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C O M PA N Y
INTRODUCTION
Randox Laboratories Ltd. has over 20 years experience in the development, manufacture and marketing of high quality diagnostic reagents and equipment for laboratory medicine. Randox supply circa 35,000 laboratories in over 130 countries worldwide. All Randox reagents are manufactured under rigorous quality procedures to achieve the high quality standards expected in clinical science. A significant proportion of resources are invested in research and development to ensure kits are developed to the highest specifications and conform to international standards. Commitment to quality is emphasised by ISO13485 accreditation for the development and manufacture of diagnostic test kits. Randoxs 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 control materials, clinical reagents and environmental diagnostics.
RIQAS
RIQAS, the external quality assessment scheme from Randox Laboratories is the worlds first clinical EQA scheme to gain
UKAS 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, RIQAS offers 8 programmes with 160 analytes to circa 5000 participants in 59 countries. The 8 programmes currently available include general clinical chemistry, specific proteins, therapeutic drugs, human urine, lipids, immunoassay, cardiac and haematology.
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Randox have introduced a new internet-driven software package. The Peer Group reporting software utilises values from laboratories 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 analytical performance (internal quality control) and enables direct comparisons with laboratories worldwide (peer group reporting).
S
Page Number
Selecting a Control Product Control Matrix Assayed and Precision Sera Urine Controls Colour-Coded Controls Easy Selection Guide
3 3 3 3 4 4 5-6
MULTI CONTROLS
Cardiac Controls CSF Controls
7 8
MONO CONTROLS
Bilirubin Elevated / CRP / Fructosamine Controls G-6-PDH / Glutathione & TAS Controls / HbA1c Lipoprotein (a) / Microalbumin Urine Controls Myoglobin / Ransel & Ransod Controls Rheumatoid Factor Positive / Syphilis RPR/VDRL Controls 21 22 23 24 25
MULTI CALIBRATORS
Calibration Sera / Apolipoprotein A-1 & B Calibrators CK-MB / Haemoglobin A1c / Hitachi Series Calibrators ) / LDL & HDL-Cholesterol Calibrators IgE / Immunoglobulin ( Specific Protein Calibrators (Liquid) / Therapeutic Drugs Calibrators 26 27 28 29
MONO CALIBRATORS
ASO / CRP 1 Point Liquid / CRP Multi Point Liquid Calibrators Ferritin / Fructosamine / Glutathione Reductase Calibrators Lipoprotein (a) / Microalbumin Calibrators Myoglobin / Rheumatoid Factor Calibrators 30 31 32 33
STANDARDS
Mono and Multi Level Standards 34 35-36 37-38
RIQAS
Brochures & CDs Available
CONTROL MATRIX
Randox manufacture both human and bovine based control products for use in all laboratories. Lyophilised controls 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 high
performance 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 antigen and HIV I and II antibodies. Human-based sera offers a matrix consistent with human patient samples and offers high performance for up to 70 analytes. It is generally preferred for immunological methods including serum proteins and hormones.
All Randox control products are manufactured to the same high specifications using procedures recognised by ISO 13485.
Unassayed serum is generally referred to as precision serum and is used only for the control of reproducibility of results. Approximate values are assigned from a consensus mean of results from independent laboratories for the most common method.
EXAMPLE OF ASSAYED AND PRECISION INFORMATION SHEETS
ASSAYED INSERT
Target Value Calcium 2.21 (8.86 mmol/l 2.19 (mg/dl) (8.78 2.13 (8.54 2.15 (8.62 2.17 (8.70 2.14 (8.58 Range 1.99 - 2.43 7.98 - 9.74) 1.97 - 2.41 7.90 - 9.66) 1.92 - 2.34 7.70 - 9.38) 1.94 - 2.36 7.78 - 9.46) 1.96 - 2.38 7.86 - 9.54) 1.93 - 2.35 7.74 - 9.42) Atomic Absorption Arsenazo III Cresolphthalein complexone ISE Methylthymol Blue Dry Chemistry/Vitros
PRECISION INSERT
Calcium Approximate Value 2.67 mmol/l 10.70 mg/dl Method Cresolphthalein
URINE CONTROLS
Values for assayed urine controls are assigned from a consensus of results from approximately 600 independent laboratories. Approximate values for unassayed urine controls are generated by results from selected reference laboratories and assigned from 3 consensus of results obtained by these laboratories.
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COLOUR-CODED CONTROLS
Easy to use, colour-coded packaging will help distinguish between different levels and minimise costly errors. Colour-coded bottles, caps and boxes will also aid stock management and usage of the products in the laboratory. Colour-coded controls were introduced in 2003 however existing stocks will be in circulation until 2007.
The descriptions, low, medium and high are all generalisations. Some analytes will fall outside these classifications.
BOVINE ASSAYED HUMAN CLINICAL CHEMISTRY MULTI - SERA BOVINE PRECISION HUMAN ASSAYED URINE CONTROLS PRECISION CSF CONTROLS ASSAYED HUMAN HUMAN HUMAN
ASSAYED
HUMAN
ASSAYED
HUMAN
ASSAYED
HUMAN
LIPID CONTROLS
ASSAYED
HUMAN
CARDIAC CONTROLS
ASSAYED
HUMAN
ASSAYED
HUMAN
TM
Level 1
247 Software on CD
247 software is an internal quality control package for daily monitoring of laboratory performance. This software can be run for the duration of the 60-day trial at no cost to the customer. Cat. No. PR060
Level 2
Registration to use 247 software
Unregistered 247 software is valid for a trial period of 60 days. Software registration will re-activate the software for unlimited use. 247 software upgrades are available via a secure site at www.randox.com/247. Users must register to gain access to the secure site.
Level 3
Registration for Peer Group licence
Customers can register to use the 247 peer group programme for rapid upload and download of data at the touch of a button. Cat. No. QC4201
TEXT ON TUTORIAL
Randox has recently developed an educational tutorial to assist all new users of the 247 software. Our free interactive 247 tutorial contains explicit instructions, for example, on how to set up the data panels, enter results, run reports and upload results via the Internet. The tutorial contains an online help manual to ensure 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 view the progress of each member of staff as frequently as they wish. At the end of each section in the tutorial there is a self-assessment exercise that allows all users to test their knowledge and understanding of the 247 software programme. This multi-lingual tutorial will be provided on each individual 247 software disc.
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
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.
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.
Acid Phos., Prostatic Acid Phos., Total AFP Albumin Alkaline Phosphatase Alpha-1-acid glycoprotein Alpha-1-antitrypsin ALT (GPT) Amylase, Pancreatic Amylase, Total Apolipoprotein A-1 Apolipoprotein B AST (GOT) Bicarbonate Bile Acids Bilirubin, Direct Bilirubin, T tal o Caeruloplasmin Calcium Carbamazepine CEA Chloride Cholesterol, T tal o Cholinesterase CK,Total Complement C3 Complement C4 Copper Cortisol Creatinine CRP D-3-Hydroxybutyrate Digoxin Ferritin Folate Free Thyroxine (FT4) Free Triiodothyronine (FT3) Gentamycin GGT GLDH Glucose Haptoglobin HBDH hCG HDL-Cholesterol IgA IgE IgG IgM Iron Lactate LAP LD (LDH) Lipase Lithium Magnesium Myoglobin Non Esterified Fatty Acids Osmolality Paracetamol (Acetaminophen) Phenobarbital Phenytoin Phosphate, Inorganic Phospholipids Potassium Prealbumin Prolactin Protein, Total PSA, T tal o Salicylate Sodium Theophylline Thyroid Stimulating Hormone (TSH) Thyroxine (T4) TIBC Tobramycin Total Lipids Transferrin Triglycerides Triiodothyronine (T3) Troponin I Troponin T Urea Uric Acid (Urate) Valproic Acid Vancomycin REGISTER NOW Vitamin B12 www.randox.com/247 Zinc
CARDIAC Control
Human Assayed Serum Analytes 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. Lyophilised product stable to expiry. CK-MB stable in serum for 5 days @ +2C to +8C and 4 weeks @ -20C. CK Total, CK-MB (Activity), CK-MB (Mass), Homocysteine, Myoglobin, Troponin I, Troponin T.
Stability
Ordering Information
Product Description Tri-level Cardiac Control Size 3 x 1ml Cat No. CQ3100
Analyte CK Total CK-MB (Activity) CK-MB (Mass) Homocysteine Myoglobin Troponin I Troponin T
multi
CSF Controls
Human Assayed Control
for the control of up to seven components and five electrophoresis regions at two levels.
Analytes
Chloride, Glucose, IgG, Lactic acid, Sodium, Total Protein (Coomassie Blue), Total Protein (Pyrogallol Red). Electrophoresis - Albumin, -1-globulin, -2 globulin, -globulin, -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 @ +2C to +8C. Size 10 x 3ml 10 x 3ml Cat No. CF1500 CF1501
Ordering Information
Product Description CSF Control Level 2 CSF Control Level 3
multi
Analytes
Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc. Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT, Amylase Total, AST, CK Total, -GT, GLDH, -HBDH, LDH, Lipase. Total Cholesterol, Triglycerides, Total Lipids, NEFA. Albumin, Protein Total, Total PSA. Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid. Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.
Enzymes
Features
Bovine-based product. Lyophilised material. Method-, Instrument- and Temperature-specific values provided. Analyte range quoted. Compatible for use on most clinical analysers. Lyophilised material stable to expiry. Reconstituted stability of 7 days @ +2C to +8C, and one month when stored @ -20C. (Refer to characteristic sheet for exceptions)
Stability
Ordering Information
Product Description Bovine Assayed Multisera Level 1 Bovine Assayed Multisera Level 2 Bovine Assayed Multisera Level 3 Size 20 x 5ml 20 x 5ml 20 x 5ml Cat No. AL1027 AN1026 AE1032
multi
Analytes
Electrolytes Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc. Acid Phosphatase Prostatic, Acid Phosphatase Total, Alkaline Phosphatase, ALT, Amylase Total, AST, CK Total, -GT, GLDH, -HBDH, LDH, Lipase. Total Cholesterol, Triglycerides, Total Lipids. Albumin, Protein Total, PSA. Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Urea, Uric Acid. Bile Acids, Cortisol, Total T4, Free T4, T3, Osmolality, TIBC.
Enzymes
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. Lyophilised material stable to expiry. Reconstituted stability of 7 days @ +2C to +8C, and one month when stored @ -20C. (Refer to characteristic sheet for exceptions)
Stability
Ordering Information
Product Description Bovine Precision Multisera Level 1 Bovine Precision Multisera Level 1 Bovine Precision Multisera Level 2 Bovine Precision Multisera Level 2 Bovine Precision Multisera Level 3 Bovine Precision Multisera Level 3 Size 20 x 5ml 12 x 10ml 20 x 5ml 12 x 10ml 20 x 5ml 12 x 10ml Cat No. SL1084 SL1097 SN1085 SN1098 SE1086 SE1099
multi
10
Analytes
Drugs Electrolytes Electrophoresis Enzymes Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline, Tobramycin. Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc. -2-globulin, -1-globulin, -1-globulin, -globulin, Albumin. Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase, ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, -GT, GLDH, -HBDH, LAP, LDH, Lipase. NEFA, Phospholipids, Total Cholesterol, Total Lipids, Triglycerides. Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM, Protein Total, PSA, Transferrin. Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Lactate, Urea, Uric Acid. Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B 12.
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. Lyophilised material stable to expiry. Reconstituted stability of 7 days @ +2C to +8C, and one month when stored @ -20C. (Refer to characteristic sheet for exceptions) Size 5 x 5ml 20 x 5ml 5 x 5ml 20 x 5ml 5 x 5ml Cat No. HN2612 HN1530 HE2613 HE1532 HS2611
Stability
Ordering Information
Product Description Human Assayed Multisera Human Assayed Multisera Human Assayed Multisera Human Assayed Multisera Human Assayed Multisera Level 2 Level 2 Level 3 Level 3 Level 2 & 3
11
multi
Analytes
Drugs Digoxin, Gentamycin, Paracetamol (Acetaminophen), Salicylate, Theophylline, Tobramycin. Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Zinc. -2-globulin, -1-globulin, -1-globulin, -globulin, Albumin. Acid Phosphatase Prostatic, Acid Phosphatase Total, Aldolase, Alkaline Phosphatase, ALT, Amylase Total, Amylase Pancreatic, AST, Butyryl Cholinesterase, CK Total, -GT, GLDH, -HBDH, LAP, LDH, Lipase. NEFA, Phospholipids, Total Cholesterol, Total Lipids, Triglycerides. Protein Total, PSA, Albumin, Apolipoprotein A-1, Apolipoprotein B, IgA, IgG, IgM, Transferrin. Bilirubin Direct, Bilirubin Total, Creatinine, D-3-Hydroxybutyrate, Glucose, Lactate, Urea, Uric Acid. Bile Acids, Cortisol, Folate, Total T4, Free T4, T3, Osmolality, TIBC, TSH, Vitamin B 12.
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. Lyophilised material stable to expiry. Reconstituted stability of 7 days @ +2C to +8C, and one month when stored @ -20C. (Refer to characteristic sheet for exceptions) Size 20 x 5ml 12 x 10ml 20 x 5ml 12 x 10ml Cat No. UN1557 UN1562 UE1558 UE1559
Stability
Ordering Information
Product Description Human Unassayed Multisera Human Unassayed Multisera Human Unassayed Multisera Human Unassayed Multisera Level 2 Level 2 Level 3 Level 3
multi
12
IMMUNOASSAY Controls
Human Assayed
sera available in three levels for the control of accuracy and precision for up to 31 analytes.
Analytes Typical Values
Level
1 2 3 Units
AFP -2-Microglobulin CA 15-3 CA 19-9 CA 125 Carbamazepine CEA HCG Cortisol Digoxin Ferritin Folate Free Thyroxine (FT4) Free Triiodothyronine (FT3) FSH Growth Hormone IgE LH Oestradiol Phenytoin Progesterone Prolactin PSA-ACT 17-OH-Progesterone Testosterone Theophylline Thyroxine (T4) Triiodothyronine (T3) TSH Valproic Acid Vitamin B 12
9 40 150 0.97 2.76 7.36 23.9 44.4 72.8 10.9 24.8 80 13.7 65.6 104 13.4 36.3 66.3 12 25 50 15 69.0 250 190 628 1005 0.97 3.03 4.73 10.0 116 319 7.33 34.6 100 7.04 20.5 62.4 1.0 10.8 30.4 9.19 36.3 120 8.10 28.9 60.9 200 85 542 5.20 55.8 91.4 77.5 776 1647 19.4 64.0 87.1 3.02 33.8 109 186 1291 2274 1.13 16.5 33.7 4.89 26.9 68.2 6.61 20.3 45.1 30.4 81.4 173 12.7 120 180 0.67 4 9 0.12 2.51 39.8 232 452 920 184 458 928
IU/ml mg/l U/ml U/ml U/ml mol/l mol/l mIU/ml nmol/l nmol/l ng/ml nmol/l pmol/l pmol/l mIU/ml IU/ml IU/ml mIU/ml pmol/l mol/l nmol/l U/ml ng/ml nmol/l nmol/l mol/l nmol/l nmol/l IU/ml mol/l pmol/l
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. Lyophilised product stable to expiry. Reconstituted stability of 7 days @ +2C to +8C, 4 weeks @ -20C. Size 10 x 5ml 10 x 5ml 10 x 5ml 12 x 5ml Cat No. IA2638 IA2639 IA2640 IA2633
Stability
Ordering Information
Product Description Immunoassay Control Level 1 Immunoassay Control Level 2 Immunoassay Control Level 3 Tri-level Immunoassay Control
15
multi
LIPID Controls
Human Assayed Sera
for the control of up to seven lipid parameters at three levels.
Analytes Typical Values
Level
1 2 3 Units
HDL Cholesterol (Direct Liquid) HDL Cholesterol (Precipitation) LDL Cholesterol (Direct Liquid) LDL Cholesterol (Precipitation) Apolipoprotein A1 Apolipoprotein B Lipoprotein (a) Total Cholesterol Triglyceride
Features
Human-based sera. Lyophilised material. Target value and range quoted. Compatible for use on most clinical analysers. Lyophilised material stable to expiry. Stable for 1 month @ -20C when frozen once. Size 5 x 1ml 5 x 3ml 5 x 1ml 5 x 3ml 5 x 1ml 5 x 3ml Cat No. LE2668 LE2661 LE2669 LE2662 LE2670 LE2663
Stability
Ordering Information
Product Description Lipid Control Level 1 Lipid Control Level 1 Lipid Control Level 2 Lipid Control Level 2 Lipid Control Level 3 Lipid Control Level 3
multi
16
AFP Albumin -1-Antitrypsin -1-Acid Glycoprotein -2-Macroglobulin ASO Antithrombin -2-Microglobulin Caeruloplasmin C3 C4 CRP Haptoglobin IgA IgE IgG IgM Kappa Light Chain Lambda Light Chain Serum Ferritin RF RBP Total Protein Transferrin Transthyretin
15.4 16.6 0.72 0.47 0.9 109 14.4 0.18 0.17 0.66 0.14 27 0.68 1.27 78.3 9.41 0.63 8.32 3.49 86 37.4 1.8 40 1.03 0.12
30.8 33.6 1.31 0.92 2.12 230 30.4 0.32 0.24 1.33 0.29 52.5 1.34 2.55 184 13 1.75 11 7.02 171 69 5.45 60 2.16 0.24
46.7 49.2 1.91 1.39 3.02 340 47.3 0.48 0.39 1.91 0.44 80 1.97 3.71 286 20 2.5 16 10.9 260 114 8.10 100 3.19 0.35
U/ml g/l g/l g/l g/l IU/ml mg/dl mg/dl g/l g/l g/l mg/l g/l g/l U/ml g/l g/l g/l g/l ng/ml IU/ml mg/dl g/l g/l g/l
Features
Liquid sera. Human-based product. Method-specific values. Analyte range quoted. Compatible for use on most clinical analysers. Stable for up to 2 years after the date of manufacture. Size 3 x 1ml 3 x 1ml 3 x 1ml Cat No. PS2682 PS2683 PS2684
17
multi
Amikacin Caffeine Carbamazepine Cyclosporin Digoxin Ethosuximide Gentamicin Lithium Methotrexate Paracetamol
(Acetaminophen)
5.9 15.5 15.4 76.2 0.76 275 5.3 0.53 0.40 0.19 37.4 19.4 13.8 0.34 30.4 4.35 224 3.54
25.6 41.8 42.0 212 2.4 563 12.8 1.09 1.30 0.55 133 68.2 39.9 1.33 91.0 11.5 592 10.5
49.3 81.0 77.0 464 4.74 964 20.4 1.71 8.76 1.41 234 93.5 61.0 3.08 178 18.7 1008 19.3
mol/l mol/l mol/l nmol/l nmol/l mol/l mol/l mmol/l mol/l mmol/l mol/l mol/l mol/l mmol/l mol/l mol/l mol/l mol/l
Features
Human-based product. Lyophilised material. Method-specific values provided. Analyte range quoted. Compatible for use on most clinical analysers. Lyophilised product stable to expiry. Reconstituted stability of 4 weeks @ -20C. Size 20 x 5ml 20 x 5ml 20 x 5ml Cat No. HD1667 HD1668 HD1669
Stability
Ordering Information
Product Description Drug Control Level 1 Drug Control Level 2 Drug Control Level 3
multi
18
Analytes
Alpha foetoprotein (AFP) -2-Microglobulin CA 19-9 CA 125 CA 15-3 Carcinoembryonic Antigen (CEA) Cyfra 21 Ferritin Free PSA Human Chorionic Gonadotrophin (HCG) Neuron Specific Enolase (NSE) Prostatic Acid Phosphatase (PAP) Prolactin PSA-ACT Tissue Polypeptide Antigen (TPA) Total PSA
Analyte values are method specific, please request kit insert for details.
Features
Human-based, liquid sera. Target value and range quoted. Compatible for use on most clinical analysers.
Stability
Stable to expiry date when stored @ +2C to +8C. Size 9 x 2ml Cat No. IA2679
Ordering Information
19
multi
Analytes
Albumin, 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. Lyophilised material stable to expiry. After reconstitution the controls are stable for 5 days @ +2C to +8C or 14 days @ -20C. (Refer to characteristics sheet for exceptions) Size 12 x 10ml 12 x 10ml Cat No. AU2352 AU2353
Stability
Ordering Information
Product Description Urine Assayed Control Level 2 Urine Assayed Control Level 3
Analytes
Calcium, 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. Lyophilised material stable to expiry. After reconstitution the controls are stable for 5 days @ +2C to +8C or 14 days @ -20C. Cat No. UC1502 UC1503
Stability
Ordering Information
Product Description Size Urine Unassayed Control Level 2 10 x 10ml Urine Unassayed Control Level 3 10 x 10ml
multi
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BILIRUBIN (Elevated)
Assayed Serum
offers control for samples with elevated bilirubin levels (total and direct values quoted).
Analytes Features
Bovine-based serum. Lyophilised material. Method-specific values. Target values and ranges quoted.
Stability
Lyophilised material stable to expiry. Stable for 24 hours @ +2C to +8C after reconstitution when protected from light. Size 10 x 3ml Cat No. BE454
Ordering Information
Product Description Bilirubin Elevated Control
Stability
Stable to expiry date when stored @ +2C to +8C. Size 10 x 1ml 10 x 1ml 10 x 1ml 10 x 1ml Cat No. CP2480 CP2481 CP2476 CP2477
Ordering Information
Product Description CRP Liquid Control Level 2 CRP Liquid Control Level 3 S CRP High Sensitivity Control Level 1 S CRP High Sensitivity Control Level 2 S Liquid
FRUCTOSAMINE Controls
Analyte Features
Lyophilised material. Two control levels. Stable to expiry date when stored @ +2C to +8C. Reconstituted components are stable for 28 days @ +2C to +8C, and 28 days @ -20C. Size 3 x 1ml 3 x 1ml Cat No. FR2994 FR2996 Fructosamine
Stability
Ordering Information
Product Description Fructosamine Control Level 1 Fructosamine Control Level 3
21
mono
G-6-PDH Controls
Human Assayed Haemolysate
for the control of G-6-PDH (Glucose-6-phosphate dehydrogenase)
Analyte Features
Human-based whole blood. Lyophilised material. Target value and range quoted.
G-6-PDH
Stability
Lyophilised product stable to expiry when stored @ +2C to +8C. Stable for 7 days @ +2C to +8C after reconstitution. Size 6 x 0.5ml 6 x 0.5ml Cat No. PD2617 PD2618
Ordering Information
Product Description G-6-PDH Control Deficient G-6-PDH Control Normal
Analytes
G. Reductase TAS Glutathione Reductase Total Antioxidant Status Human-based, lyophilised sera 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 @ +2C to +8C. Glutathione Reductase has a reconstituted stability of 1 day @ +2C to +8C. TAS control has a reconstituted stability of 2 days @ +2C to +8C.
Ordering Information
Product Description Glutathione Reductase Control Total Antioxidant Status Control Size 10 x 5ml 10 x 5ml Cat No. GR2608 NX2331
Analyte
HbA1c / Hb
Haemoglobin A1c
Features
Liquid product. Two control levels. Reconstitution fluid provided. Stable to expiry date when stored @ +2C to +8C. Reconstituted controls stable for 3 months @ +2C to +8C. Size 2 x 0.25ml Cat No. HA3445
Stability
Ordering Information
Product Description HbA1c / Hb Level 1 & 2
mono
22
Stability
Ordering Information
Product Description Lipoprotein (a) Control Level 3
Analytes Features
Albumin
Human-based product. Lyophilised material. Target value and range quoted. Compatible for use on most clinical analysers. Lyophilised material stable to expiry @ +2C to +8C. After reconstitution the controls are stable for 5 days @ +2C to +8C. Size 10 x 1ml 10 x 1ml Cat No. MA1411 MA1412
Stability
Ordering Information
Product Description Microalbumin Urine Control Level 1 Microalbumin Urine Control Level 3
23
mono
MYOGLOBIN Control
Assayed Control
for the control of myoglobin levels in immunoturbidimetric based methods.
Analyte
Myoglobin
Features
Lyophilised material. Target value and range quoted. Suitable for Immunoturbidimetric methods.
Analytes
Ransel Ransod Glutathione Peroxidase 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 @ +2C to +8C. Ransel controls have a reconstituted stability of 3 days at +2C to +8 C. Ransod controls have a reconstituted stability of 10 days at +2C to +8 C.
Ordering Information
Product Description RANSEL Control RANSOD Control Size 10 x 1ml 10 x 1ml Cat No. SC692 SD126
mono
24
Analyte Features
Liquid ready to use. Target value and range quoted.
Rheumatoid Factor
Analytes Features
Liquid ready to use.
Stability
Stable to expiry date when stored @ +2C to +8C. Size 10 x 1ml Cat No. SY2202
Ordering Information
Product Description Syphilis RPR/VDRL Control Set
25
mono
CALIBRATORS
Randox manufacture calibration sera for a range of clinical chemistry analysers.
CALIBRATION SERA
Human-based material is available in two levels for the calibration of clinical analysers, offering values for up to 39 parameters. All calibration sera is human based lyophilised serum and component concentrations are available at two levels. Calibration sera is distributed to 3000 laboratories and values are assigned from a concensus of results obtained by these laboratories.
Analytes
Electrolytes- Bicarbonate, Calcium, Chloride, Copper, Iron, Lithium, Magnesium, Inorganic Phosphorous, Osmolality, Potassium, Sodium, Zinc. EnzymesAcid 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. Cholesterol, Triglycerides. Albumin, Total Protein.
LipidsProteins-
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. Lyophilised material stable to expiry @ +2C to +8C. After reconstitution the calibrators are stable for 7 days @ +2C to +8C and 4 weeks @ -20C. (See characteristic sheet for exceptions) Size 20 x 5ml 20 x 5ml Cat No. CAL2350 CAL2351
Stability
Ordering Information
Product Description Calibration Sera Level 2 Calibration Sera Level 3
Stability
Ordering Information
Product Description Apolipoprotein A-1 & B Calibrator
multi
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CK-MB Calibrator
Analytes Features
CK-MB, Total CK
Lyophilised material. Human-based product. Compatible for use on most clinical analysers. Lyophilised material stable to expiry @ +2C to +8C. After reconstitution the calibrator is stable for 5 days @+2C to +8C. Size 10 x 1ml Cat No. CK2393
Stability
Ordering Information
Product Description CK-MB Calibrator
Features
Liquid ready to use product. Values quoted for six levels.
Stability
Stable to expiry date when stored @ +2C to +8C. Size 5 x 2ml, 1 x 8ml Cat No. HA3444
Ordering Information
Product Description HbA1c / Hb Calibrator
Features
Lyophilised material. Human based product. For use on Hitachi 704, 705, 717, 911, 912 analysers.
Stability
Lyophilised material stable to expiry when stored @ +2C to +8C. Size 10 x 3ml Cat No. HC2314
Ordering Information
Product Description Hitachi Series Calibrator
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multi
Stability
Stable to expiry date when stored @ +2C to +8C. Stable for four weeks @ +2C to +8C after reconstitution. Size 6 x 1ml Cat No. IE2492
Ordering Information
Product Description IgE Calibrator Set
IMMUNOGLOBULIN Calibrator (
Analytes Features
Ready to use liquid. For use with immunoglobulin assays. IgA, IgG, IgM
Stability
Stable to expiry. Open vials are stable for 30 days @ +2C to +8C. Size 3 x 1ml Cat No. IT3861
Ordering Information
Product Description Immunoglobulin Calibrator ( )
Stability
Ordering Information
Product Description LDL & HDL Cholesterol Calibrator (CLEARANCE)
multi
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Analytes Features
Ready to use liquid.
ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, IgE, Prealbumin, Transferrin.
Stability
Stable to expiry date when stored @ +2C to +8C. Open vials are stable for 30 days @ +2C to +8C. Size 6 x 1ml Cat No. IT2691
Ordering Information
Product Description Specific Protein Calibrator (Liquid)
Analytes Features
Ready to use liquid. For use with Randox assays that require sample pre-dilution. Stable to expiry. Open vials are stable for 30 days @ +2C to +8C. Size 5 x 1ml Cat No. IT2692
Stability
Ordering Information
Product Description Specific Protein Calibrator (Liquid)
Stability
Ordering Information
Product Description Therapeutic Drugs Calibrator Calibration Sera
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multi
Stability
Stable to expiry date when stored @ +2C to +8C. Size 3 x 1ml Cat No. CP2178
Ordering Information
Product Description CRP Calibrator (1 Point Liquid)
Stability
Stable to expiry date when stored @ +2C to +8C. Size 3 x 1ml 7 x 2ml 6 x 2ml 6 x 1ml Cat No. CP2179 CP2478 CP2479 CP2499
Ordering Information
Product Description CRP 1 Level Calibrator for Dilution Series CRP High Sensitivity 6 Level Series CRP Mid Range 6 Level Series CRP Full Range 6 Level Series
mono
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FERRITIN Calibrator
Analyte Features
Ready to use liquid. Human-based product. Compatible for most clinical analysers. Multi-level calibrator. Ferritin
Stability
Stable to expiry date when stored @ +2C to +8C. Size 6 x 1ml Cat No. FN2491
Ordering Information
Product Description Ferritin Calibrator Series
FRUCTOSAMINE Calibrator
Analyte Features
Lyophilised material. Fructosamine
Stability
Stable to expiry date when stored @ +2C to +8C. Stable for 28 days @ +2C to +8C. Size 3 x 1ml Cat No. FR2993
Ordering Information
Product Description Fructosamine Calibrator
Stability
Ordering Information
Product Description Glutathione Reductase Calibrator
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mono
Stability
Ordering Information
Product Description Lipoprotein (a) Calibrator
Stability
Calibrators are stable to expiry when stored @ +2C to +8C. Size 6 x 2ml Cat No. MA1567
Ordering Information
Product Description Microalbumin Calibrator Series
mono
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MYOGLOBIN Calibrator
Analyte Features
Myoglobin
Lyophilised material. Compatible for use on most clinical analysers. Multi-level calibrator.
Stability
Lyophilised material stable to expiry.
Ordering Information
Product Description Myoglobin Calibrator Size 4 x 1ml Cat No. MY2456
Stability
Stable to expiry date when stored @ +2C to +8C. Size 5 x 1ml Cat No. RF2301
Ordering Information
Product Description RF Calibrator Series
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mono
STANDARDS
ANALYTES
ALBUMIN (Human Serum Albumin) AMMONIA SET BICARBONATE CHOLESTEROL CREATININE CYANMETHAEMOGLOBIN SET GLUCOSE ISE (Low Standard) Sodium Potassium Chloride ISE (HIgh Standard) Sodium Potassium Chloride PROTEIN TOTALANTIOXIDANT STATUS TRIGLYCERIDE (GLYCEROL) URIC ACID URINARY PROTEIN
ASSIGNED VALUES
45g/l 118 - 588mmol/l 25mmol/l 5.17mmol/l 177mmol/l 3.1 - 12.4mmol/l 5.5mmol/l 120.3mmol/l 3.06mmol/l 80.1mmol/l 159.8mmol/l 6.95mmol/l 118.9mmol/l 60g/l 1.5mmol/l 2.26mmol/l 119 - 714mmol/l 1g/l
SIZE
10 x 5 9 x 10 10 x 5 10 x 5 10 x 5 8 x 10 10 x 5 10 x 2
CAT. NO.
ST1089 ST655 ST1589 ST1590 ST1588 ST656 ST1591 IS737
10 x 2
IS738
10 x 5 10 x 1 10 x 5 10 x 5 10 x 5
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RIQAS
I N F O R M A T I O N I S P O W E R
RIQAS Programmes
RIQAS has been providing "Proficiency Testing Schemes" for laboratories worldwide for over 12 years. Today, RIQAS offers 8 programmes with 160 analytes to circa 4500 participants in 60 countries around the world. RIQAS is a dynamic, user-led scheme, which recognises that laboratory requirements vary significantly and therefore offers a flexible programme choice. With a combined total of 60 years EQA experience, the RIQAS team are in an excellent position to offer quality EQA solutions. RIQAS is continuously developing new programmes and innovative software for EQA.
e-transfer
At present, the user-friendly, charted reports allow interpretation of performance at a glance. To advance this service, software trials are in progress for the electronic transfer of results and reports. This will reduce the turn around time and cut down significantly on the amount of paperwork. It will also make it much easier to implement method changes.
UKAS Accreditation
RIQAS, the external quality assessment scheme from Randox Laboratories is the worlds first clinical EQA scheme to gain UKAS accreditation. The United Kingdom Accreditation Service is the sole national accreditation body recognised by government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services*. The RIQAS EQA scheme has been recognised by the UK accreditation body UKAS for providing a first class inter laboratory comparison assessment service.
0010 PT
Programme Options
RIQAS RQ9110 GENERAL CLINICAL CHEMISTRY PROGRAMME
REFERENCE METHOD VALUES
RIQAS RQ9112
GENERAL CLINICAL CHEMISTRY
REDUCED SAMPLE PROGRAMME REFERENCE METHOD VALUES
RIQAS RQ9112/s
GENERAL CLINICAL CHEMISTRY
REDUCED SAMPLE PROGRAMME REFERENCE METHOD VALUES
RIQAS RQ9126/a
LIPID PROGRAMME
REFERENCE METHOD VALUES 3 Analytes only (choose from 6)
samples every 2 weeks, 2 x 6 monthly cycles 12 months subscription
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Alpha-1-AcidGlycoprotein
Alpha-1Antitrypsin
Anti-Streptolysin O
Antioxidant Products
Cardiac Testing
Complement Component 3
Complement Component 4
C-Reactive Protein
Diabetes
Enzymatic Creatinine
1 investigator
Ferritin
Food Analysis
Brochure
Fructosamine
Immunoturbidimetric
Proteins
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Lipase
Lipoprotein (a)
Microalbumin
Product Profile
Ranbut D-3Hydroxybutyrate
Renal Function
Rheumatoid Factor
RIQAS Analytes
RIQAS Explained
Brochure
Syphilis
Therapeutic Drugs
Transferrin
Transthyretin (Prealbumin)
Free Radicals CD
Product Guide CD
RIQAS e-transfer CD
To order brochures and CDs or if you require any further information email: marketing@randox.com
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International Headquarters
Randox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY Tel: +44 (0) 28 9442 2413, Fax: +44 (0) 28 9445 2912, E-Mail Address: marketing@randox.com 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 USA are directly represented by Randox Companies
Australia Randox (Australia) Pty Ltd. Suite 3, 65 Nicholson Street, St Leonards 2065, Sydney, Australia. Tel: +61 29437 4800, Fax: +61 29437 4822
Brasil Randox Brasil Ltda Avenida Ibirapuera, 2120 - 19 andar - cj 191. CEP: 04028-001 - Moema - So Paulo - Brasil Tel: +55 11 5051-3035 Fax: +55 11 5052-3952
Canada Randox Laboratories Canada Ltd. 1021 Meyerside Drive, Unit 5, Mississauga, Ontario, Canada, L5T1J6. Tel: +1 905 564 9372 Fax: +1 905 564 8979
esko Randox S.R.O. BHM, Sovadinova 7, 69002 Breclav 2, Czech Republic. Tel/Fax: +420 (0) 627 325 278
China Randox 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
Deutschland Randox Laboratories GmbH Kimplerstrae 288, 47807 Krefeld, Deutschland. Tel: +49 (0) 2151 93 706 0 Fax: +49 (0) 2151 93 706 222
Espaa Laboratorios Randox S.L. Comte Borrell 111-113, 1-5 08015 Barcelona. Tel: +34 93 292 49 98 Fax: +34 93 292 49 99
France Laboratoires Randox, BP82, 1115, rue Hlne Boucher, Montpellier Frjorgues, 34131 Mauguio Cedex, France Tel: +33 (0) 4 99 13 67 40 Fax: +33 (0) 4 99 13 67 41
India Randox 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 Magyarorszg Randox Laboratories Ltd. Magyarorszagi Kereskedelmi Kepviseleti Irodaja, H-1029 Budapest, Honfoglals u. 40. C8, Hungary. Tel/Fax: +36 1 275 7964 Puerto Rico Randox de Puerto Rico PMB 590 PO Box 29029 San Juan, PR 00929-0029. Tel: +1 787 701 7000, Fax: +1 787 701 6901
Italia Randox Laboratories Ltd. Via Casale Ferranti, 35/C 00173 Roma RM, Italia. Tel: +39 06 721 53 72 Fax: +39 06 721 53 76
Kyrgyzstan Randox Laboratories 5 Microrayon, Building 57, Apartment 53, Bishkek, Kyrgyzstan, Central Asia. Tel: +996 312 582 678 Fax: +996 312 478 059
Polska Randox Laboratories ul. Wolnosc 7 lok. 15, 01-018, Warszawa. Tel: +48 (0) 22 862 1080 Fax: +48 (0) 22 862 1081
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
Slovensko Randox S.R.O. Ivanska Cesta 15, 82104 Bratislava, Slovakia. Tel/Fax: +421 2 4341 0832, Tel: +421 2 4341 0833
South Africa Randox Laboratories SA(Pty) Ltd. Unit 6 Progress Park, Richards Drive, Midrand, South Africa. Tel: +27 (011) 3159656 Fax: +27 (011) 3159657
USA Randox 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
2001
June 2004