Take steps to prevent incorrect patient results by making one simple change
Take steps to prevent incorrect patient results by making one simple change
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 5.6.2.2 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.
Product Focus: Randox Cardiac
With World Heart Month running throughout February, we have decided to focus this month on Cardiac Markers. Over the next few weeks, we will be taking a look at some of the QC solutions available from Randox.
The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid misdiagnosis and/or incorrect treatment. Acusera True Third Party Cardiac Controls have been designed to cover a wide range of cardiac markers at clinical decision levels eliminating the need for additional low level controls at extra expense. Available in a choice of liquid ready-to-use and lyophilised formats, they are ideal for use at the point-of-care and in the lab. Manufactured from 100% human serum, a matrix similar to that of the patient is guaranteed.

Week 1- Acusera Tri-Level Cardiac Control
The Randox Acusera Tri-Level Cardiac control is designed for use in the routine monitoring of both accuracy and precision. Assayed instrument and method specific target values are provided for 7 cardiac markers along with temperature specific target values for CK and CK-MB.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Assayed target values provided for 7 cardiac markers
- Cut off levels for Troponin I and T in line with internationally recommended levels
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 5 days at 2°C – 8°C or 4 weeks at -20°C
Week 2- Acusera Liquid Cardiac Control
The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.
Features & Benefits
- Liquid ready-to-use
- 100% human serum
- Assayed target values provided for 8 cardiac markers
- Cut off levels for Troponin I and T in line with internationally recommended levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C for all analytes
Week 3 – RIQAS Cardiac Programme
RIQAS is the largest international External Quality Assessment Scheme, with more than 40,000 participants in over 124 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 32 flexible multi-parameter programmes. Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.
The RIQAS Cardiac EQA programme is designed to monitor the performance of up to 7 clinically significant cardiac markers. Two flexible reporting options are available to suit the needs of all laboratory sizes.
Features & Benefits
- Accredited to ISO/IEC 17043
- Lyophilised for enhanced stability
- 100% human serum
- Bi-weekly reporting
- Submit results and view reports online via RIQAS.Net
- Register up to five instruments at no extra cost
Week 4 – Acusera 24.7 Live Online Version 2.0
Acusera 24•7 Live Online is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities, Acusera 24•7 Live Online will help to meet regulatory requirements, improve error detection, reduce false rejections and ensure accurate patient results.
Delivering an online platform for effective QC data management, our software provides unique access to instantly updated real-time peer group data, automatically generated QC statistics, QC multi-rules, interactive charts and comprehensive reports.
Acusera 24•7 Live Online is an essential QC tool for laboratories of all sizes. By participating and implementing our software your laboratory will be able to do the following;
- Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
- Automatically calculate Measurement Uncertainty, Total Error and Sigma Metrics
- Bridge the gap between daily quality control and external quality assessment
- Improve EQA performance by eliminating any undetected bias
- Facilitate regulatory compliance
- Reduce false rejections through the use of QC multi-rules
- Increase confidence in assigned QC target values
- Speed up troubleshooting processes, shortening delays in reporting
Liquid HbA1c Quality Control

Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.
Features & Benefits
- Liquid ready-to-use
- Human based whole blood
- Assayed target values
- Convenient bi-level pack covering clinically relevant decision levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C
Description Size Analytes Cat No
Liquid HbA1c Control 2 x 2 x 0.5 ml 1 HA10155
Liquid HbA1c Control Level 1 6 x 1 ml 1 HA10224
Liquid HbA1c Control Level 2 6 x 1 ml 1 HA10225
Analytes
HbA1c (Haemoglobin A1c)
Liquid CSF Quality Control









Providing a true third party solution for the measurement of Cerebrospinal Fluid (CSF), the Acusera Liquid CSF Control is designed to deliver an unbiased, independent assessment of analytical performance for 14 analytes, helping to ensure the results clinical laboratories release are accurate and reliable.
With an extended open vial stability of 30 days at 2oC – 8oC, the Acusera Liquid CSF Control will reduce waste, while remaining easy and convenient to use.
Features & Benefits
- Liquid ready-to-use samples requiring no preparation
- Human based material
- True third party control providing unbiased performance assessment
- Assayed target values available
- Shelf life of 2 years from the date of manufacture
- Open vial stability of 30 days for all analytes when stored at 2oC to 8oC
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Liquid CSF Control Level 1 | 10 x 3ml | 14 | CF10138 | |
Liquid CSF Control Level 2 | 10 x 3ml | 14 | CF10139 | |
Analytes
- Albumin
- Albumin (electrophoresis)*
- Alpha – 1- globulin (electrophoresis)*
- Alpha – 2- globulin (electrophoresis)*
- Beta- globulin (electrophoresis)*
- Chloride
- Gamma – globulin (electrophoresis)*
- Glucose
- hsIgA*
- hsIgG
- hsIgM*
- Lactate
- Protein (Total)
- Sodium
*No claims are made regarding values and stability.
PTH Quality Control









Providing a true third party solution for the measurement of Intact PTH, the new Acusera PTH Control will deliver an unbiased,
independent assessment of analytical performance with any instrument or method.
This notoriously unstable marker, present in a number of immunoassay controls, is now available in a liquid frozen format with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use.
Features & Benefits
- Liquid for ease-of-use
- 100% human serum
- Assayed target values available for many immunoassay platforms
- Stable to expiry date at -20°C to 70°C
- Open vial stability of 30 days at 2°C to 8°C
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
PTH Control Level 1 | 3 x 3 ml | 1 | PTH10110 | |
PTH Control Level 2 | 3 x 3 ml | 1 | PTH10111 | |
PTH Control Level 3 | 3 x 3 ml | 1 | PTH10112 | |
Analytes
- Intact PTH (Parathyroid Hormone)
Related Products
Evidence Immunoassay Control









Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Reconstituted stability of 7 days at 2oC – 8oC or 4 weeks at -20oC
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Evidence Immunoassay Control | 4 x 3 x 5ml | 14 | EV3570 | |
Analytes
- CEA
- Estradiol
- FSH
- Free T4
- Free T3
- Leutinising Hormone
- Prolactin
- Progesterone
- PSA (Total)
- PSA (Free)
- Testosterone
- Total T4
- Total T3
- TSH
Cardiac Array Quality Control









Multi-analyte cardiac control designed for use in the routine monitoring of accuracy and 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-FAP). Three levels of control are supplied spanning the complete clinical range.
Features & Benefits
- Lyophilised for enhanced stability
- Assayed values available for Randox Biochip systems
- 100% human serum
- Stable to expiry at 2oC – 8oC
- Reconstituted stability of 16 hours at 2oC – 8oC or 7 weeks at -80oC
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Cardiac Array Control | 3 x 3 x 1ml | 4 | EV3691 | |
Analytes
- Heart-type acid binding protein (H-FABP)
- Myoglobin (MYO)
- Troponin I (cTnI)
- Creatine-Kinase Muscle Brain (CK-MB)
Not for sale in the USA
Canine CRP Quality Control









A dedicated control designed for the use in the quality control of the Randox Canine CRP assay.
Features & Benefits
- Liquid ready-to-use
- Human CRP in a stabilised protein matrix
- Stable to expiry date at 2oC – 8oC
- Once open stable to expiry date at 2oC – 8oC
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Canine CRP Control Level 2 | 3 x 1ml | 1 | CP2803 | |
Canine CRP Control Level 3 | 3 x 1ml | 1 | CP2804 | |
Analytes
- Canine CRP
Microalbumin Calibrator









Dedicated Microalbumin calibrator designed for use with Microalbumin assays on a wide range of clinical analysers. 6 levels are provided in a liquid ready-to-use format making it both easy and convenient to use.
Features & Benefits
- Liquid ready-to-use
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Once opened stable to expiry date at 2oC – 8oC
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Microalbumin Calibrator Series | 6 x 2ml | 1 | MA1567 | |
Analytes
- Microalbumin
Lipid Control Calibrators









Apolipoprotein Calibrator
Multi-analyte, apolipoprotein calibrator with values provided for Apolipoprotein A-1 and Apolipoprotein B.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 7 days at 2°C – 8°C
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Apolipoprotein Calibrator | 3 x 1ml | 2 | LP3023 | |
Analytes
- Apo A-1
- Apo B
Apolipoprotein Calibrator 2
Multi-analyte calibrator covering four specialised apolipoprotein assays. A reconstituted stability of up to 28 days helps to keep waste and costs to a minimum.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 8 hours at 2°C – 8°C and one month at -20°C when frozen once
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Apolipoprotein Calibrator 2 | 3 x 1ml | 4 | LP5047 | |
Analytes
- Apolipoprotein A-II
- Apolipoprotein C-III
- Apolipoprotein C-II
- Apolipoprotein E
Lipoprotein (a) Calibrator
Dedicated Lipoprotein (a) calibrator specifically designed for use with the Randox Lipoprotein (a) assay.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 14 days at 2°C – 8°C
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
Lipoprotein (a) Calibrator | 5 x 1ml | 1 | LP3404 | |
Analytes
- Lipoprotein (a)
Direct HDL/LDL Cholesterol Calibrator
Dedicated HDL and LDL cholesterol calibrator specifically designed for use with direct methods of measurement.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 5 days at 2°C – 8°C and 1 month at -20°C
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
HDL/LDL Cholesterol Calibrator | 3 x 1ml | 2 | CH2673 | |
Analytes
- HDL Cholesterol
- LDL Cholesterol
sdLDL Cholesterol Calibrator
Dedicated sdLDL Cholesterol calibrator designed for use with the Randox sdLDL Cholesterol assay.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 5 days at 2°C – 8°C
Description | Size | Analytes | Cat No | |
---|---|---|---|---|
sdLDL Cholesterol Calibrator | 3 x 1ml | 1 | CH5050 | |
Analytes
- sdLDL Cholesterol