Quality Control Serum PDF

- Quality Control Serum
The most accurate quality control material in the world

INTRODUCTION
0
WELCOME
Randox Laboratories Ltd. has been developing, manufacturing and improve. Rigorous quality procedures are used to achieve the high
marketing clinical diagnostic products and instruments worldwide for standards expected in clinical science. Our commitment to quality
30 years and is one of the worlds most reputable suppliers of Clinical is emphasised by ISO13485 accreditation for the development and
Chemistry reagents, Instruments and in particular, Quality Control manufacture of diagnostic test kits.
serum. The Randox product range also includes the revolutionary and
award winning Biochip Array Technology (BAT), which allows for the Our customer base exceeds 60,000 laboratories across the globe.
simultaneous testing of multiple analytes from a single patient sample. Randox products extend far beyond the typical hospital laboratory,
This style of testing can result in better patient care, by providing with applications in veterinary testing, food and wine testing, cosmetic
physicians with a full profile of the patient’s state of health without the testing, sports testing, employee screening, rapid point of care testing,
need for re-ordering tests. forensic toxicology and a wide range of research areas.
A significant proportion of resources is invested in Research & Our experience and expertise allow us to create a leading product
Development to ensure products are manufactured to the highest portfolio of high quality diagnostic tools which offer reliable and rapid
specifications and conform to International standards. This focus on diagnosis. We believe that by providing laboratories with the right
R&D also allows us to rapidly bring new products to the market and tools, we can improve the health status of individuals worldwide.
constantly review our existing range with the view to continually
“Revolutionising healthcare through continuously improving

diagnostic solutions”
For more information about Randox and for our full range of products, please visit www.randox.com,
or contact your local Randox representative.
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INTRODUCTION
0
Page No.
1. Clinical Chemistry 7-18

2. Immunoassay 19-24
3. Immunology/Proteins 25-30

4. Lipids 31-34
5. CARDIAC 35-38
6. Diabetes/HAEMOGLOBIN 39-42

7. Urine 43-46
8. Therapeutic Drugs 47-48
9. Toxicology 49-56
10. Coagulation 57-58
11. Blood Gas 59-60
12. Antioxidants 61-64
13. Speciality And Research Controls 65-74
14. 24/7 75-78
15. Customised Quality Control Sera 79-82
16. RIQAS 83-90
17. Analyte Index 91-105
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iNTRODUCTION
0
Introduction to Randox Acusera quality controls
Randox is one of the largest manufacturers of Quality Controls in the unassayed and human/bovine materials. Customers can even choose
world, whether it is our own branded Acusera portfolio of controls between multi-analyte controls or single analyte controls, depending
and calibrators, or customised material for individual laboratories, on their laboratory needs. In addition to this, Randox can also offer
research organisations, External Quality Assessment or Proficiency the laboratory a tailor made quality control material, should there be
Testing schemes and other diagnostic manufacturers. something you wish to adjust or change. This could be anything from
the number of analytes, vial sizes, concentrations or format we present
The Acusera range of Quality Controls and Calibrators covers over current products in.
300 parameters and guarantees excellent performance. Principle
control products include Clinical Chemistry, Immunoassay, Urine, Randox also offers Acusera 24•7, an interlaboratory peer group
Immunology/Proteins, Lipids, Cardiac, CSF, Therapeutic Drug reporting software package, which extends the capability of Internal
Monitoring, Toxicology, Urine Chemistry, Urinalysis, Coagulation, Quality Controls (IQC) by providing a tool to monitor and analyse
Blood Gas, Tumour Markers, Maternal Screening, Antioxidants, daily control data and compare results with other laboratories using
Diabetes and a number of researched based products. the same lot of control.
A wide range of formats are available providing greater flexibility

and choice. Our product range includes liquid/lyophilised, assayed/
Benefits of Randox Acusera
Material
The human based material used in the production of our Quality additional and often expensive low or high level controls.
Controls is sourced from the United Kingdom Blood Transfusion For example Troponin levels in the level 1 control from some
Service. All donors are screened for HIV, Hepatitis A, B, C, HTLV manufacturers do not adequately cover the cut-off levels used in
and Syphilis, using immunoassay techniques to detect antibodies diagnosis. This often results in the need for additional controls to
and specific DNA tests to detect any viruses even at early stages of cover these lifesaving concentrations. The levels of Troponin I and
infection. This view to safety and quality is the trademark of Randox Troponin T in our Cardiac and Liquid Cardiac controls are in line with
control manufacture. The integrity of our base materials is a critical internationally recommended levels.
factor in producing highly stable and consistent controls.
Randox also employs easy to use colour-coded packaging to help
Unlike many of our competitors Randox lyophilised Quality distinguish between different levels and reduce costly mix-ups.
Controls have no added preservatives or stabilisers which can cause
interference problems. The excellent stability seen with Randox
controls is achieved through superior manufacturing techniques and Value Assignment
strict adherence to a regulated quality manufacturing regime. All Randox controls are the most accurately assigned controls available
Randox quality controls are filtered down to 0.2 microns to ensure in the diagnostic industry! This has been made possible through
minimal bacterial load and contamination. access to a unique database of results provided by over 18,000
independent laboratories. This, coupled with unrivalled traceability
Many manufacturers, in an attempt to keep down their to International Reference Laboratories, provides a product of
manufacturing costs and remain competitive, add constituents of unsurpassed accuracy and reliability.
animal origin to their control products. At best these controls can
be described as “human based”. The use of such controls can cause For effective Internal Quality Control, an assayed serum should have
problems with antibody based tests due to differences in antibody an accurately assigned target value and range for each analyte; this will
specificity towards non human components. allow laboratories to reliably measure the accuracy and precision of
their automated or manual methods.
Many of our controls are 100% human and are manufactured using
exclusively human components therefore they do not suffer from such The assigned value for each analyte is generally a consensus mean
matrix problems. obtained from several laboratories. Obviously the more laboratories
employed, the better; smaller numbers usually result in large standard
deviations and subsequently unrealistic wide ranges. In fact, with some
Concentrations & Levels manufacturers the ranges are often so wide that laboratories are
Many manufacturers ‘cut corners’ or take shortcuts in an attempt to unlikely to fall outside them regardless of their performance.
keep costs down. This often results in unrealistic values, parameter
imbalances, a frequent lack of differentiation between levels and Sometimes disclaimers are included with other manufacturers controls
ultimately in controls that do not completely cover the clinical range. advising users to establish their own targets and ranges and use those
In many situations these inadequacies force laboratories to purchase provided in the product insert as a guide only. These disclaimers serve
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INTRODUCTION
0
Traceability
to highlight issues with regards to the reliability of the quoted data and Traceability refers to the property of a measured result or calibrator value
open questions as to how reliable the value assignment is in the first to be related or traced back to a reference measurement procedure
place. In reality, a limited number of laboratories are normally used or reference material through a series of measurements with known
uncertainties.
prior to releasing the batch, which could explain the inconsistencies
in the results reported between batches and why sometimes control The values assigned to both calibrators and control materials are required
values are changed and updated during the shelf life of the control by the European parliament and council directive 98/79/EC on in vitro
as more data is generated. Sometimes many parameters are listed in diagnostic medical devices to be traceable to a recognised reference
promotional material, but target values or ranges for certain analytes material or reference measurement procedure of higher order e.g. SI units.
are not always available or values may only become available after
release of the batch into the market. Most often these additional, The European standards EN/ISO 17511 and EN/ISO 18153 on traceability
no-value analytes are only present in the material at endogenous have set guidelines for diagnostic manufacturers to follow when assigning
calibrator values and establishing traceability. Randox Quality Control
levels and will be of little or no use to laboratories who will have to
products are CE marked signifying quality.
purchase additional control material at meaningful concentrations.
The following traceability pathway has been established with reference
Stability to standards ISO17511 and ISO18153 and has been followed to
Product shelf-life and reconstituted stability is another important establish traceability for Randox calibrators allowing patient results to
consideration when looking at controls. Randox lyophilised controls be traced back to the source.
are generally stable for 4 years from the date of manufacture,
ensuring continuity of supply for longer. Our liquid controls generally
have a two year shelf life, whether they are liquid frozen at -20ºC
or liquid stable at +2-8ºC. Each individual control will have its own Traceability Pathway
reconstituted or open vial stability claims and some parameters will
have limitations, but we pride ourselves by not trying to mislead Primary reference
customers with false claims. measurement procedure
Primary calibrator International
Scientific
We have seen examples where competing products fail to meet Secondary reference Organisations
measurement procedure
the stability claims listed in promotional materials or where stability
limitations vary from batch to batch. In some cases, stability reductions
are issued on a regular basis once the product has entered the market.
These anomalies are frustrating for the end-user and invariably result
in cost implications and mean they use much more control material Manufacturer’s selected
Secondary calibrator
than intended. measurement procedure
METROLOGICAL TRACEABILITY
Third Party Controls Manufacturer’s Manufacturer’s standing IVD

One of the most important points to highlight is that Randox controls working calibrator measurement procedure Manufacturer
UNCERTAINTY OF MEASUREMENT
are True Third Party controls! By this we mean that our material
has not been manufactured in line with, or optimised for use with Manufacturer’s
Trueness controls
any particular reagent, method or instrument and is designed to product calibrator
be compatible for use on any analyser. Also, when assigning targets
and ranges, Randox use totally independent laboratories, resulting in
genuinely independent, multi-method and multi-analyser data.
Instrument and reagent manufacturers often directly assign their own Routine sample or Lab’s routine
Laboratories
control material measurement procedure
control values meaning very few sets of results are used over very
few reagent batches. The resulting target values are therefore not as
accurate as an assayed control ought to be.
Patient result/Randox acusera control result
Adopted from EN ISO 17511

Tracing patient results to the origin
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iNTRODUCTION
0
Commitment to Quality
Randox is committed to quality at every stage of the production process from research and development to customer support. This
commitment has been recognised through official accreditation to both national and international standards including UKAS and ISO.
Accreditation to international standards ensures confidence in the quality and consistency of the products and services provided by Randox,
and demonstrates compliance to internationally agreed standards.
UKAS ISO 13485:2003

The United Kingdom Accreditation Service (UKAS) is the only The International Organisation for Standardization (ISO) is the largest
national accreditation body recognised by the government to assess developer and publisher of international standards in the world. In 2003,
against internationally agreed standards. Randox was accredited with ISO 13485:2003 approval.
In 2002 the systems and procedures within Randox Laboratories ISO 13485:2003 relates to the design/development, manufacture, service
Ltd were accredited with UKAS approval to ISO/IEC Guide and distribution of in vitro diagnostic medical devices, in vitro diagnostic test
43-1:1997 “Proficiency testing by interlaboratory comparisons Part 1: kits, in vitro diagnostic reagents and in vitro diagnostic analysers.
Development and operation of proficiency testing schemes through
assessment against ILAC-G13:2007 - Guidelines for the Requirements ISO 13485:2003 highlights the requirements for a quality management
for the Competence of Providers of Proficiency Testing Schemes”. system where an organisation needs to prove its ability to provide medical
As such the systems and procedures within Randox Laboratories also devices and other related services that consistently meet regulatory
comply with the requirements set out by CPA (Clinical Pathology requirements.
Accreditation) and NATA (Association of Testing Authorities Australia).
CE Mark FDA Cleared

Many of our Quality Control (QC) products are CE certified and Many of our quality controls and calibrators are FDA cleared and
carry the CE mark. CE marking on a product indicates that the therefore appropriate for sale in the USA. In order for an IVD to
product complies with and has satisfied the essential requirements be approved for sale in the USA it must not only be safe for use and
set out by the In Vitro Diagnostic (IVD) Medical Devices Directive effective but it must also satisfy the requirements set out in part 820
98/79/EC, it also demonstrates the fact the product is fit for its title 21 of the Code of Federal Regulations published by the FDA.
intended purpose.
The CE mark is also a declaration from the manufacturer that the

product has met all legislation in relation to health and safety and
where required has been assessed in accordance with this legislation.
CE marking is essential for products to be placed on the market and

sold in the European Union (EU). It also ensures the free movement
of product within the EFTA and EU. Queen’s Award for Enterprise
In 2007 Randox received the Queen’s Award for Enterprise. This
was Randox’s fifth Queens Award with previous awards for Export
Canadian Medical Device Regulations Achievement received in 1990, 1993, 1997 and the Queen’s Award
from Health Canada for Enterprise received in 2001.
Many Randox products, including our quality controls and calibrators, The Queens Award is a highly prestigious and coveted prize that
are licensed for use in Canada. Before an IVD device can be sold in recognizes the outstanding achievements Randox has made in
Canada, it must meet the requirements set out in the Therapeutic innovation, international trade and sustainable development.
Products Directorate. Health Canada review all medical devices to
assess their safety, effectiveness and quality before they are authorised The award is testimony to the hard work and dedication of Randox in
for sale. the global diagnostics market.
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Clinical Chemistry 1
Controls
Chapter 1
CLINICAL CHEMISTRY
1 Clinical Chemistry product range

PRODUCT DESCRIPTION SIZE CAT. NO.
Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048
Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049
Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069
Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070
Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071
Chemistry Premium Level 2 12 x 5 ml HN5067
Chemistry Premium Level 3 12 x 5 ml HE5068
Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532
Assayed Chemistry Premium Plus Level 2 & 3 10 x 5 ml HS2611
Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558
Bovine Chemistry (Assayed) Level 1 20 x 5 ml AL1027
Bovine Chemistry (Assayed) Level 2 20 x 5 ml AN1026
Bovine Chemistry (Assayed) Level 3 20 x 5 ml AE1032
Bovine Chemistry (Precision) Level 1 20 x 5 ml SL1084
Bovine Chemistry (Precision) Level 2 20 x 5 ml SN1085
Bovine Chemistry (Precision) Level 3 20 x 5 ml SE1086
Clinical Chemistry Calibration Sera Level 2 20 x 5 ml CAL2350
Clinical Chemistry Calibration Sera Level 3 20 x 5 ml CAL2351
Aldolase Calibrator 3 x 1 ml AD5000
Aldolase Control Level 2 3 x 1 ml AD5001
Ammonia / Ethanol Control Level 1 6 x 2 ml EA1366
Bilirubin Elevated Control 10 x 3 ml BE454
Glycerol Control Level 1 3 x 5 ml GY1369
Multi Calibrator 3 x 2 ml MC1382
Multi Control Level 1 5 x 2 ml MC1379
Glutamine Control Level 1 5 x 5 ml GM1376
Glutamine Calibrator 10 x 5 ml GM1375
Serum Diluent 20 x 5 ml MS5007
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CLINICAL CHEMISTRY
Liquid CHEMISTRY PREMIUM - Unassayed Control 1
Analytes
Cardiac Lipids Drugs Bicarbonate

CK Apolipoprotein A-I Carbamazepine Bile Acids
Myoglobin Apolipoprotein B Digoxin Bilirubin (Direct)
Troponin I Cholesterol Ethanol Bilirubin (Total)
Troponin T Cholesterol (HDL) Gentamicin Cholinesterase
Cholesterol (LDL) Lithium Calcium
Electrophoresis LP(a) Paracetamol (Acetaminophen) Calcium (ionised)
Albumin Triglycerides Phenobarbital Chloride
a-1-globulin Phenytoin Creatinine
a-2-globulin Proteins Salicylate gGT
b-1-globulin a-1-Acid Glycoprotein Theophylline Glucose
g-globulin a-1-Antitrypsin Valproic Acid GLDH
Ceruloplasmin Vancomycin a-HBDH
Immunoassay Complement C3 D-3-Hydroxybutyrate
AFP Complement C4 Trace Metals Iron
CEA CRP Copper TIBC
Cortisol Ferritin Zinc LAP
Folate Haptoglobin LD (LDH)
Free T3 IgA ROUTINE Chemistry Lipase
Free T4 IgE Acid Phosphatase (Prostatic) Lactate
hCG IgG Acid Phosphatase (Total) Magnesium
Prolactin IgM Albumin Osmolality
Total T3 Prealbumin Alkaline Phosphatase Phosphate (Inorganic)
Total T4 Total Protein ALT (GPT) Potassium
TSH Transferrin Amylase Sodium
Vitamin B12 Amylase (Pancreatic) Urea
AST (GOT) Uric Acid(Urate)
A comprehensive chemistry control designed for use in the routine monitoring of precision. Suitable for use with all major instruments and
methodologies, contains 92 analytes including routine chemistries, cardiac parameters, proteins, immunoassay parameters, lipids, therapeutic drugs and
electrophoresis.
• Liquid for ease of use

• Human based serum
• Stable to expiry date when at -20 ºC – 70 ºC
• Open vial stability of 7 days at +2 - 8 ºC
Description Size Cat. No.

Liquid Chemistry Premium Level 2 12 x 5ml LUN5048
Liquid Chemistry Premium Level 3 12 x 5ml LUE5049
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CLINICAL CHEMISTRY
1 LIQUID CHEMISTRY PREMIUM PLUS - Unassayed Control
Analytes
Cardiac TSH ROUTINE Chemistry Phosphate (Inorganic)

CK T uptake Acid Phosphatase (Prostatic) Potassium
CK-MB Vitamin B12 Acid Phosphatase (Total) Sodium
Myoglobin Albumin Urea
Troponin I Lipids Alkaline Phosphatase Uric Acid (Urate)
Troponin T Apolipoprotein A-1 ALT (GPT)
Apolipoprotein B Amylase Drugs
Electrophoresis Cholesterol Amylase (Pancreatic) Amikacin
Albumin HDL AST (GOT) Caffeine
a-1-globulin LDL Bicarbonate Carbamazepine
a-2-globulin LP(a) Bile Acids Digoxin
b-1-globulin Triglycerides Bilirubin (Direct) Ethanol
g-globulin Bilirubin (Total) Gentamicin
Proteins Cholinesterase Lithium
Immunoassay a-1-Acid Glycoprotein Calcium Paracetamol
AFP a-1-Antitrypsin Calcium (Ionised) Phenobarbital
CEA β-2-microglobulin Chloride Phenytoin
Cortisol Ceruloplasmin Creatinine Salicylate
DHEA Sulphate Complement C3 γGT Theophylline
Folate Complement C4 Glucose Valproic Acid
Free T3 CRP GLDH Vancomycin
Free T4 Ferritin a-HBDH
FSH Haptoglobin D-3-Hydroxybutyrate Trace Metals
GH IgA Iron Copper
hCG IgE TIBC Zinc
LH IgG LAP
Progesterone IgM LD (LDH)
Prolactin Prealbumin Lipase
Total T3 Total Protein Lactate
Total T4 Transferrin Magnesium
Testosterone Osmolality
Multi-analyte chemistry control designed for use in the routine monitoring of precision. The most comprehensive chemistry control available
includes more than100 analytes including routine chemistries, cardiac markers, lipids, therapeutic drugs, proteins, immunoassay parameters and
electrophoresis.
• Liquid for ease of use

• High CRP levels also eliminate the need for separate controls
• Stable to expiry date at -20 ºC – 70 ºC

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CLINICAL CHEMISTRY
CHEMISTRY PREMIUM CONTROL 1
Analytes
Cardiac Proteins Amylase Lactate

CK IgA Amylase (Pancreatic) LAP
IgG AST LD (LDH)
IgM Bilirubin (Direct) Lipase
Drugs Total Protein Bilirubin (Total) Magnesium
Lithium Transferrin Calcium Phosphate (Inorganic)
Chloride Potassium
Cholinesterase Sodium
Lipids ROUTINE Chemistry Creatinine TIBC
Cholesterol Acid Phosphatase (Prostatic) gGT UIBC
Triglycerides Acid Phosphatase (Total) Glucose Urea
Albumin GLDH Uric Acid (Urate)
Alkaline Phosphatase (ALP) a-HBDH
ALT (GPT) Iron
A multi-analyte, assayed control designed for use in the routine monitoring of both accuracy and precision. Temperature specific target values and ranges
are provided for the most common methods covering 40 analytes including routine chemistries and proteins.
• Lyophilised for enhanced stability

• Stable to expiry date at +2 - 8 ºC
• Reconstituted stability of 7 days at +2 - 8 ºC or 4 weeks at -20 ºC

Chemistry Premium Level 2 12 x 5 ml HN5067
Chemistry Premium Level 3 12 x 5 ml HE5068
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CLINICAL CHEMISTRY
1 ASSAYED CHEMISTRY PREMIUM PLUS CONTROL
Analytes
Lipids Immunoassay Trace Metals GLDH

Apolipoprotein A-1 Cortisol Copper α-HBDH
Apolipoprotein B Folate Zinc D-3-Hydroxybutyrate
Cholesterol PSA Iron
NEFA TSH ROUTINE Chemistry TIBC
Triglycerides Total T3 Acid Phosphatase (Prostatic) LAP
Free T4 Acid Phosphatase (Total) LD (LDH)
Cardiac Total T4 Albumin Lipase (Colorimetric)
CK Vitamin B12 Alkaline Phosphatase (ALP) Lipase (Turbidimetric)
ALT (GPT) Lactate
Drugs Proteins Amylase Magnesium
Digoxin IgA Amylase (Pancreatic) Osmolality
Gentamicin IgG AST (GOT) Phosphate (Inorganic)
Lithium IgM Bicarbonate Potassium
Paracetamol Total Protein Bile Acids Sodium
Salicylate Transferrin Bilirubin (Direct) Urea
Theophylline Bilirubin (Total) Uric Acid
Tobramycin Electrophoresis Cholinesterase
Albumin Calcium
a-1-globulin Chloride
a-2-globulin Creatinine
b-1-globulin Glucose
g-globulin γGT
A comprehensive assayed chemistry control designed for use in the routine monitoring of both accuracy and precision. This product contains method,
instrument and temperature specific target values and ranges for 68 analytes on a wide range of analysers. Electrophoresis targets are also provided as a
% breakdown of total protein.

• Typical Osmolality values: Level 2 is 300 mOsm/kg, Level 3 is 370 mOsm/kg

Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532
Assayed Chemistry Premium Plus Level 2 & 3 10 x 5 ml HS2611
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CLINICAL CHEMISTRY
precision Chemistry premium plus CONTROL 1
Analytes
Cardiac Lipids Gentamicin Bilirubin (Total)

CK Apolipoprotein A-I Lithium Cholinesterase
Myoglobin Apolipoprotein B Paracetamol (Acetaminophen) Calcium
Troponin I Cholesterol Phenobarbital Chloride
NEFA Phenytoin Creatinine
Electrophoresis Triglycerides Salicylate gGT
Albumin Theophylline Glucose
Proteins Tobramycin GLDH
a-1-globulin
Alpha-1-Acid Glycoprotein Valproic Acid a-HBDH
a-2-globulin D-3-Hydroxybutyrate
Alpha-1-Antitrypsin Vancomycin
b-1-globulin Iron
Caeruloplasmin
Gamma-globulin TIBC
Complement C3 Trace Metals
Complement C4 LAP
Copper
Immunoassay CRP LD (LDH)
Zinc Lipase
AFP Ferritin
CEA Haptoglobin Lactate
Cortisol ROUTINE Chemistry Magnesium
IgA
Folate Acid Phosphatase (Prostatic) Osmolality
IgE
Free T3 Acid Phosphatase (Total) Phosphate (Inorganic)
IgG
Free T4 Albumin Potassium
IgM
hCG Alkaline Phosphatase Sodium
Prealbumin
Prolactin ALT (GPT) Urea
Total Protein
PSA Amylase Uric Acid (Urate)
Transferrin Amylase (Pancreatic)
Total T3
Total T4 AST (GOT)
TSH Drugs Bicarbonate
Vitamin B12 Carbamazepine Bile Acids
Digoxin Bilirubin (Direct)
Multi-analyte control designed for use in the routine monitoring of precision. Contains 89 analytes including a wide range of proteins, lipids and
immunoassay parameters with additional analytes present at measurable levels.

• Stable to expiry date at +2 - 8ºC
• Reconstituted stability of 7 days at +2 - 8ºC or 4 weeks at -20ºC

Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558
13
CLINICAL CHEMISTRY
1 BOVINE CHEMISTRY ASSAYED CONTROL
Analytes
Lipids Proteins ROUTINE Chemistry

Cholesterol Total Protein Acid Phosphatase (Prostatic) GLDH
NEFA Acid Phosphatase (Total) α-HBDH
Triglycerides Trace Metals Albumin D-3-Hydroxybutyrate
Copper Alkaline Phosphatase (ALP) Iron
Cardiac Zinc ALT (GPT) Lactate
CK Amylase LD (LDH)
AST (GOT) Lipase
Drugs Bicarbonate Magnesium
Lithium Bile Acids Osmolality
Bilirubin (Direct) Phosphate (Inorganic)
Immunoassay Bilirubin (Total) Potassium
Cortisol Calcium Sodium
PSA Chloride TIBC
Total T3 Creatinine Urea
Free T4 Glucose Uric Acid
Total T4 γGT
A comprehensive bovine based, assayed serum designed for use in the routine monitoring of accuracy and precision. This product contains method,
instrument and temperature specific values for 44 analytes and is especially suited to veterinary laboratories, due to the inclusion of commonly used
veterinary parameters such as NEFA, Bile Acids, Lactate and D-3-Hydroxybutyrate.


Bovine Chemistry Assayed Level 1 20 x 5 ml AL1027
Bovine Chemistry Assayed Level 2 20 x 5 ml AN1026
Bovine Chemistry Assayed Level 3 20 x 5 ml AE1032
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CLINICAL CHEMISTRY
BOVINE CHEMISTRY precision CONTROL 1
Analytes
Lipids Proteins ROUTINE Chemistry

Cholesterol Total Protein Acid Phosphatase (Prostatic) α-HBDH
NEFA Acid Phosphatase (Total) D-3-Hydroxybutyrate
Total Lipids Trace Metals Albumin Iron
Triglycerides Copper Alkaline Phosphatase (ALP) Lactate
Zinc ALT (GPT) LD (LDH)
Cardiac Amylase Lipase
CK AST (GOT) Magnesium
Bicarbonate Osmolality
Drugs Bile Acids Phosphate (Inorganic)
Lithium Bilirubin (Direct) Potassium
Bilirubin (Total) Sodium
Immunoassay Calcium TIBC
Cortisol Chloride Urea
PSA Creatinine Uric Acid
Total T3 Glucose
Free T4 γGT
Total T4 GLDH
A comprehensive bovine based serum designed for use in the routine monitoring of precision. Contains 45 analytes including commonly used veterinary
parameters such as NEFA, Bile Acids, Lactate and D-3-Hydroxybutyrate.


Bovine Chemistry Precision Level 1 20 x 5 ml SL1084
Bovine Chemistry Precision Level 2 20 x 5 ml SN1085
Bovine Chemistry Precision Level 3 20 x 5 ml SE1086
15
CLINICAL CHEMISTRY
1 CLINICAL CHEMISTRY CALIBRATION SERUM
Analytes
Lipids Routine Chemistry

Cholesterol Acid Phosphatase (Non-Prostatic) Cholinesterase Potassium
Triglycerides Acid Phosphatase (Prostatic) Creatinine Sodium
Acid Phosphatase (Total) D-3-Hydroxybutyrate TIBC
Cardiac Albumin γGT Urea
CK Alkaline Phosphatase (ALP) GLDH Uric Acid
ALT (GPT) Glucose
Drugs Amylase (Pancreatic) α-HBDH
Lithium Amylase (Total) Iron
AST Lactate
Proteins Bicarbonate LDH
Total Protein Bile Acids LAP
Bilirubin (Direct) Lipase
Trace Metals Bilirubin (Total) Magnesium
Copper Calcium Phosphate (Inorganic)
Zinc Chloride
Multi-analyte calibrator designed for use in the calibration of commonly used clinical chemistry parameters. Method, instrument and temperature
specific values are provided for 41 analytes on a wide range of clinical analysers.


Clinical Chemistry Calibration Serum Level 2 20 x 5 ml CAL2350
Clinical Chemistry Calibration Serum Level 3 20 x 5 ml CAL2351
16
CLINICAL CHEMISTRY
ALDOLASE CONTROL & CALIBRATOR 1
Human based materials designed for use in the calibration and control of aldolase assays.

• Reconstituted stability of 5 days at +2 - 8oC

Aldolase Calibrator 3 x 1 ml AD5000
AMMONIA / ETHANOL CONTROL
Analytes
Ammonia Ethanol
A liquid ready to use control designed to monitor both the accuracy and precision of Ammonia and Ethanol assays.
• Liquid ready to use


BILIRUBIN (ELEVATED) CONTROL
Analytes
Total Bilirubin Direct Bilirubin
A bovine based serum control designed for use in the routine monitoring of both accuracy and precision. This product is suitable for monitoring
paediatric bilirubin levels and contains method specific target values and ranges.

• Reconstituted stability of 5 days at +2 - 8 ºC

Bilirubin Elevated Control 10 x 3 ml BE454
17
CLINICAL CHEMISTRY
1 GLYCEROL CONTROL
Dedicated Glycerol control designed for use in the routine monitoring of both accuracy and precision.


Glycerol Control Level 1 3 x 5 ml GY1369
MULTI CONTROL & CALIBRATOR
Analytes
Ammonia Glutamate
Glucose Lactate
A multi-analyte control designed for use in the routine monitoring of accuracy and precision.


Multi Calibrator 3 x 2 ml MC1382
Glutamine CONTROL
A dedicated control designed for use in the quality control of the Randox Glutamine assay.

• 100% human material
• Stable to expiry at +2 - 8ºC
• Reconstituted stability of 7 days at +2 - 8ºC

Glutamine Calibrator 10 x 5 ml GM1375
18
Immunoassay Controls 2
Chapter 2
IMMUNOASSAY
Immunoassay product range

Immunoassay Control Premium Level 1 10 x 5 ml IA2638
Immunoassay Control Premium Level 2 10 x 5 ml IA2639
Immunoassay Control Premium Level 3 4 x 3 x 5 ml IA2640
Immunoassay Control Premium Tri-Level 12 x 5 ml IA2633
Liquid Immunoassay Control Premium Level 1 12 x 5 ml LIA3105
Liquid Immunoassay Control Premium Tri-Level 12 x 5 ml LIA3108
Immunoassay Control Premium Plus Level 1 12 x 5 ml IA3109
Immunoassay Control Premium Plus Tri-Level 12 x 5 ml IA3112
Immunoassay Speciality I Level 1 5 x 2 ml IAS3113
Immunoassay Speciality II Level 1 5 x 1 ml IAS3117
Tumour Marker Control Level 2 3 x 2 ml TU5002
Liquid Tumour Marker Level 1 3x3ml TU5085
Maternal Screening Control Level 1 3 x 1 ml MSS5024
20
IMMUNOASSAY
immunoassay Premium control

2
Analytes
17-OH-Progesterone Estriol Paracetamol Theophylline

ACTH Ethosuximide Phenobarbital Thyroglobulin
AFP Ferritin Phenytoin Total T3
Aldosterone Folate Primidone Total T4
Amikacin Free T3 Progesterone Tobramycin
β-2-Microglobulin Free T4 Prolactin TSH
Carbamazepine FSH PSA (Free) T Uptake
CEA Gentamicin PSA (Total) Valproic Acid
C Peptide Growth Hormone (GH) PTH Vancomycin
hCG IgE Salicylate Vitamin B12
Cortisol Insulin SHBG 1-25-(OH)2-vitamin D
DHEA-Sulphate LH Testosterone 25-OH-vitamin D
Digoxin Oestradiol Testosterone (Free)
A comprehensive control designed for use in the routine monitoring of • Lyophilised for enhanced stability
both accuracy and precision. Assayed, instrument specific target values • 100% human serum
and ranges are provided for 51 analytes, including fertility and thyroid • Ferritin and Vitamin B12 levels suitable for Anaemia monitoring
hormones, steroid hormones, kidney function tests, therapeutic drugs and • TSH levels around 0.11 μU/ml in the level 1 control
vitamins. • Stable to expiry date at +2 - 8ºC
• Reconstituted stability of 7 days at +2 - 8ºC, or up to 4 weeks at -20ºC

Immunoassay Premium Level 1 10 x 5ml IA2638
Immunoassay Premium Tri-level 4 x 3 x 5 ml IA2633
LIQUID immunoassay Premium CONTROL
Analytes
17-OH- Progesterone Ethosuximide Oestradiol Testosterone

AFP Ferritin Paracetamol Testosterone (Free)
Aldosterone Folate Phenobarbital Theophylline
Amikacin Free T3 Phenytoin Tobramycin
β-2-Microglobulin Free T4 Primidone Total T3
Carbamazepine FSH Progesterone Total T4
hCG Gentamicin Prolactin TSH
Cortisol Growth Hormone (GH) PSA (Free) T Uptake
DHEA-Sulphate IgE PSA (Total) Valproic Acid
Digoxin Insulin Salicylate Vancomycin
Estriol LH SHBG Vitamin B12
A comprehensive control designed for use in the routine monitoring • Liquid for ease of use
of reproducibility and precision. Typical values are available for multiple • 100% human serum
instruments covering 44 analytes, including fertility and thyroid hormones, • Stable to expiry date at -20 - 70ºC
steroid hormones, kidney function tests, therapeutic drugs and vitamins. • Open vial stability of 7 days at +2 - 8ºC
Compatible for use on most immunoassay systems.

Liquid Immunoassay Premium Level 1 12 x 5ml LIA3105
Liquid Immunoassay Premium Tri-Level 12 x 5 ml LIA3108
21
IMMUNOASSAY
immunoassay Premium PLUS CONTROL

2
Analytes
17-OH-Progesterone Digoxin Oestradiol Testosterone (Free)

ACTH Estriol Paracetamol Theophylline
Aldosterone Ethosuximide Parathyroid Hormone (PTH) Thyroglobulin
Alphafoetoprotein Ferritin Phenobarbital Thyroid Stimulating Hormone (TSH)
Amikacin Folate Phenytoin Tobramycin
β – 2 – Microglobulin Free T3 Primidone Total T3
CA15-3 Free T4 Progesterone Total T4
CA19-9 FSH Prolactin Valproic Acid
CA125 Gentamicin PSA (Free) Vancomycin
Carbamazepine Growth Hormone (GH) PSA (Total) Vitamin B12
Carcinoembryonic Antigen (CEA) Human Chorionic Gonadotrophin (hCG) Salicylate 1-25-(OH)2 - Vitamin D
Cortisol IgE SHBG 25-OH - Vitamin D
C Peptide Insulin T Uptake
DHEA-Sulphate Leuteinising Hormone (LH) Testosterone
A comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target values
and ranges are provided for 54 analytes, including fertility and thyroid hormones, steroid hormones, cardiac & tumour markers, kidney function
tests, therapeutic drugs and vitamins. Compatible for use on a wide range of immunoassay analysers.

• 100% human serum
• Ferritin and Vitamin B12 levels suitable for Anaemia monitoring
• TSH targets are around 0.11 μU/ml in L1
• Contains routinely run tumour markers: AFP / CA15-3 / CA19-9 / CA-125 / CEA / PSA / Free-PSA

Immunoassay Premium Plus Level 1 12 x 5ml IA3109
Immunoassay Premium Plus Tri-Level 12 x 5 ml IA3112
IMMUNOASSAY SPECIALITY 1 control
Analytes
1-25-(OH)2-Vitamin D Insulin Like Growth Factor 1(IGF 1) Anti-Thyroglobulin (Anti-TG)

25-OH-Vitamin D Osteocalcin Anti-Thyroperoxidase (Anti-TPO)
C Peptide Procalcitonin
Insulin Parathyroid Hormone (PTH)
A multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are
provided for 10 more complex, specialised parameters to complement the routine immunoassay control.

• Assayed target values and ranges for a wide range of immunoassay systems
• Reconstituted stability of up to 5 days at +2 - 8ºC or 4 weeks at -20ºC

22
IMMUNOASSAY
IMMUNOASSAY SPECIALITY 1I control

2
Analytes
Calcitonin Procalcitonin
Gastrin Renin
A multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are
provided for 4 specialised parameters.

• Assayed target values and ranges for a wide range of immunoassay systems
• Reconstitutued stability of 5 days at +2 - 8ºC for Renin, Procalcitonin 1 day at +2 -8ºC and for Gastrin and Calcitonin 8 hours at +2 - 8oC

TUMOUR MARKER CONTROL
Analytes
Alphafoetoprotein (AFP) CA125 Human Chorionic Gonadotrophin (hCG)

β-2-microglobulin Calcitonin Neuron Specific Enolase (NSE)
CA 15-3 Carcinoembryonic Antigen (CEA) PSA (Free)
CA 19-9 Cyfra 21 PSA (Total)
CA 72-4 Ferritin Thyroglobulin
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 15
routine and specialised tumour markers. Compatible for use on a wide range of clinical chemistry and immunoassay systems.

• Reconstituted stability of 14 days at +2 - 8°C

23
IMMUNOASSAY
Liquid Tumour Marker Control

2
Analytes
AFP Cyfra 21-1
Beta-2-Microglobulin Ferritin
CA15-3 Free PSA
CA19-9 hCG
CA72-4 NSE
CA125 Thyroglobulin
CEA Total PSA
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 14
routine and esoteric tumour markers. Compatible for use on a wide range of clinical chemistry and immunoassay systems.

• Open vial stability of 30 days at +2-8oC

Liquid Tumour Marker Control Level 1 3 x 3ml TU5085
MATERNAL SCREENING CONTROL
Analytes
AFP PAPP-A
Free b hCG Total hCG
Inhibin A Unconjugated Estriol
Multi-analyte control designed for use in the routine monitoring of accuracy and precision. Assayed target values and ranges are provided for 6
parameters used in both First and Second Trimester screening of Down’s syndrome and Spina Bifida. Compatible for use on a wide range of clinical
chemistry and immunoassay systems.


24
Immunology/Protein
Controls 3
Chapter 3
IMMUNOlogy/protein
Immunology/ Protein product range

Specific Protein Control Level 1 3 x 1 ml PS2682
Crp Liquid Control Level 2 10 x 1 ml CP2480
Crp High Sensitivity Control Level 1 10 x 1 ml CP2476
Crp 1-Level Calibrator For Dilution Series 3 x 1 ml CP2179
Crp High Sensitivity 6-Level Calibrator Series 6 x 2 ml CP2478
Crp Full Range 6-Level Calibrator Series 6 x 1 ml CP2499
Crp Mid Range 6-Level Calbrator Series 6 x 2 ml CP2479
Cystatin C Normal Control 3 x 2 ml CYS5019
Cystatin C Elevated Control 3 x 2 ml CYS5020
Aso Calibrator 5 x 1 ml LO2306
b-2-Microglobulin Calibrator 3 x 1 ml BM1362
Immunoglobulin Calibrator (Rx Series) 3 x 1 ml IT3861
IgE Calibrator Set 3 x 1 ml IE2492
High Sensitivity IgG Control Level 1 5 x 2 ml IT3982
High Sensitivity IgG Calibrator 3 x 1 ml IT3899
Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301
Haptoglobin Calibrator 4 x 2ml HP1359

Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691
CSF Control Level 2 10 x 3 ml CF1500
CSF Control Level 3 10 x 3 ml CF1501
26
IMMUNOlogy/protein
SPECIFIC PROTEIN CONTROL
Analytes
3
AFP b-2-Microglobulin IgE Prealbumin (Transthyretin)
Albumin Ceruloplasmin IgG Serum Ferritin
a-1-Antitrypsin Complement C3 IgM RF
a-1-Acid Glycoprotein Complement C4 Kappa Light Chain RBP
a-2-Macroglobulin CRP Kappa Light Chain (Free) Total Protein
ASO Haptoglobin Lambda Light Chain Transferrin
Anti-thrombin III IgA Lambda Light Chain (Free)
A multi-analyte control designed for use in the routine monitoring of both precision and accuracy. Assayed target values are provided for 27 analytes
including immunoglobulins, complement proteins, inflammatory proteins as well as carrier and storage proteins. Method specific target values and ranges
are available for both immunoturbidimetric and nephelometric assays.

• Contains both total & Free Kappa and Lambda Light Chains
• Open vial stability of 30 days at +2 - 8ºC

CRP CONTROLS & CALIBRATOR
Dedicated control designed for use in the routine monitoring of both accuracy and precision. Suitable for use with traditional and high sensitivity CRP
assays. These controls are standardised to BCR/CAP/IFCC CRM470.


Crp 1-Level Calibrator For Dilution Series 3 x 1 ml CP2179
Crp High Sensitivity 6-Level Calibrator Series 6 x 2 ml CP2478
Crp Mid Range 6-Level Calibrator Series 6 x 2 ml CP2479
Crp Full Range 6-Level Calibrator Series 6 x 1 ml CP2499
27
IMMUNOlogy/protein
Cystatin C control
A dedicated control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for use on most clinical
3 chemistry analysers.

• Stable to expiry date at 2-8ºC

Cystatin C Normal Control 3 x 2ml CYS5019
Cystatin C Elevated Control 3 x 2ml CYS5020
ASO CALIBRATOR
A dedicated calibrator designed for use in the calibration of ASO immunoturbidimetric assays. This product is compatible for use on most clinical
analysers.


ASO Calibrator 5 x 1 ml LO2306
β-2-MICROGLOBULIN CALIBRATOR
Dedicated calibrator designed for use in the calibration of b-2-Microglobulin assays. This product is compatible for use on most clinical analysers.

• Reconstituted stability of 30 days at +2 - 8ºC or 3 months at -20ºC

β - 2 -Microglobulin Calibrator 3 x 1 ml BM1362
IMMUNOGLOBULIN CALIBRATORS
Analytes
IgA IgG IgM
Calibrator series designed for use in the calibration of IgA, IgG and IGM immunoturbidimetric assays. Suitable for use with the RX series of
immunoglobulin assays.


Immunoglobulin Calibrator RX Series 3 x 1 ml IT3861
28
IMMUNOlogy/protein
IgE Calibrator
Human based calibrator series designed for use in the calibration of IgE immunoturbidimetric assays.
3
• 6 levels supplied.
• Reconstituted stability of 4 weeks at +2 - 8ºC

IgE Calibrator 6 x 1 ml IE2492
HIGH SENSITIVITY IgG CONTROL AND CALIBRATOR
Dedicated control and calibrator designed for use with the Randox high sensitivity IgG assay.

Description Size Analytes Cat. No.

High Sensitivity IgG Control Level 1 5 x 2ml IT3982
High Sensitivity IgG Calibrator 3 x 1ml IT3899
RHEUMATOID FACTOR CALIBRATOR SERIES
Dedicated calibrator series designed for use in the calibration of rheumatoid factor immunoturbidimetric assays.


Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301
Haptoglobin Calibrator
Dedicated calibrator designed for use in the calibration of haptoglobin assays. This product is compatible for use on most clinical analysers.

Haptoglobin Calibrator 4 x 2ml HP1359
29
IMMUNOlogy/protein
SPECIFIC PROTEIN CALIBRATORS

Analytes
3 ASO CRP IgA Prealbumin
Complement C3 Ferritin IgG Transferrin
Complement C4 Haptoglobin IgM
Multi-analyte calibrator set designed for use in the calibration of the 11 analytes listed above.

• Open vial stability of 30 days at +2 - 8oC

For use with samples that do not require pre-dilution
SPECIFIC PROTEIN CALIBRATORS

Analytes
Alpha-1-Acid Glycoprotein IgA IgM

Alpha-1-Antitrypsin IgG Transferrin
Multi-analyte calibrator set designed for use in the calibration of the 6 analytes listed above.


For use with samples that require pre-dilution
CSF CONTROL
Analytes
Albumin g-globulin Lactate

a-1-globulin Chloride Protein (Total)
a-2-globulin Glucose Sodium
b-globulin IgG
Multi-analyte Cerebrospinal Fluid control designed for use in the routine monitoring of both accuracy and precision. This product is compatible for use
on most clinical analysers and provides method specific target values and ranges for 11 analytes.

• 100% human product
Csf Control Level 2 10 x 3 ml CF1500
Csf Control Level 3 10 x 3 ml CF1501
• Reconstituted stability of 2 weeks at +2 - 8 ºC
30
Lipid Controls
Chapter 4 4
LIPIDS
LIPID product range

Lipid Control Level 1 5 x 1 ml LE2668
Apolipoprotein Control Level 1 3 X 1 ml LE5016
Apolipoprotein Calibrator 3 x 1 ml LP3023
Apolipoprotein Calibrator 2 3 x 1 ml LP5047
Hdl/Ldl Cholesterol Calibrator (clearance) 3 x 1 ml CH2673
Lipoprotein (a) Control Level 3 3 x 1 ml LP3406
Lipoprotein (a) Calibrator 5 x 1 ml LP3404
sLDL Control Level 1 3 x 1 ml LE5013
sLDL Calibrator 3 x 1 ml CH5050
32
LIPIDS
Lipid CONTROL
Analytes
Apolipoprotein A-1 HDL Cholesterol (Precipitation) Total Cholesterol

Apolipoprotein B LDL Cholesterol (Direct Method) Triglycerides 4
HDL Cholesterol (Direct lipid) Lipoprotein (a)
A multi-analyte control designed for monitoring both the accuracy and precision of 7 analytes covering the full lipid profile. Accurately assigned target
values and ranges are provided for both traditional precipitation methods as well as the various direct methods used for HDL and LDL measurement.
Three levels are available in line with internationally recommended cut-off values for lipid tests.

• Sodium Azide is not present - no interference occurs with clearance methods

Apolipoprotein control & Calibrators

Analytes
Apolipoprotein Control Apolipoprotein Calibrator Apolipoprotein Calibrator 2

Apolipoprotein A-II Apolipoprotein A-I Apolipoprotein A-II
Apolipoprotein C-II Apolipoprotein B Apolipoprotein C-II
Apolipoprotein C-III Apolipoprotein C-III
Apolipoprotein E Apolipoprotein E
The multi-analyte control is designed for use in the routine monitoring of both accuracy and precision for 4 esoteric Apolipoproteins. Our
Apolipoprotein calibrators are designed for use in the calibration of 6 esoteric Apolipoprotein assays on a wide range of clinical chemistry analysers.

• Control - reconstituted stability of up to 28 days at +2 - 8ºC for Apolipoprotein A-II and Apolipoprotein C-III, 14 days for Apolipoprotein C-II and 8
hours for Apolipoprotein E
• Calibrator - reconstituted stability of 7 days at +2 - 8ºC for Apolipoprotein control A-I, B, A-II, C-II and C-III,1 day for Apolipoprotein E

Apolipoprotein Control Level 1 3 x 1 ml LE5016
Apolipoprotein Calibrator 3 x 1 ml LP3023
Apolipoprotein Calibrator 2 3 x 1 ml LP5047
33
LIPIDS
HDL & LDL Cholesterol Calibrator
Analytes
HDL Cholesterol
4 LDL Cholesterol
Designed for use in the calibration of HDL and LDL Clearance assays on clinical chemistry analysers.

• Reconstituted stability of 5 days at +2 - 8ºC and 1 month at -20ºC

Hdl / Ldl Cholesterol Calibrator (Clearance) 3 x 1 ml CH2673
Lp(a) Control and Calibrator
Dedicated control designed for use in the routine monitoring of both accuracy and precision. The calibrator is designed to calibrate Lp (a) assays on
clinical chemistry analysers.


Lipoprotein (a) Control Level 3 3 x 1 ml LP3406
Lipoprotein (a) Calibrator 5 x 1 ml LP3404
sLDL CONTROLS & Calibrator
Dedicated control designed for use in the routine monitoring of both accuracy and precision.


sLDL Control Level 1 3 x 1ml LE5013
sLDL Calibrator 3 x 1 ml CH5050
34
Cardiac Controls
Chapter 5
5
CARDIAC
Cardiac product range

Cardiac Control (Tri-Level) 3 x 1 ml CQ3100
Cardiac Control (Tri-Level) 3 x 2 ml CQ3259
Liquid Cardiac Control Level 1 3 x 3 ml CQ5051
Myoglobin Calibrator 4 x 1 ml MY2456
Ck-mb Control 10 x 2 ml CK1212
CK-MB Calibrator 10 x 1 ml CK2393
High Sensitivity Troponin T Control 3 x 3 ml CQ5080
H-FABP Control Level 1 3 x 1ml FB4026
H-FABP Control Level 2 3x2ml FB4027
H-FABP Calibrator Set 6x1ml FB3134
36
CARDIAC
CARDIAC CONTROL
Analytes
Ck Total Ck-Mb (Mass) Myoglobin Troponin T

Ck-Mb (Activity) Homocysteine Troponin I
5
A comprehensive cardiac control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are
provided for the most common instruments and methods. Temperature specific values are available for CK and CK-MB.

• Cut off levels for Troponin I and T in line with internationally recommended levels

Tri-Level Cardiac Control 3 x 1 ml CQ3100
Tri-Level Cardiac Control 3 x 2 ml CQ3259
LIQUID CARDIAC CONTROL
Analytes
BNP Digoxin Myoglobin Troponin T

CK-MB (Mass) Homocysteine NT-ProBNP
D-dimer hs CRP Troponin I
A comprehensive control designed for use in the routine monitoring of both accuracy and precision. Assayed instrument specific target values and
ranges are provided for 10 analytes including BNP, NT-proBNP and D-dimer. The control is suitable for use on a wide range of clinical chemistry,
immunoassay and POC instruments. Cut off levels for Troponin I and T are provided, in line with internationally recommended levels.

• Suitable for use in POC testing

MYOGLOBIN CALIBRATOR
Dedicated calibrator designed for use in the calibration of Myoglobin immunoturbidimetric assays.

• Prepared from purified human Myoglobin in a stabilised matrix
• Reconstituted stability of 30 days at +2 - 8ºC or 6 months at -20ºC

Myoglobin Calibrator 4 x 1 ml MY2456
37
CARDIAC
CK-MB CONTROL & CALIBRATOR
A dedicated CK-MB control designed for use in the routine monitoring of both accuracy and precision. Accurately assigned values are provided for both
serum and substrate start methods.

5 • Stable to expiry date at +2 - 8ºC
Control : Reconstituted stability of 5 days at +2 - 8ºC or 14 days at -20ºC

Calibrator: Reconstituted stability 5 days at 4ºC or 4 weeks at -20ºC

Ck-Mb Control 10 x 2 ml CK1212
Ck-Mb Calibrator 10 x 1 ml CK2393
High Sensitivity Troponin T Control
A dedicated Troponin T control designed to monitor the performance of high sensitivity Troponin T assays. The control is assayed allowing for the routine
assessment of both accuracy and precision.

• Very low Troponin T levels around 0.0165 ng/ml (16.5 ng/l)
• Stable to expiry at +2 - +8oC
• Reconstituted stability of 5 days at +2 - +8oC or 4 weeks at -20oC

High Sensitivity Troponin T Control 3 x 3ml CQ5080
Heart Type Fatty Acid Binding Protein (H-FABP) Control and Calibrator Set
Dedicated controls and calibrators designed for use in the routine monitoring and calibration of the Randox H-FABP assay.

• 100% human
• Reconstituted stability of 7 days at +2-8oC

H-FABP Calibrator Set 6 x 1ml FB3134
38
Diabetes/Haemoglobin
Controls
Chapter 6
6
DIABETES/haemoglobin
Diabetes product range

HbA1c Control Set Level 1 And 2 4 x 0.5 ml HA5072

HbA1c Calibrator Series 5 x 2 ml, 1 x 8 ml HA3444
HbA1c Linearity Set 4 x 0.25ml HA5073
G-6PDH Control Deficient 6 x 0.5 ml PD2617
G-6PDH Control Normal 6 x 0.5 ml PD2618
Fructosamine Control Level 1 3 x 1 ml FR2994
Fructosamine Calibrator 3 x 1 ml FR2993
Haemoglobin F and A2 Control 2 x 2 x 0.2ml HA5083
40
HbA1c
Analytes
HbA1c Total Haemoglobin
A human based whole blood control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for HPLC
6
and a wide range of clinical chemistry analysers.

• Treated in the same manner as a patient sample (requires pre-treatment)

HbA1c Control Set Level 1 And 2 2 x 2 x 0.5 ml HA5072
HbA1c Series Calibrator 5 x 2 ml, 1 x 8 ml HA3444
HbA1c Linearity Set
The Randox HbA1c linearity set is designed for use in assessing the linearity of HbA1c assays across the clinically important range. Accurately assigned
values are provided for the most common analyser and methods including HPLC.

• 100% human whole blood control

HbA1c Linearity Set 4 x 0.25 ml HA5073
G-6PDH (GLUCOSE-6-PHOSPHATE DEHYDROGENASE) CONTROL

Dedicated G-6-PDH control designed for use in the routine monitoring of both accuracy and precision. Two levels are available (normal and deficient)
with method specific target values and ranges provided.

• Human based whole blood

G-6-Pdh Control Deficient 6 x 0.5 ml PD2617
G-6-Pdh Control Normal 6 x 0.5 ml PD2618
41
FRUCTOSAMINE Control and calibrator
Dedicated fructosamine control and calibrator designed for use in the routine monitoring and calibration of the Randox fructosamine assay.

6 Description Size Cat. No.

Fructosamine Calibrator 3 x 1 ml FR2993
Haemoglobin F & A2 Control
Analytes
Level 1 Level 2
Haemoglobin F (HbF) Haemoglobin F (HbF)
Haemoglobin H2 (HbA2) Haemoglobin H2 (HbA2)
Haemoglobin S (HbS)
100% human whole blood control designed to routinely monitor reproducibility and precision in laboratories measuring the haemoglobin variants
associated with Thalassemia. Accurately assigned values and ranges are provided for all major systems and methods including HPLC, Immunoassay and
Glycation Specific.

• 100% human whole blood control

Haemoglobin F & A2 Control 2 x 2 x 0.2ml HA5083
42
Urine Controls
Chapter 7
7
Urine
Urine product range

Assayed Urine Chemistry Control Level 2 12 x 10 ml AU2352
Assayed Urine Chemistry Control Level 3 12 x 10 ml AU2353
Unassayed Urine Chemistry Control Level 2 10 x 10 ml UC1502
Unassayed Urine Chemistry Control Level 3 10 x 10 ml UC1503
Liquid Urine Control Level 2 10 x 10 ml UC5074
Liquid Urine Control Level 3 10 x 10ml UC5075
Liquid Urinalysis Control Level 1 12 x 12 ml UC5033
Urinalysis Control Level 1 (dropper) 6 x 25 ml UC5078
Microalbumin Control Level 1 & 2 6 x 1 ml MA1361
Microalbumin Calibrator Series 6 x 2 ml MA1567
44
urine
assayed urine CHEMISTRY
Analytes
Amylase Dopamine Microalbumin Potassium

Calcium Epinephrine Norepinephrine Total Protein
Chloride Glucose Normetanephrine Sodium
Copper 5-HIAA Osmolality Urea
Cortisol Magnesium Oxalate Uric Acid
Creatinine Metanephrine Phosphorous Vanillylmandelic Acid
7
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. Assayed values are provided for 24 analytes including
kidney function parameters, drug metabolites and urinary proteins. Method specific target values are also provided for the most commonly used
methods.

• 100% human urine
• Reconstituted stability of 5 days at +2 - 8ºC or 14 days at -20ºC

Urine Assayed Control Level 2 12 x 10 ml AU2352
Urine Assayed Control Level 3 12 x 10 ml AU2353
unassayed urine CHEMISTRY
Analytes
Calcium Glucose Phosphorous Sodium
Chloride Magnesium Potassium Urea
Creatinine Osmolality Total Protein Uric Acid
Multi-analyte control designed for use in the routine monitoring of precision of 12 analytes.
• Lyophilised offering enhanced stability

• Stable until expiry when stored at +2 - 8ºC

Urine Unassayed Control Level 2 10 x 10 ml UC1502
Urine Unassayed Control Level 3 10 x 10 ml UC1503
45
Urine
Liquid Urine Control
Amylase Glucose pH Specific Gravity

Calcium hCG Phosphate (Inorganic) Urea
Chloride Magnesium Potassium Uric Acid
Cortisol Microalbumin Protein (Total)
Creatinine Osmolarity Sodium
Multi-analyte control designed for use in the routine monitoring of precision. Instrument and method specific values and ranges are provided for 18
7 commonly analysed parameters.
• Liquid ready to use Description Size Cat. No.

• 100% human urine Liquid Urine Control Level 2 10 x 10ml UC5074
• Open vial stability 30 days at +2-8oC Liquid Urine Control Level 3 10 x 10ml UC5075
LIQUID Urinalysis
Analytes
Albumin Glucose Nitrite Urobilinogen

Bilirubin hCG pH
Blood Ketones Protein
Creatinine Leukocytes Specific Gravity
A multi-analyte control specifically designed for use in the quality control of urine test strips. Assayed values are provided for 13 parameters and a wide
range of test strip manufacturers.

• Suitable for use in POC testing
• Open vial stability of 30 days at +2 - +25ºC (20 immersions for UC5033/5034)

Microalbumin Control and Calibrator
Liquid ready to use, human control and calibrator designed for in vitro diagnostic use in the calibration and monitoring of microalbumin
immunoturbidimetric assays. This product is compatible for use on most clinical analysers.

• 100% Human material

Microalbumin Control Level 1 & 2 6 x 1ml MA1361
Microalbumin Calibrator Series 6 x 2 ml MA1567
46
Therapeutic Drug
Monitoring Controls
Chapter 8
8
THERAPEUTIC DRUGs
Therapeutic Drug product range

Therapeutic Drug Control Level 1 20 x 5 ml HD1667
Therapeutic Drug Calibrator 6 x 3 ml TD3417
Therapeutic Drug Control
8 Analytes
Amikacin Ethosuximide Phenobarbitone Tobramycin
Caffeine Gentamicin Phenytoin Valproic Acid
Carbamazepine Lithium Primidone Vancomycin
Cyclosporine Methotrexate Salicylate
Digoxin Paracetamol (Acetaminophen) Theophylline
Multi-analyte control designed for use in the quality control of therapeutic • Lyophilised for enhanced stability
drug monitoring. Assayed target values and ranges are supplied for 18 • 100% human serum
analytes including commonly used antibiotics, anti-convulsants, anti- • Stable to expiry date at +2 - 8ºC
inflammatory and anti-cancer drugs. Instrument and method specific • Reconstituted stability of 4 weeks at +2 - 8ºC
target values are provided for the most common instruments and
methods.

Therapeutic Drug Calibrator
Analytes Multi-analyte calibrator designed for use in the calibration of therapeutic

drug assays on clinical chemistry analysers. Accurately assigned values are
Carbamazepine Phenytoin
provided for 7 analytes.
Digoxin Theophylline
Gentamicin Valproic Acid
Phenobarbital
• 100% human
• Stable to expiry date at +2 - 8oC
• Reconstituted stability of 4 weeks at +2 - 8oC or 8 weeks at -20oC

Multi-Analyte Therapeutic Drug Calibrator Series 6 x 3 ml TD3417
48
Toxicology Controls
Chapter 9
Chapter 10
9
TOXICOLOGY
Toxicology product range

Drugs of Abuse Array 1 (Urine) Controls 2 x 4 x 1ml EV3551
Drugs of Abuse Array 1 (Urine) Calibrator Series 9 x 1ml EV3550
Drugs of Abuse Array 1 (Urine, Semi Quant) Controls 2 x 4 x 1ml EV3630
Drugs of Abuse Array 1 (Urine, Semi Quant) Calibrator Series 9 x 1ml EV3629
Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Controls 2 x 4 x 1ml EV3627
Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Calibrators 9 x 1ml EV3628
Drugs of Abuse Array 1 (Whole Blood) Controls 2 x 4 x 1ml EV3677
Drugs of Abuse Array 1 (Whole Blood) Calibrator Series 2 x 4 x 1ml EV3676
Drugs of Abuse Array 1 (Oral Fluid) Controls 2 x 4 x 1ml EV3649
Drugs of Abuse Array 1 (Oral Fluid) Calibrator Series 9 x 1ml EV3648
Drugs of Abuse Array 1 (High Opiate) Controls 2 x 4 x 1ml EV3647
9 Drugs of Abuse Array 1 Plus (Urine) Controls 2 x 4 x 1ml EV3745
Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1ml EV3744
Drugs of Abuse Array 1 Plus (Whole Blood) Controls 2 x 4 x 1ml EV3750
Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1ml EV3749
Drugs of Abuse Array I (Urine) Control - Evidence Multistat 3 x 1ml EV3731
Drugs of Abuse Array I (Urine) Standard - Evidence Multistat 3 x 2 x 1ml EV3730
Drugs of Abuse Array I (Whole Blood) Control - Evidence Multistat 3 x 1ml EV3734
Drugs of Abuse Array I (Whole Blood) Standard - Evidence Multistat 3 x 2 x 1ml EV3733
Drugs Of Abuse Array II (Urine) Controls 2 x 4 x 1 ml EV3657
Drugs Of Abuse Array II (Whole Blood) Controls 2 x 4 x 1 ml EV3682
Drugs Of Abuse Array II (Oral Fluid) Controls 2 x 4 x 1 ml EV3702
Drugs Of Abuse Array II (Urine) Calibrator Series 9 x 1ml EV3656
Drugs Of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687
Drugs Of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1ml EV3701
Drugs of Abuse Array III (Whole Blood) Control 4 x 2 x 1ml EV3794
Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1ml EV3797
Drugs of Abuse Array IV (Whole Blood) Control 4 x 2 x 1ml EV3809
Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1ml EV3808

Drugs of Abuse Array V (Urine) Control 4 x 2 x 1ml EV3814
Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1ml EV3815
Cannabinoid Calibrator 5 x 3 ml DA2700
Cannabinoid Control Level 1 5 x 3 ml DA3127
Ecstasy Calibrator 5 x 10 ml DA2701
Ecstasy Control Level 1 5 x 5 ml DA3125
EDDP Calibrator 5 x 10 ml DA2702
EDDP Control Level 1 5 x 5 ml DA3123
Ethanol Calibrator/Control Set 5 x 10 ml DA2703
Multidrug Calibrator 5 x 10 ml DA2704
Multidrug Control Level 1 5 x 5 ml DA3121
Benzodiazepines Control Level 1 5 x 5 ml DA3130
Benzodiazepines Control Level 2 5 x 5 ml DA3131
Benzodiazepines Calibrator Series 5 x 10 ml DA3129
50
TOXICOLOGY
Drugs of Abuse Array 1 Controls and Calibrators
Analytes
Amphetamine Benzodiazepine 2 Methadone Phencyclidine
Barbiturates Cannabinoids Methamphetamine Creatinine
Benzodiazepine 1 Cocaine Metabolite Opiates
A comprehensive control designed for use in the routine monitoring of accuracy and precision on Randox Biochip systems. Values in the level 1 control
are below the SAMHSA cut-off for urine only while values in the level 2 control are above the SAMHSA cut-off for urine only. A High Opiate control is
also available with a cut-off value of 2000ng/ml.

• Stable to expiry date at +2-8oC 9
• Urine – Reconstituted stability of 14 days at +2-8oC or 28 days at -20oC
• Urine Semi-Quantitative – Reconstituted stability of 7 days at +2-8oC or 28 days at -20oC
• Whole Blood – Reconstituted stability of 14 days at +2-8oC
• Oral Fluid - Reconstituted stability of 7 days at +2-8oC
• High Opiate - Reconstituted stability of 14 days at +2-8oC or 21 days at -20oC

Drugs of Abuse Array 1 (Urine) Controls 2 x 4 x 1ml EV3551
Drugs of Abuse Array 1 (Urine) Calibrator Series 9 x 1ml EV3550
Drugs of Abuse Array 1 (Urine, Semi Quant) Controls 2 x 4 x 1ml EV3630
Drugs of Abuse Array 1 (Urine, Semi Quant) Calibrator Series 9 x 1ml EV3629
Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Controls 2 x 4 x 1ml EV3627
Drugs of Abuse Array 1 (Whole Blood, Semi Quant) Calibrators 9 x 1ml EV3628
Drugs of Abuse Array 1 (Whole Blood) Controls 2 x 4 x 1ml EV3677
Drugs of Abuse Array 1 (Whole Blood) Calibrator Series 2 x 4 x 1ml EV3676
Drugs of Abuse Array 1 (Oral Fluid) Controls 2 x 4 x 1ml EV3649
Drugs of Abuse Array 1 (Oral Fluid) Calibrator Series 9 x 1ml EV3648
Drugs of Abuse Array 1 (High Opiate) Controls 2 x 4 x 1ml EV3647
Drugs of Abuse Array 1 Plus Controls and Calibrators
Analytes
Amphetamine Buprenorphine Methadone Tricyclic Antidepressants
Benzodiazepine 2 MDMA Phencyclidine
Assayed control for use in monitoring the accuracy and precision on Randox Biochip systems. Two levels of control are provided covering the cut-off range.

• Stable to expiry date at +2-8oC
• Urine - Reconstituted stability of 14 days at +2-8oC
• Whole Blood – Reconstituted stability of 7 days at +2-8oC or 14 days at -20oC

Drugs of Abuse Array 1 Plus (Urine) Controls 2 x 4 x 1ml EV3745
Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1ml EV3744
Drugs of Abuse Array 1 Plus (Whole Blood) Controls 2 x 4 x 1ml EV3750
Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1ml EV3749
51
TOXICOLOGY
DRUGS OF ABUSE I (URINE) CONTROL AND STANDARDS - Multistat
Analytes
Amphetamine Benzodiazepine 2 Methadone Phencyclidine
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision of urine drugs of abuse on the Evidence MultiStat analyser. Assayed
values provided for 10 parameters.

• 1 year shelf life from date of manufacture
• Control: Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC
9 • Standards: Reconstituted stability of 5 days when stored at +2 - 8ºC or 28 days when stored at -20ºC

Drugs of Abuse Array I (Urine) Control - Evidence Multistat 3 x 1ml EV3731
Drugs of Abuse Array I (Urine) Standard - Evidence Multistat 3 x 2 x 1ml EV3730
DRUGS OF ABUSE I (WHOLE BLOOD) CONTROL AND STANDARDS - Multistat
Analytes
Amphetamine Buprenorphine Methadone Tricyclic Antidepressants

Benzodiazepine 2 MDMA Phencyclidine
Multi-analyte control designed for use in the routine monitoring of both accuracy and precision. of whole blood drugs of abuse assays on the Evidence MultiStat
analyser. Assayed values provided for 10 parameters.

• 1 year shelf life from date of manufacture

Drugs of Abuse Array I (Whole Blood) Control - Evidence Multistat 3 x 1ml EV3734
Drugs of Abuse Array I (Whole Blood) Standard - Evidence Multistat 3 x 2 x 1ml EV3733
52
TOXICOLOGY
DRUGS OF ABUSE Array II CONTROL
Analytes
3,4 Methylenedioxymethamphetamine (MDMA) Buprenorphine Oxycodone II
Ketamine Fentanyl Propoxyphene
Lysergic Acid diethylamide (LSD) Generic Opioids Creatinine
Methaqualone Oxycodone I
A comprehensive control designed for use in the routine monitoring of accuracy and precision on Randox Biochip systems. Assayed values are provided
for 10 parameters.

• Stable to expiry date at +2 - 8ºC 9
• Urine - Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC
• Whole Blood - Reconstituted stability of 7 days at +2 - 8ºC or 28 days at -20ºC

Drugs Of Abuse Array II (Urine) Controls 2 x 4 x 1 ml EV3657
Drugs Of Abuse Array II (Whole Blood) Controls 2 x 4 x 1 ml EV3682
Drugs Of Abuse Array II (Oral Fluid) Controls 2 x 4 x 1 ml EV3702
Drugs Of Abuse Array II (Urine) Calibrator Series 9 x 1ml EV3656
Drugs Of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687
Drugs Of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1ml EV3701
Drugs of Abuse Array III Controls and Calibrators
Analytes
Chloral Hydrate Metabolite Meperidine Zopiclone
Ethyl Glucuronide Meprobamate 7-amino Flunitrazepam
Fentanyl Zaleplon Creatinine
Ketamine Metabolite Zolpidem
Assayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are provided
covering the cut-off range.


Drugs of Abuse Array III (Whole Blood) Control 4 x 2 x 1ml EV3794
Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1ml EV3797
53
TOXICOLOGY
Drugs of Abuse Array IV Controls and Calibrators
Analytes
Acetaminophen Ibuprofen Tramadol
Dextromethorphan Methylphenidate Trazodone
Escitalopram Salicylate Tricyclic Antidepressants
Fluoxetine Salicyluric Acid Creatinine
Haloperidol Sertraline

9 • Stable to expiry date at +2-8oC

Drugs of Abuse Array IV (Whole Blood) Control 4 x 2 x 1ml EV3809
Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1ml EV3808
Drugs of Abuse Array V Controls and Calibrators
Analytes
Bath Salts 1 (Methcathinone and Mephedrone) Phenylpiperazines Synthetic Cannabinoids 3
Bath Salts 2 (MDPV) Salvinorin Synthetic Cannabinoids 4
Benzylpipernzines Synthetic Cannabinoids 1
Mescaline Synthetic Cannabinoids 2


Drugs of Abuse Array V (Urine) Control 4 x 2 x 1ml EV3814
Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1ml EV3815
54
TOXICOLOGY
CANNABINOID Control and CALIBRATOR
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Cannabinoids assay.

• Stable to expiry date when capped and stored at +2 - 8ºC

Cannabinoid Calibrator 5 x 3ml DA2700
9
ECSTASY Control and CALIBRATOR
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ecstasy assay.


Ecstasy Calibrator 5 x 10ml DA2701
EDDP Control and CALIBRATOR
Dedicated calibrator and control set designed for the calibration and quality control of the Randox EDDP assay.


EDDP Calibrator 5 x 10ml DA2702
ETHANOL CALIBRATOR/CONTROL SET
Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.


Ethanol Calibrator/Control Set 4 x 10ml DA 2703
55
TOXICOLOGY
MULTIDRUG Calibrator
Analytes
Amphetamines Cocaine Metabolite

Barbiturates Methadone
Benzodiazepines Opiates
Multi-analyte calibrator set designed for the calibration of the Randox Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolite, Methadone and
Opiates assays.

9 • Stable to expiry date when capped and stored at +2 - 8ºC

Multidrug Calibrator 5 x 10 ml DA 2704
MULTIDRUG Control
Analytes
Methamphetamine Secobarbital
Oxazepam Methadone
Multi-analyte control designed for use in the quality control of the Randox Amphetamines, Barbiturates, Benzodiazepines and Methadone assays.


Benzodiazepines Control and calibrator
Analytes
Oxazepam
Dedicated calibrator and control set designed for the calibration and control of the Randox bezodiazepines assay.


Benzodiazepines Control Level 1 5 x 5ml DA3130
Benzodiazepines Control Level 2 5 x 5ml DA3131
Benzodiazepines Calibrator Series 5 x 10ml DA3129
56
Coagulation Controls
Chapter 10
Chapter 4
10
COAGULATION
Coagulation product range

Coagulation Control Level 1 12 x 1 ml CG5021

COAGULATION CONTROL
10 Analytes
Prothrombin Time (PT) Antithrombin III (ATIII) Factor VIII Factor XII
Activated Partial Thromboplastin Time (APTT) Factor II Factor IX Plasminogen
Thrombin Time (TT) Factor V Factor X Protein C
Fibrinogen Factor VII Factor XI Protein S
Multi-parameter control designed for use in the routine monitoring of both accuracy and precision. Assayed method and instrument specific target
values and ranges are available for a variety of factor assays, basic coagulation and thrombophilia parameters.

• Reconstituted stability of 24 hours at +2 - 8ºC

58
Blood Gas Controls
Chapter 11
11
blood gas
Blood Gas product range

Liquid Blood Gas Control Level 1 30 x 1.8 ml BG 5001
Blood Gas CONTROL
Analytes
pCO2 Total CO2 Glucose Sodium

pH Calcium Lactate
pO2 Chloride Potassium
11
Liquid ready to use blood gas control designed for use in the routine monitoring of the 10 parameters listed above. Method specific target values are provided
for the most common instruments.
• Aqueous material
• Once opened controls should be analysed within 1 minute for pH and blood gas parameters; for electrolyte measurements, the control should be analysed
within 1 hour of opening

Liquid Blood Gas Control Level 1 30 x 1.8 ml BG5001
60
Antioxidant Controls
Chapter 12
12
ANTIOXIDANTS
12
Antioxidant product range

Glutathione Reductase Control 10 x 5 ml GR2608
Glutathione Reductase Calibrator 10 x 5 ml GR2609
Ransel (Glutathione Peroxidase) Control 10 x 1 ml SC692
Ransod (Superoxide Dismutase) Control 10 x 1 ml SD126
Tas (Total Antioxidant Status) Standard 10 x 1 ml NX2615
Tas (Total Antioxidant Status) Control 10 x 5 ml NX2331
62
ANTIOXIDANTS
Glutathione reductase CONTROL AND CALIBRATOR
A bovine based control designed for use in the routine monitoring of precision. This product is compatible for use on most clinical chemistry analysers.

• Stable to expiry date at +2 - 8°C
• Reconstituted stability of 1 day at +2 - 8°C or 8 hours at +15 - 25°C

Glutathione Reductase Calibrator 10 x 5 ml GR2609
Glutathione Reductase Control 10 x 5 ml GR2608
GLUTATHIONE PEROXIDASE (RANSEL) control
A bovine based, whole blood control designed for use in the routine monitoring of precision. This product is compatible for use on most clinical chemistry 12
analysers.

• Reconstituted stability of 3 days at +2-8°C

Glutathione Peroxidase (Ransel) Control 10 x 1 ml SC692
SUPEROXIDE DISMUTASE (RANSOD) control
A bovine based, whole blood control designed for use in the routine monitoring of precision. This product is compatible for use on most clinical
chemistry analysers.

• Reconstituted stability of 10 days at +2 - 8°C

Superoxide Dismutase (Ransod) Control 10 x 1 ml SD126
63
ANTIOXIDANTS
TOTAL ANTIOXIDANT STATUS (TAS) CONTROL AND STANDARD

A human based control designed for use in the routine monitoring of reproducibility and precision. This product is compatible for use on most clinical
chemistry analysers.
Control Standard
• Lyophilised for enhanced stability • Lyophilised for enhanced stability
• Stable to expiry date at +2 - 8°C • Approximately 1.5 mmol/l
• Reconstituted stability of 2 days at +2 - 8°C or 12 hours at +15 - 25°C • Stable to expiry date at +2 - 8°C
• Reconstituted stability of 2 days at +2 - 8°C or 4 weeks at +-20°C

Tas (Total Antioxidant Status) Control 10 x 5 ml NX2331
Tas (Total Antioxidant Status) Standard 10 x 1 ml NX2615
12
64
Speciality and
Research Controls
Chapter 13
13
Speciality and research
controls
SPECIALITY AND RESEARCH product range

Antimicrobial Array 1 Plus Control 3 x 1 ml AMC5084
Antimicrobial Control II 3 x 1 ml AMC5035
Antimicrobial Control III 3 x 1 ml AMC5036
Growth Promoter Control 3 x 1 ml GP5003
Cell Adhesion Molecules Control 3 x 3 x 1 ml EV3569
Adhesion Molecules Calibrator Series 9 x 1 ml EV3568
Cerebral Series I Control 3 x 3 x 1 ml CAB5008
Cerebral Array I Calibrator Series 9 x 1 ml EV3625
Cerebral Series II Control 3 x 3 x 0.5 ml CBB5009
Cerebral Array II Calibrator Series 9 x 1 ml EV3641
Cytokine Array I Control 3 x 3 x 1 ml CY5006
Cytokine Array I Control (High Sensitivity) 3 x 3 x 2 ml CY5005
Cytokine Array Calibrator Series 9 x 1 ml EV3561
Cytokine Array Iii Control 3 x 3 x 1 ml CY5012
Cytokine Array III Calibrator Series 9 x 1 ml EV3679
Cytokine Array Iv Control 3 x 3 x 0.5 ml CY5011
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658
Cytokine Array V Control 3 x 3 x 1 ml CY5010
Cardiac Array Control 3 x 3 x1 ml EV3691
Cardiac Plus Tri-Level Control 3 x 3 x 1 ml EV3558
Cardiac Plus Calibrator Series 9 x 1ml EV3557
Cardiac Control (Multistat) 3 x 1 ml EV3729
Cardiac Standards (Multistat) 3 x 2 x 1 ml EV3728
Endocrine Array Controls 3 x 3 x 1 ml EV3713
Endocrine Array Calibrator Series 9 x 1 ml EV3712
Evidence Immunoassay Controls 3 x 4 x 5ml EV3750
Synthetic Steroids Control 3 x 1 ml EV3709
Synthetic Steroids Calibrator 9 x 1 ml EV3708
Metabolic Syndrome Array 1 Controls 3 x 3 x 1 ml EV3757
Metabolic Syndrome Array 1 Calibrators 9 x 1 ml EV3756
66
controls
Antimicrobial Controls
Antimicrobial Control I PLUS Analytes
Sulphadiazine Sulphathiazole Sulphisoxazole Sulphamethoxazole

Sulphadimethoxine Sulphachlorpyridazine Sulphamethizole Sulphamonomethoxine
Sulphaquinoxaline Sulphapyridine Sulphadoxine Trimethoprim
Sulphamethazine Sulphamethoxypyridazine Sulphamerazine
A multi-analyte control containing target values and ranges for 15 different antimicrobial agents.

• Open vial stability of 21 days at -20ºC

Antimicrobial Array 1 Plus Control 3 x 1 ml AMC5084
Antimicrobial Control II Analytes
Tetracyclines (generic) Thiamphenicol Streptomycin 13

Quinolones (generic) Tylosin Ceftiofur
A multi-analyte control supplied with values for 6 different antimicrobial agents used extensively in veterinary medicine.

• Reconstituted stability of 24 hours at +2 - 8ºC or 2 weeks at -20ºC

Antimicrobial Control II 3 x 1 ml AMC5035
Antimicrobial Control III Analytes
5-Methylmorpholino-3-amino-2-oxazolidinone (AMOZ) Semicarbazine (SEM)

1-Amino hydantoin hydrochloride (AHD) Chloramphenicol
3-Amino-2-oxazoilidinone (AOZ)
Multi-analyte control containing values for 5 different antimicrobial agents.


Antimicrobial Control III 3 x 1 ml AMC5036
67
controls
Growth Promoter CONTROL
Analytes
Boldenone Corticosteroids Trenbolone

Zeranol Nandrolone Stanozolol
Ractopamine Stilbenes Beta-Agonists (Clenbuterol)
A multi-analyte control provided with accurately assigned target values and ranges for 9 different growth promoters.


Growth Promoter Control 3 x 1 ml GP5003
Analytes
Cell Adhesion Molecules ControlS AND CALIBRATORS

Analytes
13
Analytes
Vascular cell adhesion molecule-1 (VCAM-1) P-Selectin (P-SEL)

Intercellular adhesion molecule-1 (ICAM-1) L-Selectin (L-SEL)
E-Selectin (E-SEL)
A multi-analyte control with target values and ranges supplied for 5 different adhesion molecules.

• Reconstituted stability of 24 hours at +2 - 8ºC or 7 days at -20ºC

Adhesion Molecules Tri-Level Control 3 x 3 x 1 ml EV3569
Adhesion Molecules Calibrator Series 9 x 1 ml EV3568
Analytes
68
controls
Cerebral Series I Controls AND CALIBRATORS
Analytes
Brain Derived Neurotrophic Factor (BDNF)

Fatty Acid Binding Protein (FABP)
Glial Fibrillary Acidic Protein (GFAP)
Interleukin 6 (IL6)
A multi-analyte control with target values and ranges provided for 4 analytes.


Cerebral Series I Tri-Level Control 3 x 3 x 1 ml CAB5008
Cerebral Array 1 Calibrator Series 9 x 1 ml EV3625
13
Cerebral Series II ControlS AND CALIBRATORS
Analytes
Neuron Specific Enolase (NSE)

Neutrophil Gelatinase-associated Lipocalin (NGAL)
Soluble Tumour Necrosis Factor Receptor I (sTNFRI)
D-dimer
Thrombomodulin (TM)
C-Reactive Protein (CRP)


Cerebral Series II Tri-Level Control 3 x 3 x 0.5 ml CBB5009
Cerebral Array 11 Calibrator Series 9 x 0.5ml EV3641
69
controls
Cytokine ARRAY I & high sensitivity Cytokine ARRAY I Control AND CALIBRATORS
Analytes
Interleukin - 1a (IL-1a) Vascular Endothelial Growth Factor (VEGF)

Interleukin - 1b (IL-1b) Interferon g (IFNg)
Interleukin - 2 (IL2) Tumour Necrosis Factor a (TNFa)
Interleukin - 4 (IL4) Monocyte Chemoattractant Protein-1 (MCP-1)
Interleukin - 6 (IL6) Epidermal Growth Factor (EGF)
Interleukin - 8 (IL8)
Interleukin - 10 (IL10)
Multi-analyte controls with target values and ranges provided for 12 different cytokines.

• Reconstituted stability of 10-12 hours at +2 - 8ºC or 14 days at -20ºC
• High sensitivity - Reconstituted stability of 4 hours at +2 - 8ºC or 7 days at -20ºC
13
Cytokine Array I Tri-Level Control 3 x 3 x 1 ml CY5006
High Sensitivity Cytokine Array I Tri-Level Control 3 x 3 x 2 ml CY5005
Cytokine Array Calibrator Series 9 x 1 ml EV3561
Cytokine ARRAY III ControlS AND CALIBRATORS

Analytes
Analytes
Interleukin - 5 (IL-5) Granulocyte Macrophage Colony-Stimulating Factor (GMCSF)
Interleukin - 15 (IL15) Matrix Metalloproteinase-9 (MIP-1a)
Tumour Necrosis Factor b (TNFb)


Cytokine Array III Tri-Level Control 3 x 3 x 1 ml CY5012
Cytokine Arra III Calibrator Series 9 x 1 ml EV3679
70
controls
Cytokine ARRAY IV ControlS AND CALIBRATORS
Analytes
Soluble Interleukin-2-Receptor a (sIL-2Ra) Soluble Tumour Necrosis Factor Receptor II (sTNFR II)
Soluble Interleukin-6-Receptor (sIL-6R) Matrix Metalloproteinase-9 (MMP-9)
Soluble Tumour Necrosis Factor Receptor I (sTNFR I)
• Lyophilised providing enhanced stability


Cytokine Array IV Tri-Level Control 3 x 3 x 1 ml CY5011
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658
Cytokine ARRAY V Control

13
Analytes
Interleukin-3 (IL-3) Interleukin-13 (IL13)

Interleukin-7 (IL7) Interleukin-23 (IL23)
Interleukin 12p70 (IL12p70)

• Stable to expiry when stored at +2 - 8ºC

Cytokine Array V Tri-Level Control 3 x 3 x 1 ml CY5010
Analytes
71
controls
CARDIAC Array CONTROLs
Ck-Mb Myoglobin
H - FABP Troponin I
Multi-analyte cardiac control designed for use in the routine monitoring of precision on clinical chemistry and immunoassay systems. This is the only
control of its type to include the novel marker heart type fatty acid binding protein (H - FABP). Three levels of control are supplied spanning the
complete clinical range.


Cardiac Array Controls 3 x 3 x 1 ml EV3691
Cardiac Control (Multistat) 3 x 1ml EV3729
Cardiac Standards (Multistat) 3 x 2 x 1ml EV3728
13
CARDIAC plus Tri-level CONTROL
Analytes
CAIII H-FABP Myoglobin

Ck-Mb GPBB Troponin I
Multi-analyte cardiac control designed for use in the routine monitoring of precision on clinical chemistry and immunoassay systems. Accurately assigned
target values and ranges are provided for 6 analytes including the novel marker heart type fatty acid binding protein (H-FABP). Three levels of control
are supplied spanning the complete clinical range.


Cardiac Plus Tri-Level Control 3 x 3 x 1 ml EV3558
Cardiac Plus Array Calibrator Series 9 x 1 ml EV3557
72
controls
ENDOCRINE ARRAY ControlS AND CALIBRATOR
Analytes
Cortisol 17αHydroxyprogesterone
DHEAs Leptin
Human based control designed for use in the routine monitoring of both accuracy and precision. Three levels of control are supplied with assayed target values
and ranges provided for 4 analytes.

• Assayed values available for both the Evidence and Evidence Investigator

Endocrine Array Controls 3 x 3 x 1ml EV3713
Endocrine Array Calibrator Series 9 x 1ml EV3712
13
Evidence Immunoassay Control
Analytes
CEA Leutinising Hormone Testosterone

Estradiol Prolactin Total T4
FSH Progesterone Total T3
Free T4 PSA (Total) TSH
Free T3 PSA (Free)
Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.

• Reconstituted stability of 7 days at +2-8oC or 4 weeks at -20oC

Evidence Immunoassay Controls 3 x 4 x 5ml EV3750
73
controls
SYNTHETIC STEROiDS Control AND calibrator
Analytes
17β Clostebol Gestagens (generic) Methandriol

Ethinylestradiol Methyltestosterone
Human based control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 5 different
synthetic steroids.

• Reconstituted stability of 3 days at +2 - 8oC or 14 days at -20ºC

Synthetic Steroids Control 3 x 1ml EV3709
Synthetic Steroids Calibrator 9 x 1ml EV3708
13
Metabolic Syndrome Array I Control
Analytes
C-Peptide Resistin Tumour Necrosis Factor α

Ferritin Insulin Leptin
Interleukin-6 Interleukin-1α Plasminogen Activator Inhibitor-1
A multi-analyte control with target values and ranges provided for 9 parameters associated with metabolic syndrome.

• Stable to expiry date at 2-8oC
• Reconstituted stability of 72 hours at +2-8oC and 7 days at -20oC

Metabolic Syndrome Array I Controls 3 x 3 x 1ml EV3757
Metabolic Syndrome Array I Calibrators 9 x 1ml EV3756
74
Interlaboratory Data
Management Software
Chapter 14
14
Randox Acusera 24•7
Randox Acusera 24•7 is an Interlaboratory Data Management laboratories to access peer group reports and compare results with
software and peer group reporting package designed to complement other laboratories using the same quality controls and often the same
and support the Acusera range of control sera. method and instrument.
The Acusera 24•7 software enables laboratories to monitor analytical Peer group data is updated every 24 hours, giving you access to
performance while the peer group reporting function allows the most up to date information available.
Why participate in a peer group reporting programme like Acusera 24•7?
Receive reliable information from a trustworthy source Help meet regulatory requirements
Acusera 24•7 peer group statistics are generated every 24 hours Laboratory managers are under increasing pressure to closely
from 1000’s of labs in countries worldwide. This large number monitor laboratory test results and assure their quality due to growing
of participants ensures an extensive database of results for many demands from higher authorities for national and
analytical methods, assures validity and therefore increases confidence international accreditation.
in your results.
Identify any trends, system errors or reagent issues as soon as they arise
Acusera 24•7 will help you to detect and identify errors in your
laboratory system thus minimising expensive repeats and lengthly
“The laboratory
14
unnecessary troubleshooting.
shall participate
in interlaboratory
By comparing your IQC results with peer group data, you can identify
problems that otherwise may have gone unnoticed and assess if shifts
in QC recovery are unique to your laboratory. Access to peer group
data may even alert you to future issues before they are encountered
in your laboratory.
comparisons...”
Most errors occur alongside software changes, changes in reagent
formulation and calibrator re standardisation.
-ISO 15189:2003(E), Subclause 5.6.4.
Improve EQA/PT performance by eliminating any undetected bias

Randox Acusera 24•7 supports and complements your current EQA/
PT scheme. External quality assessment is not performed on a daily
basis but periodically. Reporting is generally bi-weekly or monthly with
RIQAS, but may be less frequent with other schemes.
Errors can occur at any time or at any point in the testing process and
may go undetected until you receive your next EQA report. You may
identify a problem when you receive your EQA report but when did
the issue occur? 1 day ago, 1 week ago or just after your last EQA
sample was tested?
A well maintained internal quality control programme supplemented

with a peer group reporting scheme like Randox Acusera 24•7, is
necessary to establish and maintain reliability, precision and accuracy.
In addition to this, participation in a peer group reporting scheme may

also improve EQA/PT performance, as your results are more likely to
compare well to other laboratories participating in the same scheme.
You can have more confidence in the results you submit to your
EQA/PT provider.
76
Software Overview
The Randox 24•7 software is easy, flexible and convenient to use.
• Open system allows users to add parameters, methods, instruments, and easily. This allows the lab manager to enter data for weekend
reagents and units, for non peer group review. QC runs on a Monday morning and input the actual dates the sera
• Simple navigation through the use of fast keys and tabs providing the were run.
user ease of access to all functions. • Exclude or include data according to user defined performance
• Data can be entered quickly and easily by one of three options: multi-rules.
- Individual test • Pre-defined options for parameters, methods, instruments, reagents
- User Defined Panel and units during configuration.
- Automatically via extracted files from instrument, • Rapidly upload results and download peer group data anytime at the
middleware or LIMS touch of a button.
• Data input error messages alert the user to possible transcription • Multi level passwords ensure confidentiality and enable management
errors ensuring confidence in results. to control system settings whilst providing access for laboratory
• Multilingual software with 11 languages to choose from. personnel to enter data.
• Data can be viewed for up to 3 different lots of serum at once. • Improved network management allows several computers in the
Peer group data will be provided for the lifetime of the serum lot. same laboratory to run the same programme.
• Date changing facility allows retrospective data to be entered quickly
Detailed Reports
The Randox Acusera 24•ß7 software automatically calculates
statistical data, including the mean and standard deviation. Data is
presented in easy to read charts, allowing any sudden or gradual 14
changes in performance to be identified immediately. Data can be
displayed and viewed in 5 different ways, allowing performance to be
assessed at a glance.
On screen summary of results

The on screen summary of results report provides a quick overview of
current analytical performance.
It enables the comparison of results with user defined fixed mean and
standard deviation values. The laboratory can set fixed values based
on peer group statistics or other values such as the target and range
quoted for the particular lot in use. Data can be viewed for up to
three lots of control sera.
Levey-Jennings charts
Identify trends, biases and precision problems at a glance using the
Levey-Jennings report
Two Levey-Jennings charts are available, one is based on the standard

deviation and the other is based on percentage deviation. Rejected
or alarmed results based on user defined performance multi-rules are
highlighted in red, allowing any performance issues to be identified
at a glance. Data is displayed for up to 90 days, however historical
data can be viewed if necessary by scrolling through historical
Levey-Jennings charts.
Results may be compared to user defined acceptable limits of

performance or against pre-set acceptable limits, which can be user
defined or based on Biological Variation or governments requirements
such as CLIA.
77
Histogram
The histogram displays your monthly mean for each parameter over a
period of 12 months, allowing any long term trends to be identified and
corrected as soon as possible.
The histogram report is extremely useful in identifying both shifts and

trends in your monthly results.
Performance summary charts

Performance summary charts allow cumulative or monthly data to be
compared to a peer group based on world or affiliate group statistics.
The performance summary report highlights potential bias and

imprecision issues. Laboratory performance versus chosen peer
group and method peer group is plotted. Your cumulative or monthly
results can be compared to world or affiliate group statistics, enabling
enhanced troubleshooting capabilities.
14
Affiliate Group Performance Summary
Group co-ordinators can view the performance of others in their Powerful drill-down function allows group co-ordinators to monitor
group of affiliate laboratories. performance of their affiliate laboratories
Drill into the method statistics to reveal performance of individual

affiliate laboratories
To start your 60 day free trial request a 24-7 software CD from your Randox representative or
visit www.randox.com/247
78
Customised Quality
Control Sera
Chapter 15
15
Customised quality
control sera
Customised Quality Control Sera
For nearlly 30 years, laboratories, EQA scheme organisers and

CONSOLIDATION
other diagnostic companies have looked to Randox to provide their
QC needs. Randox Laboratories manufactures a full portfolio of
Randox will significantly consolidate your existing
quality controls, calibrators and standards for over 300 parameters.
controls. An average laboratory may rationalise from
In addition to ‘off the shelf ’ quality control products, Randox is 7 sera to a single control product
the world’s leading provider of customised control materials.
Customising control materials can involve adding analytes, removing
unused parameters, specifying analyte concentrations or choosing TAILOR MADE
alterative vial sizes.
Specify the analytes and levels you require. We can

Our principal control products are; provide the levels tailored to your cut off values
• Antioxidants
• Cardiac
• Clinical Chemistry STABILITY
• Coagulation
• Diabetes Randox Sera are stable for up to 4 years, enabling
• Immunoassay use of the same lot over an extended period
• Immunology and Specific Proteins
• Lipids
• Tumour Markers
OPTIONS
• Therapeutic Drugs and Toxicolgy
• Urine tests.
• Specialist and Research controls such as Cytokines, Growth Customised controls in different matrices
15 Promoters, Antimicrobial, Cerebral and a variety of single-analyte e.g. serum, urine, aqueous
control products.
We also produce custom sera for EQA schemes and specialised FLEXIBILITY
controls for research projects.
Batch sizes manufactured between 50 – 250,000
Quality is our focus during the manufacturing process. All control vials. Randox can provide a wide range of vial sizes
products are produced to the same high specifications using from 1ml to 10ml
procedures complying with ISO 13485 for medical devices. State of
the art clinical chemistry and immunoassay analysers are used during
the manufacturing and quality control processes.
QUALITY
To enable us to identify and fulfil your needs, please discuss your All controls are produced to high quality
requirements with your Randox representative. We are happy to specification, fully compliant with ISO 13485
consider any requirements you may have. Randox has 30 years
experience in producing customised sera, and we will ensure you
will receive the specified product you want in a professional and CHOICE
timely manner.
3 different formats – lyophilised / liquid / liquid frozen
80
Customised quality
control sera
Customised Timeline:
Week 1
QC order placed by you
You run blind sample and Randox sends blind Enables Randox to view how
return results to Randox sample to you the material recovers on your
machines
Manufacture of Sample is despatched If end sample does not meet

Customised Sample to you specifications, you are under
no obligation to accept
15
Sample checked and

approved by you
Randox generates labels

and packages kit
Randox despatches and delivers

final product to you
Week16
81
Customised quality
control sera
examples of Analytes available for Customised QC Sera

Antimicrobials Diabetic Neuron Specific Enolase Osmolality
Sulphachlorpyridazine Fructosamine Oestradiol Phosphorus
Sulphadiazine HbA1c Phenytoin Potassium
Sulphadimethoxine Progesterone PSA
Sulphadoxine Drugs of Abuse Prolactin PSA (Free)
Sulphaisoxazole Amphetamine PTH Salicylic Acid
Sulphamerazine Barbiturates Renin Sodium
Sulphamethazine Benzodiazepine SHBG Urea
Sulphamethizole Cannabinoids Syphilis RPR / VDRL Uric Acid
Sulphamethoxypyridazine Cocaine TBG Zinc
Sulphapyridine Ethanol T3 (Free)
Sulphaquinoxaline Methadone T3 (Total) Proteins
Sulphathiazole Methamphetamine T4 (Free) Alpha-1-Acid Glycoprotein (AAG)
Opiates T4 (Total) Alpha-1-Antitrypsin (AAT)
Antioxidant Phencyclidine Testosterone Alpha-2-Macroglobulin
Superoxide Dismutase Testosterone (Free) Antistreptolysin O
Glutathione Peroxidase Drugs (Therapeutic) Thyroglobulin Caeruloplasmin
Glutathione Reductase Acetaminophen (Paracetamol) TPO Complement C3
Total Antioxidant Status Amikacin Anti-TPO Complement C4
Carbamazepine Anti-TG CRP
Cardiac Cyclosporine TSH hsCRP
CK (Total) Digoxin Vitamin B12 Ferritin
CK-MB Ethosuximide Vitamin D Haptoglobin
Carbonic Anhydrase III (CAIII) Gentamicin IgA
Fatty Acid Binding Protein (FABP) Lithium Lipids IgE
Glycogen Phosphorylase BB (GPBB) Methotrexate Apolipoprotein A-I IgG
Myoglobin Netilmicin Apolipoprotein A-II IgM
Homocysteine Phenobarbital Apolipoprotein B Kappa Light Chain
Troponin I Phenytoin Apolipoprotein C-II Lambda Light Chain
Troponin T Primidone Apolipoprotein C-III Prealbumin
Theophylline Apolipoprotein E Protein (Total)
Coagulation Tobramycin Cholesterol RBP (Retinol Binding Protein)
15 Activated Partial Thromboplastin Time (aPTT) Valproic Acid Cholesterol (HDL) Rheumatoid Factor
Antithrombin III Vancomycin Cholesterol (LDL) Transferrin
D-Dimer Lipids (Total)
Factor II Growth Promoter Lipoprotein (a) Urine
Factor V β-Agonists NEFA Calcium
Factor VII Boldenone Phospholipids Chloride
Factor VIII Corticosteroids Triglycerides Copper
Factor IX Nandrolone Cortisol
Factor X Ractopamine Routine Chemistry Creatinine
Factor XI Stilbenes Albumin Epinephrine
Factor XII Stanozolol Acid Phosphatase (Total) Glucose
Fibrinogen Trenbolone Acid Phosphatase (Prostatic) 5-H1AA
Plasminogen Zeranol Aldolase Magnesium
Protein C ALT (SGPT) Metanephrine
Protein S Immunoassay Alkaline Phosphatase Microalbumin
Prothrombin Time (PT) ACTH Ammonia Norepinephrine
Thrombin Time (TT) AFP Amylase Normetanephrine
Aldosterone Amylase (Pancreatic) Osmolality
Cytokine & Growth Factors Androstenedione AST (SGOT) Phosphorous
Epidermal Growth Factor (EGF) CEA Bicarbonate Potassium
E-Selectin FSH Bile Acids Total Protein
Intercellular Adhesion Molecule 1 (ICAM-1) 17-OH – Progesterone Bilirubin (Direct) Sodium
Interferon-gamma (IFN-γ) β-2-Microglobulin Bilirubin (Total) Urea
Interleukin-1 alpha (IL-1 α) CA 125 Calcium Uric Acid
Interleukin-1 beta (IL-1β) CA 15-3 Chloride VMA (Vanillylmandelic Acid)
Interleukin-2 (IL-2) CA 19-9 Cholinesterase
Interleukin-2 Receptor Alpha (IL-2R α) CA 72-4 Copper
Interleukin-6 Soluble Receptor (IL-6SR) C Peptides Creatinine
Interleukin-4 (IL-4) Cyfra 21-1 D-3-Hydroxybutyrate
Interleukin-6 (IL-6) Cortisol Ethanol
Interleukin-8 (IL-8) DHEA-Sulphate G-6-PDH
Interleukin-10 (IL-10) Estriol GGT
L-Selectin Folate GLDH
Monocyte Chemotactic Protein-1 (MCP-1) FSH Glucose
Matrix Metalloproteinase 9 (MMP-9) Growth Hormone HBDH
P-Selectin hCG Iron (TIBC)
Soluble Tumour Necrosis Factor Receptor-1 (sTNFRI) 25-Hydroxy Vitamin D Lactate
Soluble Tumour Necrosis Factor Receptor-2 (sTNFR2) IGF-1 LAP
Tumour Necrosis Factor-alpha (TNF-α) PAPP- A LDH
Vascular Cell Adhesion Molecule 1 (VCAM-1) Inhibin A Lipase
Vascular Endothelial Growth Factor (VEGF) Insulin Magnesium
This list is not exhaustive. If the analyte you require is not present, please contact your Randox representative
82
RIQAS
Randox International Quality
Assessment Scheme
Chapter 16
16
15
RIQAS
Randox International Quality Assessment Scheme (RIQAS)

RIQAS is the largest international EQA scheme in the world, used by more than 20000 laboratories in over 90 countries worldwide. This large
number of participants makes RIQAS the best quality EQA scheme in the world and ensures an extensive database of results for many analytical
methods directly increasing statistical validity as a result.
RIQAS REPORTS
• Statistical breakdown by all methods, your method and your instrument, including running means for the last 10 samples.
• Compare your instrument group, method group and all methods using the histogram.
• Identify trends, biases and precision problems using the Levey-Jennings chart.
• The Target Score Chart grades your performance in a moving window over the last 20 samples, including the previous cycle .
• At-a-glance summary page for all analytes in the programme.
Standard Report
The unique target scoring system was developed to provide a simple interpretation of your laboratory’s performance. The system will present
the performance of your results for each RIQAS sample and also show how your laboratory’s performance varies with time.
Laboratories can register up to five instruments for each parameter at no extra cost. Individual reports for each instrument plus a unique multi-
instrument report are provided. The multi-instrument report allows the comparative performance of each instrument.
Standard Report
16 Levey-Jennings
Chart
Detailing
features of your
laboratory’s
performance
Text Section
for all Methods,
your method
and instrument
group
(programme
specific)
Target Score
This unique
chart provides
a numerical
index of
performance
allowing at
a glance
assessment
% deviation by
sample displayed
Histogram in relation to
Method and performance
instrument limits
comparison
Breakdown of other
method statistics % deviation
by sample
concentration
Ths allows easy
assessment of
concentration
related bias
84
RIQAS

Urine Toxicology Report

Your Result
Your Result

Based on weighed-in value of value of

Urine Toxicology Report

Based on weighed-in
and your chosen cut-off

and your chosenvalue of value of

cut-off

the correctthe
response
correct was
response was
False Positive
False Positive

False Negative
False Negative

Your
Your
Result
Result

Based
Based onon
weighed-in
weighed-in
value
value
of of

and
andyour
your
chosen
chosencut-off
cut-offvalue
value
of of

the
the
correct
correct
response
responsewas
was

False
False
Positive
Positive

QUANTITATIVE

SCREENING

Cut-off TN TP FN FP RC NT Total
False
False Cut-off
Negative
Negative TN TP FN FP RC NT Total

Your Result

0 0

Your Result
0 0

Cut-off TPTP FN
Cut-off TNTN FN FP
FP RC
Total
RC NTNT
Total

0 0 0 0

Your
Your
Result
Result

Performance History
Performance History

% False Negatives % False Negatives % False Negatives % False Negatives % False Negatives
% False Negatives % False Negatives % False Negatives % False Negatives % False Negatives
% False Positives % False Positives % False Positives % False Positives % False Positives
% False Positives % False Positives % False Positives % False Positives % False Positives
% Correct Responses
Performance
PerformanceHistory
History % Correct Responses % Correct Responses % Correct Responses % Correct Responses
% Correct Responses % Correct Responses % Correct Responses % Correct Responses % Correct Responses

%
%
False
False
Negatives
Negatives %
%
False
False
Negatives
Negatives %
%
False
False
Negatives
Negatives %%
False
False
Negatives
Negatives %%
False
False
Negatives
Negatives
%
%
False
False
Positives
Positives %
%
False
False
Positives
Positives %%
False
False
Positives
Positives %
%
False
False
Positives
Positives %
%
False
False
Positives
Positives
%%
Abbreviations
Correct
Correct
Responses
Responses
TN True %%Correct
Negative
Correct
Responses
Responses
FN False %%Correct
Correct
Negative
Responses
Responses
RC %%
Referred
Correct
Correct
for Responses
Responses
Confirmation %%
Correct
Correct
Responses
Responses
Abbreviations TN True Negative FN False Negative RC Referred for Confirmation
TP True Positive
TP
FP
True Positive
False Positive
FP
NT
False Positive
Not Tested
NT Not Tested
RIQAS
RIQAS
Abbreviations
Abbreviations TNTN True
True
TPTP True
Negative
True
Negative
Positive
Positive
FNFN False
False
FPFP False
Negative
False
Negative
Positive
Positive
RCRC Referred
Referred
NTNT Not
Not
forfor
Tested
Tested
Confirmation
Confirmation
RIQAS
RIQAS

Urinalysis Report 16
15
Urinalysis Report
Categories stated in your unit

Screening Results All categories (result options)

available for this parameter

for any method (dipstick)
Your method group and categories

Results from all methods (dipsticks)

Your categories (available
result options for your chosen

able to return results in the same
categories as your lab dipstick and unit)

Results from all methods for all

available categories

Comments Box
Your Result
Performance Statement 90 90 All Categories Histogram

80 80 a quick visualisation of how your
70 70 lab’s result falls into the overall
Your Categories picture for all categories
Number of Laboratories
Number of Laboratories
60 60
Histogram: 50 50
A quick visualisation of how your 40 40
lab’s result falls into the overall 30 30

Results submitted from a
picture for your categories 20 20
category not applicable to your
10 10
method
0 0

Your Result

Your categories
Possible reporting categories
for your method

DETAILED SUMMARY OF

RESULTS
All available methods for

This table enables you to see
this parameter

how you compare to all other
results

85
RIQAS
BLOOD GAS PROGRAMME + With target scoring

RQ9134 RQ9134/a* * Note to participants with multiple instruments on the Blood Gas Programme:
First registered instument Subsequent instrument RQ9134 must be purchased for the first registered instrument and individual
10 Parameters 10 Parameters RQ9134/a kits for every subsequently registered instrument.
Samples every month, 1 x 12 monthly cycle, 12 months subscription
pCO2 tCO2 K+ Lactate

pH Ca++ Na+
pO2 Cl- Glucose
CARDIAC PROGRAMME With target scoring

RQ9127/a RQ9127/b
2 Parameters only (choose from 7) Full 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
CK, Total CK-MB Mass Myoglobin Troponin T

CK-MB Activity Homocysteine Troponin I
COAGULATION PROGRAMME + With target scoring

RQ9135/a RQ9135/b
5 selected Parameters only (aPTT, Full 16 Parameters
PT,TT, Fibrinogen, Antithrombin III)
Samples every month, 1 x 12 monthly cycle, 12 month subscription
aPTT Antithrombin III Factor II Factor IX
PT (including INR) Plasminogen Factor V Factor X
TT Protein C Factor VII Factor XI
Fibrinogen Protein S Factor VIII Factor XII
GENERAL CLINICAL CHEMISTRY PROGRAMMES With target scoring

RQ9112 RQ9112/S RQ9113
10 Parameters only 17 Parameters only Full 50 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Reference Method Values
Acid phosphatase, (prostatic) Calcium, ionised HDL-Cholesterol Sodium

Acid phosphatase (total) Chloride Iron TIBC
Albumin Cholesterol Lactate* Free T3
16 Alkaline phosphatase Cholinesterase* LD (LDH) Total T3
ALT (ALAT) CK, total (CPK) Lipase Free T4
Amylase, pancreatic Copper Lithium Total T4
Amylase, total Creatinine Magnesium Triglycerides
AST (ASAT) D-3-hydroxybutyrate NEFA* TSH
Bicarbonate Fructosamine* Osmolality Urea
Bile acids Gamma GT Phosphate, inorganic Uric acid
Bilirubin, direct GLDH Potassium Zinc
Bilirubin, total Glucose Protein, total
Calcium HBDH PSA
GLYCATED HAEMOGLOBIN (HbA1c) PROGRAMME - With target scoring

RQ9129
2 Parameters
Sample every month, 1 x 12 month cycle, 12 month subscription
HbA1c Total Haemoglobin*
HAEMATOLOGY PROGRAMME With target scoring

RQ9118
12 Parameters
Haematocrit (HCT) Red Blood Cell Count (RBC)
Haemoglobin (Hb) Total White Blood Cell Count (WBC)
Mean Cell Haemoglobin (MCH) Mean Platelet Volume*
Mean Cell Haemoglobin Concentration (MCHC) Packed Cell Volume*
Mean Cell Volume (MCV) Plateletcrit*
Platelets (PLT) Red Cell distrvaition width*
HUMAN URINE PROGRAMME

RQ9115
24 Parameters
Albumin Creatinine Normetanephrine Protein, total

Amylase Dopamine Magnesium Sodium
Calcium Epinephrine Osmolality Urea
Chloride Glucose Oxalate Uric acid
Copper Metanephrine Phosphate, inorganic VMA
Cortisol Norepinephrine Potassium 5-HIAA
RED = Parameters with Reference Method Values PURPLE = The only parameters available on RQ9135/a + = Programmes awaiting accreditation To ILAC G13: 2007/ ISO/IEC 17043 * = Pilot study ongoing
86
RIQAS
IMMUNOASSAY PROGRAMMES With target scoring

RQ9125/a RQ9125/b RQ9125/c RQ9130
4 Parameters only 13 Parameters only (choose from 55) Full 55 Parameters Full 55 Parameters
(choose from 55)
2 x 6 monthly cycles (RQ9125/a, RQ9125/b, RQ9125/c) , 12 month subscription
1 x 12 month cycle (RQ9130), 12 month subscription
ACTH* DHEA Unconjugated 17-OH-progesterone Free T4

AFP Digoxin Paracetamol* Total T4
Aldosterone* Estriol Total* Phenytoin Testosterone free*
Amikacin* Ethosuximide* Primidone* Testosterone (total)
Androstenedione* Ferritin Progesterone Theophylline
Beta-2-microglobulin Folate Prolactin Thyroglobulin
CA125 FSH Free PSA Tobramycin*
CA15-3 Gentamicin* Total PSA TSH
CA19-9 GH Phenobarbital* Valproic acid
Carbamazepine hCG PTH Vancomycin*
CEA IgE Salicylate* Vitamin B12
Cortisol Insulin SHBG 1-25-(OH)²-Vitamin D*
C-peptide* LH Free T3 25-OH-Vitamin D*
DHEA-S Oestradiol Total T3
IMMUNOASSAY SPECIALITY 1 PROGRAMME +

RQ9141
10 parameters
1-25-(OH)2-Vitamin D Anti-TPO PTH

25-OH-Vitamin D IGF-1 Insulin
C-Peptide Osteocalcin
Anti-TG Procalcitonin
IMMUNOASSAY SPECIALITY 2 PROGRAMME +

RQ9142
5 parameters
Calcitonin Procalcitonin Renin, direct concentration 16

15
Gastrin Plasma renin activity
LIPID PROGRAMME With target scoring

RQ9126/a RQ9126/b
3 Parameters only (choose from 7) Full 7 Parameters, samples every 2 weeks
Apolipoprotein A1 Cholesterol, total LDL-cholesterol Triglycerides
Apolipoprotein B HDL-cholesterol Lipoprotein (a)*
LIQUID CARDIAC PROGRAMME + With target scoring

RQ9136
10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription
BNP Digoxin Myoglobin Troponin T

CK-MB Mass Homocysteine NT proBNP
D-Dimer* hsCRP Troponin I
MATERNAL SCREENING PROGRAMME + With target scoring

RQ9137
6 Parameters
AFP total hCG PAPP-A

free Beta hCG Inhibin A Unconjugated Oestriol
SEROLOGY (EBV) PROGRAMME +

RQ9153
To become routinely available in 2012
2 parameters
Quarterly Reporting, quantitative and qualitative results, 1 x 12 month cycle, 12 month subscription
Anti-EBV VCA IgG Anti-EBNA IgG
87
RIQAS
SEROLOGY (HIV-HEPATITIS) PROGRAMME +

RQ9151
10 parameters
Quarterly reporting, qualitative results only, 1 x 12 month cycle, 12 month subscription
Anti-HIV-1 Anti-HBc Anti-HTLV-1&2 Combi

Anti-HIV-2 HBsAg Anti-CMV
Anti-HIV-1&2 Combi Anti-HTLV-I
Anti-HCV Anti-HTLV-II
SEROLOGY (SYPHILIS) PROGRAMME +

RQ9154
1 parameter
Syphilis (Methods available include RPR, VDRL and TPHA)
SEROLOGY (ToRCH) PROGRAMME +

RQ9152
12 parameters
Anti-Toxoplasma IgG Anti-CMV IgG Anti-HSV2 IgG

Anti-Toxoplasma IgM Anti-CMV IgM Anti-HSV2 IgM
Anti-Rubella IgG Anti-HSV1 IgG Anti-HSV-1&2 IgG Combi
Anti-Rubella IgM Anti-HSV1 IgM Anti-HSV-1&2 IgM Combi
SPECIFIC PROTEINS PROGRAMME With target scoring

RQ9114
26 parameters,
16 AFP Beta-2-microglobulin Immunoglobulin A Total Lambda Light Chain

Albumin Claeruloplasmin Immunoglobulin E Prealbumin (Transthyretin)
Alpha-1-acid glycoprotein Complement, C3 Immunoglobulin G Retinol Binding Protein
Alpha-1-antitrypsin Complement, C4 Immunoglobulin M Rheumatoid Factor
Alpha-2-macroglobulin C-Reactive Protein Free Kappa Light Chain Transferrin
Anti Streptolysin O Ferritin Total Kappa Light Chain
Antithrombin III Haptoglobin Free Lambda Light Chain
THERAPEUTIC DRUGS PROGRAMME With target scoring

RQ9111
18 parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription,Weighed-in values
Amikacin Ethosuximide Phenobarbitone Tobramycin
Caffeine Gentamicin Phenytoin Valproic acid
Carbamazepine Lithium Primidone Vancomycin
Cyclosporine Methotrexate Salicylic acid
Digoxin Paracetamol Theophylline
URINALYSIS PROGRAMME+
RQ9138
17 Parameters
Samples every 2 months 1 x 12 month cycle, 12 month subscription
Albumin Glucose pH White Blood Cells*
Bilirubin hCG Protein Crystals*
Blood Ketones Specific Gravity
Creatinine Leukocytes Urobilinogen
Galactose Nitrite Red Blood Cells*
URINE TOXICOLOGY PROGRAMME+

RQ9139
20 Parameters
Benzoylecgonine d-Amphetamine Lorazepam Norpropoxyphene

Buprenorphine d-Methamphetamine LSD Oxazepam
Cannabinoids (THC) EDDP MDMA Phencyclidine
Creatinine Ethanol Methadone Phenobarbital
Cotinine Free Morphine Nortriptyline Secobarbitol
88
RIQAS
RIQAS results can be submitted using

Features and Benefits one of the following methods:
• RIQAS systems and procedures are recognised and accredited • Web-based data transfer (www.RIQAS.net) – RIQASNet is an
to a number of internationally recognised standards including internet based data entry system allowing participants to return
ISO 13485:2003, UKAS, ILAC-G13:2007, NQAAP and JWG results and view reports online. Participants can submit current,
QA. (ILAC-G13:2007 will be replaced by ISO/IEC17063 in corrected, late and future results, directly into the RIQAS database
2012) eliminating the need to fax or email EQA results. Reports are then
emailed directly to participants in pdf format when available. Current
• Human samples free from interfering preservatives increase and previous reports are also available to download directly from
confidence that EQA performance mirrors performance of the internet.
patient samples
• Results can also be submitted by post or by fax
• A wide range of parameters are available covering a wide
spectrum of laboratory tests allowing for effective consolidation • PDF Reporting is also available for all participants - RIQAS reports
of existing EQA programmes. can now be presented in pdf (portable document format), offering
easy review and storage of your laboratory’s EQA data. There
• User friendly reports provide a statistical breakdown of results are many advantages associated with pdf reporting, increasing the
by method and instrument, allowing analytical performance to usability and efficiency of data analysis.
be assessed at a glance. Levey Jennings and histogram charts
identify trends, biases and precision problems while the unique
Target Scoring chart grades performance in a moving window
for the last 20 samples.
• Regular reports with rapid turnaround times ensure corrective

actions can be taken as soon as possible. Reports returned in
2 - 3 days.
• Reduced analyte options for selected programmes offer greater

flexibility, ensuring suitability for laboratories of all sizes and
budgets
16
15
• Participant certificates provide evidence of participation in a

reputable EQA scheme
• Laboratories can register up to five instruments for each

parameter at no extra cost. Individual reports for each
instrument plus a unique multi-instrument report are provided.
The multi-instrument report allows comparative performance
of each instrument.
• Inter-laboratory group reports allow comparison of multiple

connected laboratories at no extra cost
• RIQAS support staff are on hand to offer advice and

troubleshoot technical queries
89
RIQAS
16
90
Analyte Index
Chapter 17
17
Analyte Index
Blood Gas
Cardiac Controls
Clinical Chemistry Calibrator Serum

Clinical Chemistry Controls
Precision Chemistry Premium Plus

Assayed Chemistry Premium Plus
Liquid Chemistry Premium Plus
b a a b - Thalassemia Control
Liquid Tumor Marker Control

Liquid Immunoassay Premium
Bovine Chemistry (Precision)
Bovine Chemistry (Assayed)
High Sensitivity Troponin T
Immunoassay Premium Plus

Multi Control & Calibrator

Liquid Chemistry Premium
Immunoassay Speciality II
Tumour Marker Control
Immunoassay Speciality I
Liquid Cardiac Control
Immunoassay Premium
Glutathione Reductase
Myoglobin Calibrator
Chemistry Premium
HbA1c Linearity Set

Diabetes Controls
Maternal Screening
Bilirubin (Elevated)
Ammonia/ Ethanol
H-FABP Control
Specific Proteins
Fructosamine
Immunoassay Controls
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
# 17-OH-progesterone x x x
17b Clostebol
5-HIAA
A AAD
Acid phosphatase, prostatic x x x x x x x x
Acid phosphatase, total x x x x x x x x
Beta-Agonists
ACTH x x
AHD
Aldosterone x x x
Alphafetoprotein (AFP) x x x x x x x x x x
Alpha-1-Antitrypsin x x x x
Alpha-1-Acid Glycoprotein x x x x
Alpha-HBDH x x x x x x x
Alanine aminotransferase (ALT) x x x x x x x x
Albumin x x x x x x x x x x
Aldolase x
Alkaline phosphatase (ALP) x x x x x x x x
Alpha-1-globulin x x x x x
Alpha-2-globulin x x x x x
Amikacin x x x x
Ammonia x x
17 AMOZ
Amphetamine
Amylase x x x x x x x x
Amylase, pancreatic x x x x x x
Amylase, total
Anti-thrombin III x x
Anti-thyroglobulin (Anti-TG) x
Anti-thyroperoxidase (Anti-TPO) x
AOZ
aPTT x
Apolipoprotein AI x x x x
Apolipoprotein AII
Apolipoprotein B x x x x
Apolipoprotein C III
Apolipoprotein CII
Apolipoprotein E
ASO x
Aspartate Aminotransferase (AST) x x x x x x x x
B Beta-Agonists
Barbiturates group
Benzodiazepines group
Benzoylecgonine
Beta-1-globulin x x x x x
Beta-2-Microglobulin x x x x x x x
Bicarbonate x x x x x x x x
Bile acids x x x x x x x
Bilirubin, direct x x x x x x x x x
Bilirubin, total x x x x x x x x x
92
Analyte Index
Immunology/ Protein Controls
Lipid Controls
(For samples that do not
require predilution)
(For samples that do
Therapeutic Drug Controls
Apolipoprotein Control & Calibrator Toxicology Controls

HDL/ LDL Cholesterol Calibrator
Ethanol Calibrator/Control Set

b-2-Microglobulin Calibrator
Cellular Adhesion Molecules
Metabolic Sydrome Control

Unassayed Urine Chemistry
Urine Controls
Immunoglobulin Calibrator
Evidence Multistat Cardiac

Specific Protein Calibrator
Assayed Urine Chemistry

Benzodiazepines Control

Cannabinoid Control
Evidence Cardiac Plus

Speciality & Research Controls
Growth Promoters
Rheumatoid Factor
Synthetic Steroids
Multidrug Control
Evidence Cardiac
Urine Toxicology
Liquid Urinalysis
Ecstacy Control
ASO Calibrator
Drugs of Abuse
EDDP Control
Lipoprotein (a)
Antimicrobials
TDM Control
sLDL Control
Microalbumin
Cystatin C
Glutamine
Cytokines
Endocrine
Cerebral
Thyroid
Lipid
IgG
IgE
x 17-OH-progesterone #
x 17b Clostebol
x 5-HIAA
AAD A
Acid phosphatase, prostatic

Acid phosphatase, total
Beta-Agonists
ACTH
x AHD
Aldosterone
Alphafetoprotein (AFP)
x Alpha-1-Antitrypsin
x Alpha-1-Acid Glycoprotein
Alpha-HBDH
Alanine aminotransferase (ALT)
x x Albumin
Aldolase
Alkaline phosphatase (ALP)
Alpha-1-globulin
Alpha-2-globulin
x Amikacin
Ammonia
x AMOZ
17
x Amphetamine
x Amylase
Amylase, pancreatic
Amylase, total
Anti-thrombin III
Anti-thyroglobulin (Anti-TG)
Anti-thyroperoxidase (Anti-TPO)
x AOZ
aPTT
x x Apolipoprotein AI
x Apolipoprotein AII
x x Apolipoprotein B
x Apolipoprotein C III
x Apolipoprotein CII
x Apolipoprotein E
x x ASO
Aspartate aminotransferase (AST)
x Beta-Agonists B
x x Barbiturates group
x x Benzodiazepines group
Benzoylecgonine
Beta-1-globulin
x Beta-2-Microglobulin
Bicarbonate
Bile acids
x Bilirubin, direct
x Bilirubin, total
93
Analyte Index
Blood Gas
Cardiac Controls




Immunoassay Premium
Diabetes Controls
Chemistry Premium
HbA1c Linearity Set
Maternal Screening
Ammonia/ Ethanol
H-FABP Control
Specific Proteins
Fructosamine
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
B Blood
Boldenone
BNP x
Brain Derived Neurotropic Factor (BDNF)

Buprenorphine
C Cholesterol x x x x x x x x
CK,Total x x x x x x x x
CK-MB x
CA72-4 x x
CA125 x x x
CA15-3 x x x
CA19-9 x x x
Ceruloplasmin x x x x
Caffeine x
Calcitonin x x
Calcium x x x x x x x x x
Calcium (Ionised) x x
Cannabinoids group
Carbamazepine x x x x x x
Carbonic Anhydrase III (CA III)

Carcinoembryonic Antigen (CEA) x x x x x x x
Ceftiofur
17 Chloramphenicol
Chloride x x x x x x x x x x
Cholinesterase x x x x x x
CK,Total x
Cocaine group: Benzoylecgonine

Copper x x x x x x x
Corticosteroids
Cortisol x x x x x x x x x
Complement C3 x x x x
Complement C4 x x x x
C-Peptide x x x
C-Reactive Protein (CRP) x x x x x
Creatine Kinase MB (CK-MB) x x x
Creatinine x x x x x x x x
Cyclosporine
Cystatin C
Cyfra 21 x x
D D-3-hydroxybutyrate x x x x x x x
D-Dimer x
DHEA-Sulphate x x x x
Digoxin x x x x x x x x
Dopamine
E Ecstasy
EDDP
Electrophoresis
Epidermal Growth Factor (EGF)
Epinephrine
E-Selectin
Estradiol
94
Analyte Index
Lipid Controls


Urine Controls



Cannabinoid Control

Growth Promoters
Rheumatoid Factor
Synthetic Steroids
Multidrug Control
Evidence Cardiac
Urine Toxicology
Liquid Urinalysis
Ecstacy Control
ASO Calibrator
Drugs of Abuse
EDDP Control
Lipoprotein (a)
Antimicrobials
TDM Control
sLDL Control
Microalbumin
Cystatin C
Glutamine
Cytokines
Endocrine
Cerebral
Thyroid
Lipid
IgG
IgE
x Blood B
x Boldenone
BNP
x Brain Derived Neurotropic Factor (BDNF)
x Buprenorphine
x Cholesterol C
CK,Total
CK-MB
CA72-4
CA125
CA15-3
CA19-9
Caeruloplasmin
x Caffeine
Calcitonin
x x x Calcium
Calcium (Ionised)
x x x Cannabinoids group
x Carbamazepine
x Carbonic Anhydrase III (CA III)
Carcinoembryonic Antigen (CEA)
x Ceftiofur
x Chloramphenicol
17
x x x Chloride
Cholinesterase
CK,Total
x x Cocaine group: Benzoylecgonine
x Copper
x Corticosteroids
x x x Cortisol
x Complement C3
x Complement C4
x C-Peptide
x x C-Reactive Protein (CRP)
x x x Creatine Kinase MB (CK-MB)
x x x x Creatinine
x Cyclosporine
x Cystatin C
Cyfra 21
D-3-hydroxybutyrate D
x D-Dimer
x DHEA-Sulphate
x Digoxin
x Dopamine
x Ecstasy E
x EDDP
Electrophoresis
x Epidermal Growth Factor (EGF)
x Epinephrine
x E-Selectin
Estradiol
95
Analyte Index
Blood Gas
Cardiac Controls





Immunoassay Premium
Chemistry Premium
HbA1c Linearity Set

Diabetes Controls
Maternal Screening
Ammonia/ Ethanol
H-FABP Control
Specific Proteins
Fructosamine
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
E Estriol x x x
Ethanol x x x
Ethinylestradiol
Ethosuximide x x x
F Factor II x
Factor V x
Factor VII x
Factor VIII x
Factor IX x
Factor X x
Factor XI x
Factor XII x
Fatty Acid Binding Protein (FABP)

Fentanyl
Ferritin x x x x x x x x x
Fibrinogen x
Folate x x x x x x x
Follicle Stimulating Hormone (FSH) x x x x
Free Prostate Specific Antigen (fPSA) x x
Free thyroxine (FT4) x x x x x x x x x
Free tri-iodothyronine (FT3) x x x x x x
Fructosamine x
17 G G-6-PDH x
Gentamicin x x x x x x x
Gestagens (generic)
Gamma-Globulin x x x x x
Gamma GT x x x x x x x x
Gastrin x
GH x x x x
GLDH x x x x x x x
Glial Fibrillary Acidic Protein (GFAP)

Glucose x x x x x x x x x x
Glutamate x
Glutamine
Glutathione Peroxidase (RANSEL) x
Glutathione Reductase (GR) x
Glycerol x
Glycogen Phosphorylase BB (GPBB)

GM-CSF
H Haptoglobin x x x x
HbA2 x
HbA1c x x
HbF x
HbS x
hCG x x x x x x x x x
hCG (Free beta) x
HDL Cholesterol x x
H-FABP x
Homocysteine x x
hsCRP x
I IgA x x x x x x
IgE x x x x x x x
96
Analyte Index
Lipid Controls



Urine Controls



Cannabinoid Control

Growth Promoters
Rheumatoid Factor
Synthetic Steroids
Multidrug Control
Evidence Cardiac
Urine Toxicology
Liquid Urinalysis
Ecstacy Control
ASO Calibrator
Drugs of Abuse
EDDP Control
Lipoprotein (a)
Antimicrobials
TDM Control
sLDL Control
Microalbumin
Cystatin C
Glutamine
Cytokines
Endocrine
Cerebral
Thyroid
Lipid
IgG
IgE
Estriol E
x x Ethanol
x Ethinylestradiol
x Ethosuximide
Factor II F
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
x x x x Fatty Acid Binding Protein (FABP)
x Fentanyl
x x Ferritin
Fibrinogen
Folate
Follicle Stimulating Hormone (FSH)
Free Prostate Specific Antigen (fPSA)
Free thyroxine (FT4)
Free tri-iodothyronine (FT3)
Fructosamine
G-6-PDH G
17
x Gentamicin
x Gestagens (generic)
Gamma-Globulin
Gamma GT G
Gastrin
GH
GLDH
x Glial Fibrillary Acidic Protein (GFAP)
x x x x Glucose
Glutamate
x Glutamine
Glutathione Peroxidase (RANSEL)
Glutathione Reductase (GR)
Glycerol
x Glycogen Phosphorylase BB (GPBB)
x GM-CSF
x Haptoglobin H
HbA2
HbA1c
HbF
HbS
x x hCG
hCG (Free beta)
x x HDL Cholesterol
H-FABP
Homocysteine
hsCRP
x x x IgA I
x IgE
97
Analyte Index
Blood Gas
Cardiac Controls





Immunoassay Premium
Chemistry Premium
HbA1c Linearity Set

Diabetes Controls
Maternal Screening
Ammonia/ Ethanol
H-FABP Control
Specific Proteins
Fructosamine
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
I IgG x x x x x x x
IgM x x x x x x
Inhibin A x
Insulin x x x x
Insulin Growth Factor x
Intercellular Adhesion Molecule-1 (ICAM-1)
Interferon-gamma (IFN-y)
Interleukin-1 alpha (IL-1a)
Interleukin-1 beta (IL-1b)
Interleukin-10 (IL-10)
Interleukin-12p70 (IL-12 p70)
Iron x x x x x x x x
17 K Kappa Light Chain x
Kappa Light Chain (free) x
Ketamine
Ketones
L Lambda Light Chain x
Lambda Light Chain (free) x
Lactate x x x x x x x x x
LAP x x x x x
LD x x x x x x x
Leptin
LDL Cholesterol x x x
Leukocytes
Luteinising Hormone (LH) x x x x
Lipase x x x x x x x x
Lipoprotein (a) x x
Lithium x x x x x x x x
Lorazepam
L-Selectin
Lysergic Acid Diethylamide (LSD)
M
Alpha-2-Macroglobulin
MIP-1a
Magnesium x x x x x x x x
Matrix Metalloproteinase-9 (MMP-9)
MDMA
Medroxyprogesteron Acetate
Metanephrine
Methadone
Methandriol
Methamphetamine
Methaqualone
98
Analyte Index
Lipid Controls



Urine Controls



Cannabinoid Control

Growth Promoters
Rheumatoid Factor
Synthetic Steroids
Multidrug Control
Evidence Cardiac
Urine Toxicology
Liquid Urinalysis
Ecstacy Control
ASO Calibrator
Drugs of Abuse
EDDP Control
Lipoprotein (a)
Antimicrobials
TDM Control
sLDL Control
Microalbumin
Cystatin C
Glutamine
Cytokines
Endocrine
Cerebral
Thyroid
Lipid
IgG
IgE
x x x x IgG I
x x x IgM
Inhibin A
x Insulin
Insulin Growth Factor
x Intercellular Adhesion Molecule-1 (ICAM-1)
x Interferon-gamma (IFN-y)
x x Interleukin-1 alpha (IL-1a)
x Interleukin-1 beta (IL-1b)
x Interleukin-10 (IL-10)
x Interleukin-12p70 (IL-12 p70)
x x x Interleukin-6 (IL-6)
Iron
Kappa Light Chain K
17
Kappa Light Chain (free)
x Ketamine
x Ketones
Lambda Light Chain L
Lambda Light Chain (free)

Lactate
LAP
LD
x x Leptin
x x LDL Cholesterol
x Leukocytes
Luteinising Hormone (LH)
Lipase
x x Lipoprotein (a)
x Lithium
Lorazepam
x L-Selectin
x x Lysergic Acid Diethylamide (LSD)
Alpha-2-Macroglobulin M
MIP-1a
x x x Magnesium
x Matrix Metalloproteinase-9 (MMP-9)
x MDMA
x Medroxyprogesteron Acetate
x Metanephrine
x x x Methadone
x Methandriol
x Methamphetamine
x Methaqualone
99
Analyte Index
Blood Gas
Cardiac Controls





Immunoassay Premium
Chemistry Premium
HbA1c Linearity Set

Diabetes Controls
Maternal Screening
Ammonia/ Ethanol
H-FABP Control
Specific Proteins
Fructosamine
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
M Methotrexate
Methyltestosterone
Microalbumin
Myoglobin x x x x x x
MCP-1
N Nandrolone
NEFA x x x
Neuron-Specific Enolase (NSE) x x
NGAL
Nitrite
Norepinephrine
Normetanephrine
NT-proBNP x
O Oestradiol x x x
Opiates group
Osmolality x x x x x x x
Osteocalcin x
Oxalate
Oxazepam
Oxycodone
P Paracetamol x x x x x x x
PAPP-A x
17 Parathyroid Hormone x
PCO2 x
pH x
Phencyclidine
Phenobarbitone x x x x x
Phenytoin x x x x x x
Phosphate x x x x x x x x
Phospholipids
Phosphorous
Plasminogen x
Plasminogen Activator Inhibitor

PO2 x
Potassium x x x x x x x x x
Prealbumin x x x x
Primidone x x x
Procalcitonin x x
Progesterone x x x x
Prolactin x x x x x x
Propoxyphene group
Protein
Protein C x
Protein S x
Protein, total x x x x x x x x x x
PSA x x x x x x x x x x x
P-Selectin
PT x
PTH x x
Q Quinolones
R Ractopamine
Renin x
Resistin
Retinol Binding Protein (RBP) x
100
ASO Calibrator
Cystatin C
IgE
IgG
Rheumatoid Factor
x
Specific Protein Calibrator require predilution)
Lipid
Apolipoprotein Control & Calibrator
Lipoprotein (a)
sLDL Control
x
x
x
x
x
TDM Control
x
x
x
Urine Toxicology
x
Cannabinoid Control
Ecstacy Control
EDDP Control
x
Multidrug Control
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Liquid Urinalysis
x
Microalbumin
x
Antimicrobials
Glutamine
x
x
Growth Promoters
x
x
x
Cerebral
x
Cytokines
x
Evidence Cardiac
x

x
x
x
x
x
Drugs of Abuse
Endocrine
x
x
Thyroid
x
Synthetic Steroids
PT
pH
PO2
PSA
PTH
Renin
PCO2
NEFA
Nitrite
NGAL
MCP-1
Protein
Resistin
PAPP-A
Oxalate
Prolactin
Protein S
Protein C
P-Selectin
Potassium
Phenytoin
Primidone
Myoglobin
Phosphate
Oestradiol
Osmolality
Oxazepam
Prealbumin
Quinolones
Osteocalcin
Oxycodone
NT-proBNP
Nandrolone
Paracetamol
Plasminogen
Protein, total
Procalcitonin
Ractopamine
Phosphorous
Phencyclidine
Progesterone
Microalbumin
Phospholipids
Methotrexate
Opiates group
Phenobarbitone
Norepinephrine
Lipid Controls
Normetanephrine
Urine Controls
Methyltestosterone
Propoxyphene group
Parathyroid Hormone
Toxicology Controls
Retinol Binding Protein (RBP)

Plasminogen Activator Inhibitor
Neuron-Specific Enolase (NSE)
R
Q
O
N
M
Analyte Index
101
17
Analyte Index
Blood Gas
Cardiac Controls





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Diabetes Controls
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H-FABP Control
Specific Proteins
Fructosamine
Coagulation
CRP Liquid
Blood Gas
RANSOD
G-6-PDH
RANSEL
Aldolase
Glycerol
Cardiac
CK-MB
HbA1c
CSF
TAS
R Rheumatoid Factor (RF) x

S
Salicylic acid x x x x x x x
Secoborbital
SEM
Sex Hormone Binding Globulin (SHBG) x x x
sLDL
Sodium x x x x x x x x x x
Soluble IL-2 Receptor Alpha (sIL-2Ra)
Soluble IL-6 Receptor (sIL-6R)
Specific Gravity
sTNFRI
sTNFRII
Stanozolol
Stilbenes
Streptomycin/Dihydrostreptomycin
Sulphachlorpyridazine
Sulphadiazine
Sulphadimethoxine
Sulphadoxine
Sulphamerazine
Sulphamethazine
Sulphamethizole
17 Sulphamethoxypyridazine
Sulphamethoxazole
Sulphapyridine
Sulphaquinoxaline
Sulphathiazole
Sulphisoxazole
Sulphamonomethoxine
Superoxide Dismutase (RANSOD) x
T TCA
Testosterone x x x x
Testosterone (Free) x x x
Tetracyclines
Theophylline x x x x x x x
Thiamphenicol/Florfenicol
Thrombomodulin (TM)
Thyroglobulin x x x x
TIBC x x x x x x x x
Tobramycin x x x
Total Lipids X
Total Antioxidant Status (TAS) X
Total Prostate Specific Antigen (tPSA)

Total Thyroxine (TT4) X X X X X X X X X
Total Tri-iodothyronine (TT3) X X X X X X X X X
Transferrin X X X X X X
Trenbolone
Triglycerides X X X X X X X X
Trimethoprim
Troponin I X X X X X
Troponin T X X X X
High Sensitivity Troponin T X
TSH X X X X X
Thrombin Time (TT) X
102 T-Uptake X X X X
Analyte Index
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Antimicrobials
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Microalbumin
Cystatin C
Glutamine
Cytokines
Endocrine
Cerebral
Thyroid
Lipid
IgG
IgE
x Rheumatoid Factor (RF) R
x Salicylic acid S
x Secoborbital
x SEM
Sex Hormone Binding Globulin (SHBG)
x sLDL
x x x Sodium
x Soluble IL-2 Receptor Alpha (sIL-2Ra)
x x Soluble IL-6 Receptor (sIL-6R)
x x x x Specific Gravity
x sTNFRI
x sTNFRII
x Stanozolol
x Stilbenes
x Streptomycin/Dihydrostreptomycin
x Sulphachlorpyridazine
x Sulphadiazine
x Sulphadimethoxine
x Sulphadoxine
x Sulphamerazine
x Sulphamethazine
x Sulphamethizole
x Sulphamethoxypyridazine 17
x Sulphamethoxazole
x Sulphapyridine
x Sulphaquinoxaline
x Sulphathiazole
x Sulphisoxazole
X Sulphamonomethoxine
Superoxide Dismutase (RANSOD)
x TCA T
Testosterone
Testosterone (Free)
x Tetracyclines
x Theophylline
x Thiamphenicol/Florfenicol
x Thrombomodulin (TM)
Thyroglobulin
TIBC
x Tobramycin
Total Lipids
Total Antioxidant Status (TAS)
Total Prostate Specific Antigen (tPSA)
X Total Thyroxine (TT4)
X Total Tri-iodothyronine (TT3)
X X Transferrin
X Trenbolone
X Triglycerides
X Trimethoprim
X X X Troponin I
Troponin T
X TSH
Thrombin Time (TT)
T-Uptake 103
17
104
T
Z
U
Zinc
Urea
VMA
UIBC
VEGF
Zeronal
Uric acid
VCAM-1
Vitamin D
Vancomycin
Vitamin B12
Valproic acid
Urobilinogen
Blood Gas
Tylosin/Tilmicosin
25-OH-Vitamin D
1-25-(OH2)-Vitamin D
Cardiac Controls
Unconjugated Oestriol
Diabetes Controls
Vanillyl Mandelic Acid (VMA)

Tumour Necrosis Factor beta (TNF-b)

Tumour Necrosis Factor-alpha (TNF-a)
RANSEL
RANSOD
TAS
Blood Gas
Cardiac
Analyte Index

CK-MB
H-FABP Control
X
X
X
Chemistry Premium
X
X
X
X
X
X Liquid Chemistry Premium
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

CSF
Aldolase
Ammonia/ Ethanol
G-6-PDH
Glycerol
Coagulation
Fructosamine
HbA1c
HbA1c Linearity Set
X
X
X
X
X
Immunoassay Premium
X
X
X

X
X
X
X
X

X
X
X
Maternal Screening
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CRP Liquid
ASO Calibrator
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IgE
IgG
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Apolipoprotein Control & Calibrator
Lipoprotein (a)
sLDL Control
X
X
TDM Control
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Cannabinoid Control
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X
X
X
X
X Unassayed Urine Chemistry
X
X
X
Liquid Urinalysis
Microalbumin
X
Antimicrobials
Glutamine
X
Growth Promoters
X Cellular Adhesion Molecules
X Cerebral
X
X
Cytokines
Evidence Cardiac
Drugs of Abuse
Endocrine
X

Thyroid
Synthetic Steroids
Zinc
Urea
VMA
UIBC
VEGF
Zeronal
Uric acid
VCAM-1
Vitamin D
Vancomycin
Vitamin B12
Valproic acid
Urobilinogen
Tylosin/Tilmicosin
Lipid Controls
25-OH-Vitamin D
Urine Controls
1-25-(OH2)-Vitamin D
Unconjugated Oestriol
Toxicology Controls
Vanillyl Mandelic Acid (VMA)

Tumour Necrosis Factor beta (TNF-b)

Tumour Necrosis Factor-alpha (TNF-a)
Z
V
T
U
Analyte Index
105
17
Cost Saving Accurate Results
The sample and reagent probes have long-life high precision Intelligent - bubble, liquid level, crash and clot detection.
ceramic pistons ensuring good precision and low maintenance Water degassing technology ensures air is purged from
costs and low water requirements (less than 30 Litres/hour). the system ensuring accurate analysis and reliable results.
Reduced Sample and Reagent Volumes Test Menu

There is a minimum reaction volume of 120ul enabling The RX series has the largest test menu on the
more tests/kit. The high precision sampling assembly allows market including general chemistries, Specific Proteins,
a minimum sample volume of 2ul, making the RX suzuka Antioxidants, Drugs of Abuse and Therapeutic Drugs
ideal for paediatric analysis. enabling a lab to consolidate all of their testing onto
one platform. Each assay goes through a comprehensive
User Friendly Interface Software validation process to ensure optimum performance.
Familiar Microsoft® Windows® based software is
simple and easy to use, resulting in minimal training, and Low Maintenance
enhanced productivity. The real-time online help system The RX suzuka’s high quality hardware requires minimal
aids with the operation and troubleshooting on the system. maintenance thus reducing costs and laboratory
downtime ensuring quality performance of the system.
106
Coagulation and clinical chemistry tests Advanced software
There is no need for two separate analysers to run these tests. The RX monza is a semi-automated analyser that has
the software functionality of an automated instrument,
Widest test menu on the market including levy-Jennings, calibration curves and patient
The RX monza’s test menu includes general chemistries, history database. The software is password protected.
specific proteins, electrolytes and antioxidants making it
ideal as a main analyser in small labs or as a backup analyser Low-test volume
in larger labs. The volumes required to perform a patient test is much
lower than other systems in the market. This means the
Low levels of maintenance required customer gets more test per kit reducing their costs.
The operator performs all maintenance, the daily maintenance
takes approximately 5 minutes and the operator will perform 3-year warranty
the yearly maintenance, reducing downtime and engineering costs. Due to the high quality parts used in the manufacture
of the RX monza Randox offers a 3 year warranty.
107
Low water consumption Throughput
The RX daytona and RX imola use 7.5 litres and 18 litres per The RX daytona and RX imola are fully automated,
hour respectively; this is considerably lower than competitor bench top clinical analysers capable of 180 and
analysers. 400 photometric tests per hour respectively.
Test Menu Cost Saving

The RX series has the largest test menu on the Both the RX daytona and imola use reusable Pyrex cuvettes
market including general chemistries, Specific Proteins, which are guaranteed to last up to 5 years reducing the cost
Antioxidants, Drugs of Abuse and Therapeutic Drugs, of consumables. Furthermore the universal sample carousel
enabling a lab to consolidate all of their testing onto is designed to hold all standard sample cups and tubes
one platform. Each assay goes through a comprehensive eliminating the need to buy specific sample cups at extra cost.
validation process to ensure optimum performance.
Optimum Laboratory efficiency
Low maintenance Both systems will automatically calculate remaining reagent
Maintenance is low, increasing laboratory efficiency and volumes and the number of tests available alerting the
reducing costs. user to any shortages. Dedicated bar-coded reagents are
also available reducing time spent programming assays.
Software
Familiar Microsoft® Windows® based software is simple
and easy-to-use, resulting in minimal training and enhanced
productivity.
108
RANDOX International Headquarters
Randox Laboratories Limited, 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E marketing@randox.com
I www.randox.com
Randox have sales and distribution agreements in over 130 countries. Australia, Brazil, China, Czech Republic, France, Germany,
Hong Kong, India, Italy, Jamaica, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Africa, South Korea, Spain,
Switzerland, USA and Vietnam are directly represented by Randox Companies
Australia Brazil China

Randox (Australia) Pty Ltd. Randox Brasil Ltda Randox Laboratories Ltd.
Suite 2/4 Charles Street, Rua Fernandes Moreira, 415 Shanghai Representative Office
Paramatta, NSW 2150, Australia. CEP: 04716-000 - São Paulo / SP - Brasil. Room 522-523, Fortune Times Tower, No.1438 North,
Tel: +61 (0) 2 9615 4640 Tel: +55 11 5181-2024 Shanxi Road, Putuo District, Shanghai, China 20060
Fax: +61 (0) 2 9615 4644 Fax: +55 11 5181-0817 Tel: +86 021 6288 6240
Fax: +86 021 6288 6246
Czech Republic France Germany

Randox S.R.O. Laboratoires Randox Randox Laboratories GmbH
BHM, Sovadinova 7, Roissy Parc, ZAC du Moulin Wilhelmstr. 147a, 42489 Wülfrath, Germany.
69002 Breclav 2, Czech Republic. 24-26 rue du Noyer, BP 40, 95700 Roissy en France Tel: +49 (0) 2151/93 706-11
Tel/Fax: +420 (0) 519 325 130 Tel: +33 (0) 130 18 96 80 Fax: +49 (0) 2151/ 93 706-222
Fax: +33 (0) 130 18 03 60
Hong Kong India Italy

Randox Laboratories Hong Kong Randox Laboratories India Pvt Ltd. Randox Laboratories Ltd.
Room 602, Skyline Commercial Centre, 3rd Floor, Godrej Coliseum, Somaiya Hospital Road, Corso Montevecchio 37,
No 71-77 Wing Lok Street, Sheung Wan, Hong Kong Off. Eastern Express Highway, Sion (East), Mumbai - 400 022, India 10129 Torino, Italy.
Tel: +852 3595 0515 Tel: +91 22 6714 0600 Tel: +39 06 9896 8954
Fax: +852 3008 5133 Fax: +91 22 2408 3803 Fax: +39 06 6051 3810
Poland Portugal Puerto Rico

Randox Laboratories Irlandox Laboratorios Quimica Analitica Ltda Randox de Puerto Rico
ul. Wolnosc 7 lok. 15, 01-018, Warszawa. Rua Agostinho de Jesus e Sousa 258, PMB 590 PO Box 29029 San Juan,
Tel: +48 (0) 22 862 1080 4000-015 Porto, Portugal. PR 00929-0029.
Fax: +48 (0) 22 862 1081 Tel: +351 22 589 8320 Tel: +1 787 701 7000
Fax: +351 22 589 8329 Fax: +1 787 701 6901
Republic of Ireland Slovakia South Africa

Randox Teoranta Randox S.R.O. Randox Laboratories (SA) (PTY) Ltd
Meenmore, Dungloe, Vilová 2, 851 01 Bratislava, Slovakia. Unit 69F Allandale Business Park
Co Donegal, Republic of Ireland Tel: +421 2 6381 3324 Cnr. Le Roux Avenue & Morkels Close
Tel: +353 7495 22600 Fax: +421 2 6381 2482 Halfway House, Midrand, South Africa
Tel: +27 011 461 371
South Korea Spain Switzerland

Randox Korea Ltd. Laboratorios Randox S.L. Randox Laboratories Ltd. (Switzerland)
904 Doosan Venturedime 126-1, Pyeongchon, C/Enric Prat de la Riba, 226, 1° Planta, C/O Wirtschafts-Treuhand Auctor Schwyz AG,
Dongan-gu, Anyang City, Kyeonggi-do, South Korea 08901 L’Hospitalet de Llobregat, Barcelona. Oberer Steisteg 18, 6430 Schwyz, Switzerland.
Tel: +82 (0) 31 478 3121 Tel: +34 93 475 09 64 Tel: +41 41 810 48 89
Fax: +82 (0) 31 478 3122 Fax: +34 93 475 09 65 Fax: +41 41 810 48 34
UK USA Vietnam
Randox Laboratories Ltd. Randox Laboratories-US, Ltd. Randox Laboratories Ltd.Vietnam
55 Diamond Road, Crumlin, Co. Antrim, 515 Industrial Boulevard, Villa Phuc Thinh 2Bis Nguyen Thi Minh Khai St.
United Kingdom, BT29 4QY Kearneysville, West Virginia, 25430 Dakao Ward, District 1, Ho Chi Minh City,Vietnam.
Tel: +44 (0) 28 9442 2413 Tel: +1 304 728 2890 Toll Free: 866 4 RANDOX Tel: +84-8-39 11 09 04
Fax: +44 (0) 28 9445 2912 Fax: +1 304 728 1890 Toll Free: 866 RANDOX 1 Fax: +84-8-39 11 09 05
LT027 NOV11
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
t +44 (0) 28 9442 2413 f +44 (0) 28 9445 2912 e marketing@randox.com I www.randox.com
Information correct at time of print. All Randox products made in the UK.
Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 353 030 400. Product availability may vary from country to country. Please contact your local Randox representative for information.

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- Quality Control Serum

The most accurate quality control material in the world

“Revolutionising healthcare through continuously improving

1. Clinical Chemistry 7-18

A wide range of formats are available providing greater flexibility

Benefits of Randox Acusera

Third Party Controls Manufacturer’s Manufacturer’s standing IVD

Adopted from EN ISO 17511

UKAS ISO 13485:2003

CE Mark FDA Cleared

The CE mark is also a declaration from the manufacturer that the

CE marking is essential for products to be placed on the market and

1 Clinical Chemistry product range

Liquid CHEMISTRY PREMIUM - Unassayed Control 1

Cardiac Lipids Drugs Bicarbonate

• Liquid for ease of use

Description Size Cat. No.

1 LIQUID CHEMISTRY PREMIUM PLUS - Unassayed Control

Cardiac TSH ROUTINE Chemistry Phosphate (Inorganic)

• Liquid for ease of use

Description Size Cat. No.

CHEMISTRY PREMIUM CONTROL 1

Cardiac Proteins Amylase Lactate

• Lyophilised for enhanced stability

Description Size Cat. No.

1 ASSAYED CHEMISTRY PREMIUM PLUS CONTROL

Lipids Immunoassay Trace Metals GLDH

• Lyophilised for enhanced stability

Description Size Cat. No.

precision Chemistry premium plus CONTROL 1

Cardiac Lipids Gentamicin Bilirubin (Total)

• Lyophilised for enhanced stability

Description Size Cat. No.

1 BOVINE CHEMISTRY ASSAYED CONTROL

Lipids Proteins ROUTINE Chemistry

• Lyophilised for enhanced stability

Description Size Cat. No.

BOVINE CHEMISTRY precision CONTROL 1

Lipids Proteins ROUTINE Chemistry

• Lyophilised for enhanced stability

Description Size Cat. No.

1 CLINICAL CHEMISTRY CALIBRATION SERUM

Lipids Routine Chemistry

• Lyophilised for enhanced stability

Description Size Cat. No.

ALDOLASE CONTROL & CALIBRATOR 1

• Lyophilised for enhanced stability

Description Size Cat. No.

AMMONIA / ETHANOL CONTROL

• Liquid ready to use

Description Size Cat. No.

BILIRUBIN (ELEVATED) CONTROL

Total Bilirubin Direct Bilirubin

• Lyophilised for enhanced stability

Description Size Cat. No.

• Lyophilised for enhanced stability

Description Size Cat. No.

MULTI CONTROL & CALIBRATOR

• Liquid ready to use

Description Size Cat. No.

• Lyophilised for enhanced stability

Description Size Cat. No.

Immunoassay product range