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- <strong>Quality</strong> <strong>Control</strong> <strong>Serum</strong>The most accurate quality control material in the world


INTRODUCTIONWELCOME0Randox Laboratories Ltd. has been developing, manufacturing andmarketing clinical diagnostic products and instruments worldwide for30 years and is one of the worlds most reputable suppliers of ClinicalChemistry reagents, Instruments and in particular, <strong>Quality</strong> <strong>Control</strong>serum. The Randox product range also includes the revolutionary andaward winning Biochip Array Technology (BAT), which allows for thesimultaneous testing of multiple analytes from a single patient sample.This style of testing can result in better patient care, by providingphysicians with a full profile of the patient’s state of health without theneed for re-ordering tests.A significant proportion of resources is invested in Research &Development to ensure products are manufactured to the highestspecifications and conform to International standards. This focus onR&D also allows us to rapidly bring new products to the market andconstantly review our existing range with the view to continuallyimprove. Rigorous quality procedures are used to achieve the highstandards expected in clinical science. Our commitment to qualityis emphasised by ISO13485 accreditation for the development andmanufacture of diagnostic test kits.Our customer base exceeds 60,000 laboratories across the globe.Randox products extend far beyond the typical hospital laboratory,with applications in veterinary testing, food and wine testing, cosmetictesting, sports testing, employee screening, rapid point of care testing,forensic toxicology and a wide range of research areas.Our experience and expertise allow us to create a leading productportfolio of high quality diagnostic tools which offer reliable and rapiddiagnosis. We believe that by providing laboratories with the righttools, we can improve the health status of individuals worldwide.“Revolutionising healthcare through continuously improvingdiagnostic solutions”For more information about Randox and for our full range of products, please visit www.randox.com,or contact your local Randox representative.1


INTRODUCTIONPage No.01. Clinical Chemistry 7-182. Immunoassay 19-243. Immunology/Proteins 25-304. Lipids 31-345. CARDIAC 35-386. Diabetes/HAEMOGLOBIN 39-427. Urine 43-468. Therapeutic Drugs 47-489. Toxicology 49-5610. Coagulation 57-5811. Blood Gas 59-6012. Antioxidants 61-6413. Speciality And Research <strong>Control</strong>s 65-7414. 24/7 75-7815. Customised <strong>Quality</strong> <strong>Control</strong> Sera 79-8216. RIQAS 83-9017. Analyte Index 91-1053


iNTRODUCTION0Introduction to Randox Acusera quality controlsRandox is one of the largest manufacturers of <strong>Quality</strong> <strong>Control</strong>s in theworld, whether it is our own branded Acusera portfolio of controlsand calibrators, or customised material for individual laboratories,research organisations, External <strong>Quality</strong> Assessment or ProficiencyTesting schemes and other diagnostic manufacturers.The Acusera range of <strong>Quality</strong> <strong>Control</strong>s and Calibrators covers over300 parameters and guarantees excellent performance. Principlecontrol products include Clinical Chemistry, Immunoassay, Urine,Immunology/Proteins, Lipids, Cardiac, CSF, Therapeutic DrugMonitoring, Toxicology, Urine Chemistry, Urinalysis, Coagulation,Blood Gas, Tumour Markers, Maternal Screening, Antioxidants,Diabetes and a number of researched based products.unassayed and human/bovine materials. Customers can even choosebetween multi-analyte controls or single analyte controls, dependingon their laboratory needs. In addition to this, Randox can also offerthe laboratory a tailor made quality control material, should there besomething you wish to adjust or change. This could be anything fromthe number of analytes, vial sizes, concentrations or format we presentcurrent products in.Randox also offers Acusera 24•7, an interlaboratory peer groupreporting software package, which extends the capability of Internal<strong>Quality</strong> <strong>Control</strong>s (IQC) by providing a tool to monitor and analysedaily control data and compare results with other laboratories usingthe same lot of control.A wide range of formats are available providing greater flexibilityand choice. Our product range includes liquid/lyophilised, assayed/Benefits of Randox AcuseraMaterialThe human based material used in the production of our <strong>Quality</strong><strong>Control</strong>s is sourced from the United Kingdom Blood TransfusionService. All donors are screened for HIV, Hepatitis A, B, C, HTLVand Syphilis, using immunoassay techniques to detect antibodiesand specific DNA tests to detect any viruses even at early stages ofinfection. This view to safety and quality is the trademark of Randoxcontrol manufacture. The integrity of our base materials is a criticalfactor in producing highly stable and consistent controls.Unlike many of our competitors Randox lyophilised <strong>Quality</strong><strong>Control</strong>s have no added preservatives or stabilisers which can causeinterference problems. The excellent stability seen with Randoxcontrols is achieved through superior manufacturing techniques andstrict adherence to a regulated quality manufacturing regime. AllRandox quality controls are filtered down to 0.2 microns to ensureminimal bacterial load and contamination.Many manufacturers, in an attempt to keep down theirmanufacturing costs and remain competitive, add constituents ofanimal origin to their control products. At best these controls canbe described as “human based”. The use of such controls can causeproblems with antibody based tests due to differences in antibodyspecificity towards non human components.Many of our controls are 100% human and are manufactured usingexclusively human components therefore they do not suffer from suchmatrix problems.Concentrations & LevelsMany manufacturers ‘cut corners’ or take shortcuts in an attempt tokeep costs down. This often results in unrealistic values, parameterimbalances, a frequent lack of differentiation between levels andultimately in controls that do not completely cover the clinical range.In many situations these inadequacies force laboratories to purchaseadditional and often expensive low or high level controls.For example Troponin levels in the level 1 control from somemanufacturers do not adequately cover the cut-off levels used indiagnosis. This often results in the need for additional controls tocover these lifesaving concentrations. The levels of Troponin I andTroponin T in our Cardiac and Liquid Cardiac controls are in line withinternationally recommended levels.Randox also employs easy to use colour-coded packaging to helpdistinguish between different levels and reduce costly mix-ups.Value AssignmentRandox controls are the most accurately assigned controls availablein the diagnostic industry! This has been made possible throughaccess to a unique database of results provided by over 18,000independent laboratories. This, coupled with unrivalled traceabilityto International Reference Laboratories, provides a product ofunsurpassed accuracy and reliability.For effective Internal <strong>Quality</strong> <strong>Control</strong>, an assayed serum should havean accurately assigned target value and range for each analyte; this willallow laboratories to reliably measure the accuracy and precision oftheir automated or manual methods.The assigned value for each analyte is generally a consensus meanobtained from several laboratories. Obviously the more laboratoriesemployed, the better; smaller numbers usually result in large standarddeviations and subsequently unrealistic wide ranges. In fact, with somemanufacturers the ranges are often so wide that laboratories areunlikely to fall outside them regardless of their performance.Sometimes disclaimers are included with other manufacturers controlsadvising users to establish their own targets and ranges and use thoseprovided in the product insert as a guide only. These disclaimers serve4


iNTRODUCTION0Commitment to <strong>Quality</strong>Randox is committed to quality at every stage of the production process from research and development to customer support. Thiscommitment has been recognised 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.UKAS ISO 13485:2003The United Kingdom Accreditation Service (UKAS) is the onlynational accreditation body recognised by the government to assessagainst internationally agreed standards.The International Organisation for Standardization (ISO) is the largestdeveloper and publisher of international standards in the world. In 2003,Randox was accredited with ISO 13485:2003 approval.In 2002 the systems and procedures within Randox LaboratoriesLtd were accredited with UKAS approval to ISO/IEC Guide43-1:1997 “Proficiency testing by interlaboratory comparisons Part 1:Development and operation of proficiency testing schemes throughassessment against ILAC-G13:2007 - Guidelines for the Requirementsfor the Competence of Providers of Proficiency Testing Schemes”.As such the systems and procedures within Randox Laboratories alsocomply with the requirements set out by CPA (Clinical PathologyAccreditation) and NATA (Association of Testing Authorities Australia).ISO 13485:2003 relates to the design/development, manufacture, serviceand distribution of in vitro diagnostic medical devices, in vitro diagnostic testkits, in vitro diagnostic reagents and in vitro diagnostic analysers.ISO 13485:2003 highlights the requirements for a quality managementsystem where an organisation needs to prove its ability to provide medicaldevices and other related services that consistently meet regulatoryrequirements.CE MarkMany of our <strong>Quality</strong> <strong>Control</strong> (QC) products are CE certified andcarry the CE mark. CE marking on a product indicates that theproduct complies with and has satisfied the essential requirementsset out by the In Vitro Diagnostic (IVD) Medical Devices Directive98/79/EC, it also demonstrates the fact the product is fit for itsintended purpose.FDA ClearedMany of our quality controls and calibrators are FDA cleared andtherefore appropriate for sale in the USA. In order for an IVD tobe approved for sale in the USA it must not only be safe for use andeffective but it must also satisfy the requirements set out in part 820title 21 of the Code of Federal Regulations published by the FDA.The CE mark is also a declaration from the manufacturer that theproduct has met all legislation in relation to health and safety andwhere required has been assessed in accordance with this legislation.CE marking is essential for products to be placed on the market andsold in the European Union (EU). It also ensures the free movementof product within the EFTA and EU.Canadian Medical Device Regulationsfrom Health CanadaMany Randox products, including our quality controls and calibrators,are licensed for use in Canada. Before an IVD device can be sold inCanada, it must meet the requirements set out in the TherapeuticProducts Directorate. Health Canada review all medical devices toassess their safety, effectiveness and quality before they are authorisedfor sale.Queen’s Award for EnterpriseIn 2007 Randox received the Queen’s Award for Enterprise. Thiswas Randox’s fifth Queens Award with previous awards for ExportAchievement received in 1990, 1993, 1997 and the Queen’s Awardfor Enterprise received in 2001.The Queens Award is a highly prestigious and coveted prize thatrecognizes the outstanding achievements Randox has made ininnovation, international trade and sustainable development.The award is testimony to the hard work and dedication of Randox inthe global diagnostics market.6


Clinical Chemistry<strong>Control</strong>s1Chapter 1


CLINICAL CHEMISTRY1 Clinical Chemistry product rangePRODUCT DESCRIPTION SIZE CAT. NO.Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE5095Chemistry Premium Level 2 12 x 5 ml HN5067Chemistry Premium Level 3 12 x 5 ml HE5068Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532Assayed Chemistry Premium Plus Level 2 & 3 10 x 5 ml HS2611Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558Bovine Chemistry (Assayed) Level 1 20 x 5 ml AL1027Bovine Chemistry (Assayed) Level 2 20 x 5 ml AN1026Bovine Chemistry (Assayed) Level 3 20 x 5 ml AE1032Bovine Chemistry (Precision) Level 1 20 x 5 ml SL1084Bovine Chemistry (Precision) Level 2 20 x 5 ml SN1085Bovine Chemistry (Precision) Level 3 20 x 5 ml SE1086Clinical Chemistry Calibration Sera Level 2 20 x 5 ml CAL2350Clinical Chemistry Calibration Sera Level 3 20 x 5 ml CAL2351Aldolase Calibrator 3 x 1 ml AD5000Aldolase <strong>Control</strong> Level 2 3 x 1 ml AD5001Aldolase <strong>Control</strong> Level 3 3 x 1 ml AD5002Ammonia / Ethanol <strong>Control</strong> Level 1 6 x 2 ml EA1366Ammonia / Ethanol <strong>Control</strong> Level 2 6 x 2 ml EA1367Ammonia / Ethanol <strong>Control</strong> Level 3 6 x 2 ml EA1368Bilirubin Elevated <strong>Control</strong> 10 x 3 ml BE454Glycerol <strong>Control</strong> Level 1 3 x 5 ml GY1369Multi Calibrator 3 x 2 ml MC1382Multi <strong>Control</strong> Level 1 5 x 2 ml MC1379Multi <strong>Control</strong> Level 2 5 x 2 ml MC1380Multi <strong>Control</strong> Level 3 5 x 2 ml MC1381Glutamine <strong>Control</strong> Level 1 5 x 5 ml GM1376Glutamine <strong>Control</strong> Level 2 5 x 5 ml GM1377Glutamine <strong>Control</strong> Level 3 5 x 5 ml GM1378Glutamine Calibrator 10 x 5 ml GM1375<strong>Serum</strong> Diluent 20 x 5 ml MS50078


CLINICAL CHEMISTRYLiquid CHEMISTRY PREMIUM - Unassayed <strong>Control</strong>1AnalytesCardiacCKMyoglobinTroponin ITroponin TElectrophoresisAlbumina-1-globulina-2-globulinb-1-globuling-globulinImmunoassayAFPCEACortisolFolateFree T 3Free T 4hCGProlactinTotal T 3Total T 4TSHVitamin B12LipidsApolipoprotein A-IApolipoprotein BCholesterolCholesterol (HDL)Cholesterol (LDL)LP(a)TriglyceridesProteinsa-1-Acid Glycoproteina-1-AntitrypsinCeruloplasminComplement C3Complement C4CRPFerritinHaptoglobinIgAIgEIgGIgMPrealbuminTotal ProteinTransferrinDrugsCarbamazepineDigoxinEthanolGentamicinLithiumParacetamol (Acetaminophen)PhenobarbitalPhenytoinSalicylateTheophyllineValproic AcidVancomycinTrace MetalsCopperZincROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline PhosphataseALT (GPT)AmylaseAmylase (Pancreatic)AST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CholinesteraseCalciumCalcium (ionised)ChlorideCreatininegGTGlucoseGLDHa-HBDHD-3-HydroxybutyrateIronTIBCLAPLD (LDH)LipaseLactateMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumUreaUric Acid(Urate)A comprehensive chemistry control designed for use in the routine monitoring of precision. Suitable for use with all major instruments andmethodologies, contains 92 analytes including routine chemistries, cardiac parameters, proteins, immunoassay parameters, lipids, therapeutic drugs andelectrophoresis.• Liquid for ease of use• Human based serum• Stable to expiry date when at -20 ºC – 70 ºC• Open vial stability of 7 days at +2 - 8 ºCDescription size Cat. No.Liquid Chemistry Premium Level 2 12 x 5ml LUN5048Liquid Chemistry Premium Level 3 12 x 5ml LUE50499


CLINICAL CHEMISTRY1LIQUID CHEMISTRY PREMIUM PLUS - Unassayed <strong>Control</strong>AnalytesCardiacCKCK-MBMyoglobinTroponin ITroponin TElectrophoresisAlbumina-1-globulina-2-globulinb-1-globuling-globulinImmunoassayAFPCEACortisolDHEA SulphateFolateFree T 3Free T 4FSHGHhCGLHProgesteroneProlactinTotal T 3Total T 4TestosteroneTSHT uptakeVitamin B12LipidsApolipoprotein A-1Apolipoprotein BCholesterolHDLLDLLP(a)TriglyceridesProteinsa-1-Acid Glycoproteina-1-Antitrypsinβ-2-microglobulinCeruloplasminComplement C 3Complement C 4CRPFerritinHaptoglobinIgAIgEIgGIgMPrealbuminTotal ProteinTransferrinROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline PhosphataseALT (GPT)AmylaseAmylase (Pancreatic)AST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CholinesteraseCalciumCalcium (Ionised)ChlorideCreatinineγGTGlucoseGLDHa-HBDHD-3-HydroxybutyrateIronTIBCLAPLD (LDH)LipaseLactateMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumUreaUric Acid (Urate)DrugsAmikacinCaffeineCarbamazepineDigoxinEthanolGentamicinLithiumParacetamolPhenobarbitalPhenytoinSalicylateTheophyllineValproic AcidVancomycinTrace MetalsCopperZincMulti-analyte chemistry control designed for use in the routine monitoring of precision. The most comprehensive chemistry control availableincludes more than100 analytes including routine chemistries, cardiac markers, lipids, therapeutic drugs, proteins, immunoassay parameters andelectrophoresis.• Liquid for ease of use• Human based serum• High CRP levels also eliminate the need for separate controls• Stable to expiry date at -20 ºC – 70 ºC• Open vial stability of 7 days at +2 - 8 ºCDescription size Cat. No.Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE509510


CLINICAL CHEMISTRYCHEMISTRY PREMIUM CONTROL1AnalytesCardiacCKDrugsLithiumLipidsCholesterolTriglyceridesProteinsIgAIgGIgMTotal ProteinTransferrinROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline Phosphatase (ALP)ALT (GPT)AmylaseAmylase (Pancreatic)ASTBilirubin (Direct)Bilirubin (Total)CalciumChlorideCholinesteraseCreatininegGTGlucoseGLDHa-HBDHIronLactateLAPLD (LDH)LipaseMagnesiumPhosphate (Inorganic)PotassiumSodiumTIBCUIBCUreaUric Acid (Urate)A multi-analyte, assayed control designed for use in the routine monitoring of both accuracy and precision. Temperature specific target values and rangesare provided for the most common methods covering 40 analytes including routine chemistries and proteins.• Lyophilised for enhanced stability• Human based serum• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºCDescription size Cat. No.Chemistry Premium Level 2 12 x 5 ml hN5067Chemistry Premium Level 3 12 x 5 ml hE5068<strong>Serum</strong> Diluent 20 x 5 ml MS500711


CLINICAL CHEMISTRY1ASSAYED CHEMISTRY PREMIUM PLUS CONTROLAnalytesLipidsApolipoprotein A-1Apolipoprotein BCholesterolNEFATriglyceridesCardiacCKDrugsDigoxinGentamicinLithiumParacetamolSalicylateTheophyllineTobramycinImmunoassayCortisolFolatePSATSHTotal T3Free T4Total T4Vitamin B12ProteinsIgAIgGIgMTotal ProteinTransferrinElectrophoresisAlbumina-1-globulina-2-globulinb-1-globuling-globulinTrace MetalsCopperZincROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline Phosphatase (ALP)ALT (GPT)AmylaseAmylase (Pancreatic)AST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CholinesteraseCalciumChlorideCreatinineGlucoseγGTGLDHα-HBDHD-3-HydroxybutyrateIronTIBCLAPLD (LDH)Lipase (Colorimetric)Lipase (Turbidimetric)LactateMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumUreaUric AcidA comprehensive assayed chemistry control designed for use in the routine monitoring of both accuracy and precision. This product contains method,instrument and temperature specific target values and ranges for 68 analytes on a wide range of analysers. Electrophoresis targets are also provided as a% breakdown of total protein.• Lyophilised 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 +2 - 8 ºC• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºCDescription size Cat. No.Assayed Chemistry Premium Plus Level 2 20 x 5 ml hN1530Assayed Chemistry Premium Plus Level 3 20 x 5 ml hE1532Assayed Chemistry Premium Plus Level 2 & 3 10 x 5 ml hs2611<strong>Serum</strong> Diluent 20 x 5 ml MS500712


CLINICAL CHEMISTRYprecision Chemistry premium plus CONTROL1AnalytesCardiacCKMyoglobinTroponin IElectrophoresisAlbumina-1-globulina-2-globulinb-1-globulinGamma-globulinImmunoassayAFPCEACortisolFolateFree T 3Free T 4hCGProlactinPSATotal T 3Total T 4TSHVitamin B12LipidsApolipoprotein A-IApolipoprotein BCholesterolNEFATriglyceridesProteinsAlpha-1-Acid GlycoproteinAlpha-1-AntitrypsinCaeruloplasminComplement C 3Complement C 4CRPFerritinHaptoglobinIgAIgEIgGIgMPrealbuminTotal ProteinTransferrinDrugsCarbamazepineDigoxinGentamicinLithiumParacetamol (Acetaminophen)PhenobarbitalPhenytoinSalicylateTheophyllineTobramycinValproic AcidVancomycinTrace MetalsCopperZincROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline PhosphataseALT (GPT)AmylaseAmylase (Pancreatic)AST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CholinesteraseCalciumChlorideCreatininegGTGlucoseGLDHa-HBDHD-3-HydroxybutyrateIronTIBCLAPLD (LDH)LipaseLactateMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumUreaUric Acid (Urate)Multi-analyte control designed for use in the routine monitoring of precision. Contains 89 analytes including a wide range of proteins, lipids andimmunoassay parameters with additional analytes present at measurable levels.• Lyophilised for enhanced stability• Human based serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558<strong>Serum</strong> Diluent 20 x 5 ml MS500713


CLINICAL CHEMISTRY1 BOVINE CHEMISTRY ASSAYED CONTROLAnalytesLipidsCholesterolNEFATriglyceridesCardiacCKDrugsLithiumImmunoassayCortisolPSATotal T 3Free T 4Total T 4ProteinsTotal ProteinTrace MetalsCopperZincROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline Phosphatase (ALP)ALT (GPT)AmylaseAST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CalciumChlorideCreatinineGlucoseγGTGLDHα-HBDHD-3-HydroxybutyrateIronLactateLD (LDH)LipaseMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumTIBCUreaUric AcidA comprehensive bovine based, assayed serum designed for use in the routine monitoring of accuracy and precision. This product contains method,instrument and temperature specific values for 44 analytes and is especially suited to veterinary laboratories, due to the inclusion of commonly usedveterinary parameters such as NEFA, Bile Acids, Lactate and D-3-Hydroxybutyrate.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºCDescription size Cat. No.Bovine Chemistry Assayed Level 1 20 x 5 ml aL1027Bovine Chemistry Assayed Level 2 20 x 5 ml aN1026Bovine Chemistry Assayed Level 3 20 x 5 ml aE1032<strong>Serum</strong> Diluent 20 x 5 ml MS500714


CLINICAL CHEMISTRYBOVINE CHEMISTRY precision CONTROL1AnalytesLipidsCholesterolNEFATotal LipidsTriglyceridesCardiacCKDrugsLithiumImmunoassayCortisolPSATotal T 3Free T 4Total T 4ProteinsTotal ProteinTrace MetalsCopperZincROUTINE ChemistryAcid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline Phosphatase (ALP)ALT (GPT)AmylaseAST (GOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CalciumChlorideCreatinineGlucoseγGTGLDHα-HBDHD-3-HydroxybutyrateIronLactateLD (LDH)LipaseMagnesiumOsmolalityPhosphate (Inorganic)PotassiumSodiumTIBCUreaUric AcidA comprehensive bovine based serum designed for use in the routine monitoring of precision. Contains 45 analytes including commonly used veterinaryparameters such as NEFA, Bile Acids, Lactate and D-3-Hydroxybutyrate.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºCDescription size Cat. No.Bovine Chemistry Precision Level 1 20 x 5 ml sL1084Bovine Chemistry Precision Level 2 20 x 5 ml sN1085Bovine Chemistry Precision Level 3 20 x 5 ml sE1086<strong>Serum</strong> Diluent 20 x 5 ml MS500715


CLINICAL CHEMISTRY1 CLINICAL CHEMISTRY CALIBRATION SERUMAnalytesLipidsCholesterolTriglyceridesCardiacCKDrugsLithiumProteinsTotal ProteinTrace MetalsCopperZincRoutine ChemistryAcid Phosphatase (Non-Prostatic)Acid Phosphatase (Prostatic)Acid Phosphatase (Total)AlbuminAlkaline Phosphatase (ALP)ALT (GPT)Amylase (Pancreatic)Amylase (Total)ASTBicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CalciumChlorideCholinesteraseCreatinineD-3-HydroxybutyrateγGTGLDHGlucoseα-HBDHIronLactateLDHLAPLipaseMagnesiumPhosphate (Inorganic)PotassiumSodiumTIBCUreaUric AcidMulti-analyte calibrator designed for use in the calibration of commonly used clinical chemistry parameters. Method, instrument and temperaturespecific values are provided for 41 analytes on a wide range of clinical analysers.• Lyophilised for enhanced stability• Human based serum• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºCDescription size Cat. No.Clinical Chemistry Calibration <strong>Serum</strong> Level 2 20 x 5 ml CAL2350Clinical Chemistry Calibration <strong>Serum</strong> Level 3 20 x 5 ml CAL235116


CLINICAL CHEMISTRYALDOLASE CONTROL & CALIBRATOR1Human based materials designed for use in the calibration and control of aldolase assays.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 5 days at +2 - 8 o CDescription size Cat. No.Aldolase Calibrator 3 x 1 ml aD5000Aldolase <strong>Control</strong> Level 2 3 x 1 ml aD5001Aldolase <strong>Control</strong> Level 3 3 x 1 ml aD5002AMMONIA / ETHANOL CONTROLAnalytesAmmoniaEthanolA liquid ready to use control designed to monitor both the accuracy and precision of Ammonia and Ethanol assays.• Liquid ready to use• Stable to expiry date at +2 - 8 ºC• Open vial stability of 30 days at +2 - 8 ºCDescription size Cat. No.Ammonia / Ethanol <strong>Control</strong> Level 1 6 x 2 ml EA1366Ammonia / Ethanol <strong>Control</strong> Level 2 6 x 2 ml EA1367Ammonia / Ethanol <strong>Control</strong> Level 3 6 x 2 ml EA1368BILIRUBIN (ELEVATED) CONTROLAnalytesTotal BilirubinDirect BilirubinA bovine based serum control designed for use in the routine monitoring of both accuracy and precision. This product is suitable for monitoringpaediatric bilirubin levels and contains method specific target values and ranges.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 5 days at +2 - 8 ºCDescription size Cat. No.Bilirubin Elevated <strong>Control</strong> 10 x 3 ml bE45417


CLINICAL CHEMISTRY1GLYCEROL CONTROLDedicated Glycerol control designed for use in the routine monitoring of both accuracy and precision.• Lyophilised for enhanced stability• Human based serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Glycerol <strong>Control</strong> Level 1 3 x 5 ml gy1369MULTI CONTROL & CALIBRATORAnalytesAmmoniaGlucoseGlutamateLactateA 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 +2 - 8ºCDescription size Cat. No.Multi Calibrator 3 x 2 ml MC1382Multi <strong>Control</strong> Level 1 5 x 2 ml MC1379Multi <strong>Control</strong> Level 2 5 x 2 ml MC1380Multi <strong>Control</strong> Level 3 5 x 2 ml MC1381Glutamine CONTROLA dedicated control designed for use in the quality control of the Randox Glutamine assay.• Lyophilised for enhanced stability• 100% human material• Stable to expiry at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºCDescription size Cat. No.Glutamine <strong>Control</strong> Level 1 5 x 5 ml gM1376Glutamine <strong>Control</strong> Level 2 5 x 5 ml gM1377Glutamine <strong>Control</strong> Level 3 5 x 5 ml gM1378Glutamine Calibrator 10 x 5 ml gM137518


Immunoassay <strong>Control</strong>s2Chapter 2


IMMUNOASSAY7Immunoassay product rangePRODUCT DESCRIPTION SIZE CAT. NO.Immunoassay <strong>Control</strong> Premium Level 1 10 x 5 ml IA2638Immunoassay <strong>Control</strong> Premium Level 2 10 x 5 ml IA2639Immunoassay <strong>Control</strong> Premium Level 3 4 x 3 x 5 ml IA2640Immunoassay <strong>Control</strong> Premium Tri-Level 12 x 5 ml IA2633Liquid Immunoassay <strong>Control</strong> Premium Level 1 12 x 5 ml LIA3105Liquid Immunoassay <strong>Control</strong> Premium Level 2 12 x 5 ml LIA3106Liquid Immunoassay <strong>Control</strong> Premium Level 3 12 x 5 ml LIA3107Liquid Immunoassay <strong>Control</strong> Premium Tri-Level 12 x 5 ml LIA3108Immunoassay <strong>Control</strong> Premium Plus Level 1 12 x 5 ml IA3109Immunoassay <strong>Control</strong> Premium Plus Level 2 12 x 5 ml IA3110Immunoassay <strong>Control</strong> Premium Plus Level 3 12 x 5 ml IA3111Immunoassay <strong>Control</strong> Premium Plus Tri-Level 12 x 5 ml IA3112Immunoassay Speciality I Level 1 5 x 2 ml IAS3113Immunoassay Speciality I Level 2 5 x 2 ml IAS3114Immunoassay Speciality I Level 3 5 x 2 ml IAS3115Immunoassay Speciality II Level 1 5 x 1 ml IAS3117Immunoassay Speciality II Level 2 5 x 2 ml IAS3118Immunoassay Speciality II Level 3 5 x 2 ml IAS3119Tumour Marker <strong>Control</strong> Level 2 3 x 2 ml TU5002Tumour Marker <strong>Control</strong> Level 3 3 x 2 ml TU5003Liquid Tumour Marker Level 1 3x3ml TU5085Liquid Tumour Marker Level 2 3x3ml TU5086Liquid Tumour Marker Level 3 3x3ml TU5087Maternal Screening <strong>Control</strong> Level 1 3 x 1 ml MSS5024Maternal Screening <strong>Control</strong> Level 2 3 x 1 ml MSS5025Maternal Screening <strong>Control</strong> Level 3 3 x 1 ml MSS502620


IMMUNOASSAYimmunoassay Premium controlAnalytes217-OH-ProgesteroneACTHAFPAldosteroneAmikacinβ-2-MicroglobulinCarbamazepineCEAC PeptidehCGCortisolDHEA-SulphateDigoxinEstriolEthosuximideFerritinFolateFree T 3Free T 4FSHGentamicinGrowth Hormone (GH)IgEInsulinLHOestradiolParacetamolPhenobarbitalPhenytoinPrimidoneProgesteroneProlactinPSA (Free)PSA (Total)PTHSalicylateSHBGTestosteroneTestosterone (Free)TheophyllineThyroglobulinTotal T 3Total T 4TobramycinTSHT UptakeValproic AcidVancomycinVitamin B121-25-(OH) 2-vitamin D25-OH-vitamin DA comprehensive control designed for use in the routine monitoring ofboth accuracy and precision. Assayed, instrument specific target valuesand ranges are provided for 51 analytes, including fertility and thyroidhormones, steroid hormones, kidney function tests, therapeutic drugs andvitamins.• Lyophilised for enhanced stability• 100% human serum• Ferritin and Vitamin B12 levels suitable for Anaemia monitoring• TSH levels around 0.11 μU/ml in the level 1 control• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC, or up to 4 weeks at -20ºCDescription size Cat. No.Immunoassay Premium Level 1 10 x 5ml IA2638Immunoassay Premium Level 2 10 x 5ml IA2639Immunoassay Premium Level 3 10 x 5ml IA2640Immunoassay Premium Tri-level 4 x 3 x 5 ml IA2633LIQUID immunoassay Premium CONTROLAnalytes17-OH- ProgesteroneAFPAldosteroneAmikacinβ-2-MicroglobulinCarbamazepinehCGCortisolDHEA-SulphateDigoxinEstriolEthosuximideFerritinFolateFree T 3Free T 4FSHGentamicinGrowth Hormone (GH)IgEInsulinLHOestradiolParacetamolPhenobarbitalPhenytoinPrimidoneProgesteroneProlactinPSA (Free)PSA (Total)SalicylateSHBGTestosteroneTestosterone (Free)TheophyllineTobramycinTotal T 3Total T 4TSHT UptakeValproic AcidVancomycinVitamin B12A comprehensive control designed for use in the routine monitoringof reproducibility and precision. Typical values are available for multipleinstruments 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 -20 - 70ºC• Open vial stability of 7 days at +2 - 8ºCDescription size Cat. No.Liquid Immunoassay Premium Level 1 12 x 5ml LIA3105Liquid Immunoassay Premium Level 2 12 x 5ml LIA3106Liquid Immunoassay Premium Level 3 12 x 5ml LIA3107Liquid Immunoassay Premium Tri-Level 12 x 5 ml LIA310821


IMMUNOASSAY2immunoassay Premium PLUS CONTROLAnalytes17-OH-ProgesteroneACTHAldosteroneAlphafoetoproteinAmikacinβ – 2 – MicroglobulinCA15-3CA19-9CA125CarbamazepineCarcinoembryonic Antigen (CEA)CortisolC PeptideDHEA-SulphateDigoxinEstriolEthosuximideFerritinFolateFree T 3Free T 4FSHGentamicinGrowth Hormone (GH)Human Chorionic Gonadotrophin (hCG)IgEInsulinLeuteinising Hormone (LH)OestradiolParacetamolParathyroid Hormone (PTH)PhenobarbitalPhenytoinPrimidoneProgesteroneProlactinPSA (Free)PSA (Total)SalicylateSHBGT UptakeTestosteroneTestosterone (Free)TheophyllineThyroglobulinThyroid Stimulating Hormone (TSH)TobramycinTotal T 3Total T 4Valproic AcidVancomycinVitamin B121-25-(OH) 2- Vitamin D25-OH - Vitamin DA comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target valuesand ranges are provided for 54 analytes, including fertility and thyroid hormones, steroid hormones, cardiac & tumour markers, kidney functiontests, therapeutic drugs and vitamins. Compatible for use on a wide range of immunoassay analysers.• Lyophilised for enhanced stability• 100% human serum• Ferritin and Vitamin B12 levels suitable for Anaemia monitoring• TSH targets are around 0.11 μU/ml in L1• Contains routinely run tumour markers: AFP / CA15-3 / CA19-9 / CA-125 / CEA / PSA / Free-PSA• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Immunoassay Premium Plus Level 1 12 x 5ml IA3109Immunoassay Premium Plus Level 2 12 x 5ml IA3110Immunoassay Premium Plus Level 3 12 x 5ml IA3111Immunoassay Premium Plus Tri-Level 12 x 5 ml IA3112IMMUNOASSAY SPECIALITY 1 controlAnalytes1-25-(OH) 2-Vitamin D25-OH-Vitamin DC PeptideInsulinInsulin Like Growth Factor 1(IGF 1)OsteocalcinProcalcitoninParathyroid Hormone (PTH)Anti-Thyroglobulin (Anti-TG)Anti-Thyroperoxidase (Anti-TPO)A multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges areprovided for 10 more complex, specialised parameters to complement the routine immunoassay control.• Lyophilised for enhanced stability• 100% human serum• Assayed target values and ranges for a wide range of immunoassay systems• Stable to expiry date at +2 - 8ºC• Reconstituted stability of up to 5 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Immunoassay Speciality I Level 1 5 x 2 ml IAS3113Immunoassay Speciality I Level 2 5 x 2 ml IAS3114Immunoassay Speciality I Level 3 5 x 2 ml IAS311522


IMMUNOASSAYIMMUNOASSAY SPECIALITY 1I controlAnalytes2CalcitoninGastrinProcalcitoninReninA multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges areprovided for 4 specialised parameters.• Lyophilised for enhanced stability• 100% human serum• Assayed target values and ranges for a wide range of immunoassay systems• Stable to expiry date at +2 - 8ºC• Reconstitutued stability of 5 days at +2 - 8ºC for Renin, Procalcitonin 1 day at +2 -8ºC and for Gastrin and Calcitonin 8 hours at +2 - 8 o CDescription size Cat. No.Immunoassay Speciality II Level 1 5 x 1 ml IAS3117Immunoassay Speciality II Level 2 5 x 1 ml IAS3118Immunoassay Speciality II Level 3 5 x 1 ml IAS3119TUMOUR MARKER CONTROLAnalytesAlphafoetoprotein (AFP)β-2-microglobulinCA 15-3CA 19-9CA 72-4CA125CalcitoninCarcinoembryonic Antigen (CEA)Cyfra 21FerritinHuman Chorionic Gonadotrophin (hCG)Neuron Specific Enolase (NSE)PSA (Free)PSA (Total)ThyroglobulinMulti-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 15routine and specialised tumour markers. Compatible for use on a wide range of clinical chemistry and immunoassay systems.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 14 days at +2 - 8°CDescription size Cat. No.Tumour Marker <strong>Control</strong> Level 2 3 x 2 ml TU5002Tumour Marker <strong>Control</strong> Level 3 3 x 2 ml TU500323


IMMUNOASSAY2Liquid Tumour Marker <strong>Control</strong>AnalytesAFPBeta-2-MicroglobulinCA15-3CA19-9CA72-4CA125CEACyfra 21-1FerritinFree PSAhCGNSEThyroglobulinTotal PSAMulti-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 14routine 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 +2-8 o CDescription size Cat. No.Liquid Tumour Marker <strong>Control</strong> Level 1 3 x 3ml TU5085Liquid Tumour Marker <strong>Control</strong> Level 2 3 x 3ml TU5086Liquid Tumour Marker <strong>Control</strong> Level 3 3 x 3ml TU5087MATERNAL SCREENING CONTROLAnalytesAFPFree b hCGInhibin APAPP-ATotal hCGUnconjugated EstriolMulti-analyte control designed for use in the routine monitoring of accuracy and precision. Assayed target values and ranges are provided for 6parameters used in both First and Second Trimester screening of Down’s syndrome and Spina Bifida. Compatible for use on a wide range of clinicalchemistry and immunoassay systems.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºCDescription size Cat. No.Maternal Screening <strong>Control</strong> Level 1 3 x 1 ml MSS5024Maternal Screening <strong>Control</strong> Level 2 3 x 1 ml MSS5025Maternal Screening <strong>Control</strong> Level 3 3 x 1 ml MSS502624


Immunology/Protein<strong>Control</strong>s3Chapter 3


IMMUNOlogy/protein5Immunology/ Protein product rangePRODUCT DESCRIPTION SIZE CAT. NO.Specific Protein <strong>Control</strong> Level 1 3 x 1 ml PS2682Specific Protein <strong>Control</strong> Level 2 3 x 1 ml PS2683Specific Protein <strong>Control</strong> Level 3 3 x 1 ml PS2684Crp Liquid <strong>Control</strong> Level 2 10 x 1 ml CP2480Crp Liquid <strong>Control</strong> Level 3 10 x 1 ml CP2481Crp High Sensitivity <strong>Control</strong> Level 1 10 x 1 ml CP2476Crp High Sensitivity <strong>Control</strong> Level 2 10 x 1 ml CP2477Crp 1-Level Calibrator For Dilution Series 3 x 1 ml CP2179Crp High Sensitivity 6-Level Calibrator Series 6 x 2 ml CP2478Crp Full Range 6-Level Calibrator Series 6 x 1 ml CP2499Crp Mid Range 6-Level Calbrator Series 6 x 2 ml CP2479Cystatin C Normal <strong>Control</strong> 3 x 2 ml CYS5019Cystatin C Elevated <strong>Control</strong> 3 x 2 ml CYS5020Aso Calibrator 5 x 1 ml LO2306b-2-Microglobulin Calibrator 3 x 1 ml BM1362Immunoglobulin Calibrator (Rx Series) 3 x 1 ml IT3861IgE Calibrator Set 3 x 1 ml IE2492High Sensitivity IgG <strong>Control</strong> Level 1 5 x 2 ml IT3982High Sensitivity IgG <strong>Control</strong> Level 2 5 x 2 ml IT3983High Sensitivity IgG <strong>Control</strong> Level 3 5 x 2 ml IT3984High Sensitivity IgG Calibrator 3 x 1 ml IT3899Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301Haptoglobin Calibrator 4 x 2ml HP1359Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692CSF <strong>Control</strong> Level 2 10 x 3 ml CF1500CSF <strong>Control</strong> Level 3 10 x 3 ml CF150126


IMMUNOlogy/proteinSPECIFIC PROTEIN CONTROLAnalytes3AFPAlbumina-1-Antitrypsina-1-Acid Glycoproteina-2-MacroglobulinASOAnti-thrombin IIIb-2-MicroglobulinCeruloplasminComplement C 3Complement C 4CRPHaptoglobinIgAIgEIgGIgMKappa Light ChainKappa Light Chain (Free)Lambda Light ChainLambda Light Chain (Free)Prealbumin (Transthyretin)<strong>Serum</strong> FerritinRFRBPTotal ProteinTransferrinA multi-analyte control designed for use in the routine monitoring of both precision and accuracy. Assayed target values are provided for 27 analytesincluding immunoglobulins, complement proteins, inflammatory proteins as well as carrier and storage proteins. Method specific target values and rangesare 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 +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription size Cat. No.Specific Protein <strong>Control</strong> Level 1 3 x 1 ml PS2682Specific Protein <strong>Control</strong> Level 2 3 x 1 ml PS2683Specific Protein <strong>Control</strong> Level 3 3 x 1 ml PS2684CRP CONTROLS & CALIBRATORDedicated control designed for use in the routine monitoring of both accuracy and precision. Suitable for use with traditional and high sensitivity CRPassays. These controls are standardised to BCR/CAP/IFCC CRM470.• Liquid ready to use• 100% human material• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription size Cat. No.Crp Liquid <strong>Control</strong> Level 2 10 x 1 ml CP2480Crp Liquid <strong>Control</strong> Level 3 10 x 1 ml CP2481Crp High Sensitivity <strong>Control</strong> Level 1 10 x 1 ml CP2476Crp High Sensitivity <strong>Control</strong> Level 2 10 x 1 ml CP2477Crp 1-Level Calibrator For Dilution Series 3 x 1 ml CP2179Crp High Sensitivity 6-Level Calibrator Series 6 x 2 ml CP2478Crp Mid Range 6-Level Calibrator Series 6 x 2 ml CP2479Crp Full Range 6-Level Calibrator Series 6 x 1 ml CP249927


IMMUNOlogy/proteinCystatin C control3A dedicated control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for use on most clinicalchemistry analysers.• Liquid ready to use• 100% human material• Stable to expiry date at 2-8ºCDescription size Cat. No.Cystatin C Normal <strong>Control</strong> 3 x 2ml CYS5019Cystatin C Elevated <strong>Control</strong> 3 x 2ml CYS5020ASO CALIBRATORA dedicated calibrator designed for use in the calibration of ASO immunoturbidimetric assays. This product is compatible for use on most clinicalanalysers.• Liquid ready to use• 100% human material• Stable to expiry date at +2 - 8ºCDescription size Cat. No.ASO Calibrator 5 x 1 ml LO2306β-2-MICROGLOBULIN CALIBRATORDedicated calibrator designed for use in the calibration of b-2-Microglobulin assays. This product is compatible for use on most clinical analysers.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 30 days at +2 - 8ºC or 3 months at -20ºCDescription size Cat. No.β - 2 -Microglobulin Calibrator 3 x 1 ml bM1362IMMUNOGLOBULIN CALIBRATORSAnalytesIgA IgG IgMCalibrator series designed for use in the calibration of IgA, IgG and IGM immunoturbidimetric assays. Suitable for use with the RX series ofimmunoglobulin assays.• Liquid ready to use• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription size Cat. No.Immunoglobulin Calibrator RX Series 3 x 1 ml IT386128


IMMUNOlogy/proteinIgE CalibratorHuman based calibrator series designed for use in the calibration of IgE immunoturbidimetric assays.• Lyophilised for enhanced stability• 6 levels supplied.• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 4 weeks at +2 - 8ºC3Description size Cat. No.IgE Calibrator 6 x 1 ml IE2492HIGH SENSITIVITY IgG CONTROL AND CALIBRATORDedicated control and calibrator designed for use with the Randox high sensitivity IgG assay.• Liquid ready to use• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription Analytessize Cat. No.High Sensitivity IgG <strong>Control</strong> Level 1 5 x 2ml IT3982High Sensitivity IgG <strong>Control</strong> Level 2 5 x 2ml IT3983High Sensitivity IgG <strong>Control</strong> Level 3 5 x 2ml IT3984High Sensitivity IgG Calibrator 3 x 1ml IT3899RHEUMATOID FACTOR CALIBRATOR SERIESDedicated 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 +2 - 8ºCDescription size Cat. No.Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301Haptoglobin CalibratorDedicated calibrator designed for use in the calibration of haptoglobin assays. This product is compatible for use on most clinical analysers.Description size Cat. No.Haptoglobin Calibrator 4 x 2ml hP135929


IMMUNOlogy/proteinSPECIFIC PROTEIN CALIBRATORS3ASOComplement C 3Complement C 4CRPFerritinHaptoglobinAnalytesIgAIgGIgMPrealbuminTransferrinMulti-analyte calibrator set designed for use in the calibration of the 11 analytes listed above.• Liquid ready to use• 100% human serum• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - 8 o CDescription size Cat. No.Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691For use with samples that do not require pre-dilutionSPECIFIC PROTEIN CALIBRATORSAnalytesAlpha-1-Acid GlycoproteinAlpha-1-AntitrypsinIgAIgGIgMTransferrinMulti-analyte calibrator set designed for use in the calibration of the 6 analytes listed above.• Liquid ready to use• 100% human serum• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription size Cat. No.Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692For use with samples that require pre-dilutionCSF CONTROLAnalytesAlbumina-1-globulina-2-globulinb-globuling-globulinChlorideGlucoseIgGLactateProtein (Total)SodiumMulti-analyte Cerebrospinal Fluid control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for useon most clinical analysers and provides method specific target values and ranges for 11 analytes.• Lyophilised for enhanced stability• 100% human product• Stable to expiry date at +2 - 8 ºC• Reconstituted stability of 2 weeks at +2 - 8 ºCDescription size Cat. No.Csf <strong>Control</strong> Level 2 10 x 3 ml CF1500Csf <strong>Control</strong> Level 3 10 x 3 ml CF150130


Lipid <strong>Control</strong>sChapter 44


LIPIDS3LIPID product rangePRODUCT DESCRIPTION SIZE CAT. NO.Lipid <strong>Control</strong> Level 1 5 x 1 ml LE2668Lipid <strong>Control</strong> Level 2 5 x 1 ml LE2669Lipid <strong>Control</strong> Level 3 5 x 1 ml LE2670Lipid <strong>Control</strong> Level 1 5 x 3 ml LE2661Lipid <strong>Control</strong> Level 2 5 x 3 ml LE2662Lipid <strong>Control</strong> Level 3 5 x 3 ml LE2663Apolipoprotein <strong>Control</strong> Level 1 3 X 1 ml LE5016Apolipoprotein <strong>Control</strong> Level 2 3 X 1 ml LE5017Apolipoprotein <strong>Control</strong> Level 3 3 X 1 ml LE5018Apolipoprotein Calibrator 3 x 1 ml LP3023Apolipoprotein Calibrator 2 3 x 1 ml LP5047Hdl/Ldl Cholesterol Calibrator (clearance) 3 x 1 ml CH2673Lipoprotein (a) <strong>Control</strong> Level 3 3 x 1 ml LP3406Lipoprotein (a) Calibrator 5 x 1 ml LP3404sLDL <strong>Control</strong> Level 1 3 x 1 ml LE5013sLDL <strong>Control</strong> Level 2 3 x 1 ml LE5014sLDL <strong>Control</strong> Level 3 3 x 1 ml LE5015sLDL Calibrator 3 x 1 ml CH505032


LIPIDSLipid CONTROLAnalytesApolipoprotein A-1Apolipoprotein BHDL Cholesterol (Direct lipid)HDL Cholesterol (Precipitation)LDL Cholesterol (Direct Method)Lipoprotein (a)Total CholesterolTriglycerides4A multi-analyte control designed for monitoring both the accuracy and precision of 7 analytes covering the full lipid profile. Accurately assigned targetvalues 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.• Lyophilised for enhanced stability• 100% human serum• Sodium Azide is not present - no interference occurs with clearance methods• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Lipid <strong>Control</strong> Level 1 5 x 1 ml LE2668Lipid <strong>Control</strong> Level 2 5 x 1 ml LE2669Lipid <strong>Control</strong> Level 3 5 x 1 ml LE2670Lipid <strong>Control</strong> Level 1 5 x 3 ml LE2661Lipid <strong>Control</strong> Level 2 5 x 3 ml LE2662Lipid <strong>Control</strong> Level 3 5 x 3 ml LE2663Apolipoprotein control & CalibratorsAnalytesApolipoprotein <strong>Control</strong>Apolipoprotein A-IIApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein EApolipoprotein CalibratorApolipoprotein A-IApolipoprotein BApolipoprotein Calibrator 2Apolipoprotein A-IIApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein EThe multi-analyte control is designed for use in the routine monitoring of both accuracy and precision for 4 esoteric Apolipoproteins. OurApolipoprotein calibrators are designed for use in the calibration of 6 esoteric Apolipoprotein assays on a wide range of clinical chemistry analysers.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• <strong>Control</strong> - reconstituted stability of up to 28 days at +2 - 8ºC for Apolipoprotein A-II and Apolipoprotein C-III, 14 days for Apolipoprotein C-II and 8hours for Apolipoprotein E• Calibrator - reconstituted stability of 7 days at +2 - 8ºC for Apolipoprotein control A-I, B, A-II, C-II and C-III,1 day for Apolipoprotein EDescription size Cat. No.Apolipoprotein <strong>Control</strong> Level 1 3 x 1 ml LE5016Apolipoprotein <strong>Control</strong> Level 2 3 x 1 ml LE5017Apolipoprotein <strong>Control</strong> Level 3 3 x 1 ml LE5018Apolipoprotein Calibrator 3 x 1 ml LP3023Apolipoprotein Calibrator 2 3 x 1 ml LP504733


LIPIDSHDL & LDL Cholesterol CalibratorAnalytes4HDL CholesterolLDL CholesterolDesigned for use in the calibration of HDL and LDL Clearance assays on clinical chemistry analysers.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºC and 1 month at -20ºCDescription size Cat. No.Hdl / Ldl Cholesterol Calibrator (Clearance) 3 x 1 ml CH2673Lp(a) <strong>Control</strong> and CalibratorDedicated control designed for use in the routine monitoring of both accuracy and precision. The calibrator is designed to calibrate Lp (a) assays onclinical chemistry analysers.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºCDescription size Cat. No.Lipoprotein (a) <strong>Control</strong> Level 3 3 x 1 ml LP3406Lipoprotein (a) Calibrator 5 x 1 ml LP3404sLDL CONTROLS & CalibratorDedicated control designed for use in the routine monitoring of both accuracy and precision.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºCDescription size Cat. No.sLDL <strong>Control</strong> Level 1 3 x 1ml LE5013sLDL <strong>Control</strong> Level 2 3 x 1 ml LE5014sLDL <strong>Control</strong> Level 3 3 x 1 ml LE5015sLDL Calibrator 3 x 1 ml CH505034


Cardiac <strong>Control</strong>sChapter 55


CARDIAC4Cardiac product rangePRODUCT DESCRIPTION SIZE CAT. NO.Cardiac <strong>Control</strong> (Tri-Level) 3 x 1 ml CQ3100Cardiac <strong>Control</strong> (Tri-Level) 3 x 2 ml CQ3259Liquid Cardiac <strong>Control</strong> Level 1 3 x 3 ml CQ5051Liquid Cardiac <strong>Control</strong> Level 2 3 x 3 ml CQ5052Liquid Cardiac <strong>Control</strong> Level 3 3 x 3 ml CQ5053Myoglobin Calibrator 4 x 1 ml MY2456Ck-mb <strong>Control</strong> 10 x 2 ml CK1212CK-MB Calibrator 10 x 1 ml CK2393High Sensitivity Troponin T <strong>Control</strong> 3 x 3 ml CQ5080H-FABP <strong>Control</strong> Level 1 3 x 1ml FB4026H-FABP <strong>Control</strong> Level 2 3x2ml FB4027H-FABP Calibrator Set 6x1ml FB313436


CARDIACCARDIAC CONTROLAnalytesCk TotalCk-Mb (Activity)Ck-Mb (Mass)HomocysteineMyoglobinTroponin ITroponin TA comprehensive cardiac control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges areprovided for the most common instruments and methods. Temperature specific values are available for CK and CK-MB.5• Lyophilised 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 +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºC or 4 weeks at -20ºCDescription size Cat. No.Tri-Level Cardiac <strong>Control</strong> 3 x 1 ml CQ3100Tri-Level Cardiac <strong>Control</strong> 3 x 2 ml CQ3259LIQUID CARDIAC CONTROLAnalytesBNPCK-MB (Mass)D-dimerDigoxinHomocysteinehs CRPMyoglobinNT-ProBNPTroponin ITroponin TA comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target values andranges are provided for 10 analytes including BNP, 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 +2 - 8ºC• Open vial stability of 30 days at +2 - 8ºCDescription size Cat. No.Liquid Cardiac <strong>Control</strong> Level 1 3 x 3 ml CQ5051Liquid Cardiac <strong>Control</strong> Level 2 3 x 3 ml CQ5052Liquid Cardiac <strong>Control</strong> Level 3 3 x 3 ml CQ5053MYOGLOBIN CALIBRATORDedicated calibrator designed for use in the calibration of Myoglobin immunoturbidimetric assays.• Lyophilised for enhanced stability• Prepared from purified human Myoglobin in a stabilised matrix• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 30 days at +2 - 8ºC or 6 months at -20ºCDescription size Cat. No.Myoglobin Calibrator 4 x 1 ml MY245637


CARDIACCK-MB CONTROL & CALIBRATORA dedicated CK-MB control designed for use in the routine monitoring of both accuracy and precision. Accurately assigned values are provided for bothserum and substrate start methods.5• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC<strong>Control</strong> : Reconstituted stability of 5 days at +2 - 8ºC or 14 days at -20ºCCalibrator: Reconstituted stability 5 days at 4ºC or 4 weeks at -20ºCDescription size Cat. No.Ck-Mb <strong>Control</strong> 10 x 2 ml CK1212Ck-Mb Calibrator 10 x 1 ml CK2393High Sensitivity Troponin T <strong>Control</strong>A dedicated Troponin T control designed to monitor the performance of high sensitivity Troponin T assays. The control is assayed allowing for the routineassessment of both accuracy and precision.• Lyophilised for enhanced stability• 100% human serum• Very low Troponin T levels around 0.0165 ng/ml (16.5 ng/l)• Stable to expiry at +2 - +8 o C• Reconstituted stability of 5 days at +2 - +8 o C or 4 weeks at -20 o CDescription size Cat. No.High Sensitivity Troponin T <strong>Control</strong> 3 x 3ml CQ5080Heart Type Fatty Acid Binding Protein (H-FABP) <strong>Control</strong> and Calibrator SetDedicated controls and calibrators designed for use in the routine monitoring and calibration of the Randox H-FABP assay.• Lyophilised for enhanced stability• 100% human• Reconstituted stability of 7 days at +2-8 o CDescription size Cat. No.H-FABP <strong>Control</strong> Level 1 3 x 1ml FB4026H-FABP <strong>Control</strong> Level 2 3 x 1ml FB4027H-FABP Calibrator Set 6 x 1ml FB313438


Diabetes/Haemoglobin<strong>Control</strong>sChapter 66


DIABETES/haemoglobin6Diabetes product rangePRODUCT DESCRIPTION SIZE CAT. NO.HbA1c <strong>Control</strong> Set Level 1 And 2 4 x 0.5 ml HA5072HbA1c Calibrator Series 5 x 2 ml, 1 x 8 ml HA3444HbA1c Linearity Set 4 x 0.25ml HA5073G-6PDH <strong>Control</strong> Deficient 6 x 0.5 ml PD2617G-6PDH <strong>Control</strong> Normal 6 x 0.5 ml PD2618Fructosamine <strong>Control</strong> Level 1 3 x 1 ml FR2994Fructosamine <strong>Control</strong> Level 3 3 x 1 ml FR2996Fructosamine Calibrator 3 x 1 ml FR2993Haemoglobin F and A2 <strong>Control</strong> 2 x 2 x 0.2ml HA508340


DIABETES/haemoglobinHbA1cAnalytesHbA1cTotal HaemoglobinA human based whole blood control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for HPLCand a wide range of clinical chemistry analysers.6• Lyophilised for enhanced stability• Treated in the same manner as a patient sample (requires pre-treatment)• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 4 weeks at +2 - 8ºCDescription size Cat. No.HbA1c <strong>Control</strong> Set Level 1 And 2 2 x 2 x 0.5 ml HA5072HbA1c Series Calibrator 5 x 2 ml, 1 x 8 ml HA3444HbA1c Linearity SetThe Randox HbA1c linearity set is designed for use in assessing the linearity of HbA1c assays across the clinically important range. Accurately assignedvalues are provided for the most common analyser and methods including HPLC.• Lyophilised for enhanced stability• 100% human whole blood control• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 4 weeks at +2 - 8ºCDescription size Cat. No.HbA1c Linearity Set 4 x 0.25 ml ha5073G-6PDH (GLUCOSE-6-PHOSPHATE DEHYDROGENASE) CONTROLDedicated G-6-PDH control designed for use in the routine monitoring of both accuracy and precision. Two levels are available (normal and deficient)with method specific target values and ranges provided.• Lyophilised for enhanced stability• Human based whole blood• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºCDescription size Cat. No.G-6-Pdh <strong>Control</strong> Deficient 6 x 0.5 ml PD2617G-6-Pdh <strong>Control</strong> Normal 6 x 0.5 ml PD261841


DIABETES/haemoglobinFRUCTOSAMINE <strong>Control</strong> and calibratorDedicated fructosamine control and calibrator designed for use in the routine monitoring and calibration of the Randox fructosamine assay.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 28 days at +2 - 8ºC6Description size Cat. No.Fructosamine <strong>Control</strong> Level 1 3 x 1 ml FR2994Fructosamine <strong>Control</strong> Level 3 3 x 1 ml FR2996Fructosamine Calibrator 3 x 1 ml FR2993Haemoglobin F & A2 <strong>Control</strong>AnalytesLevel 1 Level 2Haemoglobin F (HbF)Haemoglobin F (HbF)Haemoglobin H2 (HbA2)Haemoglobin H2 (HbA2)Haemoglobin S (HbS)100% human whole blood control designed to routinely monitor reproducibility and precision in laboratories measuring the haemoglobin variantsassociated with Thalassemia. Accurately assigned values and ranges are provided for all major systems and methods including HPLC, Immunoassay andGlycation Specific.• Lyophilised for enhanced stability• 100% human whole blood control• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 4 weeks at +2 - 8ºCDescription size Cat. No.Haemoglobin F & A2 <strong>Control</strong> 2 x 2 x 0.2ml HA508342


Urine <strong>Control</strong>sChapter 77


UrineUrine product rangePRODUCT DESCRIPTION SIZE CAT. NO.Assayed Urine Chemistry <strong>Control</strong> Level 2 12 x 10 ml AU2352Assayed Urine Chemistry <strong>Control</strong> Level 3 12 x 10 ml AU2353Unassayed Urine Chemistry <strong>Control</strong> Level 2 10 x 10 ml UC1502Unassayed Urine Chemistry <strong>Control</strong> Level 3 10 x 10 ml UC1503Liquid Urine <strong>Control</strong> Level 2 10 x 10 ml UC5074Liquid Urine <strong>Control</strong> Level 3 10 x 10ml UC5075Liquid Urinalysis <strong>Control</strong> Level 1 12 x 12 ml UC5033Liquid Urinalysis <strong>Control</strong> Level 2 12 x 12 ml UC5034Urinalysis <strong>Control</strong> Level 1 (dropper) 6 x 25 ml UC5078Urinalysis <strong>Control</strong> Level 2 (dropper) 6 x 25 ml UC5079Microalbumin <strong>Control</strong> Level 1 & 2 6 x 1 ml MA1361Microalbumin Calibrator Series 6 x 2 ml MA156744


urineassayed urine CHEMISTRYAnalytesAmylaseCalciumChlorideCopperCortisolCreatinineDopamineEpinephrineGlucose5-HIAAMagnesiumMetanephrineMicroalbuminNorepinephrineNormetanephrineOsmolalityOxalatePhosphorousPotassiumTotal ProteinSodiumUreaUric AcidVanillylmandelic Acid7Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for 24 analytes includingkidney function parameters, drug metabolites and urinary proteins. Method specific target values are also provided for the most commonly usedmethods.• Lyophilised for enhanced stability• 100% human urine• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºC or 14 days at -20ºCDescription size Cat. No.Urine Assayed <strong>Control</strong> Level 2 12 x 10 ml aU2352Urine Assayed <strong>Control</strong> Level 3 12 x 10 ml aU2353unassayed urine CHEMISTRYAnalytesCalciumChlorideCreatinineGlucoseMagnesiumOsmolalityPhosphorousPotassiumTotal ProteinSodiumUreaUric AcidMulti-analyte control designed for use in the routine monitoring of precision of 12 analytes.• Lyophilised offering enhanced stability• 100% human urine• Stable until expiry when stored at +2 - 8ºC• Reconstituted stability of 5 days at +2 - 8ºC or 14 days at -20ºCDescription size Cat. No.Urine Unassayed <strong>Control</strong> Level 2 10 x 10 ml UC1502Urine Unassayed <strong>Control</strong> Level 3 10 x 10 ml UC150345


UrineLiquid Urine <strong>Control</strong>AmylaseCalciumChlorideCortisolCreatinineGlucosehCGMagnesiumMicroalbuminOsmolaritypHPhosphate (Inorganic)PotassiumProtein (Total)SodiumSpecific GravityUreaUric Acid7Multi-analyte control designed for use in the routine monitoring of precision. Instrument and method specific values and ranges are provided for 18commonly analysed parameters.• Liquid ready to use• 100% human urine• Open vial stability 30 days at +2-8 o CDescription size Cat. No.Liquid Urine <strong>Control</strong> Level 2 10 x 10ml UC5074Liquid Urine <strong>Control</strong> Level 3 10 x 10ml UC5075LIQUID UrinalysisAnalytesAlbuminBilirubinBloodCreatinineGlucosehCGKetonesLeukocytesNitritepHProteinSpecific GravityUrobilinogenA multi-analyte control specifically designed for use in the quality control of urine test strips. Assayed values are provided for 13 parameters and a widerange of test strip manufacturers.• Liquid ready to use• 100% human urine• Suitable for use in POC testing• Stable to expiry date at +2 - 8ºC• Open vial stability of 30 days at +2 - +25ºC (20 immersions for UC5033/5034)Description size Cat. No.Liquid Urinalysis <strong>Control</strong> Level 1 12 x 12 ml UC5033Liquid Urinalysis <strong>Control</strong> Level 2 12 x 12 ml UC5034Urinalysis <strong>Control</strong> Level 1 (dropper) 6 x 25 ml UC5078Urinalysis <strong>Control</strong> Level 2 (dropper) 6 x 25 ml UC5079Microalbumin <strong>Control</strong> and CalibratorLiquid ready to use, human control and calibrator designed for in vitro diagnostic use in the calibration and monitoring of microalbuminimmunoturbidimetric assays. This product is compatible for use on most clinical analysers.• Liquid ready to use• 100% Human material• Stable to expiry date at +2 - 8ºCDescription size Cat. No.Microalbumin <strong>Control</strong> Level 1 & 2 6 x 1ml MA1361Microalbumin Calibrator Series 6 x 2 ml MA156746


Therapeutic DrugMonitoring <strong>Control</strong>sChapter 88


THERAPEUTIC DRUGsTherapeutic Drug product rangePRODUCT DESCRIPTION SIZE CAT. NO.Therapeutic Drug <strong>Control</strong> Level 1 20 x 5 ml HD1667Therapeutic Drug <strong>Control</strong> Level 2 20 x 5 ml HD1668Therapeutic Drug <strong>Control</strong> Level 3 20 x 5 ml HD1669Therapeutic Drug Calibrator 6 x 3 ml TD3417Therapeutic Drug <strong>Control</strong>8AnalytesAmikacinCaffeineCarbamazepineCyclosporineDigoxinEthosuximideGentamicinLithiumMethotrexateParacetamol (Acetaminophen)PhenobarbitonePhenytoinPrimidoneSalicylateTheophyllineTobramycinValproic AcidVancomycinMulti-analyte control designed for use in the quality control of therapeuticdrug monitoring. Assayed target values and ranges are supplied for 18analytes including commonly used antibiotics, anti-convulsants, antiinflammatoryand anti-cancer drugs. Instrument and method specifictarget values are provided for the most common instruments andmethods.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 4 weeks at +2 - 8ºCDescription size Cat. No.Therapeutic Drug <strong>Control</strong> Level 1 20 x 5 ml hD1667Therapeutic Drug <strong>Control</strong> Level 2 20 x 5 ml hD1668Therapeutic Drug <strong>Control</strong> Level 3 20 x 5 ml hD1669Therapeutic Drug CalibratorCarbamazepineDigoxinGentamicinPhenobarbitalAnalytesPhenytoinTheophyllineValproic AcidMulti-analyte calibrator designed for use in the calibration of therapeuticdrug assays on clinical chemistry analysers. Accurately assigned values areprovided for 7 analytes.• Lyophilised for enhanced stability• 100% human• Stable to expiry date at +2 - 8 o C• Reconstituted stability of 4 weeks at +2 - 8 o C or 8 weeks at -20 o CDescription size Cat. No.Multi-Analyte Therapeutic Drug Calibrator Series 6 x 3 ml TD341748


Toxicology <strong>Control</strong>sChapter 10Chapter 99


TOXICOLOGY9Toxicology product rangePRODUCT DESCRIPTION SIZE CAT. NO.Drugs of Abuse Array 1 (Urine) <strong>Control</strong>s 2 x 4 x 1ml EV3551Drugs of Abuse Array 1 (Urine) Calibrator Series 9 x 1ml EV3550Drugs of Abuse Array 1 (Urine, Semi Quant) <strong>Control</strong>s 2 x 4 x 1ml EV3630Drugs of Abuse Array 1 (Urine, Semi Quant) Calibrator Series 9 x 1ml EV3629Drugs of Abuse Array 1 (Whole Blood, Semi Quant) <strong>Control</strong>s 2 x 4 x 1ml EV3627Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Calibrators 9 x 1ml EV3628Drugs of Abuse Array 1 (Whole Blood) <strong>Control</strong>s 2 x 4 x 1ml EV3677Drugs of Abuse Array 1 (Whole Blood) Calibrator Series 2 x 4 x 1ml EV3676Drugs of Abuse Array 1 (Oral Fluid) <strong>Control</strong>s 2 x 4 x 1ml EV3649Drugs of Abuse Array 1 (Oral Fluid) Calibrator Series 9 x 1ml EV3648Drugs of Abuse Array 1 (High Opiate) <strong>Control</strong>s 2 x 4 x 1ml EV3647Drugs of Abuse Array 1 Plus (Urine) <strong>Control</strong>s 2 x 4 x 1ml EV3745Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1ml EV3744Drugs of Abuse Array 1 Plus (Whole Blood) <strong>Control</strong>s 2 x 4 x 1ml EV3750Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1ml EV3749Drugs of Abuse Array I (Urine) <strong>Control</strong> - Evidence Multistat 3 x 1ml EV3731Drugs of Abuse Array I (Urine) Standard - Evidence Multistat 3 x 2 x 1ml EV3730Drugs of Abuse Array I (Whole Blood) <strong>Control</strong> - Evidence Multistat 3 x 1ml EV3734Drugs of Abuse Array I (Whole Blood) Standard - Evidence Multistat 3 x 2 x 1ml EV3733Drugs Of Abuse Array II (Urine) <strong>Control</strong>s 2 x 4 x 1 ml EV3657Drugs Of Abuse Array II (Whole Blood) <strong>Control</strong>s 2 x 4 x 1 ml EV3682Drugs Of Abuse Array II (Oral Fluid) <strong>Control</strong>s 2 x 4 x 1 ml EV3702Drugs Of Abuse Array II (Urine) Calibrator Series 9 x 1ml EV3656Drugs Of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687Drugs Of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1ml EV3701Drugs of Abuse Array III (Whole Blood) <strong>Control</strong> 4 x 2 x 1ml EV3794Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1ml EV3797Drugs of Abuse Array IV (Whole Blood) <strong>Control</strong> 4 x 2 x 1ml EV3809Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1ml EV3808Drugs of Abuse Array V (Urine) <strong>Control</strong> 4 x 2 x 1ml EV3814Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1ml EV3815Cannabinoid Calibrator 5 x 3 ml DA2700Cannabinoid <strong>Control</strong> Level 1 5 x 3 ml DA3127Cannabinoid <strong>Control</strong> Level 2 5 x 3 ml DA3128Ecstasy Calibrator 5 x 10 ml DA2701Ecstasy <strong>Control</strong> Level 1 5 x 5 ml DA3125Ecstasy <strong>Control</strong> Level 2 5 x 5 ml DA3126EDDP Calibrator 5 x 10 ml DA2702EDDP <strong>Control</strong> Level 1 5 x 5 ml DA3123EDDP <strong>Control</strong> Level 2 5 x 5 ml DA3124Ethanol Calibrator/<strong>Control</strong> Set 5 x 10 ml DA2703Multidrug Calibrator 5 x 10 ml DA2704Multidrug <strong>Control</strong> Level 1 5 x 5 ml DA3121Multidrug <strong>Control</strong> Level 2 5 x 5 ml DA3122Benzodiazepines <strong>Control</strong> Level 1 5 x 5 ml DA3130Benzodiazepines <strong>Control</strong> Level 2 5 x 5 ml DA3131Benzodiazepines Calibrator Series 5 x 10 ml DA312950


TOXICOLOGYDrugs of Abuse Array 1 <strong>Control</strong>s and CalibratorsAnalytesAmphetamineBarbituratesBenzodiazepine 1Benzodiazepine 2CannabinoidsCocaine MetaboliteMethadoneMethamphetamineOpiatesPhencyclidineCreatinineA comprehensive control designed for use in the routine monitoring of accuracy and precision on Randox Biochip systems. Values in the level 1 controlare below the SAMHSA cut-off for urine only while values in the level 2 control are above the SAMHSA cut-off for urine only. A High Opiate control isalso available with a cut-off value of 2000ng/ml.• Lyophilised for enhanced stability• Stable to expiry date at +2-8 o C• Urine – Reconstituted stability of 14 days at +2-8 o C or 28 days at -20 o C• Urine Semi-Quantitative – Reconstituted stability of 7 days at +2- 8o C or 28 days at -20 o C• Whole Blood – Reconstituted stability of 14 days at +2-8 o C• Oral Fluid - Reconstituted stability of 7 days at +2-8 o C• High Opiate - Reconstituted stability of 14 days at +2-8 o C or 21 days at -20 o C9Description size Cat. No.Drugs of Abuse Array 1 (Urine) <strong>Control</strong>s 2 x 4 x 1ml EV3551Drugs of Abuse Array 1 (Urine) Calibrator Series 9 x 1ml EV3550Drugs of Abuse Array 1 (Urine, Semi Quant) <strong>Control</strong>s 2 x 4 x 1ml EV3630Drugs of Abuse Array 1 (Urine, Semi Quant) Calibrator Series 9 x 1ml EV3629Drugs of Abuse Array 1 (Whole Blood, Semi Quant) <strong>Control</strong>s 2 x 4 x 1ml EV3627Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Calibrators 9 x 1ml EV3628Drugs of Abuse Array 1 (Whole Blood) <strong>Control</strong>s 2 x 4 x 1ml EV3677Drugs of Abuse Array 1 (Whole Blood) Calibrator Series 2 x 4 x 1ml EV3676Drugs of Abuse Array 1 (Oral Fluid) <strong>Control</strong>s 2 x 4 x 1ml EV3649Drugs of Abuse Array 1 (Oral Fluid) Calibrator Series 9 x 1ml EV3648Drugs of Abuse Array 1 (High Opiate) <strong>Control</strong>s 2 x 4 x 1ml EV3647Drugs of Abuse Array 1 Plus <strong>Control</strong>s and CalibratorsAnalytesAmphetamineBarbituratesBenzodiazepine 1Benzodiazepine 2BuprenorphineCannabinoidsCocaine MetaboliteMDMAMethadoneMethamphetamineOpiatesPhencyclidineTricyclic AntidepressantsCreatinineAssayed control for use in monitoring the accuracy and precision on Randox Biochip systems. Two levels of control are provided covering the cut-off range.• Lyophilised for enhanced stability• Stable to expiry date at +2-8 o C• Urine - Reconstituted stability of 14 days at +2-8 o C• Whole Blood – Reconstituted stability of 7 days at +2-8 o C or 14 days at -20 o CDescription size Cat. No.Drugs of Abuse Array 1 Plus (Urine) <strong>Control</strong>s 2 x 4 x 1ml EV3745Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1ml EV3744Drugs of Abuse Array 1 Plus (Whole Blood) <strong>Control</strong>s 2 x 4 x 1ml EV3750Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1ml EV374951


TOXICOLOGYDRUGS OF ABUSE I (URINE) CONTROL AND STANDARDS - MultistatAnalytesAmphetamineBarbituratesBenzodiazepine 1Benzodiazepine 2CannabinoidsCocaine MetaboliteMethadoneMethamphetamineOpiatesPhencyclidineCreatinineMulti-analyte control designed for use in the routine monitoring of both accuracy and precision of urine drugs of abuse on the Evidence MultiStat analyser. Assayedvalues provided for 10 parameters.9• Lyophilised for enhanced stability• 1 year shelf life from date of manufacture• <strong>Control</strong>: Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC• Standards: Reconstituted stability of 5 days when stored at +2 - 8ºC or 28 days when stored at -20ºCDescription size Cat. No.Drugs of Abuse Array I (Urine) <strong>Control</strong> - Evidence Multistat 3 x 1ml EV3731Drugs of Abuse Array I (Urine) Standard - Evidence Multistat 3 x 2 x 1ml EV3730DRUGS OF ABUSE I (WHOLE BLOOD) CONTROL AND STANDARDS - MultistatAnalytesAmphetamineBarbituratesBenzodiazepine 1Benzodiazepine 2BuprenorphineCannabinoidsCocaine MetaboliteMDMAMethadoneMethamphetamineOpiatesPhencyclidineTricyclic AntidepressantsCreatinineMulti-analyte control designed for use in the routine monitoring of both accuracy and precision. of whole blood drugs of abuse assays on the Evidence MultiStatanalyser. Assayed values provided for 10 parameters.• Lyophilised for enhanced stability• 1 year shelf life from date of manufacture• Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºCDescription size Cat. No.Drugs of Abuse Array I (Whole Blood) <strong>Control</strong> - Evidence Multistat 3 x 1ml EV3734Drugs of Abuse Array I (Whole Blood) Standard - Evidence Multistat 3 x 2 x 1ml EV373352


TOXICOLOGYDRUGS OF ABUSE Array II CONTROL3,4 Methylenedioxymethamphetamine (MDMA)KetamineLysergic Acid diethylamide (LSD)MethaqualoneAnalytesBuprenorphineFentanylGeneric OpioidsOxycodone IOxycodone IIPropoxypheneCreatinineA comprehensive control designed for use in the routine monitoring of accuracy and precision on Randox Biochip systems. Assayed values are providedfor 10 parameters.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Urine - Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC• Whole Blood - Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC9Description size Cat. No.Drugs Of Abuse Array II (Urine) <strong>Control</strong>s 2 x 4 x 1 ml EV3657Drugs Of Abuse Array II (Whole Blood) <strong>Control</strong>s 2 x 4 x 1 ml EV3682Drugs Of Abuse Array II (Oral Fluid) <strong>Control</strong>s 2 x 4 x 1 ml EV3702Drugs Of Abuse Array II (Urine) Calibrator Series 9 x 1ml EV3656Drugs Of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687Drugs Of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1ml EV3701Drugs of Abuse Array III <strong>Control</strong>s and CalibratorsAnalytesChloral Hydrate MetaboliteEthyl GlucuronideFentanylKetamine MetaboliteMeperidineMeprobamateZaleplonZolpidemZopiclone7-amino FlunitrazepamCreatinineAssayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are providedcovering the cut-off range.• Lyophilised for enhanced stability• Stable to expiry date at +2-8 o C• Reconstituted stability of 7 days at +2-8 o CDescription size Cat. No.Drugs of Abuse Array III (Whole Blood) <strong>Control</strong> 4 x 2 x 1ml EV3794Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1ml EV379753


TOXICOLOGYDrugs of Abuse Array IV <strong>Control</strong>s and CalibratorsAnalytesAcetaminophenDextromethorphanEscitalopramFluoxetineHaloperidolIbuprofenMethylphenidateSalicylateSalicyluric AcidSertralineTramadolTrazodoneTricyclic AntidepressantsCreatinineAssayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are providedcovering the cut-off range.9• Lyophilised for enhanced stability• Stable to expiry date at +2-8 o C• Reconstituted stability of 7 days at +2-8 o CDescription size Cat. No.Drugs of Abuse Array IV (Whole Blood) <strong>Control</strong> 4 x 2 x 1ml EV3809Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1ml EV3808Drugs of Abuse Array V <strong>Control</strong>s and CalibratorsAnalytesBath Salts 1 (Methcathinone and Mephedrone)Bath Salts 2 (MDPV)BenzylpipernzinesMescalinePhenylpiperazinesSalvinorinSynthetic Cannabinoids 1Synthetic Cannabinoids 2Synthetic Cannabinoids 3Synthetic Cannabinoids 4Assayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are providedcovering the cut-off range.• Lyophilised for enhanced stability• Stable to expiry date at +2-8 o C• Reconstituted stability of 7 days at +2-8 o CDescription size Cat. No.Drugs of Abuse Array V (Urine) <strong>Control</strong> 4 x 2 x 1ml EV3814Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1ml EV381554


TOXICOLOGYCANNABINOID <strong>Control</strong> and CALIBRATORDedicated calibrator and control set designed for the calibration and quality control of the Randox Cannabinoids assay.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Cannabinoid Calibrator 5 x 3ml DA2700Cannabinoid <strong>Control</strong> Level 1 5 x 3 ml DA3127Cannabinoid <strong>Control</strong> Level 2 5 x 3 ml DA3128ECSTASY <strong>Control</strong> and CALIBRATOR9Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ecstasy assay.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Ecstasy Calibrator 5 x 10ml DA2701Ecstasy <strong>Control</strong> Level 1 5 x 5 ml DA3125Ecstasy <strong>Control</strong> Level 2 5 x 5 ml DA3126EDDP <strong>Control</strong> and CALIBRATORDedicated calibrator and control set designed for the calibration and quality control of the Randox EDDP assay.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.EDDP Calibrator 5 x 10ml DA2702EDDP <strong>Control</strong> Level 1 5 x 5 ml DA3123EDDP <strong>Control</strong> Level 2 5 x 5 ml DA3124ETHANOL CALIBRATOR/CONTROL SETDedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Ethanol Calibrator/<strong>Control</strong> Set 4 x 10ml DA 270355


TOXICOLOGYMULTIDRUG CalibratorAnalytesAmphetaminesBarbituratesBenzodiazepinesCocaine MetaboliteMethadoneOpiatesMulti-analyte calibrator set designed for the calibration of the Randox Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolite, Methadone andOpiates assays.9• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Multidrug Calibrator 5 x 10 ml DA 2704MULTIDRUG <strong>Control</strong>AnalytesMethamphetamineOxazepamSecobarbitalMethadoneMulti-analyte control designed for use in the quality control of the Randox Amphetamines, Barbiturates, Benzodiazepines and Methadone assays.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Multidrug <strong>Control</strong> Level 1 5 x 5 ml DA3121Multidrug <strong>Control</strong> Level 2 5 x 5 ml DA3122Benzodiazepines <strong>Control</strong> and calibratorAnalytesOxazepamDedicated calibrator and control set designed for the calibration and control of the Randox bezodiazepines assay.• Liquid ready to use• Stable to expiry date when capped and stored at +2 - 8ºCDescription size Cat. No.Benzodiazepines <strong>Control</strong> Level 1 5 x 5ml DA3130Benzodiazepines <strong>Control</strong> Level 2 5 x 5ml DA3131Benzodiazepines Calibrator Series 5 x 10ml DA312956


Coagulation <strong>Control</strong>sChapter 10Chapter 410


COAGULATIONCoagulation product rangePRODUCT DESCRIPTION SIZE CAT. NO.Coagulation <strong>Control</strong> Level 1 12 x 1 ml CG5021Coagulation <strong>Control</strong> Level 2 12 x 1 ml CG5022Coagulation <strong>Control</strong> Level 3 12 x 1 ml CG5023COAGULATION CONTROL10AnalytesProthrombin Time (PT)Activated Partial Thromboplastin Time (APTT)Thrombin Time (TT)FibrinogenAntithrombin III (ATIII)Factor IIFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIPlasminogenProtein CProtein SMulti-parameter control designed for use in the routine monitoring of both accuracy and precision. Assayed method and instrument specific targetvalues and ranges are available for a variety of factor assays, basic coagulation and thrombophilia parameters.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 24 hours at +2 - 8ºCDescription size Cat. No.Coagulation <strong>Control</strong> Level 1 12 x 1 ml CG5021Coagulation <strong>Control</strong> Level 2 12 x 1 ml CG5022Coagulation <strong>Control</strong> Level 3 12 x 1 ml CG502358


Blood Gas <strong>Control</strong>sChapter 1111


lood gasBlood Gas product rangePRODUCT DESCRIPTION SIZE CAT. NO.Liquid Blood Gas <strong>Control</strong> Level 1 30 x 1.8 ml BG 5001Liquid Blood Gas <strong>Control</strong> Level 2 30 x 1.8 ml BG 5002Liquid Blood Gas <strong>Control</strong> Level 3 30 x 1.8 ml BG 5003Blood Gas CONTROLAnalytes11Total CO pCO 2pO 2ChloridepH2CalciumGlucoseLactatePotassiumSodiumLiquid ready to use blood gas control designed for use in the routine monitoring of the 10 parameters listed above. Method specific target values are providedfor the most common instruments.• Aqueous material• Stable to expiry date at +2 - 8ºC• Once opened controls should be analysed within 1 minute for pH and blood gas parameters; for electrolyte measurements, the control should be analysedwithin 1 hour of openingDescription size Cat. No.Liquid Blood Gas <strong>Control</strong> Level 1 30 x 1.8 ml bg5001Liquid Blood Gas <strong>Control</strong> Level 2 30 x 1.8 ml bg5002Liquid Blood Gas <strong>Control</strong> Level 3 30 x 1.8 ml bg500360


Antioxidant <strong>Control</strong>sChapter 1212


ANTIOXIDANTS12Antioxidant product rangePRODUCT DESCRIPTION SIZE CAT. NO.Glutathione Reductase <strong>Control</strong> 10 x 5 ml GR2608Glutathione Reductase Calibrator 10 x 5 ml GR2609Ransel (Glutathione Peroxidase) <strong>Control</strong> 10 x 1 ml SC692Ransod (Superoxide Dismutase) <strong>Control</strong> 10 x 1 ml SD126Tas (Total Antioxidant Status) Standard 10 x 1 ml NX2615Tas (Total Antioxidant Status) <strong>Control</strong> 10 x 5 ml NX233162


ANTIOXIDANTSGlutathione reductase CONTROL AND CALIBRATORA bovine based control designed for use in the routine monitoring of precision. This product is compatible for use on most clinical chemistry analysers.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8°C• Reconstituted stability of 1 day at +2 - 8°C or 8 hours at +15 - 25°CDescription size Cat. No.Glutathione Reductase Calibrator 10 x 5 ml gR2609Glutathione Reductase <strong>Control</strong> 10 x 5 ml gR2608GLUTATHIONE PEROXIDASE (RANSEL) controlA bovine based, whole blood control designed for use in the routine monitoring of precision. This product is compatible for use on most clinical chemistryanalysers.12• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8°C• Reconstituted stability of 3 days at +2-8°CDescription size Cat. No.Glutathione Peroxidase (Ransel) <strong>Control</strong> 10 x 1 ml sC692SUPEROXIDE DISMUTASE (RANSOD) controlA bovine based, whole blood control designed for use in the routine monitoring of precision. This product is compatible for use on most clinicalchemistry analysers.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8°C• Reconstituted stability of 10 days at +2 - 8°CDescription size Cat. No.Superoxide Dismutase (Ransod) <strong>Control</strong> 10 x 1 ml sD12663


ANTIOXIDANTSTOTAL ANTIOXIDANT STATUS (TAS) CONTROL AND STANDARDA human based control designed for use in the routine monitoring of reproducibility and precision. This product is compatible for use on most clinicalchemistry analysers.<strong>Control</strong>• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8°C• Reconstituted stability of 2 days at +2 - 8°C or 12 hours at +15 - 25°CStandard• Lyophilised for enhanced stability• Approximately 1.5 mmol/l• Stable to expiry date at +2 - 8°C• Reconstituted stability of 2 days at +2 - 8°C or 4 weeks at +-20°CDescription size Cat. No.Tas (Total Antioxidant Status) <strong>Control</strong> 10 x 5 ml NX2331Tas (Total Antioxidant Status) Standard 10 x 1 ml NX26151264


Speciality andResearch <strong>Control</strong>sChapter 1313


Speciality and researchcontrolsSPECIALITY AND RESEARCH product rangePRODUCT DESCRIPTION SIZE CAT. NO.Antimicrobial Array 1 Plus <strong>Control</strong> 3 x 1 ml AMC5084Antimicrobial <strong>Control</strong> II 3 x 1 ml AMC5035Antimicrobial <strong>Control</strong> III 3 x 1 ml AMC5036Growth Promoter <strong>Control</strong> 3 x 1 ml GP5003Cell Adhesion Molecules <strong>Control</strong> 3 x 3 x 1 ml EV3569Adhesion Molecules Calibrator Series 9 x 1 ml EV3568Cerebral Series I <strong>Control</strong> 3 x 3 x 1 ml CAB5008Cerebral Array I Calibrator Series 9 x 1 ml EV3625Cerebral Series II <strong>Control</strong> 3 x 3 x 0.5 ml CBB5009Cerebral Array II Calibrator Series 9 x 1 ml EV3641Cytokine Array I <strong>Control</strong> 3 x 3 x 1 ml CY5006Cytokine Array I <strong>Control</strong> (High Sensitivity) 3 x 3 x 2 ml CY5005Cytokine Array Calibrator Series 9 x 1 ml EV3561Cytokine Array Iii <strong>Control</strong> 3 x 3 x 1 ml CY5012Cytokine Array III Calibrator Series 9 x 1 ml EV3679Cytokine Array Iv <strong>Control</strong> 3 x 3 x 0.5 ml CY5011Cytokine Array IV Calibrator Series 9 x 1 ml EV3658Cytokine Array V <strong>Control</strong> 3 x 3 x 1 ml CY5010Cardiac Array <strong>Control</strong> 3 x 3 x1 ml EV3691Cardiac Plus Tri-Level <strong>Control</strong> 3 x 3 x 1 ml EV3558Cardiac Plus Calibrator Series 9 x 1ml EV3557Cardiac <strong>Control</strong> (Multistat) 3 x 1 ml EV3729Cardiac Standards (Multistat) 3 x 2 x 1 ml EV3728Endocrine Array <strong>Control</strong>s 3 x 3 x 1 ml EV3713Endocrine Array Calibrator Series 9 x 1 ml EV3712Evidence Immunoassay <strong>Control</strong>s 3 x 4 x 5ml EV3750Synthetic Steroids <strong>Control</strong> 3 x 1 ml EV3709Synthetic Steroids Calibrator 9 x 1 ml EV3708Metabolic Syndrome Array 1 <strong>Control</strong>s 3 x 3 x 1 ml EV3757Metabolic Syndrome Array 1 Calibrators 9 x 1 ml EV375666


Speciality and researchcontrolsAntimicrobial <strong>Control</strong>sAntimicrobial <strong>Control</strong> I PLUS AnalytesSulphadiazineSulphadimethoxineSulphaquinoxalineSulphamethazineSulphathiazoleSulphachlorpyridazineSulphapyridineSulphamethoxypyridazineSulphisoxazoleSulphamethizoleSulphadoxineSulphamerazineSulphamethoxazoleSulphamonomethoxineTrimethoprimA multi-analyte control containing target values and ranges for 15 different antimicrobial agents.• Liquid ready to use• Stable to expiry date at +2 - 8ºC• Open vial stability of 21 days at -20ºCDescription size Cat. No.Antimicrobial Array 1 Plus <strong>Control</strong> 3 x 1 ml aMC5084Antimicrobial <strong>Control</strong> II AnalytesTetracyclines (generic)Quinolones (generic)ThiamphenicolTylosinStreptomycinCeftiofur13A multi-analyte control supplied with values for 6 different antimicrobial agents used extensively in veterinary medicine.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 24 hours at +2 - 8ºC or 2 weeks at -20ºCDescription size Cat. No.Antimicrobial <strong>Control</strong> II 3 x 1 ml aMC5035Antimicrobial <strong>Control</strong> III Analytes5-Methylmorpholino-3-amino-2-oxazolidinone (AMOZ)1-Amino hydantoin hydrochloride (AHD)3-Amino-2-oxazoilidinone (AOZ)Semicarbazine (SEM)ChloramphenicolMulti-analyte control containing values for 5 different antimicrobial agents.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 28 days at +2 - 8ºC or 28 days at -20ºCDescription size Cat. No.Antimicrobial <strong>Control</strong> III 3 x 1 ml aMC503667


Speciality and researchcontrolsGrowth Promoter CONTROLBoldenoneZeranolRactopamineAnalytesCorticosteroidsNandroloneStilbenesTrenboloneStanozololBeta-Agonists (Clenbuterol)A multi-analyte control provided with accurately assigned target values and ranges for 9 different growth promoters.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 14 days at +2 - 8ºCDescription size Cat. No.Growth Promoter <strong>Control</strong> 3 x 1 ml gP5003Analytes13Cell Adhesion Molecules <strong>Control</strong>S AND CALIBRATORSAnalytesAnalytesVascular cell adhesion molecule-1 (VCAM-1)Intercellular adhesion molecule-1 (ICAM-1)E-Selectin (E-SEL)P-Selectin (P-SEL)L-Selectin (L-SEL)A multi-analyte control with target values and ranges supplied for 5 different adhesion molecules.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 24 hours at +2 - 8ºC or 7 days at -20ºCDescription size Cat. No.Adhesion Molecules Tri-Level <strong>Control</strong> 3 x 3 x 1 ml EV3569Adhesion Molecules Calibrator Series 9 x 1 ml EV3568Analytes68


Speciality and researchcontrolsCerebral Series I <strong>Control</strong>s AND CALIBRATORSAnalytesBrain Derived Neurotrophic Factor (BDNF)Fatty Acid Binding Protein (FABP)Glial Fibrillary Acidic Protein (GFAP)Interleukin 6 (IL6)A multi-analyte control with target values and ranges provided for 4 analytes.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 8 hours at +2 - 8ºC or 21 days at -20ºCDescription size Cat. No.Cerebral Series I Tri-Level <strong>Control</strong> 3 x 3 x 1 ml CAB5008Cerebral Array 1 Calibrator Series 9 x 1 ml EV362513Cerebral Series II <strong>Control</strong>S AND CALIBRATORSAnalytesNeuron Specific Enolase (NSE)Neutrophil Gelatinase-associated Lipocalin (NGAL)Soluble Tumour Necrosis Factor Receptor I (sTNFRI)D-dimerThrombomodulin (TM)C-Reactive Protein (CRP)A multi-analyte control with target values and ranges provided for 6 analytes.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 8 hours at +2 - 8ºC or 14 days at -80ºCDescription size Cat. No.Cerebral Series II Tri-Level <strong>Control</strong> 3 x 3 x 0.5 ml CBB5009Cerebral Array 11 Calibrator Series 9 x 0.5ml EV364169


Speciality and researchcontrolsCytokine ARRAY I & high sensitivity Cytokine ARRAY I <strong>Control</strong> AND CALIBRATORSAnalytesInterleukin - 1a (IL-1a)Interleukin - 1b (IL-1b)Interleukin - 2 (IL2)Interleukin - 4 (IL4)Interleukin - 6 (IL6)Interleukin - 8 (IL8)Interleukin - 10 (IL10)Vascular Endothelial Growth Factor (VEGF)Interferon g (IFNg)Tumour Necrosis Factor a (TNFa)Monocyte Chemoattractant Protein-1 (MCP-1)Epidermal Growth Factor (EGF)Multi-analyte controls with target values and ranges provided for 12 different cytokines.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 10-12 hours at +2 - 8ºC or 14 days at -20ºC• High sensitivity - Reconstituted stability of 4 hours at +2 - 8ºC or 7 days at -20ºC13Description size Cat. No.Cytokine Array I Tri-Level <strong>Control</strong> 3 x 3 x 1 ml CY5006High Sensitivity Cytokine Array I Tri-Level <strong>Control</strong> 3 x 3 x 2 ml CY5005Cytokine Array Calibrator Series 9 x 1 ml EV3561Cytokine ARRAY III <strong>Control</strong>S AND CALIBRATORSInterleukin Analytes - 5 (IL-5)Interleukin - 15 (IL15)Tumour Necrosis Factor b (TNFb)AnalytesGranulocyte Macrophage Colony-Stimulating Factor (GMCSF)Matrix Metalloproteinase-9 (MIP-1a)A multi-analyte control with target values and ranges provided for 5 analytes.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 24 hours at +2 - 8ºC or 28 days at -20ºCDescription size Cat. No.Cytokine Array III Tri-Level <strong>Control</strong> 3 x 3 x 1 ml CY5012Cytokine Arra III Calibrator Series 9 x 1 ml EV367970


Speciality and researchcontrolsCytokine ARRAY IV <strong>Control</strong>S AND CALIBRATORSAnalytesSoluble 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)A multi-analyte control with target values and ranges provided for 5 analytes.• Lyophilised providing enhanced stability• 100% human material• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºCDescription size Cat. No.Cytokine Array IV Tri-Level <strong>Control</strong> 3 x 3 x 1 ml CY5011Cytokine Array IV Calibrator Series 9 x 1 ml EV3658Cytokine ARRAY V <strong>Control</strong>Analytes13Interleukin-3 (IL-3)Interleukin-7 (IL7)Interleukin 12p70 (IL12p70)Interleukin-13 (IL13)Interleukin-23 (IL23)A multi-analyte control with target values and ranges provided for 5 analytes.• Lyophilised for enhanced stability• 100% human material• Stable to expiry when stored at +2 - 8ºC• Reconstituted stability of 14 days at +2 - 8ºC or 21 days at -20ºCDescription size Cat. No.Cytokine Array V Tri-Level <strong>Control</strong> 3 x 3 x 1 ml CY5010Analytes71


Speciality and researchcontrolsCARDIAC Array CONTROLsCk-MbH - FABPMyoglobinTroponin IMulti-analyte cardiac control designed for use in the routine monitoring of precision on clinical chemistry and immunoassay systems. This is the onlycontrol of its type to include the novel marker heart type fatty acid binding protein (H - FABP). Three levels of control are supplied spanning thecomplete clinical range.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 16 hours at +2 - 8ºC or 7 weeks at -80ºCDescription size Cat. No.Cardiac Array <strong>Control</strong>s 3 x 3 x 1 ml EV3691Cardiac <strong>Control</strong> (Multistat) 3 x 1ml EV3729Cardiac Standards (Multistat) 3 x 2 x 1ml EV372813CARDIAC plus Tri-level CONTROLCAIIICk-MbAnalytesH-FABPGPBBMyoglobinTroponin IMulti-analyte cardiac control designed for use in the routine monitoring of precision on clinical chemistry and immunoassay systems. Accurately assignedtarget values and ranges are provided for 6 analytes including the novel marker heart type fatty acid binding protein (H-FABP). Three levels of controlare supplied spanning the complete clinical range.• Lyophilised for enhanced stability• 100% human serum• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 16 hours at +2 - 8ºC or 7 weeks at -80ºCDescription size Cat. No.Cardiac Plus Tri-Level <strong>Control</strong> 3 x 3 x 1 ml EV3558Cardiac Plus Array Calibrator Series 9 x 1 ml EV355772


Speciality and researchcontrolsENDOCRINE ARRAY <strong>Control</strong>S AND CALIBRATORAnalytesCortisolDHEAs17αHydroxyprogesteroneLeptinHuman based control designed for use in the routine monitoring of both accuracy and precision. Three levels of control are supplied with assayed target valuesand ranges provided for 4 analytes.• Lyophilised for enhanced stability• Assayed values available for both the Evidence and Evidence Investigator• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 7 days at +2 - 8ºC or 21 days at -20ºCDescription size Cat. No.Endocrine Array <strong>Control</strong>s 3 x 3 x 1ml EV3713Endocrine Array Calibrator Series 9 x 1ml EV371213Evidence Immunoassay <strong>Control</strong>CEAEstradiolFSHFree T4Free T3AnalytesLeutinising HormoneProlactinProgesteronePSA (Total)PSA (Free)TestosteroneTotal T4Total T3TSHMulti-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.• Lyophilised for enhanced stability• Stable to expiry date at +2-8oC• Reconstituted stability of 7 days at +2-8oC or 4 weeks at -20oCDescription size Cat. No.Evidence Immunoassay <strong>Control</strong>s 3 x 4 x 5ml EV375073


Speciality and researchcontrolsSYNTHETIC STEROiDS <strong>Control</strong> AND calibratorAnalytes17β ClostebolEthinylestradiolGestagens (generic)MethyltestosteroneMethandriolHuman based control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 5 differentsynthetic steroids.• Lyophilised for enhanced stability• Stable to expiry date at +2 - 8ºC• Reconstituted stability of 3 days at +2 - 8 o C or 14 days at -20ºCDescription size Cat. No.Synthetic Steroids <strong>Control</strong> 3 x 1ml EV3709Synthetic Steroids Calibrator 9 x 1ml EV370813Metabolic Syndrome Array I <strong>Control</strong>AnalytesC-PeptideFerritinInterleukin-6ResistinInsulinInterleukin-1αTumour Necrosis Factor αLeptinPlasminogen Activator Inhibitor-1A multi-analyte control with target values and ranges provided for 9 parameters associated with metabolic syndrome.• Lyophilised for enhanced stability• 100% human material• Stable to expiry date at 2-8 o C• Reconstituted stability of 72 hours at +2-8oC and 7 days at -20 o CDescription size Cat. No.Metabolic Syndrome Array I <strong>Control</strong>s 3 x 3 x 1ml EV3757Metabolic Syndrome Array I Calibrators 9 x 1ml EV375674


Interlaboratory DataManagement SoftwareChapter 1414


Randox Acusera 24•7Randox Acusera 24•7 is an Interlaboratory Data Managementsoftware and peer group reporting package designed to complementand support the Acusera range of control sera.The Acusera 24•7 software enables laboratories to monitor analyticalperformance while the peer group reporting function allowslaboratories to access peer group reports and compare results withother laboratories using the same quality controls and often the samemethod and instrument.Peer group data is updated every 24 hours, giving you access tothe most up to date information available.Why participate in a peer group reporting programme like Acusera 24•7?14Receive reliable information from a trustworthy sourceAcusera 24•7 peer group statistics are generated every 24 hoursfrom 1000’s of labs in countries worldwide. This large numberof participants ensures an extensive database of results for manyanalytical methods, assures validity and therefore increases confidencein your results.Identify any trends, system errors or reagent issues as soon as they ariseAcusera 24•7 will help you to detect and identify errors in yourlaboratory system thus minimising expensive repeats and lengthlyunnecessary troubleshooting.By comparing your IQC results with peer group data, you can identifyproblems that otherwise may have gone unnoticed and assess if shiftsin QC recovery are unique to your laboratory. Access to peer groupdata may even alert you to future issues before they are encounteredin your laboratory.Most errors occur alongside software changes, changes in reagentformulation and calibrator re standardisation.Improve EQA/PT performance by eliminating any undetected biasRandox Acusera 24•7 supports and complements your current EQA/PT scheme. External quality assessment is not performed on a dailybasis but periodically. Reporting is generally bi-weekly or monthly withRIQAS, but may be less frequent with other schemes.Errors can occur at any time or at any point in the testing process andmay go undetected until you receive your next EQA report. You mayidentify a problem when you receive your EQA report but when didthe issue occur? 1 day ago, 1 week ago or just after your last EQAsample was tested?A well maintained internal quality control programme supplementedwith a peer group reporting scheme like Randox Acusera 24•7, isnecessary to establish and maintain reliability, precision and accuracy.In addition to this, participation in a peer group reporting scheme mayalso improve EQA/PT performance, as your results are more likely tocompare well to other laboratories participating in the same scheme.You can have more confidence in the results you submit to yourEQA/PT provider.Help meet regulatory requirementsLaboratory managers are under increasing pressure to closelymonitor laboratory test results and assure their quality due to growingdemands from higher authorities for national andinternational accreditation.“The laboratoryshall participatein interlaboratorycomparisons...”-ISO 15189:2003(E), Subclause 5.6.4.76


Software OverviewThe Randox 24•7 software is easy, flexible and convenient to use.• Open system allows users to add parameters, methods, instruments,reagents and units, for non peer group review.• Simple navigation through the use of fast keys and tabs providing theuser ease of access to all functions.• Data can be entered quickly and easily by one of three options:- Individual test- User Defined Panel- Automatically via extracted files from instrument,middleware or LIMS• Data input error messages alert the user to possible transcriptionerrors ensuring confidence in results.• Multilingual software with 11 languages to choose from.• Data can be viewed for up to 3 different lots of serum at once.Peer group data will be provided for the lifetime of the serum lot.• Date changing facility allows retrospective data to be entered quicklyand easily. This allows the lab manager to enter data for weekendQC runs on a Monday morning and input the actual dates the serawere run.• Exclude or include data according to user defined performancemulti-rules.• Pre-defined options for parameters, methods, instruments, reagentsand units during configuration.• Rapidly upload results and download peer group data anytime at thetouch of a button.• Multi level passwords ensure confidentiality and enable managementto control system settings whilst providing access for laboratorypersonnel to enter data.• Improved network management allows several computers in thesame laboratory to run the same programme.Detailed ReportsThe Randox Acusera 24•ß7 software automatically calculatesstatistical data, including the mean and standard deviation. Data ispresented in easy to read charts, allowing any sudden or gradualchanges in performance to be identified immediately. Data can bedisplayed and viewed in 5 different ways, allowing performance to beassessed at a glance.14On screen summary of resultsThe on screen summary of results report provides a quick overview ofcurrent analytical performance.It enables the comparison of results with user defined fixed mean andstandard deviation values. The laboratory can set fixed values basedon peer group statistics or other values such as the target and rangequoted for the particular lot in use. Data can be viewed for up tothree lots of control sera.Levey-Jennings chartsIdentify trends, biases and precision problems at a glance using theLevey-Jennings reportTwo Levey-Jennings charts are available, one is based on the standarddeviation and the other is based on percentage deviation. Rejectedor alarmed results based on user defined performance multi-rules arehighlighted in red, allowing any performance issues to be identifiedat a glance. Data is displayed for up to 90 days, however historicaldata can be viewed if necessary by scrolling through historicalLevey-Jennings charts.Results may be compared to user defined acceptable limits ofperformance or against pre-set acceptable limits, which can be userdefined or based on Biological Variation or governments requirementssuch as CLIA.77


HistogramThe histogram displays your monthly mean for each parameter over aperiod of 12 months, allowing any long term trends to be identified andcorrected as soon as possible.The histogram report is extremely useful in identifying both shifts andtrends in your monthly results.Performance summary chartsPerformance summary charts allow cumulative or monthly data to becompared to a peer group based on world or affiliate group statistics.14The performance summary report highlights potential bias andimprecision issues. Laboratory performance versus chosen peergroup and method peer group is plotted. Your cumulative or monthlyresults can be compared to world or affiliate group statistics, enablingenhanced troubleshooting capabilities.Affiliate Group Performance SummaryGroup co-ordinators can view the performance of others in theirgroup of affiliate laboratories.Powerful drill-down function allows group co-ordinators to monitorperformance of their affiliate laboratoriesDrill into the method statistics to reveal performance of individualaffiliate laboratoriesTo start your 60 day free trial request a 24-7 software CD from your Randox representative orvisit www.randox.com/24778


Customised <strong>Quality</strong><strong>Control</strong> SeraChapter 1515


Customised qualitycontrol seraCustomised <strong>Quality</strong> <strong>Control</strong> Sera15For nearlly 30 years, laboratories, EQA scheme organisers andother diagnostic companies have looked to Randox to provide theirQC needs. Randox Laboratories manufactures a full portfolio ofquality controls, calibrators and standards for over 300 parameters.In addition to ‘off the shelf’ quality control products, Randox isthe world’s leading provider of customised control materials.Customising control materials can involve adding analytes, removingunused parameters, specifying analyte concentrations or choosingalterative vial sizes.Our principal control products are;• Antioxidants• Cardiac• Clinical Chemistry• Coagulation• Diabetes• Immunoassay• Immunology and Specific Proteins• Lipids• Tumour Markers• Therapeutic Drugs and Toxicolgy• Urine tests.• Specialist and Research controls such as Cytokines, GrowthPromoters, Antimicrobial, Cerebral and a variety of single-analytecontrol products.We also produce custom sera for EQA schemes and specialisedcontrols for research projects.<strong>Quality</strong> is our focus during the manufacturing process. All controlproducts are produced to the same high specifications usingprocedures complying with ISO 13485 for medical devices. State ofthe art clinical chemistry and immunoassay analysers are used duringthe manufacturing and quality control processes.To enable us to identify and fulfil your needs, please discuss yourrequirements with your Randox representative. We are happy toconsider any requirements you may have. Randox has 30 yearsexperience in producing customised sera, and we will ensure youwill receive the specified product you want in a professional andtimely manner.CONSOLIDATIONRandox will significantly consolidate your existingcontrols. An average laboratory may rationalise from7 sera to a single control productTAILOR MADESpecify the analytes and levels you require. We canprovide the levels tailored to your cut off valuesSTABILITYRandox Sera are stable for up to 4 years, enablinguse of the same lot over an extended periodOPTIONSCustomised controls in different matricese.g. serum, urine, aqueousFLEXIBILITYBatch sizes manufactured between 50 – 250,000vials. Randox can provide a wide range of vial sizesfrom 1ml to 10mlQUALITYAll controls are produced to high qualityspecification, fully compliant with ISO 13485CHOICE3 different formats – lyophilised / liquid / liquid frozen80


Customised qualitycontrol seraCustomisedTimeline:QC order placed by youWeek 1You run blind sample andreturn results to RandoxRandox sends blindsample to youEnables Randox to view howthe material recovers on yourmachinesManufacture ofCustomised SampleSample is despatchedto youIf end sample does not meetspecifications, you are underno obligation to accept15Sample checked andapproved by youRandox generates labelsand packages kitRandox despatches and deliversfinal product to youWeek1681


Customised qualitycontrol seraexamples of Analytes available for Customised QC Sera15AntimicrobialsSulphachlorpyridazineSulphadiazineSulphadimethoxineSulphadoxineSulphaisoxazoleSulphamerazineSulphamethazineSulphamethizoleSulphamethoxypyridazineSulphapyridineSulphaquinoxalineSulphathiazoleAntioxidantSuperoxide DismutaseGlutathione PeroxidaseGlutathione ReductaseTotal Antioxidant StatusCardiacCK (Total)CK-MBCarbonic Anhydrase III (CAIII)Fatty Acid Binding Protein (FABP)Glycogen Phosphorylase BB (GPBB)MyoglobinHomocysteineTroponin ITroponin TCoagulationActivated Partial Thromboplastin Time (aPTT)Antithrombin IIID-DimerFactor IIFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIFibrinogenPlasminogenProtein CProtein SProthrombin Time (PT)Thrombin Time (TT)Cytokine & Growth FactorsEpidermal Growth Factor (EGF)E-SelectinIntercellular Adhesion Molecule 1 (ICAM-1)Interferon-gamma (IFN-γ)Interleukin-1 alpha (IL-1 α)Interleukin-1 beta (IL-1β)Interleukin-2 (IL-2)Interleukin-2 Receptor Alpha (IL-2R α)Interleukin-6 Soluble Receptor (IL-6SR)Interleukin-4 (IL-4)Interleukin-6 (IL-6)Interleukin-8 (IL-8)Interleukin-10 (IL-10)L-SelectinMonocyte Chemotactic Protein-1 (MCP-1)Matrix Metalloproteinase 9 (MMP-9)P-SelectinSoluble Tumour Necrosis Factor Receptor-1 (sTNFRI)Soluble Tumour Necrosis Factor Receptor-2 (sTNFR2)Tumour Necrosis Factor-alpha (TNF-α)Vascular Cell Adhesion Molecule 1 (VCAM-1)Vascular Endothelial Growth Factor (VEGF)DiabeticFructosamineHbA1cDrugs of AbuseAmphetamineBarbituratesBenzodiazepineCannabinoidsCocaineEthanolMethadoneMethamphetamineOpiatesPhencyclidineDrugs (Therapeutic)Acetaminophen (Paracetamol)AmikacinCarbamazepineCyclosporineDigoxinEthosuximideGentamicinLithiumMethotrexateNetilmicinPhenobarbitalPhenytoinPrimidoneTheophyllineTobramycinValproic AcidVancomycinGrowth Promoterβ-AgonistsBoldenoneCorticosteroidsNandroloneRactopamineStilbenesStanozololTrenboloneZeranolImmunoassayACTHAFPAldosteroneAndrostenedioneCEAFSH17-OH – Progesteroneβ-2-MicroglobulinCA 125CA 15-3CA 19-9CA 72-4C PeptidesCyfra 21-1CortisolDHEA-SulphateEstriolFolateFSHGrowth HormonehCG25-Hydroxy Vitamin DIGF-1PAPP- AInhibin AInsulinNeuron Specific EnolaseOestradiolPhenytoinProgesteroneProlactinPTHReninSHBGSyphilis RPR / VDRLTBGT 3(Free)T 3(Total)T 4(Free)T 4(Total)TestosteroneTestosterone (Free)ThyroglobulinTPOAnti-TPOAnti-TGTSHVitamin B12Vitamin DLipidsApolipoprotein A-IApolipoprotein A-IIApolipoprotein BApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein ECholesterolCholesterol (HDL)Cholesterol (LDL)Lipids (Total)Lipoprotein (a)NEFAPhospholipidsTriglyceridesRoutine ChemistryAlbuminAcid Phosphatase (Total)Acid Phosphatase (Prostatic)AldolaseALT (SGPT)Alkaline PhosphataseAmmoniaAmylaseAmylase (Pancreatic)AST (SGOT)BicarbonateBile AcidsBilirubin (Direct)Bilirubin (Total)CalciumChlorideCholinesteraseCopperCreatinineD-3-HydroxybutyrateEthanolG-6-PDHGGTGLDHGlucoseHBDHIron (TIBC)LactateLAPLDHLipaseMagnesiumOsmolalityPhosphorusPotassiumPSAPSA (Free)Salicylic AcidSodiumUreaUric AcidZincProteinsAlpha-1-Acid Glycoprotein (AAG)Alpha-1-Antitrypsin (AAT)Alpha-2-MacroglobulinAntistreptolysin OCaeruloplasminComplement C 3Complement C 4CRPhsCRPFerritinHaptoglobinIgAIgEIgGIgMKappa Light ChainLambda Light ChainPrealbuminProtein (Total)RBP (Retinol Binding Protein)Rheumatoid FactorTransferrinUrineCalciumChlorideCopperCortisolCreatinineEpinephrineGlucose5-H1AAMagnesiumMetanephrineMicroalbuminNorepinephrineNormetanephrineOsmolalityPhosphorousPotassiumTotal ProteinSodiumUreaUric AcidVMA (Vanillylmandelic Acid)This list is not exhaustive. If the analyte you require is not present, please contact your Randox representative82


RIQASRandox International <strong>Quality</strong>Assessment SchemeChapter 1615 16


RIQASRandox International <strong>Quality</strong> Assessment Scheme (RIQAS)RIQAS is the largest international EQA scheme in the world, used by more than 20000 laboratories in over 90 countries worldwide. This largenumber of participants makes RIQAS the best quality EQA scheme in the world and ensures an extensive database of results for many analyticalmethods directly increasing statistical validity as a result.RIQAS REPORTS• Statistical breakdown by all methods, your method and your instrument, including running means for the last 10 samples.• Compare your instrument group, method group and all methods using the histogram.• Identify trends, biases and precision problems using the Levey-Jennings chart.• The Target Score Chart grades your performance in a moving window over the last 20 samples, including the previous cycle .• At-a-glance summary page for all analytes in the programme.Standard ReportThe unique target scoring system was developed to provide a simple interpretation of your laboratory’s performance. The system will presentthe 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 multiinstrumentreport are provided. The multi-instrument report allows the comparative performance of each instrument.Standard Report16Text Sectionfor all Methods,your methodand instrumentgroup(programmespecific)Levey-JenningsChartDetailingfeatures of yourlaboratory’sperformanceTarget ScoreThis uniquechart providesa numericalindex ofperformanceallowing ata glanceassessmentHistogramMethod andinstrumentcomparison% deviation bysample displayedin relation toperformancelimits84Breakdown of othermethod statistics% deviationby sampleconcentrationThs allows easyassessment ofconcentrationrelated bias


RIQASUrine Toxicology ReportYour Result Your ResultUrine Toxicology ReportBased on weighed-in value ofBased on weighed-in value ofand your chosen cut-off value of and your chosen cut-off value ofthe correct response wasthe correct response wasFalse PositiveFalse PositiveFalse NegativeFalse Negative Your Your Result Based on on weighed-in value of of and and your your chosen cut-off value of of the the correct response was was False False Positive SCREENINGCut-off TN TP FN FP RC NT TotalFalse False Negative Cut-off TN TP FN FP RC NT Total Your Result 0 0 Your 0 0 Result QUANTITATIVE Cut-off TNTP FN FP RC RC NT Total TN TP FN NT 0 0 Your Your Result 0 0 Performance HistoryPerformance HistoryUrinalysis Report % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Negatives % False Positives % False Positives % False Positives % False Positives % False Positives % False Positives % False Positives % False Positives % False Positives % False Positives % Correct Responses % Correct Responses % Correct Responses % Correct Responses % Correct Responses Performance % Correct History Responses % Correct Responses % Correct Responses % Correct Responses % Correct Responses % % False False Negatives % % False False Negatives % % False False Negatives % % False False Positives % % False False Positives % % False False PositivesAbbreviations % % Correct Responses TN True Negative % % Correct Responses FN False Negative % % Correct Responses RCFNAbbreviations TN True NegativeFalse NegativeTP True Positive FP False Positive NTTP True Positive FP False Positive% % False False Negatives % % False False PositivesReferred % % for Correct ConfirmationResponses RC Referred for ConfirmationNot TestedNT Not TestedAbbreviations TN TN True True Negative FN FNFalse Negative RC RCReferred for for ConfirmationTP TP True True Positive FP FPFalse Positive NT NT Not Not Tested% False % False % RIQAS RIQAS % False Negatives % False Positives % Correct ResponsesRIQAS15 16Urinalysis ReportScreening ResultsYour method group and categoriesResults from all methods (dipsticks)able to return results in the samecategories as your labCategories stated in your unit All categories (result options)available for this parameterfor any method (dipstick)Your categories (availableresult options for your chosendipstick and unit)Results from all methods for allavailable categoriesYour ResultComments BoxPerformance StatementYour CategoriesHistogram:A quick visualisation of how yourlab’s result falls into the overallpicture for your categoriesPossible reporting categoriesfor your methodAll available methods forthis parameterNumber of Laboratories9080706050403020100 9080706050403020100 Number of LaboratoriesYour ResultAll Categories Histograma quick visualisation of how yourlab’s result falls into the overallpicture for all categoriesResults submitted from acategory not applicable to yourmethodYour categoriesDETAILED SUMMARY OFRESULTSThis table enables you to seehow you compare to all otherresults85


RIQASBLOOD GAS PROGRAMME + With target scoringRQ9134First registered instument10 ParametersRQ9134/a*Subsequent instrument10 ParametersSamples every month, 1 x 12 monthly cycle, 12 months subscription* Note to participants with multiple instruments on the Blood Gas Programme:RQ9134 must be purchased for the first registered instrument and individualRQ9134/a kits for every subsequently registered instrument.pCO2pHpO2tCO2Ca++Cl-K+Na+GlucoseLactateCARDIAC PROGRAMME With target scoringRQ9127/aRQ9127/b2 Parameters only (choose from 7)Full 7 ParametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscriptionCK, TotalCK-MB ActivityCK-MB MassHomocysteineMyoglobinTroponin ITroponin TCOAGULATION PROGRAMME + With target scoringRQ9135/a5 selected Parameters only (aPTT,PT, TT, Fibrinogen, Antithrombin III)aPTTPT (including INR)TTFibrinogenRQ9135/bFull 16 ParametersSamples every month, 1 x 12 monthly cycle, 12 month subscriptionAntithrombin IIIPlasminogenProtein CProtein SFactor IIFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIGENERAL CLINICAL CHEMISTRY PROGRAMMES With target scoringRQ911210 Parameters onlyRQ9112/S17 Parameters onlySamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Reference Method ValuesRQ9113Full 50 Parameters16Acid phosphatase, (prostatic)Acid phosphatase (total)AlbuminAlkaline phosphataseALT (ALAT)Amylase, pancreaticAmylase, totalAST (ASAT)BicarbonateBile acidsBilirubin, directBilirubin, totalCalciumCalcium, ionisedChlorideCholesterolCholinesterase*CK, total (CPK)CopperCreatinineD-3-hydroxybutyrateFructosamine*Gamma GTGLDHGlucoseHBDHHDL-CholesterolIronLactate*LD (LDH)LipaseLithiumMagnesiumNEFA*OsmolalityPhosphate, inorganicPotassiumProtein, totalPSASodiumTIBCFree T3Total T3Free T4Total T4TriglyceridesTSHUreaUric acidZincGLYCATED HAEMOGLOBIN (HbA1c) PROGRAMME - With target scoringRQ91292 ParametersSample every month, 1 x 12 month cycle, 12 month subscriptionHbA1cTotal Haemoglobin*HAEMATOLOGY PROGRAMME With target scoringRQ911812 ParametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscriptionHaematocrit (HCT)Haemoglobin (Hb)Mean Cell Haemoglobin (MCH)Mean Cell Haemoglobin Concentration (MCHC)Mean Cell Volume (MCV)Platelets (PLT)Red Blood Cell Count (RBC)Total White Blood Cell Count (WBC)Mean Platelet Volume*Packed Cell Volume*Plateletcrit*Red Cell distrvaition width*HUMAN URINE PROGRAMMERQ911524 ParametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscriptionAlbuminAmylaseCalciumChlorideCopperCortisolCreatinineDopamineEpinephrineGlucoseMetanephrineNorepinephrineNormetanephrineMagnesiumOsmolalityOxalatePhosphate, inorganicPotassiumProtein, totalSodiumUreaUric acidVMA5-HIAARED = Parameters with Reference Method ValuesPURPLE = The only parameters available on RQ9135/a + = Programmes awaiting accreditation To ILAC G13: 2007/ ISO/IEC 17043* = Pilot study ongoing86


RIQASIMMUNOASSAY PROGRAMMES With target scoringRQ9125/a4 Parameters only(choose from 55)RQ9125/b13 Parameters only (choose from 55)RQ9125/cFull 55 ParametersRQ9130Full 55 Parameters2 x 6 monthly cycles (RQ9125/a, RQ9125/b, RQ9125/c) , 12 month subscription1 x 12 month cycle (RQ9130), 12 month subscriptionACTH*AFPAldosterone*Amikacin*Androstenedione*Beta-2-microglobulinCA125CA15-3CA19-9CarbamazepineCEACortisolC-peptide*DHEA-SDHEA UnconjugatedDigoxinEstriol Total*Ethosuximide*FerritinFolateFSHGentamicin*GHhCGIgEInsulinLHOestradiol17-OH-progesteroneParacetamol*PhenytoinPrimidone*ProgesteroneProlactinFree PSATotal PSAPhenobarbital*PTHSalicylate*SHBGFree T3Total T3Free T4Total T4Testosterone free*Testosterone (total)TheophyllineThyroglobulinTobramycin*TSHValproic acidVancomycin*Vitamin B121-25-(OH)²-Vitamin D*25-OH-Vitamin D*IMMUNOASSAY SPECIALITY 1 PROGRAMME +RQ914110 parametersSamples every month, 1 x 12 monthly cycle, 12 month subscription1-25-(OH)2-Vitamin D25-OH-Vitamin DC-PeptideAnti-TGAnti-TPOIGF-1OsteocalcinProcalcitoninPTHInsulinIMMUNOASSAY SPECIALITY 2 PROGRAMME +RQ91425 parametersSamples every month, 1 x 12 monthly cycle, 12 month subscriptionCalcitoninGastrinProcalcitoninPlasma renin activityRenin, direct concentration15 16LIPID PROGRAMME With target scoringRQ9126/a3 Parameters only (choose from 7)Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscriptionRQ9126/bFull 7 Parameters, samples every 2 weeksApolipoprotein A1Apolipoprotein BCholesterol, totalHDL-cholesterolLDL-cholesterolLipoprotein (a)*TriglyceridesLIQUID CARDIAC PROGRAMME + With target scoringRQ913610 ParametersSamples every month, 1 x 12 month cycle, 12 month subscriptionBNPCK-MB MassD-Dimer*DigoxinHomocysteinehsCRPMyoglobinNT proBNPTroponin ITroponin TMATERNAL SCREENING PROGRAMME + With target scoringRQ91376 ParametersSamples every month, 1 x 12 month cycle, 12 month subscriptionAFPfree Beta hCGtotal hCGInhibin APAPP-AUnconjugated OestriolSEROLOGY (EBV) PROGRAMME +RQ9153To become routinely available in 20122 parametersQuarterly Reporting, quantitative and qualitative results, 1 x 12 month cycle, 12 month subscriptionAnti-EBV VCA IgGAnti-EBNA IgG87


RIQASSEROLOGY (HIV-HEPATITIS) PROGRAMME +RQ9151To become routinely available in 201210 parametersQuarterly reporting, qualitative results only, 1 x 12 month cycle, 12 month subscriptionAnti-HIV-1Anti-HIV-2Anti-HIV-1&2 CombiAnti-HCVAnti-HBcHBsAgAnti-HTLV-IAnti-HTLV-IIAnti-HTLV-1&2 CombiAnti-CMVSEROLOGY (SYPHILIS) PROGRAMME +RQ9154To become routinely available in 20121 parameterQuarterly Reporting, quantitative and qualitative results, 1 x 12 month cycle, 12 month subscriptionSyphilis (Methods available include RPR, VDRL and TPHA)SEROLOGY (ToRCH) PROGRAMME +RQ9152To become routinely available in 201212 parametersQuarterly Reporting, quantitative and qualitative results, 1 x 12 month cycle, 12 month subscriptionAnti-Toxoplasma IgGAnti-Toxoplasma IgMAnti-Rubella IgGAnti-Rubella IgMAnti-CMV IgGAnti-CMV IgMAnti-HSV1 IgGAnti-HSV1 IgMAnti-HSV2 IgGAnti-HSV2 IgMAnti-HSV-1&2 IgG CombiAnti-HSV-1&2 IgM CombiSPECIFIC PROTEINS PROGRAMME With target scoringRQ911426 parameters,Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription16AFPAlbuminAlpha-1-acid glycoproteinAlpha-1-antitrypsinAlpha-2-macroglobulinAnti Streptolysin OAntithrombin IIIBeta-2-microglobulinClaeruloplasminComplement, C3Complement, C4C-Reactive ProteinFerritinHaptoglobinImmunoglobulin AImmunoglobulin EImmunoglobulin GImmunoglobulin MFree Kappa Light ChainTotal Kappa Light ChainFree Lambda Light ChainTotal Lambda Light ChainPrealbumin (Transthyretin)Retinol Binding ProteinRheumatoid FactorTransferrinTHERAPEUTIC DRUGS PROGRAMME With target scoringRQ911118 parametersSamples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Weighed-in valuesAmikacinCaffeineCarbamazepineCyclosporineDigoxinEthosuximideGentamicinLithiumMethotrexateParacetamolPhenobarbitonePhenytoinPrimidoneSalicylic acidTheophyllineTobramycinValproic acidVancomycinURINALYSIS PROGRAMME+RQ913817 ParametersSamples every 2 months 1 x 12 month cycle, 12 month subscriptionAlbuminBilirubinBloodCreatinineGalactoseGlucosehCGKetonesLeukocytesNitritepHProteinSpecific GravityUrobilinogenRed Blood Cells*White Blood Cells*Crystals*URINE TOXICOLOGY PROGRAMME+RQ913920 ParametersSamples every month, 1 x 12 month cycle, 12 month subscriptionBenzoylecgonineBuprenorphineCannabinoids (THC)CreatinineCotinined-Amphetamined-MethamphetamineEDDPEthanolFree MorphineLorazepamLSDMDMAMethadoneNortriptylineNorpropoxypheneOxazepamPhencyclidinePhenobarbitalSecobarbitol88


RIQASFeatures and Benefits• RIQAS systems and procedures are recognised and accreditedto a number of internationally recognised standards includingISO 13485:2003, UKAS, ILAC-G13:2007, NQAAP and JWGQA. (ILAC-G13:2007 will be replaced by ISO/IEC17063 in2012)• Human samples free from interfering preservatives increaseconfidence that EQA performance mirrors performance ofpatient samples• A wide range of parameters are available covering a widespectrum of laboratory tests allowing for effective consolidationof existing EQA programmes.• User friendly reports provide a statistical breakdown of resultsby method and instrument, allowing analytical performance tobe assessed at a glance. Levey Jennings and histogram chartsidentify trends, biases and precision problems while the uniqueTarget Scoring chart grades performance in a moving windowfor the last 20 samples.RIQAS results can be submitted usingone of the following methods:• Web-based data transfer (www.RIQAS.net) – RIQASNet is aninternet based data entry system allowing participants to returnresults and view reports online. Participants can submit current,corrected, late and future results, directly into the RIQAS databaseeliminating the need to fax or email EQA results. Reports are thenemailed directly to participants in pdf format when available. Currentand previous reports are also available to download directly fromthe internet.• Results can also be submitted by post or by fax• PDF Reporting is also available for all participants - RIQAS reportscan now be presented in pdf (portable document format), offeringeasy review and storage of your laboratory’s EQA data. Thereare many advantages associated with pdf reporting, increasing theusability and efficiency of data analysis.• Regular reports with rapid turnaround times ensure correctiveactions can be taken as soon as possible. Reports returned in2 - 3 days.• Reduced analyte options for selected programmes offer greaterflexibility, ensuring suitability for laboratories of all sizes andbudgets15 16• Participant certificates provide evidence of participation in areputable EQA scheme• Laboratories can register up to five instruments for eachparameter at no extra cost. Individual reports for eachinstrument plus a unique multi-instrument report are provided.The multi-instrument report allows comparative performanceof each instrument.• Inter-laboratory group reports allow comparison of multipleconnected laboratories at no extra cost• RIQAS support staff are on hand to offer advice andtroubleshoot technical queries89


RIQAS1690


Analyte IndexChapter 1717


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP Liquid# 17-OH-progesterone x x xA17b Clostebol5-HIAAAADAcid phosphatase, prostatic x x x x x x x xAcid phosphatase, total x x x x x x x xBeta-AgonistsACTH x xAHDAldosterone x x xAlphafetoprotein (AFP) x x x x x x x x x xAlpha-1-Antitrypsin x x x xAlpha-1-Acid Glycoprotein x x x xAlpha-HBDH x x x x x x xAlanine aminotransferase (ALT) x x x x x x x xAlbumin x x x x x x x x x xAldolasexAlkaline phosphatase (ALP) x x x x x x x xAlpha-1-globulin x x x x xAlpha-2-globulin x x x x x17Amikacin x x x xAmmonia x xAMOZAmphetamineAmylase x x x x x x x xBAmylase, pancreatic x x x x x xAmylase, totalAnti-thrombin III x xAnti-thyroglobulin (Anti-TG)xAnti-thyroperoxidase (Anti-TPO)xAOZaPTTxApolipoprotein AI x x x xApolipoprotein AIIApolipoprotein B x x x xApolipoprotein C IIIApolipoprotein CIIApolipoprotein EASOxAspartate Aminotransferase (AST) x x x x x x x xBeta-AgonistsBarbiturates groupBenzodiazepines groupBenzoylecgonineBeta-1-globulin x x x x xBeta-2-Microglobulin x x x x x x xBicarbonate x x x x x x x xBile acids x x x x x x xBilirubin, direct x x x x x x x x xBilirubin, total x x x x x x x x x92


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sx 17-OH-progesterone #x 17b Clostebolx5-HIAAAADAcid phosphatase, prostaticAcid phosphatase, totalBeta-AgonistsACTHxAHDAldosteroneAlphafetoprotein (AFP)xAlpha-1-AntitrypsinxAlpha-1-Acid GlycoproteinAlpha-HBDHAlanine aminotransferase (ALT)x x AlbuminAldolaseAlkaline phosphatase (ALP)Alpha-1-globulinAlpha-2-globulinxAmikacinAmmoniaxAMOZxAmphetaminexAmylaseAmylase, pancreaticAmylase, totalAnti-thrombin IIIAnti-thyroglobulin (Anti-TG)Anti-thyroperoxidase (Anti-TPO)xAOZaPTTx x Apolipoprotein AIxApolipoprotein AIIx x Apolipoprotein BxApolipoprotein C IIIxApolipoprotein CIIxApolipoprotein Ex x ASOAspartate aminotransferase (AST)A17x Beta-Agonists Bx x Barbiturates groupx x Benzodiazepines groupxxxBenzoylecgonineBeta-1-globulinBeta-2-MicroglobulinBicarbonateBile acidsBilirubin, directBilirubin, total93


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidB BloodBoldenoneBNPxBrain Derived Neurotropic Factor (BDNF)BuprenorphineC Cholesterol x x x x x x x xCK, Total x x x x x x x xCK-MBxCA72-4 x xCA125 x x xCA15-3 x x xCA19-9 x x xCeruloplasmin x x x xCaffeinexCalcitonin x xCalcium x x x x x x x x x17Calcium (Ionised) x xCannabinoids groupCarbamazepine x x x x x xCarbonic Anhydrase III (CA III)Carcinoembryonic Antigen (CEA) x x x x x x xCeftiofurChloramphenicolChloride x x x x x x x x x xCholinesterase x x x x x xCK, TotalxCocaine group: BenzoylecgonineCopper x x x x x x xCorticosteroidsCortisol x x x x x x x x xComplement C3 x x x xComplement C4 x x x xC-Peptide x x xC-Reactive Protein (CRP) x x x x xCreatine Kinase MB (CK-MB) x x xCreatinine x x x x x x x xCyclosporineCystatin CCyfra 21 x xD D-3-hydroxybutyrate x x x x x x xD-DimerxDHEA-Sulphate x x x xDigoxin x x x x x x x xEDopamineEcstasyEDDPElectrophoresisEpidermal Growth Factor (EGF)EpinephrineE-SelectinEstradiol94


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sx Blood BxBoldenoneBNPxBrain Derived Neurotropic Factor (BDNF)xBuprenorphinex Cholesterol CCK, TotalCK-MBCA72-4CA125CA15-3CA19-9CaeruloplasminxCaffeineCalcitoninx x x CalciumCalcium (Ionised)x x x Cannabinoids groupxCarbamazepinexCarbonic Anhydrase III (CA III)Carcinoembryonic Antigen (CEA)xxCeftiofurChloramphenicol17x x x ChlorideCholinesteraseCK, Totalx x Cocaine group: BenzoylecgoninexCopperxCorticosteroidsx x x CortisolxComplement C3xComplement C4xC-Peptidex x C-Reactive Protein (CRP)x x x Creatine Kinase MB (CK-MB)x x x x CreatininexCyclosporinexCystatin CCyfra 21D-3-hydroxybutyrateDxD-DimerxDHEA-SulphatexDigoxinxDopaminex Ecstasy ExEDDPElectrophoresisxEpidermal Growth Factor (EGF)xEpinephrinexE-SelectinEstradiol95


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidE Estriol x x xEthanol x x xEthinylestradiolEthosuximide x x xF Factor II xFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIFatty Acid Binding Protein (FABP)FentanylxxxxxxxFerritin x x x x x x x x xFibrinogenxFolate x x x x x x xFollicle Stimulating Hormone (FSH) x x x xFree Prostate Specific Antigen (fPSA) x xFree thyroxine (FT4) x x x x x x x x x17Free tri-iodothyronine (FT3) x x x x x xFructosaminexG G-6-PDH xGentamicin x x x x x x xGestagens (generic)Gamma-Globulin x x x x xGamma GT x x x x x x x xGastrinxGH x x x xGLDH x x x x x x xGlial Fibrillary Acidic Protein (GFAP)Glucose x x x x x x x x x xGlutamatexGlutamineGlutathione Peroxidase (RANSEL)xGlutathione Reductase (GR)xGlycerolxGlycogen Phosphorylase BB (GPBB)GM-CSFH Haptoglobin x x x xHbA2HbA1c x xHbFHbSxxxhCG x x x x x x x x xhCG (Free beta)xHDL Cholesterol x xH-FABPxHomocysteine x xhsCRPxI IgA x x x x x xIgE x x x x x x x96


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sEstriolx x Ethanolx EthinylestradiolxEthosuximideFactor IIFactor VFactor VIIFactor VIIIFactor IXFactor XFactor XIFactor XIIx x x x Fatty Acid Binding Protein (FABP)xFentanylx x FerritinFibrinogenFolateFollicle Stimulating Hormone (FSH)Free Prostate Specific Antigen (fPSA)Free thyroxine (FT4)Free tri-iodothyronine (FT3)FructosamineG-6-PDHxGentamicinx Gestagens (generic)Gamma-GlobulinGamma GTGastrinGHGLDHxGlial Fibrillary Acidic Protein (GFAP)x x x x GlucoseGlutamatexGlutamineGlutathione Peroxidase (RANSEL)Glutathione Reductase (GR)GlycerolxGlycogen Phosphorylase BB (GPBB)xGM-CSFEFGG17x Haptoglobin HHbA2HbA1cHbFHbSx x hCGhCG (Free beta)x x HDL CholesterolH-FABPHomocysteinehsCRPx x x IgA IxIgE97


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>s17Clinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidI IgG x x x x x x xIgM x x x x x xInhibin AxInsulin x x x xInsulin Growth FactorxIntercellular Adhesion Molecule-1 (ICAM-1)Interferon-gamma (IFN-y)Interleukin-1 alpha (IL-1a)Interleukin-1 beta (IL-1b)Interleukin-10 (IL-10)Interleukin-12p70 (IL-12 p70)Interleukin-13 (IL-13)Interleukin-15 (IL-15)Interleukin-2 (IL-2)Interleukin-23 (IL-23)Interleukin-3 (IL-3)Interleukin-4 (IL-4)Interleukin-5 (IL-5)Interleukin-6 (IL-6)Interleukin-7 (IL-7)Interleukin-8 (IL-8)Iron x x x x x x x xK Kappa Light Chain xKappa Light Chain (free)xKetamineKetonesL Lambda Light Chain xLambda Light Chain (free)xLactate x x x x x x x x xLAP x x x x xLD x x x x x x xLeptinLDL Cholesterol x x xLeukocytesLuteinising Hormone (LH) x x x xLipase x x x x x x x xLipoprotein (a) x xLithium x x x x x x x xLorazepamL-SelectinLysergic Acid Diethylamide (LSD)MAlpha-2-MacroglobulinMIP-1aMagnesium x x x x x x x xMatrix Metalloproteinase-9 (MMP-9)MDMAMedroxyprogesteron AcetateMetanephrineMethadoneMethandriolMethamphetamineMethaqualone98


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sx x x x IgG Ix x x IgMInhibin Ax InsulinInsulin Growth FactorxIntercellular Adhesion Molecule-1 (ICAM-1)xInterferon-gamma (IFN-y)x x Interleukin-1 alpha (IL-1a)xInterleukin-1 beta (IL-1b)xInterleukin-10 (IL-10)x Interleukin-12p70 (IL-12 p70)xInterleukin-13 (IL-13)xInterleukin-15 (IL-15)xInterleukin-2 (IL-2)xInterleukin-23 (IL-23)xInterleukin-3 (IL-3)xInterleukin-4 (IL-4)xInterleukin-5 (IL-5)x x x Interleukin-6 (IL-6)xInterleukin-7 (IL-7)xInterleukin-8 (IL-8)IronKappa Light ChainKKappa Light Chain (free)xKetaminexKetonesLambda Light ChainLLambda Light Chain (free)LactateLAPLDx x Leptinx x LDL CholesterolxLeukocytesLuteinising Hormone (LH)Lipasex x Lipoprotein (a)xLithiumLorazepamxL-Selectinx x Lysergic Acid Diethylamide (LSD)Alpha-2-MacroglobulinMMIP-1ax x x MagnesiumxMatrix Metalloproteinase-9 (MMP-9)xMDMAx Medroxyprogesteron AcetatexMetanephrinex x x Methadonex MethandriolxMethamphetaminexMethaqualone1799


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidM MethotrexateMethyltestosteroneMicroalbuminMyoglobin x x x x x xMCP-1N NandroloneNEFA x x xNeuron-Specific Enolase (NSE) x xNGALNitriteNorepinephrineNormetanephrineNT-proBNPxO Oestradiol x x xOpiates groupOsmolality x x x x x x xOsteocalcinxOxalateOxazepamOxycodoneP Paracetamol x x x x x x x17PAPP-AParathyroid HormonexxPCO 2xpHxPhencyclidinePhenobarbitone x x x x xPhenytoin x x x x x xPhosphate x x x x x x x xPhospholipidsPhosphorousPlasminogenxPlasminogen Activator InhibitorPO 2xPotassium x x x x x x x x xPrealbumin x x x xPrimidone x x xProcalcitonin x xProgesterone x x x xProlactin x x x x x xPropoxyphene groupProteinProtein CxProtein SxProtein, total x x x x x x x x x xPSA x x x x x x x x x x xP-SelectinPTxPTH x xQQuinolonesRRactopamineReninxResistin100Retinol Binding Protein (RBP)x


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sx Methotrexate Mx Methyltestosteronex x x Microalbuminx x x MyoglobinxMCP-1x Nandrolone NNEFAxNeuron-Specific Enolase (NSE)xNGALxNitriteNorepinephrinexNormetanephrineNT-proBNPOestradiolOx x Opiates groupx x x OsmolalityOsteocalcinxOxalatex x OxazepamxOxycodonexParacetamolPAPP-AParathyroid Hormone17PCO 2x x pHx x PhencyclidinexPhenobarbitonexPhenytoinxPhosphatePhospholipidsx x PhosphorousPlasminogenxPlasminogen Activator InhibitorxxPO 2x x x PotassiumPrealbuminPrimidoneProcalcitoninProgesteroneProlactinx x Propoxyphene groupxProteinProtein CProtein Sx x x Protein, totalPSAxP-SelectinPTPTHx Quinolones Qx Ractopamine RxReninResistinRetinol Binding Protein (RBP)101


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidR Rheumatoid Factor (RF) xSSalicylic acid x x x x x x xSecoborbitalSEMSex Hormone Binding Globulin (SHBG) x x xsLDLSodium x x x x x x x x x xSoluble IL-2 Receptor Alpha (sIL-2Ra)Soluble IL-6 Receptor (sIL-6R)Specific GravitysTNFRIsTNFRIIStanozololStilbenesStreptomycin/DihydrostreptomycinSulphachlorpyridazineSulphadiazineSulphadimethoxineSulphadoxineSulphamerazineSulphamethazine17SulphamethizoleSulphamethoxypyridazineSulphamethoxazoleSulphapyridineSulphaquinoxalineSulphathiazoleSulphisoxazoleSulphamonomethoxineTSuperoxide Dismutase (RANSOD)xTCATestosterone x x x xTestosterone (Free) x x xTetracyclinesTheophylline x x x x x x xThiamphenicol/FlorfenicolThrombomodulin (TM)Thyroglobulin x x x xTIBC x x x x x x x xTobramycin x x xTotal LipidsXTotal Antioxidant Status (TAS)XTotal Prostate Specific Antigen (tPSA)Total Thyroxine (TT 4) X X X X X X X X XTotal Tri-iodothyronine (TT 3) X X X X X X X X XTransferrin X X X X X XTrenboloneTriglycerides X X X X X X X XTrimethoprimTroponin I X X X X XTroponin T X X X XHigh Sensitivity Troponin TXTSH X X X X X102Thrombin Time (TT)XT-Uptake X X X X


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgGRheumatoid Factor(For samples that do notrequire predilution)Specific Protein Calibrator(For samples that dorequire predilution)Specific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sx Rheumatoid Factor (RF) Rxx Salicylic acid SxSecoborbitalxSEMSex Hormone Binding Globulin (SHBG)sLDLx x x SodiumxSoluble IL-2 Receptor Alpha (sIL-2Ra)x x Soluble IL-6 Receptor (sIL-6R)x x x x Specific GravityxsTNFRIxsTNFRIIxStanozololxStilbenesxStreptomycin/DihydrostreptomycinxSulphachlorpyridazinexSulphadiazinexSulphadimethoxinexSulphadoxinexSulphamerazinexSulphamethazinexSulphamethizolexSulphamethoxypyridazinexSulphamethoxazole17xxxxXSulphapyridineSulphaquinoxalineSulphathiazoleSulphisoxazoleSulphamonomethoxineSuperoxide Dismutase (RANSOD)x TCA TTestosteroneTestosterone (Free)xTetracyclinesxTheophyllinexThiamphenicol/FlorfenicolxThrombomodulin (TM)ThyroglobulinTIBCxTobramycinTotal LipidsTotal Antioxidant Status (TAS)Total Prostate Specific Antigen (tPSA)X Total Thyroxine (TT 4)X Total Tri-iodothyronine (TT 3)X X TransferrinXTrenboloneXTriglyceridesXTrimethoprimX X X Troponin ITroponin THigh Sensitivity Troponin TXTSHThrombin Time (TT)T-Uptake103


Analyte IndexAntioxidant <strong>Control</strong>sBlood GasCardiac <strong>Control</strong>sClinical Chemistry <strong>Control</strong>sCoagulation <strong>Control</strong>sDiabetes <strong>Control</strong>sImmunoassay <strong>Control</strong>sGlutathione ReductaseRANSELRANSODTASBlood GasCardiacLiquid Cardiac <strong>Control</strong>High Sensitivity Troponin TCK-MBMyoglobin CalibratorH-FABP <strong>Control</strong>Chemistry PremiumLiquid Chemistry PremiumAssayed Chemistry Premium PlusLiquid Chemistry Premium PlusPrecision Chemistry Premium PlusBovine Chemistry (Assayed)Bovine Chemistry (Precision)Clinical Chemistry Calibrator <strong>Serum</strong>CSFAldolaseAmmonia/ EthanolBilirubin (Elevated)G-6-PDHGlycerolMulti <strong>Control</strong> & CalibratorCoagulationFructosamineHbA1cHbA1c Linearity Setb a a b - Thalassemia <strong>Control</strong>Immunoassay PremiumLiquid Immunoassay PremiumImmunoassay Premium PlusImmunoassay Speciality IImmunoassay Speciality IITumour Marker <strong>Control</strong>Liquid Tumor Marker <strong>Control</strong>Maternal ScreeningSpecific ProteinsCRP LiquidT Tumour Necrosis Factor beta (TNF-b)Tumour Necrosis Factor-alpha (TNF-a)Tylosin/TilmicosinU UIBC XUnconjugated OestriolXUrea X X X X X X X XUric acid X X X X X X X XUrobilinogenValproic acid V X X X X X XZVancomycin X X X X X XVanillyl Mandelic Acid (VMA)VCAM-1VEGFVitamin B12 X X X X X X XVitamin D1-25-(OH 2)-Vitamin D X X X25-OH-Vitamin D X X XVMAZeronalZinc X X X X X X X17104


Analyte IndexImmunology/ Protein <strong>Control</strong>sASO Calibratorb-2-Microglobulin CalibratorCystatin CImmunoglobulin CalibratorIgEIgG(For samples that do notrequire predilution)(For samples that dorequire predilution)Rheumatoid FactorSpecific Protein CalibratorSpecific Protein CalibratorLipidApolipoprotein <strong>Control</strong> & CalibratorHDL/ LDL Cholesterol CalibratorLipoprotein (a)sLDL <strong>Control</strong>TDM <strong>Control</strong>Urine ToxicologyBenzodiazepines <strong>Control</strong>Cannabinoid <strong>Control</strong>Ecstacy <strong>Control</strong>EDDP <strong>Control</strong>Ethanol Calibrator/<strong>Control</strong> SetMultidrug <strong>Control</strong>Assayed Urine ChemistryUnassayed Urine ChemistryLiquid Urine <strong>Control</strong>Liquid UrinalysisMicroalbuminAntimicrobialsGlutamineGrowth PromotersCellular Adhesion MoleculesCerebralCytokinesEvidence CardiacEvidence Cardiac PlusEvidence Multistat CardiacDrugs of AbuseEndocrineMetabolic Sydrome <strong>Control</strong>ThyroidSynthetic SteroidsLipid <strong>Control</strong>sTherapeutic Drug <strong>Control</strong>sToxicology <strong>Control</strong>sUrine <strong>Control</strong>sSpeciality & Research <strong>Control</strong>sX Tumour Necrosis Factor beta (TNF-b) TX X Tumour Necrosis Factor-alpha (TNF-a)XTylosin/TilmicosinUIBCUnconjugated OestriolX X X UreaX X X Uric acidXUrobilinogenUX Valproic acid VXVancomycinXVanillyl Mandelic Acid (VMA)XVCAM-1XVEGFVitamin B12Vitamin D1-25-(OH 2)-Vitamin D25-OH-Vitamin DVMAX Zeronal ZZinc17105


Cost SavingThe sample and reagent probes have long-life high precisionceramic pistons ensuring good precision and low maintenancecosts and low water requirements (less than 30 Litres/hour).Reduced Sample and Reagent VolumesThere is a minimum reaction volume of 120ul enablingmore tests/kit. The high precision sampling assembly allowsa minimum sample volume of 2ul, making the RX suzukaideal for paediatric analysis.User Friendly Interface SoftwareFamiliar Microsoft ® Windows ® based software issimple and easy to use, resulting in minimal training, andenhanced productivity. The real-time online help systemaids with the operation and troubleshooting on the system.Accurate ResultsIntelligent - bubble, liquid level, crash and clot detection.Water degassing technology ensures air is purged fromthe system ensuring accurate analysis and reliable results.Test MenuThe RX series has the largest test menu on themarket including general chemistries, Specific Proteins,Antioxidants, Drugs of Abuse and Therapeutic Drugsenabling a lab to consolidate all of their testing ontoone platform. Each assay goes through a comprehensivevalidation process to ensure optimum performance.Low MaintenanceThe RX suzuka’s high quality hardware requires minimalmaintenance thus reducing costs and laboratorydowntime ensuring quality performance of the system.106


Coagulation and clinical chemistry testsThere is no need for two separate analysers to run these tests.Widest test menu on the marketThe RX monza’s test menu includes general chemistries,specific proteins, electrolytes and antioxidants making itideal as a main analyser in small labs or as a backup analyserin larger labs.Low levels of maintenance requiredThe operator performs all maintenance, the daily maintenancetakes approximately 5 minutes and the operator will performthe yearly maintenance, reducing downtime and engineering costs.Advanced softwareThe RX monza is a semi-automated analyser that hasthe software functionality of an automated instrument,including levy-Jennings, calibration curves and patienthistory database. The software is password protected.Low-test volumeThe volumes required to perform a patient test is muchlower than other systems in the market. This means thecustomer gets more test per kit reducing their costs.3-year warrantyDue to the high quality parts used in the manufactureof the RX monza Randox offers a 3 year warranty.107


Low water consumptionThe RX daytona and RX imola use 7.5 litres and 18 litres perhour respectively; this is considerably lower than competitoranalysers.Test MenuThe RX series has the largest test menu on themarket including general chemistries, Specific Proteins,Antioxidants, Drugs of Abuse and Therapeutic Drugs,enabling a lab to consolidate all of their testing ontoone platform. Each assay goes through a comprehensivevalidation process to ensure optimum performance.Low maintenanceMaintenance is low, increasing laboratory efficiency andreducing costs.SoftwareFamiliar Microsoft ® Windows ® based software is simpleand easy-to-use, resulting in minimal training and enhancedproductivity.ThroughputThe RX daytona and RX imola are fully automated,bench top clinical analysers capable of 180 and400 photometric tests per hour respectively.Cost SavingBoth the RX daytona and imola use reusable Pyrex cuvetteswhich are guaranteed to last up to 5 years reducing the costof consumables. Furthermore the universal sample carouselis designed to hold all standard sample cups and tubeseliminating the need to buy specific sample cups at extra cost.Optimum Laboratory efficiencyBoth systems will automatically calculate remaining reagentvolumes and the number of tests available alerting theuser to any shortages. Dedicated bar-coded reagents arealso available reducing time spent programming assays.108


RANDOX International HeadquartersRandox Laboratories Limited, 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYT +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E marketing@randox.comI www.randox.comRandox have sales and distribution agreements in over 130 countries. Australia, Brazil, China, Czech Republic, France, Germany,Hong Kong, India, Italy, Jamaica, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Africa, South Korea, Spain,Switzerland, USA and Vietnam are directly represented by Randox CompaniesAustraliaRandox (Australia) Pty Ltd.Suite 2/4 Charles Street,Paramatta, NSW 2150, Australia.Tel: +61 (0) 2 9615 4640Fax: +61 (0) 2 9615 4644BrazilRandox Brasil LtdaRua Fernandes Moreira, 415CEP: 04716-000 - São Paulo / SP - Brasil.Tel: +55 11 5181-2024Fax: +55 11 5181-0817ChinaRandox Laboratories Ltd.Shanghai Representative OfficeRoom 522-523, Fortune Times Tower, No.1438 North,Shanxi Road, Putuo District, Shanghai, China 20060Tel: +86 021 6288 6240Fax: +86 021 6288 6246Czech RepublicRandox S.R.O.BHM, Sovadinova 7,69002 Breclav 2, Czech Republic.Tel/Fax: +420 (0) 519 325 130FranceLaboratoires RandoxRoissy Parc, ZAC du Moulin24-26 rue du Noyer, BP 40, 95700 Roissy en FranceTel: +33 (0) 130 18 96 80Fax: +33 (0) 130 18 03 60GermanyRandox Laboratories GmbHWilhelmstr. 147a, 42489 Wülfrath, Germany.Tel: +49 (0) 2151/93 706-11Fax: +49 (0) 2151/ 93 706-222Hong KongRandox Laboratories Hong KongRoom 602, Skyline Commercial Centre,No 71-77 Wing Lok Street, Sheung Wan, Hong KongTel: +852 3595 0515Fax: +852 3008 5133IndiaRandox Laboratories India Pvt Ltd.3rd Floor, Godrej Coliseum, Somaiya Hospital Road,Off. Eastern Express Highway, Sion (East), Mumbai - 400 022, IndiaTel: +91 22 6714 0600Fax: +91 22 2408 3803ItalyRandox Laboratories Ltd.Corso Montevecchio 37,10129 Torino, Italy.Tel: +39 06 9896 8954Fax: +39 06 6051 3810PolandRandox Laboratoriesul. Wolnosc 7 lok. 15, 01-018, Warszawa.Tel: +48 (0) 22 862 1080Fax: +48 (0) 22 862 1081PortugalIrlandox Laboratorios Quimica Analitica LtdaRua Agostinho de Jesus e Sousa 258,4000-015 Porto, Portugal.Tel: +351 22 589 8320Fax: +351 22 589 8329Puerto RicoRandox de Puerto RicoPMB 590 PO Box 29029 San Juan,PR 00929-0029.Tel: +1 787 701 7000Fax: +1 787 701 6901Republic of IrelandRandox TeorantaMeenmore, Dungloe,Co Donegal, Republic of IrelandTel: +353 7495 22600SlovakiaRandox S.R.O.Vilová 2, 851 01 Bratislava, Slovakia.Tel: +421 2 6381 3324Fax: +421 2 6381 2482South AfricaRandox Laboratories (SA) (PTY) LtdUnit 69F Allandale Business ParkCnr. Le Roux Avenue & Morkels CloseHalfway House, Midrand, South AfricaTel: +27 011 461 371South KoreaRandox Korea Ltd.904 Doosan Venturedime 126-1, Pyeongchon,Dongan-gu, Anyang City, Kyeonggi-do, South KoreaTel: +82 (0) 31 478 3121Fax: +82 (0) 31 478 3122SpainLaboratorios Randox S.L.C/Enric Prat de la Riba, 226, 1° Planta,08901 L’Hospitalet de Llobregat, Barcelona.Tel: +34 93 475 09 64Fax: +34 93 475 09 65SwitzerlandRandox Laboratories Ltd. (Switzerland)C/O Wirtschafts-Treuhand Auctor Schwyz AG,Oberer Steisteg 18, 6430 Schwyz, Switzerland.Tel: +41 41 810 48 89Fax: +41 41 810 48 34UKRandox Laboratories Ltd.55 Diamond Road, Crumlin, Co. Antrim,United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413Fax: +44 (0) 28 9445 2912USARandox Laboratories-US, Ltd.515 Industrial Boulevard,Kearneysville, West Virginia, 25430Tel: +1 304 728 2890 Toll Free: 866 4 RANDOXFax: +1 304 728 1890 Toll Free: 866 RANDOX 1VietnamRandox Laboratories Ltd. VietnamVilla Phuc Thinh 2Bis Nguyen Thi Minh Khai St.Dakao Ward, District 1, Ho Chi Minh City, Vietnam.Tel: +84-8-39 11 09 04Fax: +84-8-39 11 09 05Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdomt +44 (0) 28 9442 2413 f +44 (0) 28 9445 2912 e marketing@randox.com I www.randox.comLT027 NOV11Information correct at time of print. All Randox products made in the UK.Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 353 030 400. Product availability may vary from country to country. Please contact your local Randox representative for information.

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