PageBD BiosciencesFACS Series CD-Chex Plus 19
CD-Chex Plus CD4 Low 19
CD-Chex CD34 20
CD-Chex CD117 20
CD-Chex Select 20
Instrument Control PageBeckman Coulter
EPICS XL CD-Chex Plus 19
CD-Chex Plus CD4 Low 19
CD-Chex CD34 20
CD-Chex Plus BC 19
CD-Chex Plus BC CD4 Low 19
CD-Chex Select 20
CD-Chex CD117 20
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ISO 15189 Made Easier
n freephone order 0800 387732 n buy online at www.alphalabs.co.uk21
Lupu
s A
ntic
oagu
lant
Tes
ting
Con
trol
s
vWF Abnormal Control Plasma
Intended to verify sensitivity and performance of vWF assay.
n Lyophilised, depleted human plasma
n Can be used on most optical systems
n 8-hour stability after reconstitution
Material Expected ValuesNormal Reference Plasma 90-100% activity
Abnormal Control Plasma Less than 45% activity
vWF Reference PlasmaCatalogue Number
Description Pack Size
101269 vWF Normal Reference Plasma 3 x 0.5ml
101270 vWF Abnormal Reference Plasma 3 x 0.5ml
BioData Corporation
Lupus Anticoagulant Testing
A weak positive LA control that challenges an assay’s
sensitivity to LA.
n Encourages confidence that weak LA positive patient samples will be accurately detected
n Plasma from donors confirmed to have circulating LA
n 8-hour stability once thawed
n Ready to use in minutes
CRYOcheck™ Lupus Positive Control
Intended for use as a positive control in assays for
lupus anticoagulants (LA).
n Plasma from donors with non-specific circulating anti-coagulants
n Platelet poor for consistent results
n Stable for 8 hours once thawed
frozenplasma
frozenplasma
CRYOcheck™ Weak Lupus Positive ControlCatalogue Number
Description Pack Size
CCWLP-05 Weak Lupus Plasma 25 x 0.5ml
CCWLP-10 Weak Lupus Plasma 25 x 1ml
Precision Biologic
CRYOcheck™ Lupus Positive ControlCatalogue Number
Description Pack Size
CCLP-05 Lupus Plasma 25 x 0.5ml
CCLP-10 Lupus Plasma 25 x 1ml
Precision Biologic
Precision Biologic has developed a reputation globally for its innovative and extensive CryoCheck™ range of frozen plasmas for calibration, controls and reagents. These are becoming increasingly important with the advent of ISO 15189 laboratory accreditation. Using commercially available controls and calibrators that are treated exactly as patient samples means better and more realistic quality control.
Control Plasma
CRYOcheck™ Weak Lupus Positive Control
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Fact
or D
efic
ient
Sub
stra
tes
Factor Deficient Substrate
CRYOcheck™ Factor Deficient Substrates
CRYOcheck™ Prekallikrein Deficient Substrate
Collected from:
n Congenital donor who has been assayed to have less than 1% activity for Prekallikrein
n 8 hour stability once thawed
frozenplasma
Manufactured from fresh frozen, 100% human plasma, no
bovine additives.
n Certified by antigenic and functional assays to have less than 1% activity
n All other coagulation factors are assayed within normal activity levels
n Assay certificate supplied with each lot number
n Ready to use in minutes
n 8 hour stability once thawed
n Shelf life of 3 years from the date of manufacture
Lyophilised Factor Deficient Plasma
Prepared from immunodepleted human plasma.
n Contains <1% of the deficient factor
n Stable for 1 hour at 37C after reconstitution
n Maximum shelf life, from date of manufacture, is 3 years
CRYOcheck™ Factor Deficient Substrates Catalogue Number
Description Pack Size
FDP2-10 Factor 2 Deficient Plasma 25 x 1ml
FDP5-10 Factor 5 Deficient Plasma 25 x 1ml
FDP7-10 Factor 7 Deficient Plasma 25 x 1ml
FDP8-10 Factor 8 Deficient Plasma 25 x 1ml
FDP9-10 Factor 9 Deficient Plasma 25 x 1ml
FDP10-10 Factor 10 Deficient Plasma 25 x 1ml
FDP11-10 Factor 11 Deficient Plasma 25 x 1ml
FDP12-10 Factor 12 Deficient Plasma 25 x 1ml
Precision Biologic
Lyophilised Factor Deficient PlasmaCatalogue Number
Description Pack Size
P5000-010 Factor 2 Deficient Plasma 1 x 1ml
P5100-010 Factor 5 Deficient Plasma 1 x 1ml
P5200-010 Factor 7 Deficient Plasma 1 x 1ml
P5300-010 Factor 8 Deficient Plasma 1 x 1ml
P5400-010 Factor 9 Deficient Plasma 1 x 1ml
P5500-010 Factor 10 Deficient Plasma 1 x 1ml
P5600-010 Factor 11 Deficient Plasma 1 x 1ml
P5700-010 Factor 12 Deficient Plasma 1 x 1ml
TECO Medical
CRYOcheck™ Prekallikrein Deficient Substrate Catalogue Number
Description Pack Size
FDPK-10 Prekallikrein Deficient Plasma 10 x 1ml
Precision Biologic
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ISO 15189 Made Easier
n freephone order 0800 387732 n buy online at www.alphalabs.co.uk23
Refe
renc
e Pl
asm
a
Plasma for the calibration of quantitative haemostasis assays.
n Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards
n No reconstitution is required so confidence is assured
n Product stable for 8 hours after thawing
n Assay certificate supplied with each lot
CRYOcheck™ Normal Reference Plasma
Reference Plasma
Plasma for controlling the accuracy of quantitative
assays in the borderline and pathological range.
n Donor-pool adjusted to provide a borderline abnormal control and a pathological abnormal control
n Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards
n Product stable for 8 hours after thawing
n Assay certificate supplied with each lot
CRYOcheck™ Abnormal Reference Control
Plasma for controlling the accuracy of quantitative haemostasis
assays in the normal range.
n Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards
n Product stable for 8 hours after thawing
n Assay certificate supplied with each lot
CRYOcheck™ Reference Control Normal
frozenplasma
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CRYOcheck™ Normal Reference Plasma Catalogue Number
Description Pack Size
CCNRP-10 Normal Reference Plasma 25 x 1.0ml
CCNRP-05 Normal Reference Plasma 25 x 0.5ml
Precision Biologic
CRYOcheck™ Reference Control NormalCatalogue Number
Description Pack Size
RCN-10 Reference Control Normal 25 x 1.0ml
Precision Biologic
CRYOcheck™ Abnormal Reference Plasma Catalogue Number
Description Pack Size
ARPI-10 Abnormal 1 Reference Control 25 x 1.0ml
ARPII-10 Abnormal 2 Reference Control 25 x 1.0ml
Precision Biologic
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Normal control for the one-stage Prothrombin Time
(PT), Activated Partial Thromboplastin Time (APTT), and
Fibrinogen.
n Designed for use in mixing studies
n Pool of 20 or more carefully screened donors who are a mixture of males and females aged 18 to 66
n An alternative to in-house collected normal plasma pools
n Platelet-poor (<10,000 Platelets/µl)
n 24 hours stability once thawed
CRYOcheck™ Pooled Normal Plasma
Abnormal control for the one-stage Prothrombin Time (PT)
and Activated Partial Thromboplastin Time (APTT).
n Pool of 20 healthy donors treated to contain reduced levels of clotting factors 2, 7, 9 and 10
n 24 hours stability once thawed
n Available in two levels designed to suit varying control procedures
CRYOcheck™ Abnormal Controls
Control Plasma
Intended for use as controls to monitor the performance of
routine coagulation assays.
n 8 hours stability at room ambient temperature
n TEControl N is formulated to have PT, APTT, and Fibrinogen values in the normal range
n TEControl A and TEControl A Plus have been adjusted to have prolonged PT & APTT
n Actual values recovered depend on the instrument and reagent used
TEControl Coagulation Control Plasma
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CRYOcheck™ Pooled Normal Plasma Catalogue Number
Description Pack Size
CCN-10 Pooled Normal Plasma 80 x 1.0ml
CCN-15 Pooled Normal Plasma 80 x 1.5ml
CCN-40 Pooled Normal Plasma 81 x 4.0ml
Precision Biologic
CRYOcheck™ Abnormal Controls Catalogue Number
Description Pack Size
CCA1-10 Abnormal 1 Control 80 x 1.0ml
CCA2-10 Abnormal 2 Control 80 x 1.0ml
Precision Biologic
Coagulation Control PlasmaCatalogue Number
Description Pack Size
P6001-010 TEControl N 10 x 1.0ml
P6101-010 TEControl A 10 x 1.0ml
P6200-010 TEControl A Plus 10 x 1.0ml
TECO Medical
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Recommended for use as an abnormal control in
quantitative fibrinogen assays.
n Assayed by Clauss Fibrinogen method
n Stable for 72 hours once thawed
n Modified to exhibit hypofibrinogenemic characteristics
CRYOcheck™ Low Fibrinogen Control
A positive control for clot-based assays for
activated Protein C resistance.
n Collected from donors tested positive for factor VLeiden by PCR not on oral anticoagulant therapy
n 8 hour stability once thawed
n Used to supplement or replace in-house controls
CRYOcheck™ APCR Positive Control
Frozen Control Plasma Range - No Reconstitution Errors
frozenplasma
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CRYOcheck™ Low Fibrinogen ControlCatalogue Number
Description Pack Size
CCLF-80 Low Fibrinogen Control 80 x 1ml
Precision Biologic
CRYOcheck™ APCR Positive Control Catalogue Number
Description Pack Size
APCR-05 APCR Positive Control 25 x 0.5ml
Precision Biologic
30 individual vials containing human plasma with distinct Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and fibrinogen profiles spanning the normal and pathological range.
n Donors are screened negative for Lupus Anticoagulants
n Source plasmas are screened negative for all FDA-required tests
CRYOcheck™ CorPac™
frozenplasma
CRYOcheck™ CorPac™Catalogue Number
Description Pack Size
CCCP-15 CorPac™ 30 x 1.5ml
Precision Biologic
CRYOcheck™ Normal Donor Set
Manufactured from screened donors and supplied in sets of 25 representative individuals.
n Sets of 25 different donors, 1.0ml aliquots
n Mix of male and female donors who are non-medicated and taking no oral contraceptives
n Platelet-poor and therefore usable in phospholipid-dependent assays
CRYOcheck™ Normal Donor SetCatalogue Number
Description Pack Size
CCNS-10 Normal Donor Set 25 x 1.0ml
Precision Biologic
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This comprehensive set provides ultimate
control. It gives extra confidence in the correct
functioning of your automated blood grouping
system and its sensitivity to detect clinically
significant antibodies.
n Four different group format vials cover ABO and Rh/K antigens, plus anti-D and anti-Kell antibodies
n Supplied in 6ml vials of 15% RBC suspension
n Manufactured on a 4 weekly cycle – subscription product
bestseller
Blood Grouping Control Reagents
Simulated whole blood controls for automated
grouping systems.
These consistent and affordable simulated whole
blood controls from the ALBAcheck® range
offer ABO and Rh testing for both donors and
patients.
n Twice the stability of standard controls -14 day open vial: Less wastage
n 15% cell suspension for greater volume of useable sera: More tests for your money
n Two of each 6ml vials are supplied: Just one kit needed per month
n Meets the BCSH and transfusion guidelines
n Available on a 4 week cycle for continuity of supply
ALBAcheck®-DUO
Vial Phenotype Antibody
Vial 1 Group A2B rr (ccdee) Anti-D (0.1 IU/ml)
Vial 2 Group O R1R1 (CCDee) Anti-A, Anti-B &
Anti-c
ALBAcheck®-DUOCatalogue Number
Description Pack Size
Z483 ALBAcheck-DUO Whole Blood Control 4 x 6ml
Quotient
ALBAcheck®-BGS Whole Blood Controls
Vial Phenotype Antibody
Vial 1 Group A R1R1, K Pos Anti-B
Vial 2 Group B R1R2, K Neg Anti-A and Anti-K
Vial 3 Group O R2R2, K Neg Anti-A and Anti-B
Vial 4 Group AB rr, K Neg Anti-D
ALBAcheck®-BGSCatalogue Number
Description Pack Size
Z489 ALBAcheck-BGS Whole Blood SP control 4 x 6ml
Quotient
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ALBAcheck®-BGS High Titre Controls Kit
Intended for use as an internal, self assessment QA scheme.
It assesses the ability of an individual and/or the capability of
a method for detecting weak antibodies.
n Kit consists of: l 10 randomly selected serum samples l Results available ‘on-line’ – please enquire
n Ready to use, store at 2-8 C
n Closed vial stability: 1 year
n Validated for use in column technology and tube systems
For the control of high titre anti-A and anti-B testing of
blood donations. The kit provides a positive and negative
control (2 vials each), which should be tested in the same
way as the donation test samples.
In accordance with the Guidelines for Blood Transfusion
Services in the United Kingdom 7th Edition, the positive
control has a potency of greater than 1/128 and the
negative control less than 1/128.
n Unique product
n Open-vial stability: 2 weeks
Specially formulated weak sensitivity controls, designed to
stress testing platforms.
n Validated for use in column technologies
n Derived from a pool of donations
n Polyclonal material which presents as a normal weak sample
n Different specificities demonstrates ability to detect a range of weak antibodies
Sensitivity ControlsALBAcheck® -BGS Competency Test Kit
ALBAcheck®-BGS Competency Test KitCatalogue Number
Description Pack Size
Z276 ALBAcheck-BGS Competency Test Kit 10 x 2ml
Quotient
ALBAcheck®-BGS High Titre Controls KitCatalogue Number
Description Pack Size
Z257 ALBAcheck-BGS High Titre Controls Kit 4 x 6ml
Quotient
Sensitivity ControlsCatalogue Number
Description Pack Size
Z251 Anti-D 0.3iu/ml 10 x 10ml
Z252 ALBAcheck-BGS Anti-c (weak) 3 x 5ml
Z253 ALBAcheck-BGS Anti Fya (weak) 3 x 5ml
Z262 Anti-D Control 0.1 iu/ml Anti-D 3 x 5ml
Z263 Anti-D Control 0.05 iu/ml Anti-D 3 x 5ml
Quotient
A range of control reagents, which enables the user to
validate and control testing on an individual or batch basis.
Other Control Reagents
Other Control ReagentsCatalogue Number
Description Pack Size
Z256 Enzyme Control 10 x 10ml
Z271 Reagent Control for Anti-D (Use with Z031, Z036, Z039, Z041)
10 x 10ml
Z281 AB Serum (human) 10 x 5ml
Quotient
Reagent Red Cells
ALBAcyte® 2-3% Control Cells
2-3% Red Cell Panels for conventional manual tube and
microplate testing. All ALBAcyte® red cell reagents comply
with UK BTS Guidelines.
n For both conventional tube and microplate testing
n Panels manufactured from pre-selected donors to provide consistent quality
n Comply with UK BTS Guidelines
n Available on 4-weekly subscription order to ensure 28-day shelf life on receipt
ALBAcyte® 2-3% Control CellsCatalogue Number
Description Pack Size Recommended Use
Z401 A1 Cells 10ml Reverse grouping controls
Z406 A2 Cells 10ml Controls
Z411 B Cells 10ml Reverse grouping controls
Z416 O R1r Cells 10ml Controls
Z421 Orr Cells 10ml Controls
Z427 DVI Cells 5ml Controls
Z441 IgG Sensitised Cells 10ml Confirmation and controls
Quotient
At Alpha Laboratories we are proud to have achieved the international environmental management standard certification BS EN ISO 14001 : 2004. The standard provides a straight-forward approach to using less energy resource and reducing waste.
But we go beyond that, building into our business ways to help you and your laboratory become greener too...
■ Fastrak® - the most eco-friendly tip refill system
■ Laboratree tree planting programme - regenerating UK woodlands
■ Free plastic recycling scheme
Find out more at our website
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Pipette Servicingand Calibration
Regular service and calibration will ensure that the precision and accuracy of pipettes are
maintained and your laboratory’s results are not compromised. Through our experienced
calibration partner, we offer a full range of service options for all popular pipettes and dispensers
either at your own site or at our UKAS-accreditated calibration laboratory.
Workshop ServiceSend your pipettes into our workshop where qualified technicians will perform the service and calibration in a purpose-built, environmentally controlled area.
On-site ServiceOur technicians will bring their equipment to you and perform an on-site pipette clinic. This is ideally suited to larger quantities of pipettes and can be set up as a one-off visit or on a regular scheduled basis.
Service Levels
QUIKCHECKA quick and simple performance check
for when extensive measurements and
calibration are not required.
4 readings are taken at a single volume.
Every channel is checked across multichannel pipettes.
An ISO calibration certificate is included.
QUIKCHECK
UKASCalAccreditation by UKAS gives you the
confidence of full pipette calibration
traceability. 10 readings are taken at
each of the min/mid/max volumes and
a full UKAS certificate is issued.
UKAScalibration
FULLCHECKThis service includes cleaning, servicing
and a full range performance check
with 6 readings taken at the min/mid/
max volumes for complete linearity
assessment.
An ISO calibration certificate is supplied.
FULLCHECK
FixCheckThis service is for pipettes that are
no longer performing within the
manufacturer’s tolerances or are
damaged. It includes dismantling,
cleaning, servicing and a full range performance check.
An ISO calibration certificate is supplied.
This service is not available at on-site clinics.
FIXCHECK
For further information and a price guide, visit www.alphalabs.co.uk/pipette-service or call us on
0800 387 732 for a customised quotation.
Calibrations are carried out to DIN12650, ISO17025 and UKAS accreditation levels.
For all service levels, spare parts are detailed and charged separately.
Enjoy Your Work!Pipetting Academy™ for Better Ergonomics
Improve Your Liquid Handling Skills with Free Pipetting Academy™Seminars
n Get practical training on pipetting techniques to help you achieve more accurate and precise results.n Understand how to minimise the ergonomic risks of pipetting by choosing appropriate working postures, liquid handling instruments and accessoriesn Learn how to avoid strain injuries and make work more enjoyable.
Contact us or find out more at www.alphalabs.co.uk
Pipetting is the most common laboratory technique, yet it is frequently overlooked when it comes to user training.
A pipette’s performance is heavily dependent on the skill and expertise of the operator so incorrect handling can compromise the quality of results and cause repetitive strain injuries.
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Alpha Laboratories Limited40 Parham DriveEastleigh, HampshireSO50 4NU United Kingdom
Tel: 023 8048 3000Fax: 023 8064 3701Email: [email protected]: www.alphalabs.co.uk
Customer Account Number
ISO 9001Registered
QualityManagement 015
ISO 14001Registered
EnvironmentalManagement 015