third party controls qcqc solutions for results you can...

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

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QUALITY CONTROL

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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



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




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


Ammonia / Ethanol Control Level 1 6 x 2 ml EA1366



Multi Calibrator 3 x 2 ml MC1382

Multi Control Level 1 5 x 2 ml MC1379



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


Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048

Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049

CARDIACCK

MyoglobinTroponin ITroponin T


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


PrealbuminTotal ProteinTransferrin

DRUGSAcetaminophenCarbamazepine

DigoxinEthanol

GentamicinLithium

PhenobarbitalPhenytoinSalicylate

TheophyllineValproic AcidVancomycin

TRACE METALSCopper

Zinc

ROUTINE CHEMISTRYAcid Phosphatase (Prostatic)

Acid Phosphatase (Total)Albumin

Alkaline PhosphataseALT (SGPT)


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








Analytes

CARDIACCK

CK-MBMyoglobin Troponin I Troponin T


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


a-1-Antitrypsinβ-2-Microglobulin

Ceruloplasmin Complement C3 Complement C4

CRP Ferritin

Haptoglobin IgA IgE IgG IgM

Prealbumin Total Protein Transferrin


Acid Phosphatase (Total) Albumin


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


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


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


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


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


Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557

Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558


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


a-1-AntitrypsinCeruloplasmin


CRPFerritin


PrealbuminTotal ProteinTransferrin

DRUGSAcetaminophen Carbamazepine

DigoxinGentamicin

LithiumPhenobarbital

PhenytoinSalicylate

Theophylline

TobramycinValproic AcidVancomycin

TRACE METALSCopper

Zinc





AST (SGOT)BicarbonateBile Acids


CalciumChloride

CreatinineγGT

Glucose

GLDH a-HBDH

D-3-HydroxybutyrateIronTIBCLAP

LD (LDH)LipaseLactate

MagnesiumOsmolality

Phosphate (Inorganic)PotassiumSodiumUIBCUrea

Uric Acid (Urate)

Clinical Chemistry

18


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


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




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


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


Aldolase Calibrator 3 x 1 ml AD5000







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.


Multi Calibrator 3 x 2 ml MC1382




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


Glutamine Control Level 1 5 x 5 ml GM1376



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 Tri-Level 4 x 3 x 5 ml LIA3108

Immunoassay Control Premium Plus Level 1 12 x 5 ml IA3109



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



Immunoassay Speciality I Control Level 1 5 x 2 ml IAS3113



Immunoassay Speciality II Control Level 1 5 x 1 ml IAS3117



Liquid Tumour Marker Control Level 1 6 x 3 ml TU5085



Maternal Screening Control Level 1 3 x 1 ml MSS5024



25


Immunoassay Premium Level 1 10 x 5 ml IA2638



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


Liquid Immunoassay Premium Level 1 12 x 5 ml LIA3105



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


IgEInsulin

Leuteinising Hormone (LH)Phenobarbital*

PhenytoinPrimidone


PSA (Free)PSA (Total)Salicylate

SHBGTestosteroneTheophyllineTobramycin

Total T3 Total T4

TSHT Uptake

Valproic AcidVancomycinVitamin B12

Analytes


27


Immunoassay Premium Plus Level 1 12 x 5ml IA3109



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


hCG

IgEInsulin

Leuteinising Hormone (LH)PTH (Intact)

Phenobarbital* PhenytoinPrimidone


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


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


hCGHomocysteine

IgEInsulin Like Growth Factor 1(IGF 1)

InsulinLeuteinising Hormone (LH)

NT-proBNPOestradiol

PhenobarbitalPhenytoin


PSA (Free)PSA (Total)

PTHSHBG

T UptakeTestosterone

TheophyllineThyroglobulinTobramycin

Total Beta hCGTotal T3Total T4

Anti-Thyroperoxidase (Anti-TPO)Troponin ITroponin T

TSHValproic AcidVancomycinVitamin B12

Analytes


Liquid Immunoassay Premium Plus Level 1 12 x 5 ml LIA5142



LIQUID IMMUNOASSAY PREMIUM PLUS CONTROL - Unassayed Control

29


Immunoassay Speciality I Level 1 5 x 2 ml IAS3113



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)


Immunoassay Speciality II Level 1 5 x 1 ml IAS3117



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*



Immunoassay

30

Immunoassay

Analytes


Liquid Tumour Marker Control Level 1 6 x 3ml TU5085



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





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


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



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


CSF Control Level 2 10 x 3 ml CF1500


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





SPECIFIC PROTEIN CONTROL - Assayed Control

AFPAlbumin

a-1-Antitrypsina-1-Acid Glycoprotein

a-2-MacroglobulinASO

Anti-thrombin III

β-2-MicroglobulinCeruloplasmin


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


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


Immunology/Protein

34


ASO Calibrator 5 x 1 ml LO2306


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


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


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



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



SPECIFIC PROTEIN CALIBRATORS - Calibrator

Analytes

ASOCeruloplasmin*Complement C3 Complement C4

CRPFerritin

HaptoglobinIgA

IgGIgM

Prealbumin

Rheumatoid Factor Transferrin




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


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





Apolipoprotein Control Level 1 3 x 1 ml LE5016



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 Calibrator 3 x 1 ml CH5050

Lipids

39

Description Size Cat. No.Lipid Control Level 1 5 x 1 ml LE2668






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 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


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 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)


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



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


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





Analytes

CK-MB (Mass)D-dimerDigoxin

hs CRPMyoglobin

NT-ProBNP

Troponin ITroponin T

Cardiac

44

CK-MB CONTROL & CALIBRATOR - Assayed Control


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


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 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


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




Fructosamine Calibrator 3 x 1 ml FR2993


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


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


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)



49

UrineControls

Chapter 10

50

URINE PRODUCT RANGEPRODUCT DESCRIPTION SIZE CAT. NO.

Assayed Urine Control Level 2 12 x 10 ml AU2352


Urine Precision Control Level 2 10 x 10 ml UC1502


Liquid Urine Control Level 2 10 x 10 ml UC5074


Liquid Urinalysis Control Level 1 12 x 12 ml UC5033


Urinalysis Control Level 1 (dropper) 6 x 25 ml UC5078


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




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




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


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






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




Urine

53




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 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


Therapeutic Drug Calibrator Series 6 x 3 ml TD3417

THERAPEUTIC DRUG CALIBRATOR - Assayed Control

CarbamazepineDigoxin

GentamicinPhenobarbital

PhenytoinTheophylline

Valproic Acid

Analytes





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


Benzodiazepines Control Level 1 5 x 5 ml DA3130


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




Multidrug Calibrator Set 5 x 10 ml DA2704




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.


Dedicated calibrator and control set designed for the calibration and control of the Randox Benzodiazepines assay.


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


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

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





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)


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)


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


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)


Cerebral Series II Tri-Level Control 3 x 3 x 0.5 ml CBB5009


• 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


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)


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


Cytokine Array III Tri-Level Control 3 x 3 x 1 ml CY5012

Cytokine Array III Calibrator Series 9 x 1 ml EV3679


• 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)


Cytokine Array IV Tri-Level Control 3 x 3 x 1 ml CY5011

Cytokine Array IV Calibrator Series 9 x 1 ml EV3658


• 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


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)


Cytokine Array V Tri-Level Control 3 x 3 x 1 ml CY5010


• 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


Endocrine Array Controls 3 x 3 x 1 ml EV3713

Endocrine Array Calibrator Series 9 x 1 ml EV3712


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


Metabolic Syndrome Array I Controls 3 x 3 x 1 ml EV3757

Metabolic Syndrome Array I Calibrators 9 x 1 ml EV3756


76


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


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:


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


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)


82


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*


CARDIAC PROGRAMME With target scoring

RQ9127/a2 Parameters only (choose from 7)



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)


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


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


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)



Apolipoprotein A1Apolipoprotein B

Cholesterol, totalHDL

LDLLipoprotein (a)*

Triglycerides


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


95

Chapter 19

AnalyteIndex

96

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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


Haematology

Diabetes Controls

Immunoassay Controls

ANALYTE INDEX

Page

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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

ANALYTE INDEX

Immunology/ Protein Controls

Lipid Controls


Toxicology Controls

Urine Controls


( For

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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


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


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

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Car

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Liqu

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CK

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Ass

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Che

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Prem

ium

Plu

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Liqu

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Prec

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Bovi

ne C

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reci

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)

Clin

ical

Che

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try

Cal

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tor

Seru

m

Ald

olas

e

Am

mon

ia/ E

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ti C

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Hae

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Spe

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Spe

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Liqu

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Mat

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Spec

ific

Prot

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CR

P Li

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Cal

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tor

Cys

tatin

C

Rhe

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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

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Benz

odia

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Con

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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



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


Lipid Controls


Toxicology Controls

Urine 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

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Liqu

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ardi

ac C

ontr

ol

CK

-MB

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glob

in C

alib

rato

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Liqu

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hem

istr

y Pr

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m P

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Liqu

id C

hem

istr

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m

Ass

ayed

Che

mis

try

Prem

ium

Plu

s

Liqu

id C

hem

istr

y Pr

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m P

lus

Prec

isio

n C

hem

istr

y Pr

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m P

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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

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n F

& A

2

Imm

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Pre

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m

Liqu

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Imm

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Pre

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Liqu

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ay P

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Plu

s

Imm

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Spe

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Imm

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ssay

Spe

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ity II

Liqu

id T

umou

r M

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r C

ontr

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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

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Cal

ibra

tor

Lipo

prot

ein

(a)

sLD

L

TD

M C

ontr

ol

Benz

odia

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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-6 (IL-6) x x x Interleukin-6 (IL-6)



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


Haematology

Diabetes Controls


101


Lipid Controls


Toxicology Controls

Urine 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

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Liqu

id A

ssay

ed C

hem

istr

y Pr

emiu

m P

lus

Liqu

id C

hem

istr

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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

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ssay

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Liqu

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ay P

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Liqu

id Im

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ay P

rem

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Plu

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Imm

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Spe

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Imm

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Spe

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ity II

Liqu

id T

umou

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Mat

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eeni

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Spec

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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

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Cal

ibra

tor

Lipo

prot

ein

(a)

sLD

L

TD

M C

ontr

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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

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ontr

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Ass

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Uri

ne C

hem

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y

Una

ssay

ed U

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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-12p70 (IL-12 p70) x Interleukin-12p70 (IL-12 p70)








Interleukin-6 (IL-6) x x x Interleukin-6 (IL-6)



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

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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

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Liqu

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Imm

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Pre

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Liqu

id Im

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ay P

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Plu

s

Imm

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Spe

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Imm

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Spe

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Liqu

id T

umou

r M

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Mat

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Spec

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Cys

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C

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Fact

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Spec

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Lipi

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Che

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Liqu

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Con

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Mic

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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


Haematology

Diabetes 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

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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)


Lipid Controls


Toxicology Controls

Urine Controls


Page

104

Blood Gas

Cardiac Controls


Haematology

Diabetes 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

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Car

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Liqu

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Ass

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Che

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Prec

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Bovi

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)

Clin

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Che

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okin

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Cyt

okin

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rray

I

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e A

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IV

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okin

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V

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crin

e

Met

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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

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Car

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Liqu

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)

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in

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lula

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1

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II

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okin

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Cyt

okin

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I

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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


Lipid Controls


Toxicology Controls

Urine 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

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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


Haematology

Diabetes Controls


107


Lipid Controls


Toxicology Controls

Urine 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

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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

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( For

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Page

108

Analyte Index

109

Chapter 20

A - ZIndex

110

A

Adiponectin ControlAldolaseAmmonia/EthanolApolipoprotein Control & CalibratorASO CalibratorAssayed Chemistry Premium PlusAssayed Urine Chemistry

BBenzodiazepines ControlBlood GasBovine Chemistry (Precision)

CCannabinoid ControlCardiacCellular Adhesion MoleculesCerebral Series ICerebral Series IICK-MBClinical Chemistry Calibrator SerumCRP LiquidCSFCystatin CCytokine & hs Cytokine Array ICytokine Array IIICytokine Array IVCytokine V

EEcstasy ControlEDDP ControlEndocrineEthanol Calibrator/Control Set

FFructosamine

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

Randox Laboratories-US Ltd. 515 Industrial Boulevard, Kearneysville, WV 25430 +1 304 728 2890 Toll Free: 8664 RANDOX +1 304 728 1890 Toll Free: 866 RANDOX 1

[email protected] www.randoxqc.com

FRANCELaboratoires Randox

Tel: +33 (0) 130 18 96 80

GERMANYRandox Laboratories GmbHTel: +49 (0) 2151/93 706-11

HONG KONGRandox Laboratories Hong Kong Limited

Tel: +852 3595 0515

ITALYRandox Laboratories Ltd.Tel: +39 06 9896 8954

PUERTO RICOClinical Diagnostics of Puerto Rico, LLC

Tel: +1 787 701 7000

PORTUGALRandox Laboratorios Quimica Analitica Ltda

Tel: +351 22 589 8320

POLANDRandox Laboratories Polska Sp. z o.o.

Tel: +48 22 862 1080

INDIARandox Laboratories India Pvt Ltd.

Tel: +91 80 280 250 00

REPUBLIC OF IRELANDRandox Teoranta

Tel: +353 7495 22600

SLOVAKIARandox S.R.O.

Tel: +421 2 6381 3324

SOUTH AFRICARandox Laboratories SA (Pty) Ltd.

Tel: +27 (0) 11 312 3590

SOUTH KOREARandox Korea

Tel: +82 (0) 31 478 3121

SPAINLaboratorios Randox S.L.Tel: +34 93 475 09 64

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Tel: +41 41 810 48 89

UNITED KINGDOMRandox Laboratories LimitedTel: +44 (0) 28 9442 2413

VIETNAMRandox Laboratories Ltd. Vietnam

Tel: +84-8-39 11 09 04

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Tel: +420 2 1115 1661

CHINARandox Laboratories Ltd.Tel: +86 021 6288 6240

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BRAZILRandox Brasil Ltda.

Tel: +55 11 5181-2024

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