third party controls qcqc solutions for results you can...
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QUALITY CONTROL
QQC trustComplete QC solutions for results you can trust
QQQUALITY CONTROL
Third Party Controls
Complete QC solutions for results you can trust
QQQUALITY CONTROL
Third Party Controls
Contact us for more information
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1
Chapter
1. Introduction 2 - 32. Benefits 4 - 93. Quality 10
Internal Quality Controls
4. Clinical Chemistry 11 - 225. Immunoassay 23 - 306. Immunology/Proteins 31 - 36 7. Lipids 37 - 408. Cardiac 41 - 449 Diabetes/Haemoglobin 45 - 48 10. Urine 49 - 5211. Therapeutic Drugs 53 - 5612. Toxicology 57 - 6013. Haematology 61 - 6414. Blood Gas 65 - 6815. Speciality and Research Controls 69 - 7616. Customized Quality Control Sera 77 - 82
Interlaboratory Data Management
17. Acusera 24•7 83 - 86
Proficiency Testing
18. RIQAS 87 - 94 Analyte Index
19. Analyte Index 95 - 10820. A - Z Index 109 - 111
Page No.
Hematology ControlsChapter 13
Table of Contents
2
Patient health is reliant on accurate and timely diagnosis but this can only be facilitated through the use of high quality diagnostic testing solutions.
Given that over 70% of all medical decisions are based on laboratory test results it is extremely important accurate and reliable results are provided the first time. With over 30 years’ experience the Randox Quality Control range is designed to help medical laboratories ensure just this. Our range of QC solutions are designed primarily with user convenience and patient safety in mind and includes true third party quality controls & calibrators, proficiency testing and interlaboratory data management.
With products and solutions available to suit all areas of laboratory medicine including routine chemistry, special chemistry, toxicology, serology, immunology, hemostasis and respiratory care our customer base exceeds 100,000 laboratories in all four corners of the world.
Our continued focus on research and development allows us to not only review existing products but to rapidly bring new products to the market with the view to continually improve customer choice and support. We believe that by providing laboratories with appropriate knowledge and tools we can help to improve patient health on a global scale.
“Revolutionizing healthcare through continuouslyimproving diagnostic solutions”
Introduction
For more information about Randox and for our full range of products, please visit www.randoxqc.com, or contact your local Randox representative.
Complete QC solutions for results you can trust
Welcome
3
Randox is one of the largest manufacturers of Quality Controls in the world, whether it is our own branded Acusera portfolio of controls and calibrators, or customized material for individual laboratories, research organizations, Proficiency Testing schemes and other diagnostic manufacturers.
With over 350 parameters available in our Acusera range, choice and flexibility is guaranteed. Principle control products include Clinical Chemistry, Immunoassay, Urine, Immunology/Proteins, Lipids, Cardiac, CSF, Therapeutic Drug Monitoring, Toxicology, Urine Chemistry, Urinalysis, Coagulation, Blood Gas, Tumour Markers, Maternal Screening, Antioxidants, Diabetes and a number of research based products.
A wide range of formats are available, providing greater flexibility and choice. Our product range includes liquid/lyophilized, assayed/unassayed and human/bovine materials.
Customers can even choose between multi-analyte controls or single analyte controls, depending on their laboratory needs. In addition to this, Randox can also offer the laboratory a tailor made quality control material, should there be something you wish to adjust or change. This could be anything from the number of analytes, vial sizes, concentrations or format we present current products in.
Randox also offers Acusera 24•7, an interlaboratory peer group reporting software package, designed to assist laboratories when managing and interpreting QC data. Online access anytime, anywhere to interactive charts, reports and peer group statistics uniquely updated every 24 hours will improve error detection and enable real time performance monitoring across multiple platforms.
Introduction
Introduction to Randox Acusera Quality Controls
4
MaterialThe human based material used in the production of our Quality Controls is sourced from the United Kingdom Blood Transfusion Service. All donors are screened for infectious diseases, using immunoassay techniques to detect antibodies and specific DNA tests to detect any viruses even at early stages of infection. This view to safety and quality is the trademark of Randox control manufacture.
Our lyophilized controls have no added preservatives or stabilizers which can cause interference. The excellent stability seen with Randox controls is achieved through superior manufacturing techniques and strict adherence to a regulated quality manufacturing regime. All Randox quality controls are filtered down to 0.2 microns to ensure minimal bacterial load and contamination. The ideal quality control should not only have a matrix similar to real life patient samples but should also behave in the same manner as a patient sample, if a QC sample meets both these requirements then we can say it is commutable.
The value of a commutable control material is internationally recognized, ISO 15189 states that laboratories must “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
In reality it is not uncommon for a change in reagent batch to cause a shift in QC results that is not reflected in patient samples this ultimately leads to a frequent need to re-assign control values which can be both time consuming and expensive. Randox controls are proven to be the most commutable on the market meeting the requirements set out in ISO 15189 and eliminating the need to constantly re-assign target values when a reagent batch is changed or expires.
Benefits
5
Value AssignmentRandox controls are the most accurately assigned controls available in the diagnostic industry! Our unique value assignment process employs over 28,000 laboratory participants worldwide ensuring the availability of data for a wide range of instruments and methods.This, coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.
For effective Internal Quality Control, an assayed serum should have an accurately assigned target value and range for each analyte; this will allow laboratories to reliably measure the accuracy and reproducibility of the method in use. The assigned value for each analyte is generally a consensus mean obtained from multiple laboratories. Obviously the more laboratories employed, the better ; smaller numbers usually result in large standard deviations and subsequently unrealistic wide ranges. In fact, with some manufacturers, the ranges are often so wide that laboratories are unlikely to fall outside them regardless of their performance.
Benefits
6
ConsolidationRandox is a world leading provider of multi-analyte, third party controls designed to help streamline QC in even the most demanding laboratories. Our unique combination of analytes enables complete test menu consolidation and will ultimately reduce costs without compromising on quality or performance. The use of fewer controls will decrease the time spent preparing multiple controls, increase storage space and simplify QC procedures in any lab.
Many manufacturers ‘cut corners’ in an attempt to keep costs low, this can result in unrealistic values and ultimately controls that do not adequately cover the clinical range. The inclusion of analytes at clinically relevant concentrations in all Randox controls will eliminate the need to purchase additional low or high level controls at extra expense.
Benefits
7
Third Party ControlsOur complete range of true third party controls is designed to provide unbiased performance assessment across a wide range of instruments and methods. By this we mean that our material has not been manufactured in line with, or optimized for use with any particular reagent, method or instrument and is designed to be compatible for use on any analyzer. Also, when assigning targets and ranges, Randox uses totally independent laboratories, resulting in genuinely independent, multi-method and multi-analyzer data.
Instrument and reagent manufacturers often directly assign their own control values, meaning very few sets of results are used over very few reagent batches. The resulting target values are therefore not as accurate as an assayed control ought to be.
Benefits
8
StabilityProduct shelf-life and stability is an important consideration when choosing quality control material. Our lyophilized controls generally have a shelf life of up to 4 years from the date of manufacture while our liquid controls are stable for up to 2 years ensuring continuity of lot supply.
Each individual control will have its own reconstituted or open vial stability claims and some parameters will have limitations, but we pride ourselves by not trying to mislead customers with false claims. The extended reconstituted and open vial stability of many Randox controls will help laboratories to minimize waste and ultimately reduce costs.
Benefits
9
TraceabilityTraceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.
The values assigned to both calibrators and control materials are required by the European parliament and council directive 98/79/EC on in vitro diagnostic medical devices to be traceable to a recognized reference material or reference measurement procedure of higher order e.g. SI units.
The European standards EN/ISO17511and EN/ISO18153 on traceability have set guidelines for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability.
The adjacent traceability pathway has been established with reference to standards ISO17511 and ISO18153 and has been followed to establish traceability for Randox calibrators allowing patient results to be traced back to the source.
MET
ROLO
GIC
AL
TR
AC
EABI
LIT
Y
Primary calibrator
Secondary calibrator
working calibrator
product calibrator
Routine sample or control material
Primary reference measurement procedure
Secondary reference measurement procedure
measurement procedure
measurement procedure
measurement procedure
Patient result/Randox Acusera control result
Laboratories
Trueness controls
International
Organizations
UN
CER
TA
INT
Y O
F M
EASU
REM
ENT
TRACING PATIENT RESULTS TO THE ORIGIN
IVD Manufacturer
Adopted from EN ISO 17511
TRACEABILITY PATHWAY
Manufacturer’s
Manufacturer’s
Manufacturer’s selected
Manufacturer’s standing
Lab’s routine
Benefits
10
Randox is committed to quality at every stage of the production process from research and development to customer support. This commitment has been recognized through official accreditation to both national and international standards including UKAS and ISO.
Accreditation to international standards ensures confidence in the quality and consistency of the products and services provided by Randox, and demonstrates compliance to internationally agreed standards.
Commitment to Quality
The United Kingdom Accreditation Service (UKAS) is the only national accreditation body recognized by the government to assess against internationally agreed standards.
In 2002 the systems and procedures within Randox Laboratories Ltd were accredited with UKAS approval to ISO/IEC 17043:2010 “Conformity assessment - General requirements for proficiency testing”
UKAS
The International Organization for Standardization (ISO) is the largest developer and publisher of international standards in the world. In 2003, Randox was accredited with ISO 13485:2003 approval.
ISO 13485:2003 relates to the design/development, manufacture, service and distribution of in vitro diagnostic medical devices, in vitro diagnostic test kits, in vitro diagnostic reagents and in vitro diagnostic analyzers.
ISO 13485:2003 highlights the requirements for a quality management system where an organization needs to prove its ability to provide medical devices and other related services that consistently meet regulatory requirements.
ISO 13485:2003
Many of our Quality Control (QC) products are CE certified and carry the CE mark. CE marking on a product indicates that the product complies with and has satisfied the essential requirements set out by the In Vitro Diagnostic (IVD) Medical Devices Directive 98/79/EC, it also demonstrates the fact the product is fit for its intended purpose.
The CE mark is also a declaration from the manufacturer that the product has met all legislation in relation to health and safety and where required has been assessed in accordance with this legislation.
CE marking is essential for products to be placed on the market and sold in the European Union (EU). It also ensures the free movement of product within the EFTA and EU.
CE Mark
Many of our quality controls and calibrators are FDA cleared and therefore appropriate for sale in the USA. In order for an IVD to be approved for sale in the USA it must not only be safe for use and effective but it must also satisfy the requirements set out in part 820 title 21 of the Code of Federal Regulations published by the FDA.
FDA Cleared
Many Randox products, including our quality controls and calibrators, are licensed for use in Canada. Before an IVD device can be sold in Canada, it must meet the requirements set out in the Therapeutic Products Directorate. Health Canada review all medical devices to assess their safety, effectiveness and quality before they are authorized for sale.
Canadian Medical Device Regulations from Health Canada
Quality
abc
1111
Clinical Chemistry Controls
Chapter 4
12
CLINICAL CHEMISTRY PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Liquid Assayed Chemistry Premium Plus Level 1 12 x 5 ml LAL4213
Liquid Assayed Chemistry Premium Plus Level 2 12 x 5 ml LAN4214
Liquid Assayed Chemistry Premium Plus Level 3 12 x 5 ml LAE4215
Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048
Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049
Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069
Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070
Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071
Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093
Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094
Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE5095
Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532
Assayed Chemistry Premium Plus Level 2 & 3 2 x 5 x 5 ml HS2611
Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558
Bovine Chemistry (Precision) Level 1 20 x 5 ml SL1084
Bovine Chemistry (Precision) Level 2 20 x 5 ml SN1085
Bovine Chemistry (Precision) Level 3 20 x 5 ml SE1086
Clinical Chemistry Calibration Sera Level 2 20 x 5 ml CAL2350
Clinical Chemistry Calibration Sera Level 3 20 x 5 ml CAL2351
Aldolase Calibrator 3 x 1 ml AD5000
Aldolase Control Level 2 3 x 1 ml AD5001
Aldolase Control Level 3 3 x 1 ml AD5002
Ammonia / Ethanol Control Level 1 6 x 2 ml EA1366
Ammonia / Ethanol Control Level 2 6 x 2 ml EA1367
Ammonia / Ethanol Control Level 3 6 x 2 ml EA1368
Multi Calibrator 3 x 2 ml MC1382
Multi Control Level 1 5 x 2 ml MC1379
Multi Control Level 2 5 x 2 ml MC1380
Multi Control Level 3 5 x 2 ml MC1381
Serum Diluent 20 x 5 ml MS5007
13
With instrument specific target values provided for 100 analytes, the Acusera Liquid Assayed Chemistry Premium Plus control is the most comprehensive on the market. Our unique combination of proteins, lipids, immunoassays, cardiac markers, therapeutic drugs and routine chemistry analytes enables effective consolidation and cost savings. As a true third party control, target values are available for most major analyzers.
• Liquid for ease of use • Human based serum • Assayed instrument specific target values and ranges• High levels of CRP and other proteins eliminate the need for multiple controls • Stable to expiry when stored at -20oC to -70oC• Open vial stability of up to 7 days at 2oC to 8oC
LIQUID ASSAYED CHEMISTRY PREMIUM PLUS - Assayed Control
CARDIACCK
MyoglobinTroponin T
ELECTROPHORESISAlbumin
α-1-Globulinα-2-Globulinβ-Globulinγ-Globulin
IMMUNOASSAYAFPCEA
Cortisol DHEA Sulphate
Folate Free T3Free T4
FSH hCG
Leuteinising Hormone (LH)Progesterone
ProlactinPSA TotalTotal T3Total T4
Testosterone TSH
T UptakeVitamin B12
LIPIDS
Apolipoprotein A-IApolipoprotein B
Cholesterol HDLLDLLP(a)
Triglycerides
PROTEINSα-1- Acid Glycoprotein
α-1-Antitrypsinβ-2-Microglobulin
Ceruloplasmin Complement C3Complement C4
CRP Ferritin
HaptoglobinIgAIgEIgGIgM
PrealbuminProtein TotalTransferrin
TRACE METALSCopper
Zinc
DRUGSAcetaminophen
AmikacinCaffeine
CarbamazepineDigoxinEthanol
GentamicinLithium
Phenobarbital Phenytoin Salicylate
TheophyllineValproic AcidVancomycin
ROUTINE CHEMISTRYAcid Phosphatase (Total)
Albumin Alkaline Phosphatase
α-HBDHALT (SGPT)
AmylaseAmylase (Pancreatic)
AST (SGOT)Bicarbonate
Bile AcidsBilirubin (Direct)Bilirubin (Total)
CalciumCalcium Ionised
ChlorideCholinesterase
Creatinine D-3-Hydroxybutyrate
γGTGLDHGlucose
IronLactate
LAPLDHLipase
MagnesiumOsmolality
Phosphate InorganicPotassiumSodiumTIBCUrea
Uric Acid
Analytes
Description Size Cat. No.
Liquid Assayed Chemistry Premium Plus Level 1 12 x 5 ml LAL4213
Liquid Assayed Chemistry Premium Plus Level 2 12 x 5 ml LAN4214
Liquid Assayed Chemistry Premium Plus Level 3 12 x 5 ml LAE4215
Clinical Chemistry
14
An unassayed, comprehensive chemistry control suitable for use with all major instruments and methodologies, contains 92 analytes including routine chemistries, cardiac markers, proteins, immunoassay parameters, lipids, therapeutic drugs and electrophoresis.
• Liquid for ease of use• Human based serum• Stable to expiry date when stored at -20oC to -70ºC• Open vial stability of 7 days at 2oC to 8ºC• Typical values provided for all analytes
LIQUID CHEMISTRY PREMIUM - Unassayed Control
Description Size Cat. No.
Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048
Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049
CARDIACCK
MyoglobinTroponin ITroponin T
ELECTROPHORESISAlbumin
a-1-globulina-2-globulinβ-1-globulinγ-globulin
IMMUNOASSAYAFPCEA
Cortisol FolateFree T3Free T4hCG
ProlactinTotal T3Total T4
TSHVitamin B12
LIPIDSApolipoprotein A-IApolipoprotein B
CholesterolHDLLDLLP(a)
Triglycerides
PROTEINSa-1-Acid Glycoprotein
a-1-AntitrypsinCeruloplasmin
Complement C3Complement C4
CRPFerritin
HaptoglobinIgAIgEIgGIgM
PrealbuminTotal ProteinTransferrin
DRUGSAcetaminophenCarbamazepine
DigoxinEthanol
GentamicinLithium
PhenobarbitalPhenytoinSalicylate
TheophyllineValproic AcidVancomycin
TRACE METALSCopper
Zinc
ROUTINE CHEMISTRYAcid Phosphatase (Prostatic)
Acid Phosphatase (Total)Albumin
Alkaline PhosphataseALT (SGPT)
AmylaseAmylase (Pancreatic)
AST (SGOT)
BicarbonateBile Acids
Bilirubin (Direct)Bilirubin (Total)Cholinesterase
CalciumCalcium (Ionized)
ChlorideCreatinine
γGT GlucoseGLDH
a-HBDH D-3-Hydroxybutyrate
IronTIBCLAP
LD (LDH)LipaseLactate
MagnesiumOsmolality
Phosphate (Inorganic)PotassiumSodiumUrea
Uric Acid (Urate)
Analytes
Clinical Chemistry
15
LIQUID CHEMISTRY PREMIUM PLUS - Unassayed Control
Multi-analyte, unassayed chemistry control. Combining more than 100 analytes including routine chemistries, cardiac markers, lipids, therapeutic drugs, proteins, immunoassay parameters and electrophoresis.
• Liquid for ease of use• Human based serum • High CRP levels also eliminate the need for separate controls• Stable to expiry date at -20ºC to -70ºC • Open vial stability of 7 days at 2oC to 8ºC • Typical values provided for all analytes
Description Size Cat. No.
Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069
Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070
Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071
Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093
Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094
Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE5095
Analytes
CARDIACCK
CK-MBMyoglobin Troponin I Troponin T
ELECTROPHORESISAlbumin
a-1-globulin a-2-globulin β-1-globulin γ-globulin
IMMUNOASSAYAFP CEA
CortisolDHEA Sulphate
FolateFree T3 Free T4FSH
Growth Hormone (GH)hCG
Leuteinising Hormone (LH)Progesterone
ProlactinTotal T3Total T4
Testosterone
TSHT uptake
Vitamin B12
LIPIDSApolipoprotein A-1Apolipoprotein B
Cholesterol HDL LDL LP(a)
Triglycerides
PROTEINSa-1-Acid Glycoprotein
a-1-Antitrypsinβ-2-Microglobulin
Ceruloplasmin Complement C3 Complement C4
CRP Ferritin
Haptoglobin IgA IgE IgG IgM
Prealbumin Total Protein Transferrin
ROUTINE CHEMISTRYAcid Phosphatase (Prostatic)
Acid Phosphatase (Total) Albumin
Alkaline PhosphataseALT (SGPT)
Amylase Amylase (Pancreatic)
AST (SGOT) Bicarbonate Bile Acids
Bilirubin (Direct) Bilirubin (Total) Cholinesterase
Calcium Calcium (Ionized)
Chloride Creatinine
γGT Glucose GLDH
a-HBDH D-3-Hydroxybutyrate
Iron TIBC LAP
LD (LDH) Lipase Lactate
Magnesium Osmolality
Phosphate (Inorganic) Potassium Sodium Urea
Uric Acid (Urate)
DRUGSAcetaminophen
AmikacinCaffeine
Carbamazepine Digoxin Ethanol
Gentamicin Lithium
Phenobarbital Phenytoin Salicylate
Theophylline Valproic Acid Vancomycin
TRACE METALSCopper
Zinc
Clinical Chemistry
16
ASSAYED CHEMISTRY PREMIUM PLUS CONTROL - Assayed Control
A comprehensive assayed chemistry control designed for use in the routine monitoring of both accuracy and reproducibility. This product contains method, instrument and temperature specific target values and ranges for 70 analytes on a wide range of analyzers. Electrophoresis targets are also provided as a % breakdown of total protein.
• Lyophilized for enhanced stability• Human based serum • Typical Osmolality values: Level 2 is 300 mOsm/kg, Level 3 is 370 mOsm/kg• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC or 4 weeks at -20ºC
Description Size Cat. No.
Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532
Assayed Chemistry Premium Plus Level 2 & 3 2 x 5 x 5 ml HS2611
Serum Diluent 20 x 5 ml MS5007
LIPIDSApolipoprotein A-1Apolipoprotein B
Cholesterol HDLNEFA
Triglycerides
CARDIACCK
DRUGSAcetaminophen
Digoxin Gentamicin
LithiumSalicylate
TheophyllineTobramycin
IMMUNOASSAY Cortisol Folate
PSATSH
Total T3Free T4Total T4
Vitamin B12
PROTEINSIgAIgGIgM
Total ProteinTransferrin
ELECTROPHORESISAlbumin
a-1-globulin a-2-globulin β-1-globulin γ-globulin
TRACE METALSCopper
Zinc
ROUTINE CHEMISTRYAcid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)Acid Phosphatase (Total)
AlbuminAlkaline Phosphatase
ALT (SGPT)Amylase
Amylase (Pancreatic)AST (SGOT)BicarbonateBile Acids
Bilirubin (Direct)Bilirubin (Total)Cholinesterase
CalciumChloride
CreatinineGlucose
γGTGLDH
a-HBDHD-3-Hydroxybutyrate
IronTIBCLAP
LD (LDH)Lipase (Colorimetric)Lipase (Turbidimetric)
LactateMagnesiumOsmolality
Phosphate (Inorganic)PotassiumSodiumUrea
Uric Acid (Urate)
Analytes
Clinical Chemistry
17
Description Size Cat. No.
Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558
Serum Diluent 20 x 5 ml MS5007
Unassayed, multi-analyte control designed for use in the routine monitoring of reproducibility. Contains 86 analytes including a wide range of proteins, lipids and immunoassay parameters with additional analytes present at measurable levels.
• Lyophilized for enhanced stability• Human based serum • Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC or 4 weeks at -20ºC
PRECISION CHEMISTRY PREMIUM PLUS CONTROL - Unassayed Control
Analytes
CARDIACCK
MyoglobinTroponin I
IMMUNOASSAYAFPCEA
CortisolFolateFree T3Free T4hCG
ProlactinPSA
Total T3Total T4TSH
Vitamin B12
LIPIDSApolipoprotein A-IApolipoprotein B
CholesterolHDLNEFA
Triglycerides
PROTEINSa-1-Acid Glycoprotein
a-1-AntitrypsinCeruloplasmin
Complement C3Complement C4
CRPFerritin
HaptoglobinIgAIgEIgGIgM
PrealbuminTotal ProteinTransferrin
DRUGSAcetaminophen Carbamazepine
DigoxinGentamicin
LithiumPhenobarbital
PhenytoinSalicylate
Theophylline
TobramycinValproic AcidVancomycin
TRACE METALSCopper
Zinc
ROUTINE CHEMISTRYAcid Phosphatase (Prostatic)
Acid Phosphatase (Total)Albumin
Alkaline PhosphataseALT (SGPT)
AmylaseAmylase (Pancreatic)
AST (SGOT)BicarbonateBile Acids
Bilirubin (Direct)Bilirubin (Total)Cholinesterase
CalciumChloride
CreatinineγGT
Glucose
GLDH a-HBDH
D-3-HydroxybutyrateIronTIBCLAP
LD (LDH)LipaseLactate
MagnesiumOsmolality
Phosphate (Inorganic)PotassiumSodiumUIBCUrea
Uric Acid (Urate)
Clinical Chemistry
18
Description Size Cat. No.
Bovine Chemistry Precision Level 1 20 x 5 ml SL1084
Bovine Chemistry Precision Level 2 20 x 5 ml SN1085
Bovine Chemistry Precision Level 3 20 x 5 ml SE1086
Serum Diluent 20 x 5 ml MS5007
A comprehensive bovine based, unassayed control designed for use in the routine monitoring of reproducibility. Contains 45 analytes including commonly used veterinary parameters such as NEFA, Bile Acids, Lactate and D-3-Hydroxybutyrate.
• Lyophilized for enhanced stability• Bovine based serum• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC or 4 weeks at -20ºC
BOVINE CHEMISTRY PRECISION CONTROL - Unassayed Control
Analytes
LIPIDSCholesterol
NEFATotal LipidsTriglycerides
CARDIACCK
DRUGSLithium
IMMUNOASSAY Cortisol
PSATotal T3Free T4Total T4
PROTEINSTotal Protein
TRACE METALSCopper
Zinc
ROUTINE CHEMISTRYAcid Phosphatase (Prostatic)
Acid Phosphatase (Total)Albumin
Alkaline PhosphataseALT (SGPT)
AmylaseAST (SGOT)BicarbonateBile Acids
Bilirubin (Direct)Bilirubin (Total)
CalciumChloride
CreatinineGlucose
γGTGLDH
a-HBDHD-3-Hydroxybutyrate
Iron Lactate
LD (LDH)Lipase
MagnesiumOsmolality
Phosphate (Inorganic)PotassiumSodiumTIBCUrea
Uric Acid (Urate)
Clinical Chemistry
19
CLINICAL CHEMISTRY CALIBRATION SERUM - Calibrator
Multi-analyte calibrator designed for use in the calibration of commonly used clinical chemistry tests. Method, instrument and temperature specific values are provided for 42 analytes on a wide range of clinical analyzers.
• Lyophilized for enhanced stability• Human based serum• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC or 4 weeks at -20ºC
Description Size Cat. No.
Clinical Chemistry Calibration Serum Level 2 20 x 5 ml CAL2350
Clinical Chemistry Calibration Serum Level 3 20 x 5 ml CAL2351
Analytes
LIPIDSCholesterol Triglycerides
CARDIACCK
DRUGSLithium
PROTEINSTotal Protein
TRACE METALS Copper
Zinc
ROUTINE CHEMISTRY Acid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)Acid Phosphatase (Total)
Albumin Alkaline Phosphatase
ALT (SGPT)Amylase (Pancreatic)
Amylase (Total)AST (SGOT)BicarbonateBile Acids
Bilirubin (Direct)Bilirubin (Total)
CalciumChloride
CholinesteraseCreatinine
D-3-HydroxybutyrateγGT
GLDHGlucosea-HBDH
Iron LactateLDHLAP
LipaseMagnesiumOsmolality
Phosphate (Inorganic)
PotassiumSodiumTIBCUrea
Uric Acid (Urate)
Clinical Chemistry
20
Human based materials designed for use in the calibration and control of Aldolase assays.
• Lyophilized for enhanced stability• Human based serum• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 5 days at 2oC to 8oC
ALDOLASE CONTROL & CALIBRATOR - Assayed Control
Description Size Cat. No.
Aldolase Calibrator 3 x 1 ml AD5000
Aldolase Control Level 2 3 x 1 ml AD5001
Aldolase Control Level 3 3 x 1 ml AD5002
Description Size Cat. No.
Ammonia / Ethanol Control Level 1 6 x 2 ml EA1366
Ammonia / Ethanol Control Level 2 6 x 2 ml EA1367
Ammonia / Ethanol Control Level 3 6 x 2 ml EA1368
A liquid ready-to-use control designed to monitor both the accuracy and reproducibility of Ammonia and Ethanol assays.
• Liquid ready-to-use• Aqueous material• Stable to expiry date at 2oC to 8ºC • Open vial stability of 30 days at 2oC to 8ºC
AMMONIA / ETHANOL CONTROL - Assayed Control
Ammonia Ethanol
Analytes
Clinical Chemistry
21
*FOR BIOTECHNOLOGY INDUSTRIAL USE. Not for use in diagnostic procedures.
*FOR BIOTECHNOLOGY INDUSTRIAL USE. Not for use in diagnostic procedures.
Description Size Cat. No.
Multi Calibrator 3 x 2 ml MC1382
Multi Control Level 1 5 x 2 ml MC1379
Multi Control Level 2 5 x 2 ml MC1380
Multi Control Level 3 5 x 2 ml MC1381
A multi-analyte control designed for use in the routine monitoring of accuracy and precision.
• Liquid ready-to-use • Human based serum• Stable to expiry date at 2oC to 8ºC
MULTI CONTROL & CALIBRATOR - Assayed Control*
Analytes
AmmoniaGlucose
GlutamateLactate
Description Size Cat. No.
Glutamine Control Level 1 5 x 5 ml GM1376
Glutamine Control Level 2 5 x 5 ml GM1377
Glutamine Control Level 3 5 x 5 ml GM1378
Glutamine Calibrator 10 x 5 ml GM1375
A dedicated control designed for use in the quality control of the Randox Glutamine assay.
• Lyophilized for enhanced stability• 100% human material• Stable to expiry at 2oC to 8ºC • Reconstituted stability of 7 days at 2oC to 8ºC
GLUTAMINE CONTROL - Assayed Control*
Clinical Chemistry
22
Clinical Chemistry
23
ImmunoassayControls
Chapter 5
24
Immunoassay
IMMUNOASSAY PRODUCT RANGE
PRODUCT DESCRIPTION SIZE CAT. NO.Immunoassay Control Premium Level 1 12 x 5 ml IA2638
Immunoassay Control Premium Level 2 12 x 5 ml IA2639
Immunoassay Control Premium Level 3 12 x 5 ml IA2640
Immunoassay Control Premium Tri-Level 4 x 3 x 5 ml IA2633
Liquid Immunoassay Control Premium Level 1 12 x 5 ml LIA3105
Liquid Immunoassay Control Premium Level 2 12 x 5 ml LIA3106
Liquid Immunoassay Control Premium Level 3 12 x 5 ml LIA3107
Liquid Immunoassay Control Premium Tri-Level 4 x 3 x 5 ml LIA3108
Immunoassay Control Premium Plus Level 1 12 x 5 ml IA3109
Immunoassay Control Premium Plus Level 2 12 x 5 ml IA3110
Immunoassay Control Premium Plus Level 3 12 x 5 ml IA3111
Immunoassay Control Premium Plus Tri-Level 4 x 3 x 5 ml IA3112
Liquid Immunoassay Control Premium Plus Level 1 12 x 5 ml LIA5142
Liquid Immunoassay Control Premium Plus Level 2 12 x 5 ml LIA5143
Liquid Immunoassay Control Premium Plus Level 3 12 x 5 ml LIA5144
Immunoassay Speciality I Control Level 1 5 x 2 ml IAS3113
Immunoassay Speciality I Control Level 2 5 x 2 ml IAS3114
Immunoassay Speciality I Control Level 3 5 x 2 ml IAS3115
Immunoassay Speciality II Control Level 1 5 x 1 ml IAS3117
Immunoassay Speciality II Control Level 2 5 x 1 ml IAS3118
Immunoassay Speciality II Control Level 3 5 x 1 ml IAS3119
Liquid Tumour Marker Control Level 1 6 x 3 ml TU5085
Liquid Tumour Marker Control Level 2 6 x 3 ml TU5086
Liquid Tumour Marker Control Level 3 6 x 3 ml TU5087
Maternal Screening Control Level 1 3 x 1 ml MSS5024
Maternal Screening Control Level 2 3 x 1 ml MSS5025
Maternal Screening Control Level 3 3 x 1 ml MSS5026
25
Description Size Cat. No.
Immunoassay Premium Level 1 10 x 5 ml IA2638
Immunoassay Premium Level 2 10 x 5 ml IA2639
Immunoassay Premium Level 3 10 x 5 ml IA2640
Immunoassay Premium Tri-level 4 x 3 x 5 ml IA2633
A comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed, instrument specific target values and ranges are provided for 51 analytes, including fertility and thyroid hormones, steroid hormones, kidney function tests, therapeutic drugs and vitamins.
• Lyophilized for enhanced stability• 100% human serum• Ferritin and Vitamin B12 levels suitable for Anemia monitoring• TSH levels around 0.11 μU/ml in the level 1 control • Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC, or up to 4 weeks at -20ºC
IMMUNOASSAY PREMIUM CONTROL - Assayed Control
17-OH-Progesterone Acetaminophen
ACTHAFP
AldosteroneAmikacin
β-2-MicroglobulinCarbamazepine
CEAC Peptide
hCGCortisol
DHEA-Sulphate
DigoxinEstradiolEstriol
EthosuximideFerritinFolateFree T3Free T4FSH
GentamicinGrowth Hormone (GH)
IgEInsulin
Leuteinising Hormone (LH)Phenobarbital
PhenytoinPrimidone
ProgesteroneProlactin
PSA (Free)PSA (Total)PTH (intact)
Salicylate SHBG
TestosteroneTestosterone (Free)*
TheophyllineThyroglobulin
Total T3 Total T4
TobramycinTSH
T UptakeValproic AcidVancomycinVitamin B12
1-25-(OH)2-Vitamin D*25-OH-Vitamin D
Analytes
*For international use only. Not available for diagnostic use in the United States.
Immunoassay
26
Analytes
Immunoassay
Description Size Cat. No.
Liquid Immunoassay Premium Level 1 12 x 5 ml LIA3105
Liquid Immunoassay Premium Level 2 12 x 5 ml LIA3106
Liquid Immunoassay Premium Level 3 12 x 5 ml LIA3107
Liquid Immunoassay Premium Tri-Level 12 x 5 ml LIA3108
A comprehensive control designed for use in the routine monitoring of accuracy and precision. Assayed values are available for multiple instruments covering 44 analytes, including fertility and thyroid hormones, steroid hormones, kidney function tests, therapeutic drugs and vitamins. Compatible for use on most immunoassay systems.
• Liquid for ease of use• 100% human serum• Stable to expiry date at -20oC to - 70ºC• Open vial stability of 7 days at 2oC to 8ºC
LIQUID IMMUNOASSAY PREMIUM CONTROL - Assayed Control
17-OH- Progesterone Acetaminophen
AFPAldosterone*
Amikacinβ-2-Microglobulin*
CarbamazepineCEAhCG
CortisolDHEA-Sulphate
DigoxinEstradiolEstriol*
EthosuximideFerritinFolateFree T3Free T4FSH
GentamicinGrowth Hormone (GH)
IgEInsulin
Leuteinising Hormone (LH)Phenobarbital*
PhenytoinPrimidone
ProgesteroneProlactin
PSA (Free)PSA (Total)Salicylate
SHBGTestosteroneTheophyllineTobramycin
Total T3 Total T4
TSHT Uptake
Valproic AcidVancomycinVitamin B12
Analytes
*For international use only. Not available for diagnostic use in the United States.
27
Description Size Cat. No.
Immunoassay Premium Plus Level 1 12 x 5ml IA3109
Immunoassay Premium Plus Level 2 12 x 5ml IA3110
Immunoassay Premium Plus Level 3 12 x 5ml IA3111
Immunoassay Premium Plus Tri-Level 12 x 5 ml IA3112
A comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target values and ranges are provided for 54 analytes, including fertility and thyroid hormones, steroid hormones, cardiac & tumour markers, kidney function tests, therapeutic drugs and vitamins. Compatible for use on a wide range of immunoassay analyzers.
• Lyophilized for enhanced stability• 100% human serum• Ferritin and Vitamin B12 levels suitable for Anemia monitoring • TSH targets are around 0.11 μU/ml in Level 1 control• Contains routinely run tumour markers: AFP / CA15-3 / CA19-9 / CA-125 / CEA / PSA / Free-PSA• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 7 days at 2ºC to 8ºC or 4 weeks at -20ºC
IMMUNOASSAY PREMIUM PLUS CONTROL - Assayed Control
17-OH-Progesterone*Acetaminophen
ACTHAldosterone
AlphafoetoproteinAmikacin
Androstenedioneβ-2-Microglobulin
CA15-3CA19-9CA125
CarbamazepineCEA
Cortisol
C PeptideDHEA-Sulphate
DigoxinEstradiol Estriol*
Ethosuximide*FerritinFolateFree T3Free T4 FSH
GentamicinGrowth Hormone (GH)
hCG
IgEInsulin
Leuteinising Hormone (LH)PTH (Intact)
Phenobarbital* PhenytoinPrimidone
ProgesteroneProlactin
PSA (Free)PSA (Total)SalicylateSHBG
T Uptake
TestosteroneTestosterone (Free)*
TheophyllineThyroglobulin
TSHTobramycin
Total T3Total T4
Valproic AcidVancomycinVitamin B12
1-25-(OH)2 - Vitamin D*25-OH - Vitamin D
*For international use only. Not available for diagnostic use in the United States.
Immunoassay
Analytes
28
Immunoassay
Combining over 50 analytes including routine tumour markers, cardiac markers, therapeutic drugs, hormones and Vitamin D our Liquid Immunoassay Premium Plus control is designed to significantly reduce the number of individual controls required whilst remaining easy and convenient to use. As a true third party
control it is ideal for monitoring precision on a wide range of immunoassay platforms.
• Liquid for ease of use • 100% human serum• Contains routinely run tumour markers: AFP / CA15-3 / CA19-9 / CA-125 / CEA / PSA / Free-PSA • Stable to expiry date at -20oC to - 70ºC• Open vial stability of up to 7 days at 2oC to 8°C
25-OH-Vitamin D17-OH-Progesterone
AcetaminophenACTHAFP
AldosteroneAndrostenedione
C-Peptideβ-2-microglobulin
CA125CA15-3CA19-9
CarbamazepineCEA
CortisolDHEA- Sulphate
DigoxinFerritinFolateFSH
Free T3Free T4
GentamicinGrowth Hormone (GH)
hCGHomocysteine
IgEInsulin Like Growth Factor 1(IGF 1)
InsulinLeuteinising Hormone (LH)
NT-proBNPOestradiol
PhenobarbitalPhenytoin
ProgesteroneProlactin
PSA (Free)PSA (Total)
PTHSHBG
T UptakeTestosterone
TheophyllineThyroglobulinTobramycin
Total Beta hCGTotal T3Total T4
Anti-Thyroperoxidase (Anti-TPO)Troponin ITroponin T
TSHValproic AcidVancomycinVitamin B12
Analytes
Description Size Cat. No.
Liquid Immunoassay Premium Plus Level 1 12 x 5 ml LIA5142
Liquid Immunoassay Premium Plus Level 2 12 x 5 ml LIA5143
Liquid Immunoassay Premium Plus Level 3 12 x 5 ml LIA5144
LIQUID IMMUNOASSAY PREMIUM PLUS CONTROL - Unassayed Control
29
Description Size Cat. No.
Immunoassay Speciality I Level 1 5 x 2 ml IAS3113
Immunoassay Speciality I Level 2 5 x 2 ml IAS3114
Immunoassay Speciality I Level 3 5 x 2 ml IAS3115
A multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 10 more complex, specialized parameters to complement the routine immunoassay control.
• Lyophilized for enhanced stability• 100% human serum• Assayed target values and ranges for a wide range of immunoassay systems• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of up to 5 days at 2ºC to 8ºC or 4 weeks at -20ºC
IMMUNOASSAY SPECIALITY 1 CONTROL - Assayed Control
Analytes
1-25-(OH)2-Vitamin D25-OH-Vitamin D
C PeptideInsulin
Insulin Like Growth Factor 1(IGF 1)Osteocalcin*Procalcitonin* PTH (Intact)
Anti-Thyroglobulin (Anti-TG)Anti-Thyroperoxidase (Anti-TPO)
Description Size Cat. No.
Immunoassay Speciality II Level 1 5 x 1 ml IAS3117
Immunoassay Speciality II Level 2 5 x 1 ml IAS3118
Immunoassay Speciality II Level 3 5 x 1 ml IAS3119
A multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 4 specialized parameters.
• Lyophilized for enhanced stability• 100% human serum • Assayed target values and ranges for a wide range of immunoassay systems• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 5 days at 2ºC to 8ºC for Renin, Procalcitonin 1 day at 2ºC to 8ºC and for Gastrin and Calcitonin 8 hours at 2ºC to 8oC
IMMUNOASSAY SPECIALITY 1I CONTROL - Assayed Control
Analytes
CalcitoninGastrin
ProcalcitoninRenin*
*For international use only. Not available for diagnostic use in the United States.
*For international use only. Not available for diagnostic use in the United States.
Immunoassay
30
Immunoassay
Analytes
Description Size Cat. No.
Liquid Tumour Marker Control Level 1 6 x 3ml TU5085
Liquid Tumour Marker Control Level 2 6 x 3ml TU5086
Liquid Tumour Marker Control Level 3 6 x 3ml TU5087
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 15 routine and esoteric tumour markers. Compatible for use on a wide range of clinical chemistry and immunoassay systems.
• Liquid ready-to-use • 100% human serum • Open vial stability of 30 days at 2ºC to 8oC• Stable to expiry date at 2ºC to 8oC
LIQUID TUMOUR MARKER CONTROL - Assayed Control
Analytes
AFPβ-2-Microglobulin
CA15-3CA19-9CA72-4
CA125CA27-29
CEACyfra 21-1
Ferritin
NSEPSA (Free)PSA (Total)
Total Beta hCGThyroglobulin
Description Size Cat. No.
Maternal Screening Control Level 1 3 x 1 ml MSS5024
Maternal Screening Control Level 2 3 x 1 ml MSS5025
Maternal Screening Control Level 3 3 x 1 ml MSS5026
Multi-analyte control designed for use in the routine monitoring of accuracy and precision. Assayed target values and ranges are provided for 6 parameters used in both First and Second Trimester screening of Down’s syndrome and Spina Bifida. Compatible for use on a wide range of clinical chemistry and immunoassay systems.
• Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 7 days at 2ºC to 8ºC
MATERNAL SCREENING CONTROL - Assayed Control
Analytes
AFP*Free β hCGInhibin A*
PAPP-A*Total hCG
Unconjugated Estriol
*For international use only. Not available for diagnostic use in the United States.
31
Immunology/Protein Controls
Chapter 6
32
IMMUNOLOGY/ PROTEIN PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Specific Protein Control Level 1 3 x 1 ml PS2682
Specific Protein Control Level 2 3 x 1 ml PS2683
Specific Protein Control Level 3 3 x 1 ml PS2684
Liquid CRP Control Level 2 10 x 1 ml CP2480
Liquid CRP Control Level 3 10 x 1 ml CP2481
High Sensitivity CRP Control Level 1 10 x 1 ml CP2476
High Sensitivity CRP Control Level 2 10 x 1 ml CP2477
CRP Calibrator 3 x 1 ml CP2179
High Sensitivity CRP Calibrator Series 6 x 2 ml CP2478
CRP Calibrator Series 6 x 2 ml CP2479
CRP Full Range Calibrator 6 x 1 ml CP2499
Cystatin C Normal Control 3 x 2 ml CYS5019
Cystatin C Elevated Control 3 x 2 ml CYS5020
Cystatin C Calibrator 5 x 2 ml CYS2699
ASO Standard 5 x 1 ml LO2306
IgE Calibrator Series 6 x 1 ml IE2492
Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692
CSF Control Level 2 10 x 3 ml CF1500
CSF Control Level 3 10 x 3 ml CF1501
Immunology/Protein
33
Analytes
A multi-analyte control designed for use in the routine monitoring of both precision and accuracy. Assayed target values are provided for 27 analytes including immunoglobulins, complement proteins, inflammatory proteins as well as carrier and storage proteins. Method specific target values and ranges are available for both immunoturbidimetric and nephelometric assays.
• Liquid ready-to-use • 100% human serum• Contains both Total & Free Kappa and Lambda Light Chains• Stable to expiry date at 2ºC to 8ºC• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Specific Protein Control Level 1 3 x 1 ml PS2682
Specific Protein Control Level 2 3 x 1 ml PS2683
Specific Protein Control Level 3 3 x 1 ml PS2684
SPECIFIC PROTEIN CONTROL - Assayed Control
AFPAlbumin
a-1-Antitrypsina-1-Acid Glycoprotein
a-2-MacroglobulinASO
Anti-thrombin III
β-2-MicroglobulinCeruloplasmin
Complement C3Complement C4
CRPHaptoglobin
IgA
IgEIgGIgM
Kappa Light ChainKappa Light Chain (Free)*
Lambda Light ChainLambda Light Chain (Free)*
Prealbumin (Transthyretin)Serum Ferritin
Rheumatoid Factor Retinol Binding Protein
Total ProteinTransferrin
Description Size Cat. No.
CRP Liquid Control Level 2 10 x 1 ml CP2480
CRP Liquid Control Level 3 10 x 1 ml CP2481
CRP High Sensitivity Control Level 1 10 x 1 ml CP2476
CRP High Sensitivity Control Level 2 10 x 1 ml CP2477
CRP 1-Level Calibrator For Dilution Series 3 x 1 ml CP2179
CRP High Sensitivity 6-Level Calibrator Series 6 x 2 ml CP2478
CRP Mid Range 6-Level Calibrator Series 6 x 2 ml CP2479
CRP Full Range 6-Level Calibrator Series 6 x 1 ml CP2499
Dedicated control designed for use in the routine monitoring of both accuracy and precision. Suitable for use with traditional and high sensitivity CRP assays. These controls are standardized to BCR/CAP/IFCC CRM470.
• Liquid ready-to-use • 100% human serum• Stable to expiry date at 2ºC to 8ºC • Open vial stability of 30 days at 2ºC to 8ºC
CRP CONTROLS & CALIBRATOR - Assayed Control
*For international use only. Not available for diagnostic use in the United States.
Immunology/Protein
34
Description Size Cat. No.
ASO Calibrator 5 x 1 ml LO2306
Description Size Cat. No.
Cystatin C Normal Control 3 x 2 ml CYS5019
Cystatin C Elevated Control 3 x 2 ml CYS5020
Cystatin C Calibrator 5 x 2 ml CYS2699
A dedicated calibrator designed for use in the calibration of ASO immunoturbidimetric assays. This product is compatible for use on most clinical analyzers.
• Liquid ready to use• 100% human material• Stable to expiry date at 2ºC to 8ºC
A dedicated control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for use on most clinical chemistry analyzers.
• Liquid ready-to-use• 100% human material • Stable to expiry date at 2ºC to 8ºC• Open vial stability of 30 days at 2ºC to 8ºC
ASO CALIBRATOR - Calibrator
CYSTATIN C CONTROL - Assayed Control
Immunology/Protein
35
Description Size Cat. No.
IgE Calibrator Series 6 x 1 ml IE2492
Human based calibrator series designed for use in the calibration of IgE immunoturbidimetric assays.
• Lyophilized for enhanced stability• 6 levels supplied.• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 4 weeks at 2ºC to 8ºC
IgE CALIBRATOR - Calibrator
Description Size Cat. No.
Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301
Dedicated calibrator series designed for use in the calibration of Rheumatoid Factor immunoturbidimetric assays.
• Liquid ready-to-use • 100% human serum• Stable to expiry date at 2ºC to 8ºC• Once opened stable to expiry date at 2ºC to 8ºC
RHEUMATOID FACTOR CALIBRATOR SERIES - Calibrator
Immunology/Protein
36
Multi-analyte Cerebrospinal Fluid control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for use on most clinical analyzers and provides method specific target values and ranges for 11 analytes.
• Lyophilized for enhanced stability• 100% human product• Stable to expiry date at 2ºC to 8ºC • Reconstituted stability of 2 weeks at 2ºC to 8ºC
FOR USE WITH SAMPLES THAT REQUIRE PRE-DILUTION
Multi-analyte calibrator set designed for use in the calibration of the 5 analytes listed above.
• Liquid ready-to-use• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692
SPECIFIC PROTEIN CALIBRATORS - Calibrator Analytes
FOR USE WITH SAMPLES THAT DO NOT REQUIRE PRE-DILUTION
Multi-analyte calibrator set designed for use in the calibration of the 13 analytes listed above.
• Liquid ready-to-use• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Open vial stability of 30 days at 2ºC to 8oC
Description Size Cat. No.
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691
SPECIFIC PROTEIN CALIBRATORS - Calibrator
Analytes
ASOCeruloplasmin*Complement C3 Complement C4
CRPFerritin
HaptoglobinIgA
IgGIgM
Prealbumin
Rheumatoid Factor Transferrin
Description Size Cat. No.
CSF Control Level 2 10 x 3 ml CF1500
CSF Control Level 3 10 x 3 ml CF1501
CSF CONTROL - Assayed Control
a-1-Acid Glycoproteina-1-Antitrypsin
IgAIgG
IgM
Analytes
Analytes
Albumina-1-globulina-2-globulinβ-globulin
γ-globulinChlorideGlucose
IgG
LactateProtein (Total)
Sodium
*For international use only. Not available for diagnostic use in the United States.
Immunology/Protein
37
LipidControls
Chapter 7
38
LIPID PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.Lipid Control Level 1 5 x 1 ml LE2668
Lipid Control Level 2 5 x 1 ml LE2669
Lipid Control Level 3 5 x 1 ml LE2670
Lipid Control Level 1 5 x 3 ml LE2661
Lipid Control Level 2 5 x 3 ml LE2662
Lipid Control Level 3 5 x 3 ml LE2663
Apolipoprotein Control Level 1 3 x 1 ml LE5016
Apolipoprotein Control Level 2 3 x 1 ml LE5017
Apolipoprotein Control Level 3 3 x 1 ml LE5018
Apolipoprotein Calibrator 3 x 1 ml LP3023
Apolipoprotein Calibrator 2 3 x 1 ml LP5047
HDL/LDL Cholesterol Calibrator (clearance) 3 x 1 ml CH2673
Lipoprotein (a) Control Level 3 3 x 1 ml LP3406
Lipoprotein (a) Calibrator Series 5 x 1 ml LP3404
sLDL Control Level 1 3 x 1 ml LE5013
sLDL Control Level 2 3 x 1 ml LE5014
sLDL Control Level 3 3 x 1 ml LE5015
sLDL Calibrator 3 x 1 ml CH5050
Lipids
39
Description Size Cat. No.Lipid Control Level 1 5 x 1 ml LE2668
Lipid Control Level 2 5 x 1 ml LE2669
Lipid Control Level 3 5 x 1 ml LE2670
Lipid Control Level 1 5 x 3 ml LE2661
Lipid Control Level 2 5 x 3 ml LE2662
Lipid Control Level 3 5 x 3 ml LE2663
LIPID CONTROL - Assayed Control
Analytes
Apolipoprotein A-1Apolipoprotein BHDL (Direct lipid)
HDL (Precipitation)LDL (Direct Method)
LP (a)
Total CholesterolTriglycerides
A multi-analyte control designed for monitoring both the accuracy and precision of 7 analytes covering the full lipid profile. Accurately assigned target values and ranges are provided for both traditional precipitation methods as well as the various direct methods used for HDL and LDL measurement. Three levels are available in line with internationally recommended cut-off values for lipid tests.
• Lyophilized for enhanced stability• 100% human serum• Sodium Azide is not present - no interference occurs with clearance methods• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 7 days at 2ºC to 8ºC or 4 weeks at -20ºC
The multi-analyte control is designed for use in the routine monitoring of both accuracy and precision for 4 esoteric Apolipoproteins. Our Apolipoprotein calibrators are designed for use in the calibration of 6 esoteric Apolipoprotein assays on a wide range of clinical chemistry analyzers.
• Lyophilized for enhanced stability• Stable to expiry date at 2ºC to 8ºC• Control - reconstituted stability of up to 28 days at 2ºC to 8ºC for Apolipoprotein A-II and Apolipoprotein C-III, 14 days for Apolipoprotein C-II and 8
hours for Apolipoprotein E• Calibrator - reconstituted stability of 7 days at 2ºC to 8ºC for Apolipoprotein control A-I, B, A-II, C-II and C-III,1 day for Apolipoprotein E
APOLIPOPROTEIN CONTROL & CALIBRATORS - Assayed Control (RESEARCH USE ONLY)
Description Size Cat. No.Apolipoprotein Control Level 1 3 x 1 ml LE5016
Apolipoprotein Control Level 2 3 x 1 ml LE5017
Apolipoprotein Control Level 3 3 x 1 ml LE5018
Apolipoprotein Calibrator 3 x 1 ml LP3023
Apolipoprotein Calibrator 2 3 x 1 ml LP5047
Analytes
Apolipoprotein ControlApolipoprotein A-IIApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein E
Apolipoprotein CalibratorApolipoprotein A-IApolipoprotein B
Apolipoprotein Calibrator 2Apolipoprotein A-IIApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein E
*For international use only. Not available for diagnostic use in the United States.
Lipids
40
Designed for use in the calibration of HDL and LDL Clearance assays on clinical chemistry analyzers. • Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 5 days at 2ºC to 8ºC and 1 month at -20ºC
Description Size Cat. No.HDL / LDL Cholesterol Calibrator (Clearance) 3 x 1 ml CH2673
HDL & LDL CHOLESTEROL CALIBRATOR - Calibrator
Analytes
HDL LDL
Dedicated control designed for use in the routine monitoring of both accuracy and precision. The calibrator is designed to calibrate LP(a) assays on clinical chemistry analyzers. • Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 14 days at 2ºC to 8ºC
Description Size Cat. No.Lipoprotein (a) Control Level 3 3 x 1 ml LP3406
Lipoprotein (a) Calibrator Series 5 x 1 ml LP3404
LP(a) CONTROL AND CALIBRATOR - Assayed Control
Description Size Cat. No.sLDL Control Level 1 3 x 1 ml LE5013
sLDL Control Level 2 3 x 1 ml LE5014
sLDL Control Level 3 3 x 1 ml LE5015
sLDL Calibrator 3 x 1 ml CH5050
Dedicated control designed for use in the routine monitoring of both accuracy and precision. • Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 5 days at 2oC to 8ºC
sLDL CONTROLS & CALIBRATOR (RESEARCH USE ONLY)
*For international use only. Not available for diagnostic use in the United States.
Lipids
41
CardiacControls
Chapter 8
42
CARDIAC PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Cardiac Control (Tri-Level) 3 x 1 ml CQ3100
Cardiac Control (Tri-Level) 3 x 2 ml CQ3259
Liquid Cardiac Control Level 1 3 x 3 ml CQ5051
Liquid Cardiac Control Level 2 3 x 3 ml CQ5052
Liquid Cardiac Control Level 3 3 x 3 ml CQ5053
Myoglobin Calibrator Series 4 x 1 ml MY2456
CK-MB Control 10 x 2 ml CK1212
CK-MB Calibrator 10 x 1 ml CK2393
Cardiac
43
A comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target values and ranges are provided for 8 analytes, including NT-proBNP and D-dimer. The control is suitable for use on a wide range of clinical chemistry, immunoassay and POC instruments. Cut off levels for Troponin I and T are provided in line with internationally recommended levels.
• Liquid ready-to-use• 100% human serum• Suitable for use in POC testing • Stable to expiry date at 2ºC to 8ºC • Open vial stability of 30 days at 2ºC to 8ºC
Analytes
CK TotalCK-MB (Activity)
CK-MB (Mass)Homocysteine
MyoglobinTroponin I
Troponin T
CARDIAC CONTROL - Assayed Control
Description Size Cat. No.
Tri-Level Cardiac Control 3 x 1 ml CQ3100
Tri-Level Cardiac Control 3 x 2 ml CQ3259
A comprehensive cardiac control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for the most common instruments and methods. Temperature specific values are available for CK and CK-MB.
• Lyophilized for enhanced stability• 100% human serum• Cut off levels for Troponin I and T in line with internationally recommended levels• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 5 days at 2ºC to 8ºC or 4 weeks at -20ºC
LIQUID CARDIAC CONTROL - Assayed Control
Description Size Cat. No.
Liquid Cardiac Control Level 1 3 x 3 ml CQ5051
Liquid Cardiac Control Level 2 3 x 3 ml CQ5052
Liquid Cardiac Control Level 3 3 x 3 ml CQ5053
Analytes
CK-MB (Mass)D-dimerDigoxin
hs CRPMyoglobin
NT-ProBNP
Troponin ITroponin T
Cardiac
44
CK-MB CONTROL & CALIBRATOR - Assayed Control
Description Size Cat. No.
CK-MB Control 10 x 2 ml CK1212
CK-MB Calibrator 10 x 1 ml CK2393
A dedicated CK-MB control designed for use in the routine monitoring of both accuracy and precision. Accurately assigned target values are provided for serum start, substrate start and CK-NAC methods.
• Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2 to 8ºC • Reconstituted stability of 5 days at 2ºC to 8ºC or 4 weeks at -20ºC
Analytes
CK-MB CK-NAC
MYOGLOBIN CALIBRATOR - Calibrator
Dedicated calibrator designed for use in the calibration of Myoglobin immunoturbidimetric assays.
• Lyophilized for enhanced stability• Prepared from purified human Myoglobin in a stabilized matrix• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 30 days at 2ºC to 8ºC or 6 months at -20ºC
Description Size Cat. No.
Myoglobin Calibrator 4 x 1 ml MY2456
Cardiac
45
Diabetes/HaemoglobinControls
Chapter 9
46
DIABETES PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
HbA1c Control Set Level 1 And 2 2 x 2 x 0.5 ml HA5072
HbA1c Calibrator Series 5 x 2 ml, 1 x 8 ml HA3444
G-6PDH Control Deficient 6 x 0.5 ml PD2617
G-6PDH Control Normal 6 x 0.5 ml PD2618
Fructosamine Control Level 1 3 x 1 ml FR2994
Fructosamine Control Level 3 3 x 1 ml FR2996
Fructosamine Calibrator 3 x 1 ml FR2993
Haemoglobin F and A2 Control 2 x 2 x 0.2 ml HA5083
Adiponectin Control Level 2 3 x 1 ml AO2801
Adiponectin Control Level 3 3 x 1 ml AO2802
Adiponectin Calibrator 4 x 1 ml AO2800
Diabetes/Haemoglobin
47
Analytes
HbA1c Total Haemoglobin
HbA1c - Assayed Control
Description Size Cat. No.
HbA1c Control Set Level 1 And 2 2 x 2 x 0.5 ml HA5072
HbA1c Series Calibrator 5 x 2 ml, 1 x 8 ml HA3444
A human based whole blood control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for HPLC and a wide range of clinical chemistry analyzers.
• Lyophilized for enhanced stability• Treated in the same manner as a patient sample (requires pre-treatment)• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 4 weeks at 2ºC to 8ºC
FRUCTOSAMINE CONTROL AND CALIBRATOR - Assayed Control
Dedicated Fructosamine control and calibrator designed for use in the routine monitoring and calibration of the Randox Fructosamine assay.
• Lyophilized for enhanced stability• Human based serum• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 28 days at 2ºC to 8ºC
Description Size Cat. No.
Fructosamine Control Level 1 3 x 1 ml FR2994
Fructosamine Control Level 3 3 x 1 ml FR2996
Fructosamine Calibrator 3 x 1 ml FR2993
Diabetes/Haemoglobin
48
Analytes
Level 1 Level 2 Haemoglobin F (HbF) Haemoglobin F (HbF)Haemoglobin A2 (HbA2) Haemoglobin A2 (HbA2) Haemoglobin S (HbS)
HAEMOGLOBIN F & A2 CONTROL - Unassayed Control
Description Size Cat. No.
Haemoglobin F & A2 Control 2 x 2 x 0.2 ml HA5083
Unassayed, whole blood control designed to routinely monitor reproducibility and precision in laboratories measuring the Haemoglobin variants associated with Thalassemia. Suitable for use with all major systems and methods including HPLC, Immunoassay and Glycation Specific.
• Lyophilized for enhanced stability• 100% human whole blood • Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 4 weeks at 2ºC to 8ºC
Dedicated Adiponectin control and calibrator designed for use in the routine monitoring and calibration of the Randox Adiponectin assay.
• Liquid ready-to-use• Human based serum• Stable to expiry date at 2oC to 8ºC• Once opened stable to expiry date at 2oC to 8ºC
Description Size Cat. No.
Adiponectin Control Level 2 3 x 1 ml AO2801Adiponectin Control Level 3 3 x 1 ml AO2802Adiponectin Calibrator 4 x 1 ml AO2800
ADIPONECTIN CONTROL AND CALIBRATOR (RESEARCH USE ONLY)
*For international use only. Not available for diagnostic use in the United States.
Diabetes/Haemoglobin
49
UrineControls
Chapter 10
50
URINE PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Assayed Urine Control Level 2 12 x 10 ml AU2352
Assayed Urine Control Level 3 12 x 10 ml AU2353
Urine Precision Control Level 2 10 x 10 ml UC1502
Urine Precision Control Level 3 10 x 10 ml UC1503
Liquid Urine Control Level 2 10 x 10 ml UC5074
Liquid Urine Control Level 3 10 x 10 ml UC5075
Liquid Urinalysis Control Level 1 12 x 12 ml UC5033
Liquid Urinalysis Control Level 2 12 x 12 ml UC5034
Urinalysis Control Level 1 (dropper) 6 x 25 ml UC5078
Urinalysis Control Level 2 (dropper) 6 x 25 ml UC5079
Microalbumin Control Level 1 & 2 6 x 1 ml MA1361
Microalbumin Calibrator Series 6 x 2 ml MA1567
Urine
51
ASSAYED URINE CHEMISTRY - Assayed Control
AmylaseCalciumChlorideCopperCortisol
Creatinine
DopamineEpinephrine
Glucose5-HIAA
MagnesiumMetanephrine
MicroalbuminNorepinephrine
NormetanephrineOsmolalityOxalate
Phosphorous
PotassiumTotal Protein
SodiumUrea
Uric AcidVanillylmandelic Acid
Analytes
Description Size Cat. No.
Assayed Urine Control Level 2 12 x 10 ml AU2352
Assayed Urine Control Level 3 12 x 10 ml AU2353
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for 24 analytes including kidney function parameters, drug metabolites and urinary proteins. Method specific target values are also provided for the most commonly used methods.
• Lyophilized for enhanced stability • 100% human urine • Stable to expiry date at 2ºC to 8ºC • Reconstituted stability of 5 days at 2ºC to 8ºC or 14 days at -20ºC
UNASSAYED URINE CHEMISTRY - Unassayed Control
Analytes
CalciumChloride
Creatinine
GlucoseMagnesiumOsmolality
PhosphorousPotassium
Total Protein
SodiumUrea
Uric Acid
Description Size Cat. No.
Urine Precision Control Level 2 10 x 10 ml UC1502
Urine Precision Control Level 3 10 x 10 ml UC1503
Multi-analyte control designed for use in the routine monitoring of 12 urine chemistry tests.
• Lyophilized offering enhanced stability • 100% human urine • Stable until expiry when stored at 2ºC to 8ºC • Reconstituted stability of 5 days at 2ºC to 8ºC or 14 days at -20ºC
Urine
52
AmylaseCalciumChlorideCortisol
Creatinine
GlucosehCG
Magnesium Microalbumin
Osmolality
pHPhosphate (Inorganic)
PotassiumProtein (Total)
Sodium
Specific GravityUrea
Uric Acid
Description Size Cat. No.
Microalbumin Control Level 1 & 2 6 x 1 ml MA1361
Microalbumin Calibrator Series 6 x 2 ml MA1567
MICROALBUMIN CONTROL AND CALIBRATOR - Assayed Control
Liquid ready-to-use, control and calibrator designed for in vitro diagnostic use in the calibration and monitoring of Microalbumin immunoturbidimetric assays. This product is compatible for use on most clinical analyzers.
• Liquid ready-to-use• 100% human urine• Stable to expiry date at 2ºC to 8ºC
LIQUID URINALYSIS - Assayed Control
AlbuminBilirubinBlood
Creatinine
GlucosehCG
KetonesLeukocytes
NitritepH
ProteinSpecific Gravity
Urobilinogen
Analytes
Analytes
Description Size Cat. No.
Liquid Urinalysis Control Level 1 12 x 12 ml UC5033
Liquid Urinalysis Control Level 2 12 x 12 ml UC5034
Urinalysis Control Level 1 (dropper) 6 x 25 ml UC5078
Urinalysis Control Level 2 (dropper) 6 x 25 ml UC5079
A multi-analyte control specifically designed for use in the quality control of urine test strips. Assayed values are provided for 13 parameters and a wide range of test strip manufacturers.
• Liquid ready-to-use• 100% human urine• Suitable for use in POC testing • Stable to expiry date at 2ºC to 8ºC • Open vial stability of 30 days at 2ºC to 25ºC (20 immersions for UC5033/5034)
LIQUID URINE CONTROL - Assayed Control
Multi-analyte control designed for use in the routine monitoring of accuracy and precision. Instrument and method specific values and ranges are provided for 18 commonly analyzed parameters.
• Liquid ready-to-use • Human based urine• Stable to expiry date at 2ºC to 8ºC • Open vial stability 30 days at 2ºC to 8oC
Description Size Cat. No.
Liquid Urine Control Level 2 10 x 10 ml UC5074
Liquid Urine Control Level 3 10 x 10 ml UC5075
Urine
53
Description Size Cat. No.
Liquid Urine Control Level 2 10 x 10 ml UC5074
Liquid Urine Control Level 3 10 x 10 ml UC5075
Therapeutic Drug Controls
Chapter 11
54
THERAPEUTIC DRUG PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.Therapeutic Drug Control Level 1 20 x 5 ml HD1667
Therapeutic Drug Control Level 2 20 x 5 ml HD1668
Therapeutic Drug Control Level 3 20 x 5 ml HD1669
Therapeutic Drug Calibrator 6 x 3 ml TD3417
Therapeutic Drugs
55
Multi-analyte calibrator designed for use in the calibration of therapeutic drug assays on clinical chemistry analyzers. Accurately assigned values are provided for 7 analytes.
• Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2ºC to 8oC• Reconstituted stability of 4 weeks at 2ºC to 8oC or 8 weeks at -20oC
Description Size Cat. No.
Therapeutic Drug Calibrator Series 6 x 3 ml TD3417
THERAPEUTIC DRUG CALIBRATOR - Assayed Control
CarbamazepineDigoxin
GentamicinPhenobarbital
PhenytoinTheophylline
Valproic Acid
Analytes
Description Size Cat. No.
Therapeutic Drug Control Level 1 20 x 5 ml HD1667
Therapeutic Drug Control Level 2 20 x 5 ml HD1668
Therapeutic Drug Control Level 3 20 x 5 ml HD1669
THERAPEUTIC DRUG CONTROL - Assayed Control
AcetaminophenAmikacinCaffeine
CarbamazepineCyclosporine
DigoxinEthosuximideGentamicin
LithiumMethotrexate
PhenobarbitonePhenytoinPrimidoneSalicylate
Theophylline
TobramycinValproic AcidVancomycin
Analytes
Multi-analyte control designed for use in the quality control of therapeutic drug monitoring. Assayed target values and ranges are supplied for 18 analytes including commonly used antibiotics, anti-convulsants, anti-inflammatory and anti-cancer drugs. Instrument and method specific target values are provided for the most common instruments and methods.
• Lyophilized for enhanced stability• 100% human serum• Stable to expiry date at 2ºC to 8ºC• Reconstituted stability of 4 weeks at 2ºC to 8ºC
Therapeutic Drugs
56
Therapeutic Drugs
57
ToxicologyControls
Chapter 12
58
TOXICOLOGY PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Cannabinoid Calibrator Set 5 x 3 ml DA2700
Cannabinoid Control Level 1 5 x 3 ml DA3127
Cannabinoid Control Level 2 5 x 3 ml DA3128
Ecstasy Calibrator Set 5 x 10 ml DA2701
Ecstasy Control Level 1 5 x 5 ml DA3125
Ecstasy Control Level 2 5 x 5 ml DA3126
EDDP Calibrator Set 5 x 10 ml DA2702
EDDP Control Level 1 5 x 5 ml DA3123
EDDP Control Level 2 5 x 5 ml DA3124
Ethanol Calibrator/Control Set 5 x 10 ml DA2703
Multidrug Calibrator Set 5 x 10 ml DA2704
Multidrug Control Level 1 5 x 5 ml DA3121
Multidrug Control Level 2 5 x 5 ml DA3122
Benzodiazepines Control Level 1 5 x 5 ml DA3130
Benzodiazepines Control Level 2 5 x 5 ml DA3131
Benzodiazepines Calibrator Set 5 x 10 ml DA3129
Toxicology
59
Description Size Cat. No.Cannabinoid Calibrator Set 5 x 3 ml DA2700 Cannabinoid Control Level 1 5 x 3 ml DA3127Cannabinoid Control Level 2 5 x 3 ml DA3128
CANNABINOID CONTROL AND CALIBRATOR - Assayed Control
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Cannabinoids assay.
• Liquid ready-to-use • 100% human urine• Stable to expiry date when capped and stored at 2ºC to 8ºC • Open vial stability of 28 days at 2ºC to 8ºC
Description Size Cat. No.Ecstasy Calibrator Set 5 x 10ml DA2701Ecstasy Control Level 1 5 x 5 ml DA3125Ecstasy Control Level 2 5 x 5 ml DA3126
ECSTASY CONTROL AND CALIBRATOR - Assayed Control
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ecstasy assay.
• Liquid ready-to-use • Human urine • Stable to expiry date when capped and stored at 2ºC to 8ºC • Open vial stability of 28 days at 2ºC to 8ºC
Description Size Cat. No.Ethanol Calibrator/Control Set 4 x 10ml DA 2703
ETHANOL CALIBRATOR/CONTROL SET - Assayed Control
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.
• Liquid ready-to-use • Human urine• Stable to expiry date when capped and stored at 2ºC to 8ºC • Open vial stability of 28 days at 2ºC to 8ºC
Description Size Cat. No.EDDP Calibrator Set 5 x 10ml DA2702EDDP Control Level 1 5 x 5 ml DA3123EDDP Control Level 2 5 x 5 ml DA3124
EDDP CONTROL AND CALIBRATOR - Assayed Control
Dedicated calibrator and control set designed for the calibration and quality control of the Randox EDDP assay.
• Liquid ready-to-use • Human urine• Stable to expiry date when capped and stored at 2ºC to 8ºC • Once opened stable to expiry date at 2ºC to 8ºC
Toxicology
60
Description Size Cat. No.
Multidrug Control Level 1 5 x 5 ml DA3121
Multidrug Control Level 2 5 x 5 ml DA3122
Multidrug Calibrator Set 5 x 10 ml DA2704
Description Size Cat. No.
Benzodiazepines Control Level 1 5 x 5 ml DA3130
Benzodiazepines Control Level 2 5 x 5 ml DA3131
Benzodiazepines Calibrator Set 5 x 10 ml DA3129
MULTIDRUG CONTROL - Assayed Control
BENZODIAZEPINES CONTROL AND CALIBRATOR - Assayed Control
Benzoylecgonine (Cocaine)Methamphetamine
Secobarbital
MethadoneMorphine (Opiates)
Analytes
Oxazepam
Analytes
Multi-analyte control and calibrator designed for use in the quality control of the Randox Amphetamines, Barbiturates, Opiates, Cocaine and Methadone assays.
• Liquid ready-to-use • Human urine• Stable to expiry date when capped and stored at 2ºC to 8ºC • Open vial stability of 28 days at 2ºC to 8ºC
Dedicated calibrator and control set designed for the calibration and control of the Randox Benzodiazepines assay.
• Liquid ready-to-use • Human urine• Stable to expiry date when capped and stored at 2ºC to 8ºC • Open vial stability of 28 days at 2ºC to 8ºC
Toxicology
61
HaematologyControls
Chapter 13
62
Haematology
COAGULATION PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.
Haematology Control 3 x 2 x 4.5 ml HM5162
63
Description Size Cat. No.
Haematology Control Tri-Level 3 x 2 x 4.5 ml HM5162
Analytes
Basophils (BASO)
% Basophils (% BASO)
BASO-X
BASO -Y
DIFF-X
DIFF-Y
Eosinophils (EOS)
% Eosinophils (%EOS)
FSC-X
Haematocrit (HCT)
Haemoglobin (HGB)
Haemopioetic Progenitor Cell (HPC)
IMIDC
IMIRF
Immature Granulocytes (IG)
% Immature Granulocytes (%IG)
Immature Myeloid Information (IMI)
Immature Platelet Fraction (IPF)
Lymphocytes (LYMPH)
% Lymphocytes (% LYMPH)
Mean Corpuscular Volume (MCV)
Mean Corpuscular Haemoglobin (MCH)
Mean Corpuscular Haemoglobin Concentration (MCHC)
Mean Platelet Volume (MPV)
Monocytes (MONO)
% Monocytes (% MONO)
Neutrophils (NEUT)
% Neutrophils (% NEUT)
Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y)
Nucleated Red Blood Cells (NRBC)
% Nucleated Red Blood Cells (%NRBC)
Platelet Distribution Width (PDW)
Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT)
Platelets (PLT)
Platelets Optical Count (PLT-0)
Red Blood Cell X (RBC-X)
Red Blood Cell Y (RBC-Y)
Red Blood Cell Distribution Width CV (RDW-CV)
Red Blood Cell Distribution Width SD (RDW-SD)
Red Blood Cells (RBC)
Red Blood Cells Optical Count (RBC-O)
White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)
Combining 45 parameters in total the new Randox Acusera Haematology control completely covers the commonly tested full blood profile in a single control. Providing a true third party solution for Sysmex haematology analyzers with 5-part differential technology an unbiased, independent assessment of analytical performance is guaranteed.
•Liquid ready-to-use samples requiring no preparation •True third party control providing unbiased performance assessment •Target values available for Sysmex instruments with 5-part differential technology•Barcoded labels enabling quick and easy sample recognition and increased productivity •Open vial stability of 14 days for all analytes when stored at 2ºC to 8°C
HAEMATOLOGY CONTROL - Assayed Control
Haematology
64
Haematology
65
Blood GasControls
Chapter 14
66
BLOOD GAS PRODUCT RANGE
PRODUCT DESCRIPTION SIZE CAT. NO.Blood Gas Control Level 1 30 x 1.8 ml BG5001
Blood Gas Control Level 2 30 x 1.8 ml BG5002
Blood Gas Control Level 3 30 x 1.8 ml BG5003
Blood Gas
67
BLOOD GAS CONTROL - Assayed Control
Liquid ready-to-use Blood Gas Control designed for use in the routine monitoring of the 10 parameters listed above. Method specific target values are provided for the most common instruments.
• Aqueous material• Stable to expiry date at 2ºC to 8ºC• Once opened controls should be analyzed within 1 minute for pH and blood gas parameters; for electrolyte measurements, the control should be analyzed within 1
hour of opening
Description Size Cat. No.
Blood Gas Control Level 1 30 x 1.8 ml BG5001
Blood Gas Control Level 2 30 x 1.8 ml BG5002
Blood Gas Control Level 3 30 x 1.8 ml BG5003
Analytes
pCO2pH pO2
Total CO2CalciumChloride
GlucoseLactate
Potassium
Sodium
Blood Gas
68
Blood Gas
69
SpecialityControls
Chapter 15
70
SPECIALITY AND RESEARCH PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.Cell Adhesion Molecules Control 3 x 3 x 1 ml EV3569
Cerebral Series I Control 3 x 3 x 1 ml CAB5008
Cerebral Array I Calibrator Series 9 x 1 ml EV3625
Cerebral Series II Control 3 x 3 x 0.5 ml CBB5009
Cytokine Array I Control 3 x 3 x 1 ml CY5006
Cytokine Array I Control (High Sensitivity) 3 x 3 x 2 ml CY5005
Cytokine Array Calibrator Series 9 x 1 ml EV3561
Cytokine Array Iii Control 3 x 3 x 1 ml CY5012
Cytokine Array III Calibrator Series 9 x 1 ml EV3679
Cytokine Array IV Control 3 x 3 x 1 ml CY5011
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658
Cytokine Array V Control 3 x 3 x 1 ml CY5010
Endocrine Array Controls 3 x 3 x 1 ml EV3713
Metabolic Syndrome Array 1 Controls 3 x 3 x 1 ml EV3757
Speciality & Research Controls
71
CELL ADHESION MOLECULES CONTROLS AND CALIBRATORS (RESEARCH USE ONLY)
Vascular cell adhesion molecule-1 (VCAM-1)Intercellular adhesion molecule-1 (ICAM-1)
E-Selectin (E-SEL)
P-Selectin (P-SEL)L-Selectin (L-SEL)
Description Size Cat. No.
Adhesion Molecules Tri-Level Control 3 x 3 x 1 ml EV3569
Adhesion Molecules Calibrator Series 9 x 1 ml EV3568
A multi-analyte control with target values and ranges supplied for 5 different adhesion molecules.
• Lyophilized for enhanced stability• 100% human material • Stable to expiry date at 2oC to 8ºC • Reconstituted stability of 24 hours at 2oC to 8ºC or 7 days at -20ºC
Analytes
CEREBRAL SERIES I CONTROLS AND CALIBRATORS (RESEARCH USE ONLY)
Brain Derived Neurotrophic Factor (BDNF)Fatty Acid Binding Protein (FABP)
Glial Fibrillary Acidic Protein (GFAP)Interleukin 6 (IL6)
Description Size Cat. No.
Cerebral Series I Tri-Level Control 3 x 3 x 1 ml CAB5008
A multi-analyte control with target values and ranges provided for 4 analytes.
• Lyophilized for enhanced stability• 100% human material• Stable to expiry date at 2oC to 8ºC • Reconstituted stability of 8 hours at 2oC to 8ºC or 21 days at -20ºC
Speciality & Research Controls
72
CEREBRAL SERIES II CONTROLS AND CALIBRATORS (RESEARCH USE ONLY)
Analytes
Neuron Specific Enolase (NSE)Neutrophil Gelatinase-associated Lipocalin (NGAL)
Soluble Tumour Necrosis Factor Receptor I (sTNFRI)D-dimer
Thrombomodulin (TM)C-Reactive Protein (CRP)
Description Size Cat. No.
Cerebral Series II Tri-Level Control 3 x 3 x 0.5 ml CBB5009
A multi-analyte control with target values and ranges provided for 6 analytes.
• Lyophilized for enhanced stability• 100% human material• Stable to expiry date at 2oC to 8ºC • Reconstituted stability of 8 hours at 2oC to 8ºC or 14 days at -80ºC
Interleukin - 1a (IL-1a)
Interleukin - 1β (IL-1β)
Interleukin - 2 (IL2)Interleukin - 4 (IL4)Interleukin - 6 (IL6)Interleukin - 8 (IL8)
Interleukin - 10 (IL10)
Vascular Endothelial Growth Factor (VEGF)Interferon γ (IFNγ)
Tumour Necrosis Factor a (TNFa)
Monocyte Chemoattractant Protein-1 (MCP-1)Epidermal Growth Factor (EGF)
Analytes
Description Size Cat. No.
Cytokine Array I Tri-Level Control 3 x 3 x 1 ml CY5006
High Sensitivity Cytokine Array I Tri-Level Control 3 x 3 x 2 ml CY5005
Cytokine Array Calibrator Series 9 x 1 ml EV3561
Multi-analyte controls with target values and ranges provided for 12 different cytokines.
• Lyophilized for enhanced stability• 100% human material • Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 10 -12 hours at 2oC to 8ºC or 14 days at -20ºC• High sensitivity - Reconstituted stability of 4 hours at 2oC to 8ºC or 7 days at -20ºC
CYTOKINE ARRAY I & HIGH SENSITIVITY CYTOKINE ARRAY I CONTROL AND CALIBRATORS (RESEARCH USE ONLY)
Speciality & Research Controls
73
CYTOKINE ARRAY III CONTROLS AND CALIBRATORS (RESEARCH USE ONLY)
Interleukin - 5 (IL-5)Interleukin - 15 (IL15)
Granulocyte Macrophage Colony-Stimulating Factor (GMCSF)Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Analytes
Description Size Cat. No.
Cytokine Array III Tri-Level Control 3 x 3 x 1 ml CY5012
Cytokine Array III Calibrator Series 9 x 1 ml EV3679
A multi-analyte control with target values and ranges provided for 4 analytes.
• Lyophilized for enhanced stability• 100% human material • Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 24 hours at 2oC to 8ºC or 28 days at -20ºC
CYTOKINE ARRAY IV CONTROLS AND CALIBRATORS (RESEARCH USE ONLY)
Soluble Interleukin-2-Receptor a (sIL-2Ra)Soluble Interleukin-6-Receptor (sIL-6R)
Soluble Tumour Necrosis Factor Receptor I (sTNFR I)
Soluble Tumour Necrosis Factor Receptor II (sTNFR II)Matrix Metalloproteinase-9 (MMP-9)
Description Size Cat. No.
Cytokine Array IV Tri-Level Control 3 x 3 x 1 ml CY5011
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658
A multi-analyte control with target values and ranges provided for 5 analytes.
• Lyophilized for enhanced stability• 100% human material • Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC 8ºC or 28 days at -20ºC
Analytes
Speciality & Research Controls
74
CYTOKINE ARRAY V CONTROL (RESEARCH USE ONLY)
Analytes
Interleukin-3 (IL-3)Interleukin-7 (IL7)
Interleukin 12p70 (IL12p70)
Interleukin-13 (IL13)Interleukin-23 (IL23)
Description Size Cat. No.
Cytokine Array V Tri-Level Control 3 x 3 x 1 ml CY5010
A multi-analyte control with target values and ranges provided for 5 analytes.
• Lyophilized for enhanced stability• 100% human material • Stable to expiry when stored at 2oC to 8ºC • Reconstituted stability of 14 days at 2oC to 8ºC or 21 days at -20ºC
Human based control designed for use in the routine monitoring of both accuracy and precision. Three levels of control are supplied with assayed target values and ranges provided for 4 analytes.
• Lyophilized for enhanced stability• Assayed values available for both the Evidence and Evidence Investigator• Stable to expiry date at 2oC to 8ºC• Reconstituted stability of 7 days at 2oC to 8ºC or 21 days at -20ºC
ENDOCRINE ARRAY CONTROLS AND CALIBRATOR (RESEARCH USE ONLY)
Cortisol DHEA- Sulphate
17-a-HydroxyprogesteroneLeptin
Analytes
Description Size Cat. No.
Endocrine Array Controls 3 x 3 x 1 ml EV3713
Endocrine Array Calibrator Series 9 x 1 ml EV3712
Speciality & Research Controls
75
A multi-analyte control with target values and ranges provided for 9 parameters associated with metabolic syndrome.
• Lyophilized for enhanced stability • 100% human material• Stable to expiry date at 2oC to 8oC• Reconstituted stability of 72 hours at 2oC to 8oC and 7 days at -20oC
METABOLIC SYNDROME ARRAY I CONTROL (RESEARCH USE ONLY)
Analytes
C-PeptideFerritin
Interleukin-6 (1L6)
ResistinInsulin
Interleukin-1a (1L-1a)
Tumour Necrosis Factor a (TNFa)Leptin
Plasminogen Activator Inhibitor-1
Description Size Cat. No.
Metabolic Syndrome Array I Controls 3 x 3 x 1 ml EV3757
Metabolic Syndrome Array I Calibrators 9 x 1 ml EV3756
Speciality & Research Controls
76
Speciality & Research Controls
77
Customized Quality Control Sera
Chapter 16
78
For over 30 years, laboratories, PT scheme organizers and other diagnostic companies have looked to Randox to provide their QC needs. Randox Laboratories manufactures a full portfolio of quality controls, calibrators and standards for over 350 parameters. In addition to ‘off the shelf ’ quality control products, Randox is the world’s leading provider of customized control materials. Customizing control materials can involve adding analytes, removing unused parameters, specifying analyte concentrations or choosing alternative vial sizes.
Our principal control products are;
• Antioxidants • Cardiac• Clinical Chemistry• Coagulation• Diabetes• Immunoassay• Immunology and Specific Proteins• Lipids• Tumour Markers• Therapeutic Drugs and Toxicology• Urine tests. • Specialist and Research controls such as Cytokines, Growth
Promoters, Antimicrobial, Cerebral and a variety of single-analyte control products.
We also produce custom sera for PT schemes and specialized controls for research projects.
Quality is our focus during the manufacturing process. All control products are produced to the same high specifications using procedures complying with ISO 13485 for medical devices. State of the art clinical chemistry and immunoassay analyzers are used during the manufacturing and quality control processes.
To enable us to identify and fulfil your needs, please discuss your requirements with your Randox representative. We are happy to consider any requirements you may have. Randox has over 30 years experience in producing customized sera, and we will ensure you will receive the specified product you want in a professional and timely manner.
CUSTOMIZED QUALITY CONTROL SERA
CONSOLIDATION
Randox will significantly consolidate your existing controls. An average laboratory may rationalize from 7 sera to a single control product
TAILOR MADE
Specify the analytes and levels you require. We can provide the levels tailored to your cut off values
STABILITY
Randox Sera are stable for up to 4 years, enabling use of the same lot over an extended period
OPTIONS
Customized controls in different matricese.g. serum, urine, aqueous
FLEXIBILITY
Batch sizes of between 20 - 250,000 vials are manufactured Randox can provide a wide range of vial sizes from 1ml to 10ml
QUALITY
All controls are produced to high quality specification, fully compliant with ISO 13485
CHOICE
3 different formats – lyophilized / liquid / liquid frozen
Customized Quality Control Sera
79
Enables Randox to view how the material recovers
on your machines
If end sample does not meet specifications, you are under
no obligation to accept
Week 1
Week16
You run blind sample and return results to Randox
Randox sends blind sample to you
QC order placed by you
Manufacture of Customized Sample
Sample is despatched to you
Sample checked and approved by you
Randox generates labels and packages kit
Randox despatches and delivers final product to you
CUSTOMIZED TIMELINE:
Customized Quality Control Sera
80 This list is not exhaustive. If the analyte you require is not present, please contact your Randox representative
Prothrombin Time (PT)Thrombin Time (TT)
CSFAlbuminAlpha-1-globulinAlpha-2-globulinBeta-globulinChlorideGamma-globulinGlucoseIgGLactateProteinSodium CYTOKINE & GROWTH FACTORSEpidermal Growth Factor (EGF) Granulocyte Macrophage Colony-Stimulating Factor (GMCSF)Intercellular Adhesion Molecule 1 (ICAM-1)Interferon-gamma (IFN-γ)Interleukin-1 alpha (IL-1 a)Interleukin-1 beta (IL-1β)Interleukin-2 (IL-2)Soluble Interleukin-2 Receptor Alpha (SIL-2Ra)Interleukin-3 (IL-3)Interleukin-5 (IL-5)Soluble Interleukin-6 Soluble Receptor(SIL-6SR)Interleukin-4 (IL-4)Interleukin-6 (IL-6)Interleukin-7 (IL-7)Interleukin-7D (IL-7D)Interleukin-8 (IL-8)Interleukin-10 (IL-10)Interleukin-12p (IL-12p)Interleukin-13 (IL-13)Interleukin-15 (IL-15)Interleukin-23 (IL-23)Macrophage Inflammatory Protein-1 Alpha (MIP-1a)Matrix Metalloproteinase 9 (MMP-9)Monocyte Chemotactic Protein-1 (MCP-1)Soluble Tumour Necrosis Factor Receptor-1 (sTNFRI)Soluble Tumour Necrosis Factor Receptor-2 (sTNFR2) Tumour Necrosis Factor - alpha (TNF - a)Tumour Necrosis Factor - beta (TNF - β)Vascular Endothelial Growth Factor (VEGF)
DIABETESFructosamineHbA1c HbfHbsHbA2
DRUGS (THERAPEUTIC)AcetaminophenAmikacin CarbamazepineCaffeineCyclosporine
ANTIOXIDANTGlutathione PeroxidaseGlutathione Reductase Superoxide DismutaseTotal Antioxidant Status
BLOOD GASCalciumChlorideGlucoseLactatepCO2pHpO2PotassiumSodiumTotal CO2
CARDIACBNPCK (Total)CK-MBCarbonic Anhydrase III (CAIII)D-DimerDigoxinHeart-type Fatty Acid-Binding Protein (H-FABP)Glycogen Phosphorylase BB (GPBB)hs-CRPHigh Sensitivity Troponin THomocysteineMyoglobinNT-ProBNPTroponin ITroponin T
CELLULAR ADHESION MOLECULESE-Selectin ICAM-1L-SelectinP-SelectinVCAM-1
CEREBRAL BDNFGFAPIL-6NSENGALsTNFRiThrombomodulin
COAGULATIONActivated Partial Thromboplastin Time (aPTT)Antithrombin III Factor IIFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIFibrinogenPlasminogenProtein CProtein S
DigoxinEthosuximideGentamicinLithiumMethotrexatePhenobarbitalPhenytoinPrimidoneSalicylateTheophyllineTobramycinValproic AcidVancomycin
DRUGS OF ABUSE7-aminoflunitrazepam11-Nor D-9-THC-9-COOHAcetaminophenAmphetamineBath Salts 1+2BenzylpiperazinesBarbituratesBenzodiazepineBenzoylecgonine BuprenorphineCannabinoidsChloral Hydrate MetaboliteCocaine MetaboliteDextromethorphanEcstasyEDDPEthyl Glucuronide EthanolEscitalopramFentanylGeneric OpiodsHaloperidolIbuprofenKetamine LSDMescalineMeprobamateMeperidineMethadoneMethamphetamineMethaqualoneMethylphenidateMorphineMDMAOpiatesOxazepamOxycodone IOxycodone IIPhencyclidine Phenobarbital PhenylpiperazinesPropoxypheneSalicylateSalicyluric AcidSalvinorinSecobarbitalSetralineTricyclic AntidepressantsTramadolTrazodoneZoleplon
Customized Quality Control Sera
81
ZolpidemZopiclone
ENDOCRINE Leptin IMMUNOASSAY17-OH – ProgesteroneAcetaminophen ACTH AFPAldosterone Amikacinβ-2-MicroglobulinCEACA 125CA 15-3CA 19-9CA 72-4CalcitoninCarbamazepineC-PeptidesCyfra 21-1CortisolC-PeptideDHEA-SulphateDigoxinEstradiolEstriolEstriol (unconjugated)EthosuximideFerritinFolateFSHGastrinGentamicinGrowth HormonehCGFree β hCGIgEIGF-1Inhibin AInsulinLHNeuron Specific EnolaseOsteocalcinPAPP- A PhenobarbitalPhenytoinPrimidoneProcalcitoninProgesteroneProlactinPSA (Free)PSA (Total)PTH (Intact)ReninSalicylateSHBGTBGT UptakeT3 (Free)T3 (Total)T4 (Free)T4 (Total)Testosterone
Testosterone (Free)TheophyllineThyroglobulinAnti-TGAnti-TPOTobramycinTSHVanomycinValproic AcidVitamin B121-25-(OH)2-Vitamin D25-OH-Vitamin D
LIPIDSApolipoprotein A-IApolipoprotein A-IIApolipoprotein BApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein ECholesterol (Total)Cholesterol (HDL)Cholesterol (LDL)Lipoprotein (a)Triglycerides sLDL
METABOLIC SYNDROMEResistinPlasminogen Activator Inhibitor-1
PROTEINSAFPAlbuminAlpha-1-Acid Glycoprotein (AAG)Alpha-1-Antitrypsin (AAT)Alpha-2-Macroglobulin Antistreptolysin OAnti-thrombin IIIβ-2-MicroglobulinCeruloplasminComplement C3Complement C4CRPCystatin CFerritinHaptoglobinIgAIgEIgGIgMKappa Light ChainKappa Light Chain (Free)Lambda Light ChainLambda Light Chain (Free)PrealbuminProtein (Total)RBP (Retinol Binding Protein)Rheumatoid FactorTransferrin
ROUTINE CHEMISTRYAlbumin Alpha-1-globulin Alpha-2-globulin Beta-1-globulin
Acid Phosphatase (Prostatic) Acid Phosphatase (Total) AlbuminALP ALT (SGPT) Amylase Amylase (Pancreatic) AST (SGOT) Bicarbonate Bile Acids Bilirubin (Direct) Bilirubin (Total) Cholinesterase Calcium Calcium (Ionised) Chloride CopperCreatinine Gamma GT Gamma-globulinGlucose GLDH a-HBDH D-3-Hydroxybutyrate Iron LAP LD (LDH) Lipase Lactate Magnesium Osmolality Phosphate (Inorganic) Potassium SodiumTIBC Urea Uric Acid (Urate) Zinc
URINEAmylaseCalciumChlorideCopperCortisolCreatinineDopamineEpinephrineGlucose5-H1AAhCGMagnesiumMetanephrineMicroalbuminNorepinephrineNormetanephrineOsmolalityOxalatepHPhosphorousPotassiumTotal ProteinSodiumSpecific GravityUreaUric AcidVMA (Vanillylmandelic Acid)
Customized Quality Control Sera
82
Customized Quality Control Sera
83
Interlaboratory DataManagement
24•7 Chapter 17
84
What is Acusera 24•7?
Acusera 24•7 Live Online is an interlaboratory data management and peer group repor ting package designed to complement the Acusera range of third par ty controls. Using Acusera 24•7 will help medical laboratories to improve error detection, reduce false rejections and ensure accurate patient test results.
Acusera 24•7 provides access anytime, anywhere to an extensive range of features including: user defined QC multi-rules and interactive char ts & repor ts. With peer statistics generated from over 20,000 laboratory par ticipants, interlaboratory data management has never been easier.
With Acusera 24•7 peer group data is updated every 24 hours giving you access to the most up-to-date information available. Access to relevant peer group data enables rapid and effective troubleshooting, it may even help to identify errors earlier.
Why run a peer group reporting program?
• Quickly identify trends, system errors and reagent issues minimizing expensive repeat tests• Bridges the gap between daily quality control and external quality assessment • Improve PT performance by eliminating any undetected bias• Facilitate regulatory compliance• Fewer false rejections through the use of QC multi-rules• Increased confidence in assigned QC target values • Rapid and effective troubleshooting therefore shorter delays in reporting
85
Multiple Comparisons
With Acusera 24•7 Live Online, users have the ability to add multiple instruments, parameters and lots onto the same interactive Levey-Jennings, Histogram or Par ticipant Summary Char t. The ability to combine data enables users to identify and assess trends in QC data or a bias between instruments. Automatically generated by the software, char ts can be based on either Standard Deviation or Percentage Deviation.
Dashboard
The unique Dashboard interface is displayed each time a user logs onto the software, conveniently displaying all aler ted or rejected QC results that have fallen outside user defined performance limits and multi-rules in the last seven days.
Audit Trail Report
The comprehensive Audit Trail Repor t provides a secure, electronic record of the creation, modification and deletion of data. This effective method of documenting the review process can help laboratories meet regulatory requirements and gain accreditation.
Peer Group Statistics
Uniquely updated every 24 hours, users can customize peer groups depending on their instrument, methods or reagents. Peer Group Repor ting allows users to compare the performance of their own instrument and/or assay method against other laboratories using the same lot of control but with a different instrument and/or method. Statistics are generated from up to 20,000 laboratory par ticipants.
86
Acusera 24•7 Connect
Our fully automated connectivity solution is designed to meet the needs of all laboratory types and sizes. QC data can be quickly and efficiently impor ted from your laboratory instrument, LIS or middleware to Acusera 24•7 Live Online services.
• Eliminates issues associated with manual data entry • Increases productivity and efficiency• Automatic impor t of QC data to 24•7 • Captures and impor ts only QC data• Continue to use standard LIS QC repor ts
Analyzer Analyzer
LIMs/Middleware Middleware
LIMs/LISAcusera24•7 Connect
EDIMapping
Acusera24•7 Live Online
Manualentry
QC Data ManagementAutomated Semi-AutomatedYour Laboratory Process Your Laboratory Process
1 2 3
File Import File Import
The diagram below demonstrates the three different methods of transferring QC data to Acusera 24•7 Live Online.
QC result capture options
Fully automated import via Acusera 24•7 Connect. Manual data entry. Semi-automated import using EDI Mapping.
1
2
3
Ordering details
Description Catalogue Number Acusera 24•7 Peer group activation and 12 month license QC4218Acusera 24•7 Peer group 12 month license renewal QC4204Acusera 24•7 Connect* QC4205Acusera 24•7 Live Upgrade QC4220Acusera 24•7 Live Online Training QC4221*pending site survey completion
87
Randox International Quality Assessment
Scheme
Chapter 18
88
RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME (RIQAS)
RIQAS is the largest global PT scheme which is used by more than 28,000 laboratory participants in over 105 countries. This large number of participants makes RIQAS the best quality PT scheme in the world and ensures an extensive database of results for many analytical methods, directly
increasing statistical validity as a result.
• RIQAS systems and procedures are recognized and accredited to a number of internationally recognized standards including ISO 13485:2003, ISO/IEC 17043, NQAAP and JWG QA
• Human samples free from interfering preservatives increase confidence that PT performance mirrors performance of patient samples
• A wide range of parameters are available covering a wide spectrum of laboratory tests allowing for effective consolidation of existing PT programs
• User friendly reports provide a statistical breakdown of results by method and instrument, allowing analytical performance to be assessed at a glance. Levey Jennings and histogram charts identify trends, biases and precision problems while the unique Target Scoring chart grades performance in a moving window for the last 20 samples
• Regular reports with rapid turnaround times ensure corrective actions can be taken as soon as possible. Reports returned in 2 - 3 days
• Reduced parameter options for selected programs offer greater flexibility, ensuring suitability for laboratories of all sizes and budgets
• Participant certificates provide evidence of participation in a reputable PT scheme
• Laboratories can register up to five instruments for each parameter at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided.
• Interlaboratory group reports allow comparison of multiple connected laboratories at no extra cost
• RIQAS support staff are on hand to offer advice and troubleshoot technical queries
• Submit results and view reports online via RIQAS.net
FEATURES AND BENEFITS
89
STANDARD REPORT
The unique target scoring system was developed to provide a simple interpretation of your laboratory’s performance. The system will present the performance of your results for each RIQAS sample and also show how your laboratory’s performance varies with time.
Laboratories can register up to five instruments for each parameter at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report allows the comparative performance of each instrument.
Performance data is presented in a one page format with up to seven sub-reports
1 Text Section: Statistics for all methods, your method and instrument group (Program specific)
2 Histogram: Method and instrument comparison
3 Multi Method Stat Section: Enables assessment of the performance of each method
4 Levey-Jennings Chart: Details features of your laboratory’s performance
5 Target Score: This unique chart provides a numerical index of performance, allowing at a glance assessment
6 % Deviation by Sample: Helps to identify trends and shifts in performance
7 % Deviation by Concentration: Rapid assessment of concentration related biases
N C
1
2
3
4
5
6
7
90
BLOOD GAS PROGRAMME With target scoring
RQ9134First registered instrument10 Parameters
RQ9134/ASubsequent instruments10 Parameters
* Note to participants with multiple instruments on the Blood Gas Programme RQ9134 must be purchased for the first registered instrument and individual RQ9134/A kits for every subsequently registered instrument.
Samples every month, 1 x 12 month cycle, 12 months subscription, liquid ready-to-use.
pCO2pHpO2
tCO2Ca++Cl-
K+Na+Glucose
Lactate
COAGULATION PROGRAMME With target scoring
RQ9135/a5 Selected Parameters only (aPTT, PT, TT, Fibrinogen, Antithrombin III)
RQ9135/bFull 17 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilized.
aPTTPT (including INR)TTFibrinogenAntithrombin III
PlasminogenProtein CProtein SFactor IIFactor V
Factor VIIFactor VIIIFactor IX Factor XFactor XI
Factor XIID-Dimer*
GENERAL CLINICAL CHEMISTRY PROGRAMME With target scoring
RQ911210 Parameters only
RQ9112/S17 Parameters only
RQ9113Full 50 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilized.
Acid phosphatase, prostaticAcid phosphatase, totalAlbuminAlkaline phosphataseALT (ALAT)Amylase, pancreaticAmylase, totalAST (ASAT)BicarbonateBile acidsBilirubin, directBilirubin, totalCalcium
Calcium, ionisedChloride CholesterolCholinesterase*CK, total (CPK) CopperCreatinine D-3-hydroxybutyrateFructosamine*Gamma GTGLDHGlucoseHBDH
HDLIronLactate*LD (LDH)LipaseLithium Magnesium NEFA*OsmolalityPhosphate, inorganicPotassiumProtein, total PSA
Sodium TIBCFree T3Total T3Free T4Total T4Triglycerides TSHUreaUric acid Zinc
BNP PROGRAMME+
RQ91651 parameter (BNP alone)
RQ9165/aOrder with RQ9136/a when BNP and Liquid Cardiac parameters are required
BNP*
Samples every month, 1 x 12 month cycle, 12 months subscription, liquid ready-to-use.
CARDIAC PROGRAMME With target scoring
RQ9127/a2 Parameters only (choose from 7)
RQ9127/bFull 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilized.
CK, TotalCK-MB Activity units
CK-MB Mass unitsHomocysteine
MyoglobinTroponin I
Troponin T
ESR PROGRAMME+
RQ91631 parameter (ESR)
ESR*
2 samples per quarterly distribution, 1 x 12 month cycle, 12 months subscription, liquid ready-to-use.
Ammonia*Ethanol*
AMMONIA / ETHANOL PROGRAMME +
RQ91642 parameters (Ammonia / Ethanol)
Samples every month, 1 x 12 month cycle, 12 months subscription, liquid ready-to-use.
PURPLE = The only parameters available on RQ9135/a + = Not accredited to ISO/IEC 17043 * = Pilot study ongoing
91
GLYCATED HAEMOGLOBIN PROGRAMME (HbAlc) With target scoring
RQ91292 ParametersSamples every month, 1 x 12 month cycle, 12 month subscription, lyophilized.
HbA1c Total Haemoglobin
HAEMATOLOGY PROGRAMME With target scoring
RQ911812 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, liquid ready-to-use.
Hematocrit (HCT)Haemoglobin (Hb)Mean Cell Haemoglobin (MCH)
Mean Cell Haemoglobin Concentration (MCHC)Mean Cell Volume (MCV)Mean Platelet Volume (MPV)*
Packed Cell Volume (PCV)*Platelets (PLT)Plateletcrit (PCT)*
Red Blood Cell Count (RBC)Red Cell distribution width (RDW)*Total White Blood Cell Count (WBC)
IMMUNOASSAY SPECIALITY 1 PROGRAMME+
RQ914110 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilized.
1-25-(OH)2-Vitamin D25-OH-Vitamin DC-Peptide
Anti-TGAnti-TPOIGF-1
OsteocalcinProcalcitonin PTH
Insulin
IMMUNOASSAY SPECIALITY 2 PROGRAMME+
RQ91425 ParametersSamples every month, 1 x 12 month cycle, 12 month subscription, lyophilized.
Calcitonin Gastrin
ProcalcitoninPlasma Renin Activity
Renin, direct concentration
IMMUNOASSAY PROGRAMME With target scoring
ACTH*AFPAldosterone*Amikacin*Androstenedione*β-2-microglobulinCA125CA15-3CA19-9CarbamazepineCEACortisolC-peptide*DHEA- SulphateDHEA, Unconjugated
DigoxinEstriol Total* Ethosuximide*FerritinFolateFSHGentamicin*GHhCGIgEInsulinLHEstradiol17-OH-progesteroneAcetaminophen*
Phenobarbital*PhenytoinPrimidone*ProgesteroneProlactinFree PSATotal PSAPTH (Intact)Salicylate*SHBGFree T3Total T3Free T4Total T4Testosterone, free*
Testosterone, totalTheophyllineThyroglobulinTobramycin*TSHValproic acidVancomycin*Vitamin B121-25-(OH)
²-Vitamin D*
25-OH-Vitamin D*
RQ9125/a 4 Parameters only (choose from 55)
RQ9125/b13 Parameters only (choose from 55)
RQ9125/cFull 55 Parameters
RQ9130 (monthly)Full 55 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles (RQ9125/a, RQ9125/b, RQ9125/c), 12 month subscription - Samples every month, 1 x 12 month cycle (RQ9130), 12 month subscription
HUMAN URINE PROGRAMME With target scoring
RQ911524 ParametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilized.
Albumin Creatinine Ratio (ACR)*Albumin/MicroalbuminAmylaseCalciumChlorideCopperCortisol
CreatinineDopamineEpinephrineGlucoseMetanephrineNorepinephrineNormetanephrine
MagnesiumOsmolalityOxalatePhosphate, inorganicPotassiumProtein, total Sodium
Urea Uric acidVMA5-HIAA
PURPLE = The only parameters available on RQ9135/a + = Not accredited to ISO/IEC 17043 * = Pilot study ongoing
92
SEROLOGY (HIV/HEPATITIS) PROGRAMME+
RQ9151 10 Parameters5 Samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Qualitative results only, liquid ready-to-use.
Anti-CMV (total)Anti-HBc Anti-HCV
Anti-HIV-1Anti-HIV-2Anti-HIV-Combi
Anti-HTLV-IAnti-HTLV-IIAnti-HTLV-Combi
HBsAg
SEROLOGY (ToRCH) PROGRAMME+
RQ915212 Parameters5 Samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use.
Anti-Toxoplasma IgGAnti-Toxoplasma IgMAnti-Rubella IgG
Anti-Rubella IgMAnti-CMV IgGAnti-CMV IgM
Anti-HSV1 IgGAnti-HSV1 IgMAnti-HSV2 IgG
Anti-HSV2 IgMAnti-HSV-1&2 IgG CombinedAnti-HSV-1&2 IgM Combined
SEROLOGY (SYPHILIS) PROGRAMME+
RQ9154 1 Parameter
3 Samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use.
Syphilis (Methods available include Immunoassay RPR, VDRL and TPHA)
SEROLOGY (EBV) PROGRAMME+
RQ91533 Parameters3 Samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use.
Anti-EBV VCA IgG Anti-EBNA IgG Anti-EBV VCA IgM
LIQUID CARDIAC PROGRAMME With target scoring
RQ9136 9 parameters (No BNP)
RQ9136/aOrder with RQ9165/a when BNP and Liquid Cardiac parameters are required
CK-MB MassD-Dimer*Digoxin
HomocysteinehsCRPMyoglobin
NT proBNPTroponin ITroponin T
Samples every month, 1 x 12 month cycle, 12 months subscription, liquid ready-to-use.
MATERNAL SCREENING PROGRAMME With target scoring
RQ91376 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised.
AFPFree β hCG
Total hCG Inhibin A
PAPP-AUnconjugated Oestriol
LIPID PROGRAMME With target scoring
RQ9126/a3 Parameters only (choose from 7)
RQ9126/bFull 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilized.
Apolipoprotein A1Apolipoprotein B
Cholesterol, totalHDL
LDLLipoprotein (a)*
Triglycerides
PURPLE = The only parameters available on RQ9135/a + = Not accredited to ISO/IEC 17043 * = Pilot study ongoing
93
SPECIFIC PROTEINS PROGRAMME With target scoring
RQ9114 (3 ml)26 Parameters
RQ9160 (2 ml)
RQ9161 (1 ml)
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, liquid ready-to-use.
AFPAlbumina-1-acid glycoproteina-1-antitrypsina-2-macroglobulinAnti Streptolysin OAntithrombin III
β-2-microglobulinCeruloplasminComplement, C3Complement, C4C-Reactive ProteinFerritinHaptoglobin
Immunoglobulin AImmunoglobulin EImmunoglobulin GImmunoglobulin MFree Kappa Light ChainTotal Kappa Light ChainFree Lambda Light Chain
Total Lambda Light Chain Prealbumin (Transthyretin)Retinol Binding ProteinRheumatoid FactorTransferrin
THERAPEUTIC DRUGS PROGRAMME With target scoring
RQ911118 ParametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Weighed-in values, lyophilized.
AmikacinCaffeineCarbamazepineCyclosporineDigoxin
EthosuximideGentamicinLithiumMethotrexateParacetamol (Acetaminophen)
PhenobarbitalPhenytoinPrimidoneSalicylic acidTheophylline
TobramycinValproic acid Vancomycin
URINALYSIS PROGRAMME+
RQ913814 ParametersSamples every 2 months 1 x 12 month cycle, 12 month subscription, liquid ready-to-use.
AlbuminBilirubinBloodCreatinine
GalactoseGlucosehCGKetones
LeukocytesNitritepHProtein
Specific GravityUrobilinogen
URINE TOXICOLOGY PROGRAMME+
RQ913920 ParametersSamples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use.
BenzoylecgonineBuprenorphineCannabinoids (THC)Cotinine*Creatinine
d-Amphetamined-MethamphetamineEDDPEthanolFree Morphine
LorazepamLSDMDMA MethadoneNorpropoxyphene
NortriptylineOxazepamPhencyclidine PhenobarbitalSecobarbital
PURPLE = The only parameters available on RQ9135/a + = Not accredited to ISO/IEC 17043 * = Pilot study ongoing
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Chapter 19
AnalyteIndex
96
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
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# 17-OH-progesterone x x x x x 17-OH-progesterone #
17β Clostebol 17b Clostebol5-HIAA x 5-HIAA
A Acid phosphatase, prostatic x x x x x x Acid phosphatase, prostatic A
Acid phosphatase, total x x x x x x x Acid phosphatase, totalAcid phosphatase (non prostatic) x Acid phosphatase (non prostatic)Acetaminophen x AcetaminophenAdiponectin x AdiponectinACTH x x x ACTHAldosterone x x x x AldosteroneAlphafetoprotein (AFP) x x x x x x x x x x x Alphafetoprotein (AFP)Alpha-1-Antitrypsin x x x x x x Alpha-1-AntitrypsinAlpha-1-Acid Glycoprotein x x x x x x Alpha-1-Acid GlycoproteinAlpha-HBDH x x x x x x Alpha-HBDHAlpha-2-Macroglobulin x Alpha-2-MacroglobulinAlanine aminotransferase (ALT) x x x x x x x Alanine aminotransferase (ALT)Albumin x x x x x x x x x AlbuminAldolase x AldolaseAlkaline phosphatase (ALP) x x x x x x x Alkaline phosphatase (ALP)Alpha-1-globulin x x x x x Alpha-1-globulinAlpha-2-globulin x x x x x Alpha-2-globulinAmikacin x x x x x x AmikacinAmmonia x x AmmoniaAmylase x x x x x x x x x AmylaseAmylase, pancreatic x x x x x x Amylase, pancreaticAndrostenedione x AndrostenedioneAnti-thrombin III x Anti-thrombin IIIAnti-thyroglobulin (Anti-TG) x Anti-thyroglobulin (Anti-TG)Anti-thyroperoxidase (Anti-TPO) x x Anti-thyroperoxidase (Anti-TPO)Apolipoprotein AI x x x x x x Apolipoprotein AIApolipoprotein AII x Apolipoprotein AIIApolipoprotein B x x x x x x Apolipoprotein BApolipoprotein C III x Apolipoprotein C IIIApolipoprotein CII x Apolipoprotein CIIApolipoprotein E x Apolipoprotein EAnti-Streptolysin O x x x Anti-Streptolysin OAspartate Aminotransferase (AST) x x x x x x x Aspartate aminotransferase (AST)
B Basophils (BASO) x Basophils (BASO) B
Basophils % (%BASO) x Basophils % (%BASO)BASO-X x BASO-XBASO-Y x BASO-Y
Benzoylecgonine x Benzoylecgonine
Beta-1-globulin x x x x x Beta-1-globulinBeta-2-Microglobulin x x x x x x x Beta-2-MicroglobulinBicarbonate x x x x x x x x BicarbonateBile acids x x x x x x x Bile acidsBilirubin, direct x x x x x x x Bilirubin, directBilirubin, total x x x x x x x Bilirubin, totalBrain Derived Neurotropic Factor (BDNF) x Brain Derived Neurotropic Factor (BDNF)
C Cholesterol x x x x x x x x Cholesterol C
CK, Total x x x x x x x CK, TotalCK-MB x x x x x CK-MBCK-NAC x CK-NAC
CA72-4 x CA72-4CA125 x x CA125CA15-3 x x CA15-3CA19-9 x x CA19-9
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay Controls
ANALYTE INDEX
Page
97
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
hs
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
# 17-OH-progesterone x x x x x 17-OH-progesterone #
17β Clostebol 17b Clostebol5-HIAA x 5-HIAA
A Acid phosphatase, prostatic x x x x x x Acid phosphatase, prostatic A
Acid phosphatase, total x x x x x x x Acid phosphatase, totalAcid phosphatase (non prostatic) x Acid phosphatase (non prostatic)Acetaminophen x AcetaminophenAdiponectin x AdiponectinACTH x x x ACTHAldosterone x x x x AldosteroneAlphafetoprotein (AFP) x x x x x x x x x x x Alphafetoprotein (AFP)Alpha-1-Antitrypsin x x x x x x Alpha-1-AntitrypsinAlpha-1-Acid Glycoprotein x x x x x x Alpha-1-Acid GlycoproteinAlpha-HBDH x x x x x x Alpha-HBDHAlpha-2-Macroglobulin x Alpha-2-MacroglobulinAlanine aminotransferase (ALT) x x x x x x x Alanine aminotransferase (ALT)Albumin x x x x x x x x x AlbuminAldolase x AldolaseAlkaline phosphatase (ALP) x x x x x x x Alkaline phosphatase (ALP)Alpha-1-globulin x x x x x Alpha-1-globulinAlpha-2-globulin x x x x x Alpha-2-globulinAmikacin x x x x x x AmikacinAmmonia x x AmmoniaAmylase x x x x x x x x x AmylaseAmylase, pancreatic x x x x x x Amylase, pancreaticAndrostenedione x AndrostenedioneAnti-thrombin III x Anti-thrombin IIIAnti-thyroglobulin (Anti-TG) x Anti-thyroglobulin (Anti-TG)Anti-thyroperoxidase (Anti-TPO) x x Anti-thyroperoxidase (Anti-TPO)Apolipoprotein AI x x x x x x Apolipoprotein AIApolipoprotein AII x Apolipoprotein AIIApolipoprotein B x x x x x x Apolipoprotein BApolipoprotein C III x Apolipoprotein C IIIApolipoprotein CII x Apolipoprotein CIIApolipoprotein E x Apolipoprotein EAnti-Streptolysin O x x x Anti-Streptolysin OAspartate Aminotransferase (AST) x x x x x x x Aspartate aminotransferase (AST)
B Basophils (BASO) x Basophils (BASO) B
Basophils % (%BASO) x Basophils % (%BASO)BASO-X x BASO-XBASO-Y x BASO-Y
Benzoylecgonine x Benzoylecgonine
Beta-1-globulin x x x x x Beta-1-globulinBeta-2-Microglobulin x x x x x x x Beta-2-MicroglobulinBicarbonate x x x x x x x x BicarbonateBile acids x x x x x x x Bile acidsBilirubin, direct x x x x x x x Bilirubin, directBilirubin, total x x x x x x x Bilirubin, totalBrain Derived Neurotropic Factor (BDNF) x Brain Derived Neurotropic Factor (BDNF)
C Cholesterol x x x x x x x x Cholesterol C
CK, Total x x x x x x x CK, TotalCK-MB x x x x x CK-MBCK-NAC x CK-NAC
CA72-4 x CA72-4CA125 x x CA125CA15-3 x x CA15-3CA19-9 x x CA19-9
ANALYTE INDEX
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Page
98
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
hs
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
CA27-29 x CA27-29
Ceruloplasmin x x x x x x Ceruloplasmin
Caffeine x x x Caffeine
Calcitonin x Calcitonin
Calcium x x x x x x x x x x x Calcium
Calcium (Ionised) x x x Calcium (Ionised) Cannabinoids group x Cannabinoids group
Carbamazepine x x x x x x x x x Carbamazepine
Carcinoembryonic Antigen (CEA) x x x x x x x x x Carcinoembryonic Antigen (CEA)
Chloride x x x x x x x x x x x x Chloride
Cholinesterase x x x x x x Cholinesterase
Cocaine group: Benzoylecgonine Cocaine group: Benzoylecgonine
Copper x x x x x x x x Copper
Corticosteroids Corticosteroids
Cortisol x x x x x x x x x x x x x Cortisol
Complement C3 x x x x x x Complement C3
Complement C4 x x x x x x Complement C4
C-Peptide x x x x x C-Peptide
C-Reactive Protein (CRP) x x x x x x x x C-Reactive Protein (CRP)
Creatinine x x x x x x x x x x Creatinine
Cyclosporine x Cyclosporine
Cystatin C x Cystatin C
Cyfra 21 x Cyfra 21 D D-3-hydroxybutyrate x x x x x x x D-3-hydroxybutyrate D
Dextromethorphan Dextromethorphan
D-Dimer x x D-Dimer
DHEA-Sulphate x x x x x x x DHEA-Sulphate
DIFF-X x DIFF-X
DIFF-Y x DIFF-Y
Digoxin x x x x x x x x x x x Digoxin
Dopamine x Dopamine E Ecstasy x Ecstasy E
EDDP x EDDP
Electrophoresis x Electrophoresis
Eosinophils (EOS) x Eosinophils (EOS)
Eosinophils % (%EOS) x Eosinophils % (%EOS)
Epidermal Growth Factor (EGF) x Epidermal Growth Factor (EGF)
Epinephrine x Epinephrine
E-Selectin x E-Selectin
Estradiol x x x x Estradiol
Estriol x x x Estriol
Ethanol x x x x x Ethanol
Ethinylestradiol Ethinylestradiol
Ethosuximide x x x x Ethosuximide F Fatty Acid Binding Protein (FABP) x Fatty Acid Binding Protein (FABP)
Ferritin x x x x x x x x x x x Ferritin
Fibrinogen Fibrinogen
Folate x x x x x x x x Folate
Follicle Stimulating Hormone (FSH) x x x x x Follicle Stimulating Hormone (FSH)
Free thyroxine (FT4) x x x x x x x x x x Free thyroxine (FT4)
Free tri-iodothyronine (FT3) x x x x x x x Free tri-iodothyronine (FT3)
Fructosamine x Fructosamine
ANALYTE INDEX
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay ControlsPa
ge
C
99
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
hs
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
CA27-29 x CA27-29
Ceruloplasmin x x x x x x Ceruloplasmin
Caffeine x x x Caffeine
Calcitonin x Calcitonin
Calcium x x x x x x x x x x x Calcium
Calcium (Ionised) x x x Calcium (Ionised) Cannabinoids group x Cannabinoids group
Carbamazepine x x x x x x x x x Carbamazepine
Carcinoembryonic Antigen (CEA) x x x x x x x x x Carcinoembryonic Antigen (CEA)
Chloride x x x x x x x x x x x x Chloride
Cholinesterase x x x x x x Cholinesterase
Cocaine group: Benzoylecgonine Cocaine group: Benzoylecgonine
Copper x x x x x x x x Copper
Corticosteroids Corticosteroids
Cortisol x x x x x x x x x x x x x Cortisol
Complement C3 x x x x x x Complement C3
Complement C4 x x x x x x Complement C4
C-Peptide x x x x x C-Peptide
C-Reactive Protein (CRP) x x x x x x x x C-Reactive Protein (CRP)
Creatinine x x x x x x x x x x Creatinine
Cyclosporine x Cyclosporine
Cystatin C x Cystatin C
Cyfra 21 x Cyfra 21 D D-3-hydroxybutyrate x x x x x x x D-3-hydroxybutyrate D
Dextromethorphan Dextromethorphan
D-Dimer x x D-Dimer
DHEA-Sulphate x x x x x x x DHEA-Sulphate
DIFF-X x DIFF-X
DIFF-Y x DIFF-Y
Digoxin x x x x x x x x x x x Digoxin
Dopamine x Dopamine E Ecstasy x Ecstasy E
EDDP x EDDP
Electrophoresis x Electrophoresis
Eosinophils (EOS) x Eosinophils (EOS)
Eosinophils % (%EOS) x Eosinophils % (%EOS)
Epidermal Growth Factor (EGF) x Epidermal Growth Factor (EGF)
Epinephrine x Epinephrine
E-Selectin x E-Selectin
Estradiol x x x x Estradiol
Estriol x x x Estriol
Ethanol x x x x x Ethanol
Ethinylestradiol Ethinylestradiol
Ethosuximide x x x x Ethosuximide F Fatty Acid Binding Protein (FABP) x Fatty Acid Binding Protein (FABP)
Ferritin x x x x x x x x x x x Ferritin
Fibrinogen Fibrinogen
Folate x x x x x x x x Folate
Follicle Stimulating Hormone (FSH) x x x x x Follicle Stimulating Hormone (FSH)
Free thyroxine (FT4) x x x x x x x x x x Free thyroxine (FT4)
Free tri-iodothyronine (FT3) x x x x x x x Free tri-iodothyronine (FT3)
Fructosamine x Fructosamine
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
ANALYTE INDEX
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n)
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Page
C
F
100
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
F FSC-X x FSC-X F
G Gentamicin x x x x x x x x x Gentamicin G
Gamma-Globulin x x x x x Gamma-Globulin
Gamma GT x x x x x x x Gamma GT
Gastrin x Gastrin
GH x x x x GH
GLDH x x x x x x GLDH
Glial Fibrillary Acidic Protein (GFAP) x Glial Fibrillary Acidic Protein (GFAP)
Glutamate x Glutamate
GM-CSF x GM-CSF H Haptoglobin x x x x x x Haptoglobin H
Hematocrit (HCT) x Hematocrit (HCT)
Haemoglobin (Total) x x Haemoglobin (Total)
Haemoglobin A2 (HbA2) x Haemoglobin A2 (HbA2)
Haemoglobin F (HbF) x Haemoglobin F (HbF)
Haemoglobin S (HbS) x Haemoglobin S (HbS)
Hemopioetic Progenitor Cell (HPC) x Hemopioetic Progenitor Cell (HPC)
HbA1c x HbA1c
hCG x x x x x x x x x x hCG
hCG (Free beta) x hCG (Free beta)
HDL Cholesterol x x x x x x x HDL Cholesterol
Homocysteine x x Homocysteine
hsCRP x hsCRP I IgA x x x x x x x x IgA I
IgE x x x x x x x x x IgE
IgG x x x x x x x x x IgG
IgM x x x x x x x x IgM
Inhibin A x Inhibin A
Insulin x x x x x x Insulin
Insulin Like Growth Factor x Insulin Like Growth Factor
Intercellular Adhesion Molecule-1 (ICAM-1) x Intercellular Adhesion Molecule-1 (ICAM-1)
Interferon-gamma (IFN-y) x Interferon-gamma (IFN-y)
Interleukin-1 alpha (IL-1a) x x Interleukin-1 alpha (IL-1a)
Interleukin-1 beta (IL-1b) x Interleukin-1 beta (IL-1b)
Interleukin-10 (IL-10) x Interleukin-10 (IL-10)
Interleukin-12p70 (IL-12 p70) x Interleukin-12p70 (IL-12 p70)
Interleukin-13 (IL-13) x Interleukin-13 (IL-13)
Interleukin-15 (IL-15) x Interleukin-15 (IL-15)
Interleukin-2 (IL-2) x Interleukin-2 (IL-2)
Interleukin-23 (IL-23) x Interleukin-23 (IL-23)
Interleukin-3 (IL-3) x Interleukin-3 (IL-3)
Interleukin-4 (IL-4) x Interleukin-4 (IL-4)
Interleukin-5 (IL-5) x Interleukin-5 (IL-5)
Interleukin-6 (IL-6) x x x Interleukin-6 (IL-6)
Interleukin-7 (IL-7) x Interleukin-7 (IL-7)
Interleukin-8 (IL-8) x Interleukin-8 (IL-8)
Iron x x x x x x x Iron
IMIDC x IMIDC
IMIRF x IMIRF
Immature Granulocytes (IG) x Immature Granulocytes (IG)
Immature Granulocytes % (%IG) x Immature Granulocytes % (%IG)
ANALYTE INDEX
Page
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay Controls
101
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
F FSC-X x FSC-X F
G Gentamicin x x x x x x x x x Gentamicin G
Gamma-Globulin x x x x x Gamma-Globulin
Gamma GT x x x x x x x Gamma GT
Gastrin x Gastrin
GH x x x x GH
GLDH x x x x x x GLDH
Glial Fibrillary Acidic Protein (GFAP) x Glial Fibrillary Acidic Protein (GFAP)
Glutamate x Glutamate
GM-CSF x GM-CSF H Haptoglobin x x x x x x Haptoglobin H
Hematocrit (HCT) x Hematocrit (HCT)
Haemoglobin (Total) x x Haemoglobin (Total)
Haemoglobin A2 (HbA2) x Haemoglobin A2 (HbA2)
Haemoglobin F (HbF) x Haemoglobin F (HbF)
Haemoglobin S (HbS) x Haemoglobin S (HbS)
Hemopioetic Progenitor Cell (HPC) x Hemopioetic Progenitor Cell (HPC)
HbA1c x HbA1c
hCG x x x x x x x x x x hCG
hCG (Free beta) x hCG (Free beta)
HDL Cholesterol x x x x x x x HDL Cholesterol
Homocysteine x x Homocysteine
hsCRP x hsCRP I IgA x x x x x x x x IgA I
IgE x x x x x x x x x IgE
IgG x x x x x x x x x IgG
IgM x x x x x x x x IgM
Inhibin A x Inhibin A
Insulin x x x x x x Insulin
Insulin Like Growth Factor x Insulin Like Growth Factor
Intercellular Adhesion Molecule-1 (ICAM-1) x Intercellular Adhesion Molecule-1 (ICAM-1)
Interferon-gamma (IFN-y) x Interferon-gamma (IFN-y)
Interleukin-1 alpha (IL-1a) x x Interleukin-1 alpha (IL-1a)
Interleukin-1 beta (IL-1b) x Interleukin-1 beta (IL-1b)
Interleukin-10 (IL-10) x Interleukin-10 (IL-10)
Interleukin-12p70 (IL-12 p70) x Interleukin-12p70 (IL-12 p70)
Interleukin-13 (IL-13) x Interleukin-13 (IL-13)
Interleukin-15 (IL-15) x Interleukin-15 (IL-15)
Interleukin-2 (IL-2) x Interleukin-2 (IL-2)
Interleukin-23 (IL-23) x Interleukin-23 (IL-23)
Interleukin-3 (IL-3) x Interleukin-3 (IL-3)
Interleukin-4 (IL-4) x Interleukin-4 (IL-4)
Interleukin-5 (IL-5) x Interleukin-5 (IL-5)
Interleukin-6 (IL-6) x x x Interleukin-6 (IL-6)
Interleukin-7 (IL-7) x Interleukin-7 (IL-7)
Interleukin-8 (IL-8) x Interleukin-8 (IL-8)
Iron x x x x x x x Iron
IMIDC x IMIDC
IMIRF x IMIRF
Immature Granulocytes (IG) x Immature Granulocytes (IG)
Immature Granulocytes % (%IG) x Immature Granulocytes % (%IG)
ANALYTE INDEX
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n)
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Page
102
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
Hem
istr
y Pr
emiu
m P
lus
Che
mis
try
Prem
ium
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
hs
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
I Immature Myeloid Information (IMI) x Immature Myeloid Information (IMI) I
Immature Platelet Fraction (IPF) x Immature Platelet Fraction (IPF)K Kappa Light Chain x Kappa Light Chain K
Kappa Light Chain (free) x Kappa Light Chain (free)L Lambda Light Chain x Lambda Light Chain L
Lambda Light Chain (free) x Lambda Light Chain (free)
Lactate x x x x x x x x x x Lactate
LAP x x x x x LAP
LDH x x x x x x LDH
Leptin x x Leptin
LDL Cholesterol x x x x x LDL Cholesterol
Luteinising Hormone (LH) x x x x x x Luteinising Hormone (LH)
Lipase x x x x x x x Lipase
Lipoprotein (a) x x x x x Lipoprotein (a)
Lithium x x x x x x x x Lithium
L-Selectin x L-Selectin
Lymphocytes (LYMPH) x Lymphocytes (LYMPH)
Lymphocytes % (%LYMPH) x Lymphocytes % (%LYMPH)M MIP-1a x MIP-1a M
Magnesium x x x x x x x Magnesium
Matrix Metalloproteinase-9 (MMP-9) x x x x Matrix Metalloproteinase-9 (MMP-9)
Mean Corpuscular Volume (MCV) x Mean Corpuscular Volume (MCV)
Mean Corpuscular Haemoglobin (MCH) x Mean Corpuscular Haemoglobin (MCH)Mean Corpuscular Haemoglobin Concentration(MCHC) x Mean Corpuscular Haemoglobin Concentration(MCHC)
Mean Platelet Volume (MPV) x Mean Platelet Volume (MPV) Medroxyprogesteron Acetate Medroxyprogesteron Acetate
Metanephrine x Metanephrine
Methadone x Methadone
Methandriol Methandriol
Methamphetamine x Methamphetamine
Methotrexate x Methotrexate
Methyltestosterone Methyltestosterone
Microalbumin x x x Microalbumin
Monocytes (MONO) x Monocytes (MONO)
Monocytes % (%MONO) x Monocytes % (%MONO)
Morphine x Morphine
Myoglobin x x x x x x x Myoglobin
MCP-1 x MCP-1 N NEFA x x NEFA N
Neuron-Specific Enolase (NSE) x x Neuron-Specific Enolase (NSE)
Neutrophils (NEUT) x Neutrophils (NEUT)
Neutrophils % (%NEUT) x Neutrophils % (%NEUT)
NGAL x NGAL
Norepinephrine x Norepinephrine
Normetanephrine x Normetanephrine
NT-proBNP x x NT-proBNP
Nucleated Red Blood Cells X (NRBC-X) x Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y) x Nucleated Red Blood Cells Y (NRBC-Y)
Nucleated Red Blood Cells (NRBC) x Nucleated Red Blood Cells (NRBC)
Nucleated Red Blood Cells % (%NRBC) x Nucleated Red Blood Cells % (%NRBC) O Osmolality x x x x x x x x x Osmolality O
Osteocalcin x Osteocalcin
Oxalate x Oxalate
Oxazepam x Oxazepam P PAPP-A x PAPP-A P
pCO2 x pCO2
ANALYTE INDEX
Page
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay Controls
103
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
Hem
istr
y Pr
emiu
m P
lus
Che
mis
try
Prem
ium
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
I
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
hs
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
I Immature Myeloid Information (IMI) x Immature Myeloid Information (IMI) I
Immature Platelet Fraction (IPF) x Immature Platelet Fraction (IPF)K Kappa Light Chain x Kappa Light Chain K
Kappa Light Chain (free) x Kappa Light Chain (free)L Lambda Light Chain x Lambda Light Chain L
Lambda Light Chain (free) x Lambda Light Chain (free)
Lactate x x x x x x x x x x Lactate
LAP x x x x x LAP
LDH x x x x x x LDH
Leptin x x Leptin
LDL Cholesterol x x x x x LDL Cholesterol
Luteinising Hormone (LH) x x x x x x Luteinising Hormone (LH)
Lipase x x x x x x x Lipase
Lipoprotein (a) x x x x x Lipoprotein (a)
Lithium x x x x x x x x Lithium
L-Selectin x L-Selectin
Lymphocytes (LYMPH) x Lymphocytes (LYMPH)
Lymphocytes % (%LYMPH) x Lymphocytes % (%LYMPH)M MIP-1a x MIP-1a M
Magnesium x x x x x x x Magnesium
Matrix Metalloproteinase-9 (MMP-9) x x x x Matrix Metalloproteinase-9 (MMP-9)
Mean Corpuscular Volume (MCV) x Mean Corpuscular Volume (MCV)
Mean Corpuscular Haemoglobin (MCH) x Mean Corpuscular Haemoglobin (MCH)Mean Corpuscular Haemoglobin Concentration(MCHC) x Mean Corpuscular Haemoglobin Concentration(MCHC)
Mean Platelet Volume (MPV) x Mean Platelet Volume (MPV) Medroxyprogesteron Acetate Medroxyprogesteron Acetate
Metanephrine x Metanephrine
Methadone x Methadone
Methandriol Methandriol
Methamphetamine x Methamphetamine
Methotrexate x Methotrexate
Methyltestosterone Methyltestosterone
Microalbumin x x x Microalbumin
Monocytes (MONO) x Monocytes (MONO)
Monocytes % (%MONO) x Monocytes % (%MONO)
Morphine x Morphine
Myoglobin x x x x x x x Myoglobin
MCP-1 x MCP-1 N NEFA x x NEFA N
Neuron-Specific Enolase (NSE) x x Neuron-Specific Enolase (NSE)
Neutrophils (NEUT) x Neutrophils (NEUT)
Neutrophils % (%NEUT) x Neutrophils % (%NEUT)
NGAL x NGAL
Norepinephrine x Norepinephrine
Normetanephrine x Normetanephrine
NT-proBNP x x NT-proBNP
Nucleated Red Blood Cells X (NRBC-X) x Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y) x Nucleated Red Blood Cells Y (NRBC-Y)
Nucleated Red Blood Cells (NRBC) x Nucleated Red Blood Cells (NRBC)
Nucleated Red Blood Cells % (%NRBC) x Nucleated Red Blood Cells % (%NRBC) O Osmolality x x x x x x x x x Osmolality O
Osteocalcin x Osteocalcin
Oxalate x Oxalate
Oxazepam x Oxazepam P PAPP-A x PAPP-A P
pCO2 x pCO2
ANALYTE INDEX
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n)
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
Page
104
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay Controls
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
1
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
P pH x x pH P
Phenobarbitital x x x x x x x Phenobarbitital
Phenytoin x x x x x x x x Phenytoin
Phosphate x x x x x x x x Phosphate
Phosphorous x x Phosphorous
Plasminogen Activator Inhibitor x Plasminogen Activator Inhibitor
Platelet Distrabution Width (PDW) Platelet Distrabution Width (PDW)
Platelet Large Cell Ratio (P-LCR) x Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT) x Plateletcrit (PCT)
Platelets (PLT) x Platelets (PLT)
Platelets Optical Count (PLT-0) x Platelets Optical Count (PLT-0)
pO2 x pO2
Potassium x x x x x x x x x x x Potassium
Prealbumin x x x x x Prealbumin
Primidone x x x x Primidone
Procalcitonin x x Procalcitonin
Progesterone x x x x x Progesterone
Prolactin x x x x x x x Prolactin
Protein, total x x x x x x x x x x x x Protein, total
PSA (Total) x x x x x x x x x PSA (Total)
PSA (Free) x x x x PSA (Free)
P-Selectin x P-Selectin
PT PT
PTH x x x x PTHR Red Blood Cell X (RBC-X) x Red Blood Cell X (RBC-X) R
Red Blood Cell Y (RBC-Y) x Red Blood Cell Y (RBC-Y)
Red Blood Cell Distribution Width CV (RDW-CV) x Red Blood Cell Distribution Width CV (RDW-CV)
Red Blood Cell Distribution Width SD (RDW-SD) x Red Blood Cell Distribution Width SD (RDW-SD)
Red Blood Cells (RBC) x Red Blood Cells (RBC)
Red Blood Cells Optical Count (RBC-O) x Red Blood Cells Optical Count (RBC-O)
Renin x Renin
Resistin x Resistin
Retinol Binding Protein (RBP) x Retinol Binding Protein (RBP)
Rheumatoid Factor (RF) x x Rheumatoid Factor (RF)S Salicylate x x x x Salicylate S
Secoborbital x Secoborbital
Sex Hormone Binding Globulin (SHBG) x x x x Sex Hormone Binding Globulin (SHBG)
sLDL x sLDL
Sodium x x x x x x x x x x x Sodium
Soluble IL-2 Receptor Alpha (sIL-2Ra) x Soluble IL-2 Receptor Alpha (sIL-2Ra)
Soluble IL-6 Receptor (sIL-6R) x Soluble IL-6 Receptor (sIL-6R)
Specific Gravity x Specific Gravity
sTNFR I x x sTNFR I
sTNFR II x sTNFR IIT Testosterone x x x x x x Testosterone T
Theophylline x x x x x x x x x x Theophylline
Thrombomodulin (TM) x Thrombomodulin (TM)
Thyroglobulin x x x x Thyroglobulin
TIBC x x x x x x x TIBC
Tobramycin x Tobramycin
ANALYTE INDEX
Page
105
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
1
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
P pH x x pH P
Phenobarbitital x x x x x x x Phenobarbitital
Phenytoin x x x x x x x x Phenytoin
Phosphate x x x x x x x x Phosphate
Phosphorous x x Phosphorous
Plasminogen Activator Inhibitor x Plasminogen Activator Inhibitor
Platelet Distrabution Width (PDW) Platelet Distrabution Width (PDW)
Platelet Large Cell Ratio (P-LCR) x Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT) x Plateletcrit (PCT)
Platelets (PLT) x Platelets (PLT)
Platelets Optical Count (PLT-0) x Platelets Optical Count (PLT-0)
pO2 x pO2
Potassium x x x x x x x x x x x Potassium
Prealbumin x x x x x Prealbumin
Primidone x x x x Primidone
Procalcitonin x x Procalcitonin
Progesterone x x x x x Progesterone
Prolactin x x x x x x x Prolactin
Protein, total x x x x x x x x x x x x Protein, total
PSA (Total) x x x x x x x x x PSA (Total)
PSA (Free) x x x x PSA (Free)
P-Selectin x P-Selectin
PT PT
PTH x x x x PTHR Red Blood Cell X (RBC-X) x Red Blood Cell X (RBC-X) R
Red Blood Cell Y (RBC-Y) x Red Blood Cell Y (RBC-Y)
Red Blood Cell Distribution Width CV (RDW-CV) x Red Blood Cell Distribution Width CV (RDW-CV)
Red Blood Cell Distribution Width SD (RDW-SD) x Red Blood Cell Distribution Width SD (RDW-SD)
Red Blood Cells (RBC) x Red Blood Cells (RBC)
Red Blood Cells Optical Count (RBC-O) x Red Blood Cells Optical Count (RBC-O)
Renin x Renin
Resistin x Resistin
Retinol Binding Protein (RBP) x Retinol Binding Protein (RBP)
Rheumatoid Factor (RF) x x Rheumatoid Factor (RF)S Salicylate x x x x Salicylate S
Secoborbital x Secoborbital
Sex Hormone Binding Globulin (SHBG) x x x x Sex Hormone Binding Globulin (SHBG)
sLDL x sLDL
Sodium x x x x x x x x x x x Sodium
Soluble IL-2 Receptor Alpha (sIL-2Ra) x Soluble IL-2 Receptor Alpha (sIL-2Ra)
Soluble IL-6 Receptor (sIL-6R) x Soluble IL-6 Receptor (sIL-6R)
Specific Gravity x Specific Gravity
sTNFR I x x sTNFR I
sTNFR II x sTNFR IIT Testosterone x x x x x x Testosterone T
Theophylline x x x x x x x x x x Theophylline
Thrombomodulin (TM) x Thrombomodulin (TM)
Thyroglobulin x x x x Thyroglobulin
TIBC x x x x x x x TIBC
Tobramycin x Tobramycin
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
ANALYTE INDEX
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n)
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Page
106
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
1
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
T Total Lipids x Total Lipids T
Total Thyroxine (TT4) x x x x x x x x x x Total Thyroxine (TT4)
Total Tri-iodothyronine (TT3) x x x x x x x x x x Total Tri-iodothyronine (TT3)
Transferrin x x x x x x x Transferrin
Triglycerides x x x x x x x x Triglycerides
Troponin I x x x x x x Troponin I
Troponin T x x x x x x Troponin T
TSH x x x x x x x x TSH
T-Uptake x x x x x x T-Uptake
Tumour Necrosis Factor-alpha (TNF-a) x x Tumour Necrosis Factor-alpha (TNF-a)U UIBC x x UIBC U
Unconjugated Estriol Unconjugated Estriol
Urea x x x x x x x x x x Urea
Uric acid x x x x x x x x x x Uric acidV Valproic acid x x x x x x x x x Valproic acid V
Vancomycin x x x x x x x x x Vancomycin
Vanillyl Mandelic Acid (VMA) x Vanillyl Mandelic Acid (VMA)
VCAM-1 x VCAM-1
VEGF x VEGF
Vitamin B12 x x x x x x x x x Vitamin B12
1-25-(OH2)-Vitamin D x x x 1-25-(OH2)-Vitamin D
25-OH-Vitamin D x x x 25-OH-Vitamin DW White Blood Cells (WBC) x White Blood Cells (WBC) W
White Blood Cells Differential (WBC-D) x White Blood Cells Differential (WBC-D)Z Zinc x x x x x x x Zinc Z
ANALYTE INDEX
Page
Blood Gas
Cardiac Controls
Clinical Chemistry Controls
Haematology
Diabetes Controls
Immunoassay Controls
107
Immunology/ Protein Controls
Lipid Controls
Therapeutic Drug Controls
Toxicology Controls
Urine Controls
Speciality & Research Controls
67 43 43 44 44 13 14 16 15 17 18 19 20 20 21 63 48 47 47 48 25 26 27 28 29 29 30 30 33 33 36 34 34 35 36 36 39 39 40 40 40 55 60 59 59 59 59 60 51 51 52 52 71 71 72 72 73 73 74 74 75
Bloo
d G
as
Car
diac
Liqu
id C
ardi
ac C
ontr
ol
CK
-MB
Myo
glob
in C
alib
rato
r
Liqu
id A
ssay
ed C
hem
istr
y Pr
emiu
m P
lus
Liqu
id C
hem
istr
y Pr
emiu
m
Ass
ayed
Che
mis
try
Prem
ium
Plu
s
Liqu
id C
hem
istr
y Pr
emiu
m P
lus
Prec
isio
n C
hem
istr
y Pr
emiu
m P
lus
Bovi
ne C
hem
istr
y (P
reci
sion
)
Clin
ical
Che
mis
try
Cal
ibra
tor
Seru
m
Ald
olas
e
Am
mon
ia/ E
than
ol
Mul
ti C
ontr
ol &
Cal
ibra
tor
Hae
mat
olog
y
Adi
pone
ctin
Fruc
tosa
min
e
HbA
1c
Hae
mog
lobi
n F
& A
2
Imm
unoa
ssay
Pre
miu
m
Liqu
id Im
mun
oass
ay P
rem
ium
Imm
unoa
ssay
Pre
miu
m P
lus
Liqu
id Im
mun
oass
ay P
rem
ium
Plu
s
Imm
unoa
ssay
Spe
cial
ity I
Imm
unoa
ssay
Spe
cial
ity II
Liqu
id T
umou
r M
arke
r C
ontr
ol
Mat
erna
l Scr
eeni
ng
Spec
ific
Prot
eins
CR
P Li
quid
CSF
ASO
Cal
ibra
tor
Cys
tatin
C
Rhe
umat
oid
Fact
or
Spec
ific
Prot
ein
Cal
ibra
tor
Spec
ific
Prot
ein
Cal
ibra
tor
Lipi
d
Apo
lipop
rote
in C
ontr
ol &
Cal
ibra
tor
HD
L/ L
DL
Cho
lest
erol
Cal
ibra
tor
Lipo
prot
ein
(a)
sLD
L
TD
M C
ontr
ol
Benz
odia
zepi
nes
Con
trol
Can
nabi
noid
Con
trol
Ecst
asy
Con
trol
EDD
P C
ontr
ol
Etha
nol C
alib
rato
r/C
ontr
ol S
et
Mul
tidru
g C
ontr
ol
Ass
ayed
Uri
ne C
hem
istr
y
Una
ssay
ed U
rine
Che
mis
try
Liqu
id U
rine
Con
trol
Mic
roal
bum
in
Cel
lula
r Adh
esio
n M
olec
ules
Cer
ebra
l Ser
ies
1
Cer
ebra
l Ser
ies
II
Cyt
okin
e &
Cyt
okin
e A
rray
I
Cyt
okin
e A
rray
III
Cyt
okin
e A
rray
IV
Cyt
okin
e A
rray
V
Endo
crin
e
Met
abol
ic S
yndr
ome
Con
trol
T Total Lipids x Total Lipids T
Total Thyroxine (TT4) x x x x x x x x x x Total Thyroxine (TT4)
Total Tri-iodothyronine (TT3) x x x x x x x x x x Total Tri-iodothyronine (TT3)
Transferrin x x x x x x x Transferrin
Triglycerides x x x x x x x x Triglycerides
Troponin I x x x x x x Troponin I
Troponin T x x x x x x Troponin T
TSH x x x x x x x x TSH
T-Uptake x x x x x x T-Uptake
Tumour Necrosis Factor-alpha (TNF-a) x x Tumour Necrosis Factor-alpha (TNF-a)U UIBC x x UIBC U
Unconjugated Estriol Unconjugated Estriol
Urea x x x x x x x x x x Urea
Uric acid x x x x x x x x x x Uric acidV Valproic acid x x x x x x x x x Valproic acid V
Vancomycin x x x x x x x x x Vancomycin
Vanillyl Mandelic Acid (VMA) x Vanillyl Mandelic Acid (VMA)
VCAM-1 x VCAM-1
VEGF x VEGF
Vitamin B12 x x x x x x x x x Vitamin B12
1-25-(OH2)-Vitamin D x x x 1-25-(OH2)-Vitamin D
25-OH-Vitamin D x x x 25-OH-Vitamin DW White Blood Cells (WBC) x White Blood Cells (WBC) W
White Blood Cells Differential (WBC-D) x White Blood Cells Differential (WBC-D)Z Zinc x x x x x x x Zinc Z
ANALYTE INDEX
( For
sam
ples
that
do
not
requ
ire p
redi
lutio
n)
( For
sam
ples
that
do
requ
ire p
redi
lutio
n)
Page
108
Analyte Index
109
Chapter 20
A - ZIndex
110
A
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HHaematologyHaemoglobin F & A2HbAlcHDL/LDL Cholesterol Calibrator
IImmunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality II
LLipidLipoprotein (a)Liquid Assayed Chemistry Premium PlusLiquid Cardiac Control
A - Z Index
48202039341751
606718
594371
7172441933363472
737374
59597459
47
63484740
25272929
39401343
Page No.
111
L
Liquid Chemistry PremiumLiquid Chemistry Premium PlusLiquid Immunoassay PremiumLiquid Immunoassay Premium PlusLiquid Tumour Marker ControlLiquid Urine Control
MMaternal ScreeningMetabolic Syndrome ControlMicroalbuminMulti Control & CalibratorMultidrug ControlMyoglobin Calibrator
PPrecision Chemistry Premium Plus
RRIQAS Ammonia/Ethonal ProgrammeRIQAS Bood Gas ProgrammeRIQAS BNP ProgrammeRIQAS Cardiac ProgrammeRIQAS Coagulation ProgrammeRIQAS ESR ProgrammeRIQAS General Clinical Chemistry ProgrammeRIQAS Glycated Haemoglobin ProgrammeRIQAS Haematology ProgrammeRIQAS Human Urine ProgrammeRIQAS Immunoassay ProgrammeRIQAS Immunoassay Speciality I ProgrammeRIQAS Immunoassay Speciality 2 ProgrammeRIQAS Lipid ProgrammeRIQAS Liquid Cardiac ProgrammeRIQAS Maternal Screening ProgrammeRIQAS Serology (EBV) ProgrammeRIQAS Serology (Syphilis) ProgrammeRIQAS Serology (ToRCH) ProgrammeRIQAS Specific Proteins ProgrammeRIQAS Therapeutic Drugs ProgrammeRIQAS Urinalysis Programme RIQAS Urine Toxicology ProgrammeRheumatoid Factor Calibrator
SsLDLSpecific Protein CalibratorSpecific Protein Calibrator (Predilution)Specific Proteins
TTDM Control
UUnassayed Urine Chemistry
A - Z Index
1415 26283052
307552216044
17
909090909090909191919191919292929292929393939335
40363633
55
51
112
The clinical analysers from our RX series have an impressive range of time-saving, labour-saving and cost-saving features. They offer outstanding flexibility coupled with optimum reliability. RX series software has been designed with users in mind to ensure straightforward and intuitive operation.
RX series analysers
RX monzaThe RX monza is a compact semi-automated analyser with astonishing functionality, offering 192 channels, 79 of which have dedicated parameters. The RX monza will open exciting opportunties for both routine and specialised testing including coagulation testing.
RX monacoThe RX monaco is a fully automated random access clinical analyser capable of carrying out 170 tests per hour. It provides unrivalled performance for low to mid volume testing.
RX daytona+Superior performance for mid volume laboratories. The RX daytona+ is capable of running 270 photometric tests per hour or 450 tests per hour including ISEs.
RX imolaEfficiency for medium sized laboratories. The RX imola is a random access benchtop clinical analyser with a throughput of 560 tests per hour including ISEs.
The clinical analysers from our RX series have an impressive range of time-saving, labour-saving and cost-saving features. They offer outstanding flexibility coupled with optimum reliability. RX series software has been designed with users in mind to ensure straightforward and intuitive operation.
RX series analysers
RX monzaThe RX monza is a compact semi-automated analyser with astonishing functionality, offering 192 channels, 79 of which have dedicated parameters. The RX monza will open exciting opportunties for both routine and specialised testing including coagulation testing.
RX monacoThe RX monaco is a fully automated random access clinical analyser capable of carrying out 170 tests per hour. It provides unrivalled performance for low to mid volume testing.
RX daytona+Superior performance for mid volume laboratories. The RX daytona+ is capable of running 270 photometric tests per hour or 450 tests per hour including ISEs.
RX imolaEfficiency for medium sized laboratories. The RX imola is a random access benchtop clinical analyser with a throughput of 560 tests per hour including ISEs.
RX series analyzers
analyzers
Superior performance for mid volume laboratories. The RX daytona+ is capable of running 270 photometric tests per hour or 450 tests per hour including ISEs.
Efficiency for medium sized laboratories. The RX imola is a random access benchtop clinical analzyer with a throughput of 560 tests per hour including ISEs.
CLINICAL
Autoimmune:Complement Component 3 Complement Component 4 CRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity IgA IgEIgGIgMRheumatoid Factor
Basic Metabolic Profile:Calcium CO2 TotalChlorideCreatinine EnzymaticCreatinine (Jaffe)GlucosePotassiumSodiumUrea
Bone Profile:Alkaline PhosphataseCalciumPhosphorusTotal Protein
Cardiac:CholesterolCK-MBCK-NACCRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity DigoxinDirect HDL CholesterolDirect LDL CholesterolHeart-Type Fatty Acid Binding Protein (H-FABP) HomocysteineLipoprotein (a)Myoglobin sLDLTriglyceridesTxB Cardio
Comprehensive Metabolic Profile:Albumin Alkaline PhosphataseALTAST (GOT) Direct BilirubinCalcium ChlorideCO2 Total Creatinine EnzymaticCreatinine (Jaffe)GlucoseLactate Potassium SodiumTotal BilirubinTotal Protein Urea
Diabetes:AdiponectinCholesterolCreatinine EnzymaticCreatinine (Jaffe)Cystatin CDirect HDL CholesterolDirect LDL Cholesterol FructosamineGlucoseGlycerol HbA1c/Hb Microalbumin NEFA (Non-Esterified Fatty Acids)Ranbut (Hydroxybutyrate)Total Protein Triglycerides Urinary Protein
Electrolytes:Calcium Chloride (Direct / Nondirect)CO2 Total LithiumMagnesium Potassium (Direct / Nondirect)Sodium (Direct / Nondirect)
Haemolytic Anaema:G-6-P-DHHaptoglobinLDH
Hepatic Function:Albumin AldolaseAlkaline PhosphataseAlpha-1 AntitrypsinALTAmmoniaAST (GOT) CholinesteraseComplement Component 3 Complement Component 4 Direct Bilirubin Gamma GTGLDHGlycerolHaptoglobin IgA IgG IgM Iron (UIBC)Leucine Arylamidase (LAP)LDHTotal Bilirubin Total Protein Transferrin Transthyretin (Prealbumin)
Inflammation and Infection:Acid PhosphataseAlpha-1Acid GlycoproteinASOCRPLactateRheumatoid Factor
Lipids:Apolipoprotein A-1 Apolipoprotein AII Apolipoprotein B Apolipoprotein CIIIApolipoprotein CII Apolipoprotein E CholesterolDirect HDL CholesterolDirect LDL CholesterolLipoprotein (a)sLDLTriglycerides
Neonatal Screening:Alpha-1 AntitrypsinCRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity IgETransthyretin (Prealbumin)
Neurological Disorders (CSF):IgA IgG IgM
Nutritional Status:AlbuminCopper FerritinIronIron (UIBC)LipaseMagnesiumPotassiumTIBCTransferrin Transthyretin (Prealbumin) Zinc
Pancreatic Function:AmylaseGlucoseLDHLipasePancreatic Amylase
Renal Function:Albumin AmmoniaBeta-2 MicroglobulinCalciumChloride Creatinine EnzymaticCreatinine (Jaffe)Cystatin CGlucose HbA1c/Hb IgGLDHMagnesium Microalbumin PotassiumSodiumPhosphorus (Inorganic)Urinary ProteinUrea Uric Acid
VETERINARY
Albumin Alkaline phosphatase ALT (GPT) AldolaseAmmonia AmylaseAST (GOT) Bile acids Bilirubin Calcium Chloride Cholesterol Cholinesterase (Butyryl)CK-NAC CO2 Total Copper Creatinine CRPCanine CRPFructosamine Gamma-GT GLDH Glucose GlycerolHDLIron (UIBC) Lactate Lactate dehydrogenase LDLLipaseMagnesium NEFA (Non-esterified fatty acids)Phosphorus (Inorganic) PotassiumRanbut (Hydroxybutyrate)Glutathione Peroxidase (Ransel)Superoxide Dismutase (Ransod)SodiumTherapeutic drugsTotal ProteinTriglyceridesUreaUric AcidUrinary proteinZinc
TOXICOLOGY
Therapeutic Drugs:AcetaminophenCarbamazepineDigoxin GentamicinLithiumPhenobarbitolPhenytoinSalicylateTheophylineValproic Acid
Drugs of Abuse:BarbituratesBenzodiazepinesCannabinoidsCocaine metaboliteEDDPEcstasyEthanolMethadoneMethamphetamine Opiates
PROTEINS
Specific Proteins:Alpha-1 AntitrypsinAlpha-1 Acid GlycoproteinApolipoprotein A-1 Apolipoprotein AII Apolipoprotein B Apolipoprotein CII Apolipoprotein CIII Apolipoprotein E ASO Beta-2 MicroglobulinCeruloplasminComplement Component 3 Complement Component 4 CRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity Cystatin CFerritinFructosamineHaptoglobin HbA1c/Hb IgA IgEIgG IgM Lipoprotein (a)Microalbumin Myoglobin Rheumatoid Factor Transthyretin (Prealbumin) Transferrin
RESEARCH
Antioxidants:AlbuminBilirubinFerritinGlutathione Reductase Glutathione Peroxidase (Ransel)Superoxide Dismutase (Ransod)TIBCTotal Antioxidant StatusTransferrinUric Acid
Biotechnology:GlutamateGlutamine
Food and Wine Testing:Acetic AcidAmmonia CalciumCopperGlucose Glucose/FructoseGlycerolIron L-Lactic AcidMalic AcidPotassiumTotal Antioxidant Status
Randox Clinical Chemistry Test Menu
Information correct at time of print. Randox Laboratories Limited is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic
procedures in the USA.
QUALITY CONTROL
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[email protected] www.randoxqc.com
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