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Quality Control Brochure

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Page 1: Quality Control Brochure

Q U A L I T Y

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C O N T R O L S

Page 2: Quality Control Brochure

Randox Laboratories Ltd. has over 20 years experience in the development, manufacture and marketing of high qualitydiagnostic reagents and equipment for laboratory medicine. Randox supply circa 35,000 laboratories in over 130 countriesworldwide. All Randox reagents are manufactured under rigorous quality procedures to achieve the high quality standardsexpected in clinical science. A significant proportion of resources are invested in research and development to ensure kitsare developed to the highest specifications and conform to international standards. Commitment to quality is emphasisedby ISO13485 accreditation for the development and manufacture of diagnostic test kits.

Randox’s clinical products can be found in almost every country. The Randox portfolio includes Biochip Array Technology,clinical chemistry automation systems, external quality assurance schemes, Internet driven QA systems, quality controlmaterials, clinical reagents and environmental diagnostics.

Quality Control SeraRandox manufacture a broad range of human and bovine-based quality control material. The Randox product range ofcontrol products includes clinical chemistry multi sera, tumour markers, cardiac, CSF, urine controls, lipid controls, specificprotein controls, therapeutic drug and a range of mono controls. All control products come in easy to use, colour-codedpackaging to help distinguish different analyte levels and minimise costly errors. Bottles, caps and packaging are allcolour-coded to aid stocking and usage of the products in the laboratory.

Randox assayed and precision sera are available in human and bovine (only available in clinical chemistry controls) form.Method-, temperature and instrument specific target values and ranges are available for all assayed sera. Randoxprecision serum is supported with guideline values from a consensus mean of results from independent laboratories forthe most regular methods.

RIQASRIQAS, the external quality assessment scheme from Randox Laboratories is the world’s first clinical EQA scheme to gainUKAS accreditation. The programme results and reports can be transmitted through postal, fax or e-transfer services.

RIQAS has been providing "Proficiency Testing Schemes" for laboratories worldwide for over 12 years. Today, RIQASoffers 8 programmes with 160 analytes to circa 5000 participants in 59 countries. The 8 programmes currently availableinclude general clinical chemistry, specific proteins, therapeutic drugs, human urine, lipids, immunoassay, cardiac andhaematology.

aRandox have introduced a new internet-driven software package. The Peer Group reporting software utilises values fromlaboratories worldwide and allows access to reports showing your analytical performance 24 hours a day, 7 days a week.

Designed to complement the Randox product range of control sera, a facilitates the monitoring of analyticalperformance (internal quality control) and enables direct comparisons with laboratories worldwide (peer group reporting).

C O M P A N YINTRODUCTION

Page 3: Quality Control Brochure

PageNumber

Selecting a Control Product 3Control Matrix 3Assayed and Precision Sera 3Urine Controls 3Colour-Coded Controls 4Easy Selection Guide 4

a 5-6

MULTI CONTROLSCardiac Controls 7CSF Controls 8

General Clinical ChemistryBovine Assayed Serum 9Bovine Precision Serum 10Human Assayed Serum 11Human Precision Serum 12Quick Reference Guide 13-14

Immunoassay Controls 15Lipid Controls 16Specific Protein Controls 17Therapeutic Drug Controls 18Tumour Marker Control 19Urine Assayed / Urine Precision Controls 20

MONO CONTROLSBilirubin Elevated / CRP / Fructosamine Controls 21G-6-PDH / Glutathione & TAS Controls / HbA1c 22Lipoprotein (a) / Microalbumin Urine Controls 23Myoglobin / Ransel & Ransod Controls 24Rheumatoid Factor Positive / Syphilis RPR/VDRL Controls 25

MULTI CALIBRATORSCalibration Sera / Apolipoprotein A-1 & B Calibrators 26CK-MB / Haemoglobin A1c / Hitachi™ Series Calibrators 27IgE / Immunoglobulin ( ) / LDL & HDL-Cholesterol Calibrators 28Specific Protein Calibrators (Liquid) / Therapeutic Drugs Calibrators 29

MONO CALIBRATORSASO / CRP 1 Point Liquid / CRP Multi Point Liquid Calibrators 30Ferritin / Fructosamine / Glutathione Reductase Calibrators 31Lipoprotein (a) / Microalbumin Calibrators 32Myoglobin / Rheumatoid Factor Calibrators 33

STANDARDSMono and Multi Level Standards 34

RIQAS 35-36

Brochures & CD’s Available 37-38

C O N T E N T S

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SELECTING A CONTROL PRODUCT Technology improvements in clinical pathology have revolutionised laboratory analysis by facilitating amassive throughput of samples and the adaptation of the most up-to-date methodologies. Standardisationand calibration of modern instruments play a pivotal role in the generation of quality information for accurateclinical decision making. These developments have created a demand for a broad range of quality controlproducts to cover the ever-increasing list of tests carried out in clinical laboratories.

CONTROL MATRIXRandox manufacture both human and bovine based control products for use in all laboratories. Lyophilisedcontrols are stable for up to 4 years after the date of manufacture.

Bovine-based sera is prepared from certified disease-free animal source material and offers highperformance for up to 44 clinical chemistry analytes when cost considerations are paramount.

Human-based sera is donor tested at source and found to be non-reactive for Hepatitis B and C antigenand HIV I and II antibodies. Human-based sera offers a matrix consistent with human patient samples andoffers high performance for up to 70 analytes. It is generally preferred for immunological methods includingserum proteins and hormones.

All Randox control products are manufactured to the same high specifications using procedures recognisedby ISO 13485.

HUMAN ASSAYED AND PRECISION SERAAssayed sera are used for the control of accuracy of results. Each parameter has an assigned mean +/-2SD range generated from 3000 independent laboratories world-wide and approximately 98,000 results.Method, temperature and instrument-specific values are provided for up to 70 parameters in the clinicalchemistry multisera. A unique feature of Randox assayed serum is the use of reference method values for up to 12 parameters for generation of the target value. Reference methods are generally considered mostaccurate for the determination of a specific analyte and are traceable to international standards, enablinginter-laboratory standardisation.

Unassayed serum is generally referred to as precision serum and is used only for the control ofreproducibility of results. Approximate values are assigned from a consensus mean of results fromindependent laboratories for the most common method.

EXAMPLE OF ASSAYED AND PRECISION INFORMATION SHEETS

All the above data is now available in mini CDROM format

URINE CONTROLSValues for assayed urine controls are assigned from a consensus of results from approximately 600independent laboratories. Approximate values for unassayed urine controls are generated by results fromselected reference laboratories and assigned from 3 consensus of results obtained by these laboratories.

ASSAYED INSERTTarget Value Range

Calcium 2.21 1.99 - 2.43 Atomic Absorption (8.86 7.98 - 9.74)

mmol/l 2.19 1.97 - 2.41 Arsenazo III(mg/dl) (8.78 7.90 - 9.66)

2.13 1.92 - 2.34 Cresolphthalein complexone(8.54 7.70 - 9.38) 2.15 1.94 - 2.36 ISE(8.62 7.78 - 9.46)2.17 1.96 - 2.38 Methylthymol Blue(8.70 7.86 - 9.54)2.14 1.93 - 2.35 Dry Chemistry/Vitros(8.58 7.74 - 9.42)

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PRECISION INSERTApproximate Value Method

Calcium 2.67 mmol/l Cresolphthalein10.70 mg/dl

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COLOUR-CODED CONTROLSEasy to use, colour-coded packaging will help distinguish between different levels and minimise costlyerrors. Colour-coded bottles, caps and boxes will also aid stock management and usage of the products inthe laboratory. Colour-coded controls were introduced in 2003 however existing stocks will be in circulationuntil 2007.

Level 1 LowLevel 2 MediumLevel 3 High

EASY SELECTION GUIDESelecting control products to suit your laboratory’s needs has never been easier! Randox have introduced an easy selection guide with colour-coded control levels to enable rapid selection of control products to suit the needs of your laboratory.

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CLINICAL CHEMISTRYMULTI - SERA

URINE CONTROLS

CSF CONTROLS

THERAPEUTIC DRUG CONTROLS

IMMUNOASSAYCONTROLS

SPECIFIC PROTEIN CONTROLS

ASSAYED

PRECISION

BOVINE

HUMAN

ASSAYED

PRECISION

ASSAYED

ASSAYED

ASSAYED

ASSAYED

BOVINE

HUMAN

HUMAN

HUMAN

HUMAN

HUMAN

HUMAN

HUMAN

LEVEL ILEVEL 2LEVEL 3LEVEL 2LEVEL 3LEVEL ILEVEL 2LEVEL 3LEVEL 2LEVEL 3

LEVEL 2LEVEL 3

LEVEL 2LEVEL 3

LEVEL 2LEVEL 3

LEVEL ILEVEL 2LEVEL 3

LEVEL ILEVEL 2LEVEL 3

LEVEL ILEVEL 2LEVEL 3

LIPID CONTROLS ASSAYED HUMANLEVEL ILEVEL 2LEVEL 3

CARDIAC CONTROLS ASSAYED HUMAN

HUMAN

LEVEL ILEVEL 2LEVEL 3

TUMOUR MARKER CONTROLS ASSAYEDLEVEL ILEVEL 2LEVEL 3

The descriptions, low, medium and high are all generalisations. Some analytes will fall outside these classifications.

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NEW PEER GROUP REPORTING PACKAGE!Now you can access reports showing your analytical performance 24 hours a day and 7 days a week with 247,the new Internet-driven software from Randox!Designed to complement Randox control sera, 247 facilitates monitoring of analytical performance (internalquality control) and enables direct comparisons with laboratories worldwide (peer group reporting).

OPERATIONAL LEVELS OF 247Customers have the option to select one of three access levels within 247. Level 3 represents the highestlevel of QC management and provides unlimited access to all 247 functions.

247 Software on CD

Registration to use 247 software

Registration for Peer Group licence

247 software is an internal quality control package fordaily monitoring of laboratory performance. Thissoftware can be run for the duration of the 60-day trialat no cost to the customer.

Unregistered 247 software is valid for a trial period of60 days. Software registration will re-activate thesoftware for unlimited use. 247 software upgrades areavailable via a secure site at www.randox.com/247.Users must register to gain access to the secure site.

Customers can register to use the 247 peer groupprogramme for rapid upload and download of data atthe touch of a button.

Level 1

Level 2

Level 3

TM

Cat. No. PR060

Cat. No. QC4201

TEXT ON TUTORIALRandox has recently developed an educational tutorial to assist all new users of the 247 software. Our freeinteractive 247 tutorial contains explicit instructions, for example, on how to set up the data panels, enterresults, run reports and upload results via the Internet. The tutorial contains an online help manual toensure that the client always has access to a solution on any problem or query they may have.

Each user of the tutorial will have a unique username and password; a laboratory manager can then viewthe progress of each member of staff as frequently as they wish. At the end of each section in the tutorialthere is a self-assessment exercise that allows all users to test their knowledge and understanding of the247 software programme.

This multi-lingual tutorial will be provided on each individual 247 software disc.

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The 247 tutorial and online help manual have been designed to help users perform tasks within the 247 system. The interactive tutorial allows the user to test their understanding of the 247 software program.

It is recommended that the user reads the relevant section of the manual whilst they are completing a section of the tutorial.

Acid Phos., ProstaticAcid Phos., To t a lA F PA l b u m i nAlkaline PhosphataseAlpha-1-acid glycoproteinA l p h a - 1 - a n t i t r y p s i nA LT (GPT)Amylase, PancreaticAmylase, To t a lApolipoprotein A - 1Apolipoprotein BAST (GOT)B i c a r b o n a t eBile A c i d sBilirubin, DirectBilirubin, To t a lC a e r u l o p l a s m i nC a l c i u mC a r b a m a z e p i n eC E AC h l o r i d eCholesterol, To t a lC h o l i n e s t e r a s eC K , To t a lComplement C3Complement C4C o p p e rC o r t i s o lC r e a t i n i n e

C R PD - 3 - H y d r o x y b u t y r a t eD i g o x i nF e r r i t i nF o l a t eFree Thyroxine (FT4)Free Triiodothyronine (FT3)G e n t a m y c i nG G TG L D HG l u c o s eH a p t o g l o b i nH B D Hh C GH D L - C h o l e s t e r o lI g AI g EI g GI g MI r o nL a c t a t eL A PLD (LDH)L i p a s eL i t h i u mM a g n e s i u mM y o g l o b i nNon Esterified Fatty A c i d sO s m o l a l i t yParacetamol (Acetaminophen)

P h e n o b a r b i t a lP h e n y t o i nPhosphate, InorganicP h o s p h o l i p i d sP o t a s s i u mP r e a l b u m i nP r o l a c t i nProtein, To t a lPSA, To t a lS a l i c y l a t eS o d i u mT h e o p h y l l i n eThyroid Stimulating Hormone( T S H )Thyroxine (T4)T I B CTo b r a m y c i nTotal LipidsTr a n s f e r r i nTr i g l y c e r i d e sTriiodothyronine (T3)Troponin ITroponin TU r e aUric Acid (Urate)Valproic A c i dVa n c o m y c i nVitamin B1 2

Z i n c

All analytes can be entered during the user-defined QC test set-up process. New analytes can then be added as required by following the same process.

REGISTER NOWwww.randox.com/247

aadelivers ...delivers ...

• INTERNET-DRIVEN SOFTWARE with peer group values from laboratories worldwide

• DATA VALIDATION user-defined selection criteria

• MULTILEVEL PASSWORDS for system security

• RAPID DATA ENTRY by user-defined panels and tests

• LEVEY-JENNINGS AND HISTOGRAM PLOTS for internal analysis

• PEER GROUP DATA updated every 24 hours

• GROUP CO-ORDINATOR REPORTS

• EASY TO LOAD SOFTWARE

• FREE INSTRUCTION MANUAL provided on software CD and 247 website

• PARTICIPANT PERFORMANCE SUMMARY CHARTS for peer group comparisons

• ONSCREEN DISPLAY of laboratory results and peer group statistics

• FLEXIBLE SERUM COMBINATION

• PEER GROUP DATA automatically downloaded on the upload of laboratory QC data

• PEER GROUP STATISTICS worldwide and laboratory groups

™™

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CARDIAC Control

Human Assayed SerumAnalytes CK Total, CK-MB (Activity), CK-MB (Mass), Homocysteine, Myoglobin,

Troponin I, Troponin T.

Features• Human-based sera.

• Lyophilised material.

• Target values and ranges quoted.

• For the control of CK-MB and CK-NAC activities at three levels.

• Temperature-specific values.

• Values for serum-start and substrate-start methods.

Stability• Lyophilised product stable to expiry.

• CK-MB stable in serum for 5 days @ +2°C to +8°C and 4 weeks @ -20°C.

Ordering InformationProduct Description Size Cat No.Tri-level Cardiac Control 3 x 1ml CQ3100

Guide Control Levels

Analyte Level 1 Level 2 Level 3 Unit

CK Total 74.3 259 735 U/l

CK-MB (Activity) 4.6 17.7 133 U/l

CK-MB (Mass) 5.1 23 237 ng/ml

Homocysteine 12.4 20.6 38.5 µmol/l

Myoglobin 62.6 186 335 ng/ml

Troponin I 1.04 2.27 8.85 ng/ml

Troponin T 0.07 0.15 0.49 ng/ml

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CSF ControlsHuman Assayed Controlfor the control of up to seven components and five electrophoresis regions at two levels.

AnalytesChloride, Glucose, IgG, Lactic acid, Sodium, Total Protein (Coomassie Blue), Total Protein (Pyrogallol Red).Electrophoresis - Albumin, α-1-globulin, α-2 globulin, β-globulin, γ-globulin.

Features• Human-based product.

• Lyophilised material.

• Target values and ranges quoted for components.

• % Total Protein quoted for electrophoresis.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.• After reconstitution the controls are stable for 2 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.CSF Control Level 2 10 x 3ml CF1500 CSF Control Level 3 10 x 3ml CF1501

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GENERAL CLINICAL CHEMISTRYBovine Assayed Serumoffers high quality lyophilised product for 44 clinical chemistry parameters at three levels.

AnalytesElectrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,

Potassium, Sodium, Zinc.

Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT,Amylase Total, AST, CK Total, γ-GT, GLDH, α-HBDH, LDH, Lipase.

Lipids Total Cholesterol, Triglycerides, Total Lipids, NEFA.

Proteins Albumin, Protein Total, Total PSA.

Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid.

Others Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.

Features• Bovine-based product.

• Lyophilised material.

• Method-, Instrument- and Temperature-specific values provided.

• Analyte range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.

• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.(Refer to characteristic sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Bovine Assayed Multisera Level 1 20 x 5ml AL1027 Bovine Assayed Multisera Level 2 20 x 5ml AN1026 Bovine Assayed Multisera Level 3 20 x 5ml AE1032

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GENERAL CLINICAL CHEMISTRYBovine Precision Serumoffers a high quality lyophilised product for 43 clinical chemistry parameters at three levels.

AnalytesElectrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,

Potassium, Sodium, Zinc.

Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT,Amylase Total, AST, CK Total, γ-GT, GLDH, α-HBDH, LDH, Lipase.

Lipids Total Cholesterol, Triglycerides, Total Lipids.

Proteins Albumin, Protein Total, PSA.

Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid.

Others Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.

Features• Bovine-based product.

• Lyophilised material.

• Approximate values quoted for most common method.

• Variety of vial sizes to suit the needs of all laboratories.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.

• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.(Refer to characteristic sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Bovine Precision Multisera Level 1 20 x 5ml SL1084 Bovine Precision Multisera Level 1 12 x 10ml SL1097 Bovine Precision Multisera Level 2 20 x 5ml SN1085 Bovine Precision Multisera Level 2 12 x 10ml SN1098 Bovine Precision Multisera Level 3 20 x 5ml SE1086 Bovine Precision Multisera Level 3 12 x 10ml SE1099

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GENERAL CLINICAL CHEMISTRY

Human Assayed Serumoffers a quality lyophilised product for 70 clinical chemistry parameters at two levels.

AnalytesDrugs Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline,

Tobramycin.

Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc.

Electrophoresis α-2-globulin, α-1-globulin, β-1-globulin, γ-globulin, Albumin.

Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase, ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, γ-GT,GLDH, α-HBDH, LAP, LDH, Lipase.

Lipids NEFA, Phospholipids, Total Cholesterol, Total Lipids, Triglycerides.

Proteins Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM, Protein Total, PSA, Transferrin.

Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Lactate, Urea, Uric Acid.

Others Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B12.

Features• Lyophilised material, 100% Human matrix.• Method-, Instrument- and Temperature-specific values provided.• Analyte range provided.• Reference method values offered are with particular lots for calcium, chloride, cholesterol, creatinine,

glucose, lithium, magnesium, potassium, total protein, sodium, triglycerides and uric acid.• Variety of pack sizes to suit the needs of all laboratories.• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.

(Refer to characteristic sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Human Assayed Multisera Level 2 5 x 5ml HN2612 Human Assayed Multisera Level 2 20 x 5ml HN1530 Human Assayed Multisera Level 3 5 x 5ml HE2613 Human Assayed Multisera Level 3 20 x 5ml HE1532 Human Assayed Multisera Level 2 & 3 5 x 5ml HS2611

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AnalytesDrugs Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline,

Tobramycin.

Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc.

Electrophoresis α-2-globulin, α-1-globulin, β-1-globulin, γ-globulin, Albumin.

Enzymes Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase, ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, γ-GT,GLDH, α-HBDH, LAP, LDH, Lipase.

Lipids NEFA, Phospholipids, Total Cholesterol, Total Lipids, Triglycerides.

Proteins Protein Total, PSA, Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM, Transferrin.

Substrates Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Lactate,Urea, Uric Acid.

Others Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B12.

Features• Lyophilised material, 100% Human matrix.• Approximate target values are provided for most common analytes and method.• Variety of vial sizes to suit the needs of all laboratories.• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.• Reconstituted stability of 7 days @ +2°C to +8°C, and one month when stored @ -20°C.

(Refer to characteristic sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Human Unassayed Multisera Level 2 20 x 5ml UN1557 Human Unassayed Multisera Level 2 12 x 10ml UN1562 Human Unassayed Multisera Level 3 20 x 5ml UE1558 Human Unassayed Multisera Level 3 12 x 10ml UE1559

Human Precision Serumoffers a high quality lyophilised product for 70 clinical chemistry parameters at two levels.

GENERAL CLINICAL CHEMISTRY

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Analytes Typical ValuesLevel

1 2 3 Units

IMMUNOASSAY Controls

Human Assayedsera available in three levels for the control of accuracy and precision for up to 31 analytes.

Features• Human-based product.

• Lyophilised material.

• Combined control includes thyroid hormones, fertility hormones and tumour markers.

• Very low TSH levels in level 1 allowing assessment of assay sensitivity.

• Instrument-specific values provided.

• Analyte range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised product stable to expiry.

• Reconstituted stability of 7 days @ +2°C to +8°C, 4 weeks @ -20°C.

Ordering InformationProduct Description Size Cat No.Immunoassay Control Level 1 10 x 5ml IA2638 Immunoassay Control Level 2 10 x 5ml IA2639 Immunoassay Control Level 3 10 x 5ml IA2640 Tri-level Immunoassay Control 12 x 5ml IA2633

AFP 9 40 150 IU/mlβ-2-Microglobulin 0.97 2.76 7.36 mg/lCA 15-3 23.9 44.4 72.8 U/mlCA 19-9 10.9 24.8 80 U/mlCA 125 13.7 65.6 104 U/mlCarbamazepine 13.4 36.3 66.3 mol/lCEA 12 25 50 µmol/lH C G 15 69.0 250 mIU/mlCortisol 190 628 1005 nmol/lDigoxin 0.97 3.03 4.73 nmol/lFerritin 10.0 116 319 ng/mlFolate 7.33 34.6 100 nmol/lFree Thyroxine (FT4) 7.04 20.5 62.4 pmol/lFree Triiodothyronine (FT3) 1.0 10.8 30.4 pmol/lFSH 9.19 36.3 120 mIU/mlGrowth Hormone 8.10 28.9 60.9 µIU/mlIgE 200 85 542 IU/mlLH 5.20 55.8 91.4 mIU/mlOestradiol 77.5 776 1647 pmol/lPhenytoin 19.4 64.0 87.1 µmol/lProgesterone 3.02 33.8 109 nmol/lProlactin 186 1291 2274 µU/mlPSA-ACT 1.13 16.5 33.7 ng/ml17-OH-Progesterone 4.89 26.9 68.2 nmol/lTestosterone 6.61 20.3 45.1 nmol/lTheophylline 30.4 81.4 173 µmol/lThyroxine (T4) 12.7 120 180 nmol/lTriiodothyronine (T3) 0.67 4 9 nmol/lTSH 0.12 2.51 39.8 µIU/mlValproic Acid 232 452 920 µmol/lVitamin B12 184 458 928 pmol/l

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LIPID ControlsHuman Assayed Serafor the control of up to seven lipid parameters at three levels.

Analytes Typical ValuesLevel

1 2 3 Units

HDL Cholesterol (Direct Liquid) 0.79 1.29 1.85 mmol/lHDL Cholesterol (Precipitation) 0.73 1.11 1.93 mmol/lLDL Cholesterol (Direct Liquid) 2.56 3.74 4.78 mmol/lLDL Cholesterol (Precipitation) 2.99 4.32 5.6 mmol/lApolipoprotein A1 1.20 1.63 2.32 g/lApolipoprotein B 1.23 1.39 1.68 g/lLipoprotein (a) 24.5 29.3 29 mg/UTotal Cholesterol 4.66 6.33 8.41 mmol/lTriglyceride 1.18 2.02 4.27 mmol/l

Features• Human-based sera.

• Lyophilised material.

• Target value and range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.

• Stable for 1 month @ -20°C when frozen once.

Ordering InformationProduct Description Size Cat No.Lipid Control Level 1 5 x 1ml LE2668 Lipid Control Level 1 5 x 3ml LE2661 Lipid Control Level 2 5 x 1ml LE2669 Lipid Control Level 2 5 x 3ml LE2662 Lipid Control Level 3 5 x 1ml LE2670 Lipid Control Level 3 5 x 3ml LE2663

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Features• Liquid sera.

• Human-based product.

• Method-specific values.

• Analyte range quoted.

• Compatible for use on most clinical analysers.

Stability• Stable for up to 2 years after the date of manufacture.

Ordering InformationProduct Description Size Cat No.Specific Protein Control Level 1 3 x 1ml PS2682 Specific Protein Control Level 2 3 x 1ml PS2683 Specific Protein Control Level 3 3 x 1ml PS2684

SPECIFIC PROTEIN Controls

Human Assayed Serahuman-based assayed sera available in three levels for the control of accuracy and precision for up to 25 analytes.

AFP 15.4 30.8 46.7 U/mlAlbumin 16.6 33.6 49.2 g/lα-1-Antitrypsin 0.72 1.31 1.91 g/lα-1-Acid Glycoprotein 0.47 0.92 1.39 g/lα-2-Macroglobulin 0.9 2.12 3.02 g/lASO 109 230 340 IU/mlAntithrombin 14.4 30.4 47.3 mg/dlβ-2-Microglobulin 0.18 0.32 0.48 mg/dlCaeruloplasmin 0.17 0.24 0.39 g/lC3 0.66 1.33 1.91 g/lC4 0.14 0.29 0.44 g/lCRP 27 52.5 80 mg/lHaptoglobin 0.68 1.34 1.97 g/lIgA 1.27 2.55 3.71 g/lIgE 78.3 184 286 U/mlIgG 9.41 13 20 g/lIgM 0.63 1.75 2.5 g/lKappa Light Chain 8.32 11 16 g/lLambda Light Chain 3.49 7.02 10.9 g/lSerum Ferritin 86 171 260 ng/mlRF 37.4 69 114 IU/mlRBP 1.8 5.45 8.10 mg/dlTotal Protein 40 60 100 g/lTransferrin 1.03 2.16 3.19 g/lTransthyretin 0.12 0.24 0.35 g/l

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Analytes Typical ValuesLevel

1 2 3 Units

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THERAPEUTIC DRUG Controls

Human Assayed SeraDrug controls sera available in three levels for the control of accuracy and precision for up to 18 analytes.

Amikacin 5.9 25.6 49.3 µmol/lCaffeine 15.5 41.8 81.0 µmol/lCarbamazepine 15.4 42.0 77.0 µmol/lCyclosporin 76.2 212 464 nmol/lDigoxin 0.76 2.4 4.74 nmol/lEthosuximide 275 563 964 µmol/lGentamicin 5.3 12.8 20.4 µmol/lLithium 0.53 1.09 1.71 mmol/lMethotrexate 0.40 1.30 8.76 µmol/lParacetamol 0.19 0.55 1.41 mmol/l(Acetaminophen)

Phenobarbitone 37.4 133 234 µmol/lPhenytoin 19.4 68.2 93.5 µmol/lPrimidone 13.8 39.9 61.0 µmol/lSalicylate 0.34 1.33 3.08 mmol/lTheophylline 30.4 91.0 178 µmol/lTobramycin 4.35 11.5 18.7 µmol/lValproate 224 592 1008 µmol/lVancomycin 3.54 10.5 19.3 µmol/l

Features• Human-based product.

• Lyophilised material.

• Method-specific values provided.

• Analyte range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised product stable to expiry.

• Reconstituted stability of 4 weeks @ -20°C.

Ordering InformationProduct Description Size Cat No.Drug Control Level 1 20 x 5ml HD1667Drug Control Level 2 20 x 5ml HD1668Drug Control Level 3 20 x 5ml HD1669

multi 18

Analytes Typical ValuesLevel

1 2 3 Units

Page 20: Quality Control Brochure

Analytes Alpha foetoprotein (AFP)β-2-MicroglobulinCA 19-9CA 125CA 15-3Carcinoembryonic Antigen (CEA)Cyfra 21FerritinFree PSAHuman Chorionic Gonadotrophin (HCG)Neuron Specific Enolase (NSE)Prostatic Acid Phosphatase (PAP)ProlactinPSA-ACTTissue Polypeptide Antigen (TPA)Total PSA

Features• Human-based, liquid sera.

• Target value and range quoted.

• Compatible for use on most clinical analysers.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Tri-Level Tumour Marker Control 9 x 2ml IA2679

TUMOUR MARKER Control

Human Assayed Serafor the control of up to 16 tumour markers at three levels.

Analyte values are method specific,please request kit insert for details.

multi19

Page 21: Quality Control Brochure

URINE ASSAYED Controlshuman-based material available in two levels for the control of accuracy and precision for up to 23 analytes.

AnalytesAlbumin, Calcium, Chloride, Copper, Cortisol, Creatinine, Dopamine, Epinephrine, Glucose, 5-Hydroxy-indole acetic acid, Magnesium, Metanephrine, Norepinephrine, Normetanephrine, Osmolality,Oxalate, Inorganic Phosphorous, Potassium, Total Protein, Sodium, Urea, Urate, Vanillylmandelic acid.

Features• Lyophilised material.

• Human-based product.

• Method-specific values provided.

• Target value and range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.

• After reconstitution the controls are stable for 5 days @ +2°C to +8°C or 14 days @ -20°C.(Refer to characteristics sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Urine Assayed Control Level 2 12 x 10ml AU2352Urine Assayed Control Level 3 12 x 10ml AU2353

multi 20

URINE PRECISION Controlshuman-based material available in two levels for the control of precision for up to 10 analytes.

AnalytesCalcium, Chloride, Creatinine, Glucose, Magnesium, Phosphorous, Potassium, Sodium, Urea, Urate.

Features• Lyophilised material.

• Human-based product.

• Approximate values quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry.

• After reconstitution the controls are stable for 5 days @ +2°C to +8°C or 14 days @ -20°C.

Ordering InformationProduct Description Size Cat No.Urine Unassayed Control Level 2 10 x 10ml UC1502Urine Unassayed Control Level 3 10 x 10ml UC1503

Page 22: Quality Control Brochure

BILIRUBIN (Elevated)

Assayed Serumoffers control for samples with elevated bilirubin levels (total and direct values quoted).

Analytes Total Bilirubin, Direct Bilirubin

Features• Bovine-based serum.

• Lyophilised material.

• Method-specific values.

• Target values and ranges quoted.

Stability• Lyophilised material stable to expiry.

• Stable for 24 hours @ +2°C to +8°C after reconstitution when protected from light.

Ordering InformationProduct Description Size Cat No.Bilirubin Elevated Control 10 x 3ml BE454

CRP LIQUID ControlsAnalyte CRP

Features• Ready to use liquid.

• Standardised against BCR/CAP/IFCC CRM 470.

• Target value and range quoted.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.CRP Liquid Control Level 2 10 x 1ml CP2480CRP Liquid Control Level 3 10 x 1ml CP2481CRP High Sensitivity Control Level 1 10 x 1ml CP2476CRP High Sensitivity Control Level 2 10 x 1ml CP2477

FRUCTOSAMINE ControlsAnalyte Fructosamine

Features• Lyophilised material.

• Two control levels.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Reconstituted components are stable for 28 days @ +2°C to +8°C, and 28 days @ -20°C.

Ordering InformationProduct Description Size Cat No.Fructosamine Control Level 1 3 x 1ml FR2994 Fructosamine Control Level 3 3 x 1ml FR2996

mono21

S

S

S Liquid

Page 23: Quality Control Brochure

GLUTATHIONE & TAS Controlsindividual controls for Glutathione Reductase and Total Antioxidant Status (TAS) assays.

AnalytesG. Reductase Glutathione Reductase Human-based, lyophilised seraTAS Total Antioxidant Status Human-based, lyophilised sera

Features• Target values and ranges quoted.

• Controls compatible for use on most clinical analysers.

Stability• Controls are stable to expiry when stored @ +2ºC to +8ºC.• Glutathione Reductase has a reconstituted stability of 1 day @ +2ºC to +8ºC.• TAS control has a reconstituted stability of 2 days @ +2ºC to +8ºC.

Ordering InformationProduct Description Size Cat No.Glutathione Reductase Control 10 x 5ml GR2608Total Antioxidant Status Control 10 x 5ml NX2331

G-6-PDH Controls

Human Assayed Haemolysatefor the control of G-6-PDH (Glucose-6-phosphate dehydrogenase)

Analyte G-6-PDH

Features• Human-based whole blood.

• Lyophilised material.

• Target value and range quoted.

Stability• Lyophilised product stable to expiry when stored @ +2°C to +8°C.

• Stable for 7 days @ +2°C to +8°C after reconstitution.

Ordering InformationProduct Description Size Cat No.G-6-PDH Control Deficient 6 x 0.5ml PD2617G-6-PDH Control Normal 6 x 0.5ml PD2618

mono 22

HbA1c / HbAnalyte Haemoglobin A1c

Features• Liquid product.

• Two control levels.

• Reconstitution fluid provided.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Reconstituted controls stable for 3 months @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.HbA1c / Hb Level 1 & 2 2 x 0.25ml HA3445

Page 24: Quality Control Brochure

MICROALBUMIN URINE ControlsHuman Assayed Urinefor the control of low levels of Albumin.

Analytes Albumin

Features• Human-based product.

• Lyophilised material.

• Target value and range quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry @ +2°C to +8°C.

• After reconstitution the controls are stable for 5 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Microalbumin Urine Control Level 1 10 x 1ml MA1411Microalbumin Urine Control Level 3 10 x 1ml MA1412

mono23

LIPOPROTEIN (a) ControlAnalytes Lp(a)

Features• Human-based product.

• Lyophilised material.

Stability• Unreconstituted controls are stable to expiry.

• After reconstitution the control is stable for 14 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Lipoprotein (a) Control Level 3 3 x 1ml LP3406

Page 25: Quality Control Brochure

MYOGLOBIN Control

Assayed Controlfor the control of myoglobin levels in immunoturbidimetric based methods.

Analyte Myoglobin

Features• Lyophilised material.

• Target value and range quoted.• Suitable for Immunoturbidimetric methods.

Stability• Lyophilised material stable to expiry when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Myoglobin Control Level 2 & 3 4 x 3ml MY2490

RANSEL & RANSOD Controlsindividual mono controls for Glutathione Peroxidase (Ransel) and Superoxide Dismutase (Ransod) assays.

AnalytesRansel Glutathione PeroxidaseRansod Superoxide Dismutase

Features• Lyophilised whole blood.

• Target values and range quoted.

• Controls compatible for use on most clinical analysers.

Stability• All controls are stable to expiry when stored @ +2°C to +8°C.

• Ransel controls have a reconstituted stability of 3 days at +2°C to +8°C.• Ransod controls have a reconstituted stability of 10 days at +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.RANSEL Control 10 x 1ml SC692RANSOD Control 10 x 1ml SD126

mono 24

Page 26: Quality Control Brochure

SYPHILIS RPR/VDRL Control SetHuman Serumfor the qualitative determination of syphilis reagins.

Analytes Positive Control, Negative Control

Features• Liquid ready to use.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Syphilis RPR/VDRL Control Set 10 x 1ml SY2202

RHEUMATOID FACTOR POSITIVE Control

Human Assayed Serumlatex enhanced immunoturbidimetric assays.

Analyte Rheumatoid Factor

Features• Liquid ready to use.

• Target value and range quoted.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Rheumatoid Factor Positive Control 5 x 1ml RF2302

mono25

Page 27: Quality Control Brochure

CALIBRATORSRandox manufacture calibration sera for a range of clinical chemistry analysers.

CALIBRATION SERAHuman-based material is available in two levels for the calibration of clinical analysers, offering values forup to 39 parameters. All calibration sera is human based lyophilised serum and component concentrationsare available at two levels. Calibration sera is distributed to 3000 laboratories and values are assigned froma concensus of results obtained by these laboratories.

AnalytesElectrolytes- Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous,

Osmolality, Potassium, Sodium, Zinc.

Enzymes- Acid Phosphatase Total, Acid Phosphatase Prostatic, Alkaline Phosphatase, Alanine Transaminase, Amylase, Pancreatic Amylase, Aspartate Transaminase, Cholinesterase, Creatine Kinase, Gamma Glutamyl Transferase, GLDH, Hydroxybutyrate Dehydrogenase, Lactate Dehydrogenase.

Lipids- Cholesterol, Triglycerides.

Proteins- Albumin, Total Protein.

Substrates - Bile acids, Bilirubin Total, Bilirubin Direct, Creatinine, D-3-Hydroxybutyrate, Glucose, Lactate, TIBC, Urea, Uric acid.

Features• Human-based product.

• Lyophilised material.

• Instrument, Method and Temperature specific values quoted.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry @ +2°C to +8°C.

• After reconstitution the calibrators are stable for 7 days @ +2°C to +8°C and 4 weeks @ -20°C.(See characteristic sheet for exceptions)

Ordering InformationProduct Description Size Cat No.Calibration Sera Level 2 20 x 5ml CAL2350 Calibration Sera Level 3 20 x 5ml CAL2351

APOLIPOPROTEIN A-1 & B CalibratorAnalytes Apolipoprotein A-1, Apolipoprotein B

Features• Lyophilised material.

• Human-based product.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry @ +2°C to +8°C.

• After reconstitution the controls are stable for 4 weeks @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Apolipoprotein A-1 & B Calibrator 10 x 1ml LP2381

multi 26

Page 28: Quality Control Brochure

CK-MB CalibratorAnalytes CK-MB, Total CK

Features• Lyophilised material.• Human-based product.• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry @ +2°C to +8°C.

• After reconstitution the calibrator is stable for 5 days @+2°C to +8°C.

Ordering InformationProduct Description Size Cat No.CK-MB Calibrator 10 x 1ml CK2393

multi27

HbA1c SERIES Calibrator Analytes Haemoglobin, Haemoglobin A1c

Features• Liquid ready to use product.• Values quoted for six levels.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.HbA1c / Hb Calibrator 5 x 2ml, 1 x 8ml HA3444

HITACHI™ SERIES Calibrator

AnalytesAlbumin, Bicarbonate, Total Bilirubin, Direct bilirubin, Calcium, Chloride, Cholesterol, Creatinine, Glucose,Iron, Lactate, Magnesium, Inorganic phosphate, Potassium, Sodium, Total Protein, Triglycerides, Urea, Uric Acid, Acid Phosphatase(Total), Acid Phosphatase (Prostatic), Alkaline Phosphatase, ALT, Amylase,Pancreatic amylase, AST, Butyryl cholinesterase, CK, γ-GT, HBDH, LDH (P), LDH (L), Lipase.

Features• Lyophilised material.• Human based product.• For use on Hitachi™ 704, 705, 717, 911, 912 analysers.

Stability• Lyophilised material stable to expiry when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Hitachi™ Series Calibrator 10 x 3ml HC2314

Page 29: Quality Control Brochure

LDL & HDL-CHOLESTEROL CalibratorAnalytes Direct LDL-Cholesterol, Direct HDL-Cholesterol

Features• Lyophilised material.

• Human-based product.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry when stored @ +2°C to +8°C.

• After reconstitution the controls are stable for 5 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.LDL & HDL Cholesterol Calibrator (CLEARANCE) 3 x 1ml CH2673

IMMUNOGLOBULIN Calibrator ( )Analytes IgA, IgG, IgM

Features• Ready to use liquid.

• For use with immunoglobulin assays.

Stability• Stable to expiry.

• Open vials are stable for 30 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Immunoglobulin Calibrator ( ) 3 x 1ml IT3861

multi 28

IgE Calibrator Set

Analytes IgE

Features• Human-based product.

• Lyophilised material.• 6 level calibrator.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Stable for four weeks @ +2°C to +8°C after reconstitution.

Ordering InformationProduct Description Size Cat No.IgE Calibrator Set 6 x 1ml IE2492

Page 30: Quality Control Brochure

multi29

THERAPEUTIC DRUGS Calibrators SeriesAnalytes Carbamazepine, Digoxin, Digitoxin, Gentamicin, Phenobarbital,

Phenytoin, Theophylline, Valproic Acid.

Features• Lyophilised material.

• Human-based product.

• Values quoted for six drug levels.

• Eight therapeutic drugs combined in a single calibrator.

Stability• Lyophilised material stable to expiry.

• After reconstitution the calibrator is stable for 28 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Therapeutic Drugs Calibrator 6 x 3ml TD3417Calibration Sera 6 x 3ml TD3422

SPECIFIC PROTEIN Calibrator (Liquid) For use with samples that DO NOT require pre-dilution

Analytes ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG,

IgM, IgE, Prealbumin, Transferrin.

Features• Ready to use liquid.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Open vials are stable for 30 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Specific Protein Calibrator (Liquid) 6 x 1ml IT2691

SPECIFIC PROTEIN Calibrator (Liquid) For use with samples that DO require pre-dilution

Analytes Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, IgA, IgG, IgM, Transferrin.

Features• Ready to use liquid.

• For use with Randox assays that require sample pre-dilution.

Stability• Stable to expiry.

• Open vials are stable for 30 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Specific Protein Calibrator (Liquid) 5 x 1ml IT2692

Page 31: Quality Control Brochure

CRP Calibrator (1 Point Liquid)Analyte CRP

Features• Ready to use liquid.

• Human-based product.

• Compatible for use on most clinical analysers.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.CRP Calibrator (1 Point Liquid) 3 x 1ml CP2178

mono 30

ASO Calibrator(Latex enhanced Immunoturbidimetric)

Analyte ASO

Features• Ready to use liquid.

• Human-based product.

• Compatible for most clinical analysers.

Stability• After opening calibrators are stable up to expiry @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.ASO Calibrator 5 x 1ml LO2306

CRP MULTI POINT LIQUID Calibrators

Analyte CRP

Features• Human-based liquid.

• Suitable for preparation of a dilution series and multipoint calibration.

• Compatible for use on most clinical analysers.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.CRP 1 Level Calibrator for Dilution Series 3 x 1ml CP2179CRP High Sensitivity 6 Level Series 7 x 2ml CP2478CRP Mid Range 6 Level Series 6 x 2ml CP2479CRP Full Range 6 Level Series 6 x 1ml CP2499

Page 32: Quality Control Brochure

FERRITIN CalibratorAnalyte Ferritin

Features• Ready to use liquid.

• Human-based product.

• Compatible for most clinical analysers.• Multi-level calibrator.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Ferritin Calibrator Series 6 x 1ml FN2491

FRUCTOSAMINE CalibratorAnalyte Fructosamine

Features• Lyophilised material.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Stable for 28 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Fructosamine Calibrator 3 x 1ml FR2993

mono31

GLUTATHIONE REDUCTASE CalibratorAnalyte Glutathione Reductase

Features• Lyophilised material.

• Human-based product.

• Compatible for use on most clinical analysers.

Stability• Lyophilised material stable to expiry when stored @ +2°C to +8°C.

• Stable for 24 hours @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Glutathione Reductase Calibrator 10 x 5ml GR2609

Page 33: Quality Control Brochure

LIPOPROTEIN (a) Calibrator SeriesAnalytes Lp(a)

Features• Lyophilised material.

• Five levels.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

• Reconstituted components are stable for 14 days @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Lipoprotein (a) Calibrator 5 x 1ml LP3404

MICROALBUMIN Calibrator Series

Analyte Albumin

Features• Ready to use liquid.

• Human-based product.

• Compatible for most clinical analysers.• Multi-level Calibrator.

Stability• Calibrators are stable to expiry when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.Microalbumin Calibrator Series 6 x 2ml MA1567

mono 32

Page 34: Quality Control Brochure

mono33

RHEUMATOID FACTOR Calibrator Series (Latex Enhanced Immunoturbidimetric)Analyte Rheumatoid Factor

Features• Ready to use liquid.

• Human-based product.

• Compatible for use on most clinical analysers.• Multi-level calibrator.

Stability• Stable to expiry date when stored @ +2°C to +8°C.

Ordering InformationProduct Description Size Cat No.RF Calibrator Series 5 x 1ml RF2301

MYOGLOBIN CalibratorAnalyte Myoglobin

Features• Lyophilised material.

• Compatible for use on most clinical analysers.• Multi-level calibrator.

Stability• Lyophilised material stable to expiry.

Ordering InformationProduct Description Size Cat No.Myoglobin Calibrator 4 x 1ml MY2456

Page 35: Quality Control Brochure

34

ALBUMIN (Human Serum Albumin) 45g/l 10 x 5 ST1089

AMMONIA SET 118 - 588mmol/l 9 x 10 ST655

BICARBONATE 25mmol/l 10 x 5 ST1589

CHOLESTEROL 5.17mmol/l 10 x 5 ST1590

CREATININE 177mmol/l 10 x 5 ST1588

CYANMETHAEMOGLOBIN SET 3.1 - 12.4mmol/l 8 x 10 ST656

GLUCOSE 5.5mmol/l 10 x 5 ST1591

ISE (Low Standard) Sodium 120.3mmol/l 10 x 2 IS737

Potassium 3.06mmol/l

Chloride 80.1mmol/l

ISE (HIgh Standard) Sodium 159.8mmol/l 10 x 2 IS738

Potassium 6.95mmol/l

Chloride 118.9mmol/l

PROTEIN 60g/l 10 x 5 ST1088

TOTALANTIOXIDANT STATUS 1.5mmol/l 10 x 1 NX2615

TRIGLYCERIDE (GLYCEROL) 2.26mmol/l 10 x 5 ST1592

URIC ACID 119 - 714mmol/l 10 x 5 ST1069

URINARY PROTEIN 1g/l 10 x 5 ST1568

STANDARDS

ANALYTES ASSIGNED VALUES SIZE CAT. NO.

Page 36: Quality Control Brochure

RIQAS

For further information, contact the RIQAS team on

Tel: + 44 (0) 28 9445 4399Fax: + 44 (0) 28 9445 4398E-mail: [email protected] or visit www.riqas.com

RIQAS ProgrammesRIQAS has been providing "Proficiency Testing Schemes" for laboratories worldwide for over 12years. Today, RIQAS offers 8 programmes with 160 analytes to circa 4500 participants in 60countries around the world. RIQAS is a dynamic, user-led scheme, which recognises that laboratory requirements varysignificantly and therefore offers a flexible programme choice. With a combined total of 60 yearsEQA experience, the RIQAS team are in an excellent position to offer quality EQA solutions. RIQASis continuously developing new programmes and innovative software for EQA.

e-transferAt present, the user-friendly, charted reports allow interpretation ofperformance ‘at a glance’. To advance this service, software trials are inprogress for the electronic transfer of results and reports. This will reduce theturn around time and cut down significantly on the amount of ‘paperwork’. Itwill also make it much easier to implement method changes.

UKAS AccreditationRIQAS, the external quality assessment scheme from Randox Laboratories is theworld’s first clinical EQA scheme to gain UKAS accreditation. The United Kingdom Accreditation Service is the sole national accreditationbody recognised by government to assess, against internationally agreedstandards, organisations that provide certification, testing, inspection andcalibration services*. The RIQAS EQA scheme has been recognised by the UKaccreditation body UKAS for providing a first class inter laboratory comparisonassessment service.

I N F O R M A T I O N I S P O W E R

35

0010 PT

*UKAS website www.ukas.com

Page 37: Quality Control Brochure

RIQAS RQ9126/aLIPID PROGRAMME

REFERENCE METHOD VALUES3 Analytes only (choose from 6)

samples every 2 weeks, 2 x 6 monthly cycles12 months subscription

RIQAS RQ9112GENERAL CLINICAL CHEMISTRYREDUCED SAMPLE PROGRAMME

REFERENCE METHOD VALUES10 Analytes only (choose from 41)

samples every 2 weeks, 2 x 6 monthly cycles12 months subscription

RIQAS RQ9113GENERAL CLINICAL CHEMISTRYREDUCED SAMPLE PROGRAMME

REFERENCE METHOD VALUESFull 41 Analytes, samples every 2 weeks2 x 6 monthly cycles 12 months subscription

RIQAS RQ9110GENERAL CLINICAL CHEMISTRY PROGRAMME

REFERENCE METHOD VALUES41 Analytes, weekly samples

2 x 6 monthly cycles12 months subscription

36

Programme Options

RIQAS RQ9127/bCARDIAC PROGRAMME

Full 7 Analytes, samples every 2 weeks2 x 6 monthly cycles, 12 months subscription

RIQAS RQ9111THERAPEUTIC DRUGS PROGRAMME

WEIGHED - IN VALUES18 Analytes, samples every 2 weeks

2 x 6 monthly cycles12 months subscription

RIQAS RQ9112/sGENERAL CLINICAL CHEMISTRYREDUCED SAMPLE PROGRAMME

REFERENCE METHOD VALUES17 Analytes only (choose from 41)

samples every 2 weeks, 2 x 6 monthly cycles12 months subscription

RIQAS RQ9114SPECIFIC PROTEINS PROGRAMME

24 Analytes, samples every 2 weeks2 x 6 monthly cycles

12 months subscription

RIQAS RQ9115HUMAN URINE PROGRAMME

24 Analytes, samples every 2 weeks2 x 6 monthly cycles

12 months subscription

RIQAS RQ9118HAEMATOLOGY PROGRAMME

8 Parameters, samples every 2 weeks2 x 6 monthly cycles

12 months subscription

RIQAS RQ9125/aIMMUNOASSAY PROGRAMME4 Analytes only (choose from 32)

samples every 2 weeks, 2 x 6 monthly cycles12 months subscription

RIQAS RQ9125/bIMMUNOASSAY PROGRAMME13 Analytes only (choose from 32)

samples every 2 weeks, 2 x 6 monthly cycles12 months subscription

RIQAS RQ9125/cIMMUNOASSAY PROGRAMME

Full 32 Analytes, samples every 2 weeks2 x 6 monthly cycles

12 months subscription

RIQAS RQ9126/bLIPID PROGRAMME

REFERENCE METHOD VALUESFull 6 Analytes, samples every 2 weeks

2 x 6 monthly cycles, 12 months subscription

RIQAS RQ9127/aCARDIAC PROGRAMME

2 Analytes only (choose from 7), samplesevery 2 weeks, 2 x 6 monthly cycles,

12 months subscription

Page 38: Quality Control Brochure

a AntioxidantProducts

DedicatedReagents forCX® & LX®

EnzymaticCreatinine

Drug Residue& E n v i r o n m e n t al

Te s t i n g

Fructosamine

1

HbA1C (glycated

Haemoglobin)

1investigator®

Brochure

Ferritin

HDL DirectLDL Direct

High SensitivityC R P

DedicatedReagents forDimension®

Dedicated Reagents for

Hitachi™

Diabetes

Cardiac Testing ClinicalPathology

Automation

ComplementComponent 3

ComplementComponent 4

C-ReactiveProtein

Alpha-1-Acid-Glycoprotein

Alpha-1-Antitrypsin

Anti-Streptolysin O

Food Analysis

I m m u n o t u r b i d i m e t r i cProteins

37

Brochures & CD’s Available from

Page 39: Quality Control Brochure

Lipase ProductProfile

R h e u m a t o i dF a c t o r

Syphilis

Transthyretin(Prealbumin)

Brochure

HDL & LDLCD

Product GuideCD

Syphilis BenchCard

TherapeuticDrugs

Total AntioxidantStatus &

Beverages

Transferrin

RIQAS Analytes RIQAS A Good EQA

Scheme

RIQASExplained

Quality ControlsIntro Brochure

Quality ControlsBrochure

QuantitativeSerodiagnostic

Assays

RanbutD-3-

Hydroxybutyrate

Renal Function

Lipoprotein (a) Microalbumin Powerline...the electronic

library

38

RIQASe-transfer CD

Free RadicalsCD

To order brochures and CD’s or if you require any further information email: [email protected]

Page 40: Quality Control Brochure

2001 June 2004 *All trademarks are recognised.

®

International Headquarters

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413, Fax: +44 (0) 28 9445 2912, E-Mail Address: [email protected]

www.randox.com

Randox have sales and distribution agreements in 130 countries. Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Iran, Italy,

Kyrgyzstan, Netherlands, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Africa, Spain and USAare directly represented by Randox Companies

DeutschlandRandox Laboratories GmbH

Kimplerstraße 288, 47807 Krefeld,Deutschland.

Tel: +49 (0) 2151 93 706 0 Fax: +49 (0) 2151 93 706 222

E s p a ñ aLaboratorios Randox S.L.

Comte Borrell 111 - 113, 1-5 08015 Barcelona.

Tel: +34 93 292 49 98Fax: +34 93 292 49 99

�eskoRandox S.R.O.

BHM, Sovadinova 7, 69002 Breclav 2, Czech Republic.

Tel/Fax: +420 (0) 627 325 278

ChinaRandox Diagnostics (Kunshan) Co. Ltd.,

Floor 4, West Side, No. 327 Tongfeng Road, Eco & Tec. Dev. Zone, Kunshan,

Jiangsu, P.R.C. Tel: +86 512 573 61956

Fax: +86 512 573 61960

CanadaRandox Laboratories Canada Ltd.

1021 Meyerside Drive, Unit 5, Mississauga, Ontario, Canada, L5T1J6.

Tel: +1 905 564 9372Fax: +1 905 564 8979

Kyrgyzstan Randox Laboratories

5 Microrayon, Building 57, Apartment 53, Bishkek, Kyrgyzstan, Central Asia.

Tel: +996 312 582 678Fax: +996 312 478 059

PolskaRandox Laboratories

ul. Wolnosc 7 lok. 15, 01-018, Warszawa.Tel: +48 (0) 22 862 1080Fax: +48 (0) 22 862 1081

Magyarország Randox Laboratories Ltd.

Magyarorszagi Kereskedelmi KepviseletiIrodaja, H-1029 Budapest,

Honfoglalás u. 40. C8, Hungary.Tel/Fax: +36 1 275 7964

France Laboratoires Randox,

BP82, 1115, rue Hélène Boucher, MontpellierFréjorgues, 34131 Mauguio Cedex, France

Tel: +33 (0) 4 99 13 67 40Fax: +33 (0) 4 99 13 67 41

Slovensko Randox S.R.O.

Ivanska Cesta 15, 82104 Bratislava, Slovakia.Tel/Fax: +421 2 4341 0832,

Tel: +421 2 4341 0833

South AfricaRandox Laboratories SA(Pty) Ltd.

Unit 6 Progress Park , Richards Drive,Midrand, South Africa.

Tel: +27 (011) 3159656Fax: +27 (011) 3159657

USARandox Laboratories

4065 Oceanside Blvd., Suite Q, Oceanside, CA92056. Tel: +1 760-639-1500,

Toll Free: 866 4 RANDOX Fax: +1 760-639-1509,

Toll Free: 866 RANDOX 1

Puerto RicoRandox de Puerto Rico

PMB 590 PO Box 29029 San Juan,PR 00929-0029.

Tel: +1 787 701 7000, Fax: +1 787 701 6901

Portugal Irlandox Laboratorios Quimica Analitica Ltda

Rua Agostinho de Jesus e Sousa 258, 4000 Porto, Portugal.

Tel: +351 22 589 8320, Fax: +351 22 589 8329

IndiaRandox Laboratories Ltd.

Madhur Business Centre, 3rd Floor,554 G. M. Bhosale Marg, Near Mahindra

Towers, Worli, Mumbai-400 018. Tel: +91 22 5662 6813, +91 22 5662 6814,

Fax: +91 22 5662 6815

ItaliaRandox Laboratories Ltd.

Via Casale Ferranti, 35/C 00173 Roma RM, Italia.

Tel: +39 06 721 53 72Fax: +39 06 721 53 76

BrasilRandox Brasil Ltda

Avenida Ibirapuera, 2120 - 19º andar - cj 191. CEP: 04028-001 - Moema - São Paulo - Brasil

Tel: +55 11 5051-3035Fax: +55 11 5052-3952

AustraliaRandox (Australia) Pty Ltd.Suite 3, 65 Nicholson Street,

St Leonards 2065, Sydney, Australia.

Tel: +61 29437 4800, Fax: +61 29437 4822