Protected: QCMD – Molecular External Quality Control (NEW)
Protected: QCMD – Molecular External Quality Control (NEW)
Complete QC Solutions for Results you can Trust
Randox is one of the largest manufacturers of true third party quality control solutions. With over 35 years’ experience delivering reliable, high quality products designed to effectively challenge instrument performance you can be confident in the accuracy of patient test results, whilst reducing time and costs. With more than 390 analytes available across the Acusera range and a wide range of formats providing flexibility & choice, we have a solution to suit you.
Our diverse range of multi-analyte, third party controls offer industry leading opportunities for consolidation, ultimately delivering cost savings, reduced preparation time and increased efficiency all without compromising on quality. Manufactured using the highest quality raw materials, lot to lot consistency and unrivalled commutability is guaranteed, ensuring performance mirrors that of the patient sample and costly shifts in QC results are reduced.
Benefits
Consolidation
Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number of individual controls required to cover your test menu, ultimately reducing costs, preparation time and storage space.
Commutability
All Acusera controls are designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements whilst reducing inconvenient and costly shifts in QC results when reagent batch is changed.
Clinically Relevant Levels
The presence of analytes at key decision levels not only helps to ensure accurate instrument performance but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra expense.
Reduced Waste
The unrivalled working stability of the Acusera control range helps to keep waste and costs to a minimum.
Flexibility
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.
True Third Party Controls
Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.
Choose below to find a control that suits you.
Complementing our Internal Quality Control range is Acusera 24•7, a powerful data management tool designed to help even the most demanding laboratories manage their daily QC activities. Delivering unique access to real-time peer group statistics, a variety of fully interactive charts and automatic calculation of performance metrics such as Measurement Uncertainty, Acusera 24•7 will speed up data review and troubleshooting.
Acusera Third Party Controls
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RX series (Concept 3)
The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.
Consolidation of Routine & Specialised Testing on One Single Platform
With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.
Low Reagents & Sample Volumes
Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering accurate, reliable and precise results each time, every time.
Unrivalled Customer Support
Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.
Fully Automated
Test Menu
Semi-Automated
Test Menu
Niche
Test Menu
QCMD – Molecular External Quality Control
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.
With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Frequency
A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.
Online EQA Management System
ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.
High level of participation
Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.
Comprehensive reports
Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.
International accreditation
Programmes are accredited to ISO 17043.
- Blood Borne Viruses
- Central Nervous System Diseases
- Drug Resistance
- Exotic / Emerging Diseases
- Gastrointestinal Diseases
- Immunocompromised Associated Diseases
- Multiple Pathogen / Syndromic Infections
- Respiratory Diseases
- Serology
- Sexually Transmitted Infections
- Transplant Associated diseases
- Typing
- New Pilot Studies
After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
Contact Us
QCMD Website
RIQAS EQA
*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.
Protected: RX series (Concept)
Product Spotlight: Liquid Lipid Control
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is usually associated with a build-up of fatty deposits inside the arteries and increased risk of blood clots. It can be associated with damage to arteries in organs such as the brain, heart, kidney and eyes. Some types of CVD include coronary heart disease, strokes and aortic disease. Some of the main causes of CVD are smoking, high cholesterol, diabetes and high blood pressure (NHS, 2016).
These diseases can be extremely dangerous and lead to permanent damage or even death, therefore, it is vitally important for laboratories to be confident in their analyser’s ability to accurately diagnose and monitor the risk of these diseases.
The Randox Acusera Liquid Lipid quality control includes assayed target values and ranges for 8 analytes covering the complete lipid profile. With a 30 day open vial stability the Acusera Liquid Lipid control will reduce waste, whilst remaining easy and convenient to use. Three distinct levels are available covering low risk, borderline risk, and high risk concentrations of HDL and LDL cholesterol, ensuring the clinically relevant decision levels are tested, eliminating the need to purchase additional high and low level controls. Containing no Sodium Azide, which can interfere with direct clearance methods for detecting HDL and LDL cholesterol, ensuring ultimate accuracy and confidence in results.
Key Features & Benefits
- Liquid for ease of use
- 100% human serum
- Assayed target values provided
- True third party control
- Stable to expiry date at -20°C to -80°
- Open vial stability of 30 days at 2°C to 8°C
Analytes
Apolipoprotein A | Apolipoprotein B | Cholesterol (HDL) | Cholesterol (LDL)
Cholesterol (Total) | C-Reactive Protein (CRP) | Lipoprotein (a) | Triglycerides
HDL Cholesterol
High-Density Lipoproteins (HDL) are one of the major classes of plasma lipoproteins. HDL is often referred to as ‘good cholesterol’ because it transports cholesterol from the tissues of the liver for removal from the body. High levels of HDL can indicate a lower risk of developing heart disease.
Apolipoprotein A-1
Apolipoprotein A-1 is one of the main protein forms found in High Density Lipoproteins (HDL). The chief role of Apolipoprotein A-1 is in the activation of lecithin cholesterol acyltransferase (LCAT) and the capture and removal of free cholesterol from extra hepatic tissue. Studies have shown that there is an inverse relationship between Apolipoprotein A-1 and coronary artery disease (CAD).
References
NHS. (2016). Heart attack. nhs.uk. Retrieved 15 February 2018, from https://www.nhs.uk/conditions/heart-attack/
National Institute for Health and Care Excellence. (2014). Myocardial infarction (acute) Early rule out using high-sensitivity troponin tests. Nice.org.uk. Retrieved 15 February 2018, from https://www.nice.org.uk/guidance/dg15/chapter/3-clinical-need-and-practice
Protected: The Benefits of True Third Party Controls -New Test
Product Spotlight: RIQAS CO-Oximetry EQA
RIQAS CO-Oximetry EQA
The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).
Background
CO-Oximetry is a methodology that measures the levels of the oxygen-carrying protein haemoglobin, which is the chief component of red blood cells. CO-Oximetry is a useful tool in that it helps determine the levels of various forms of haemoglobin.
Key Benefits & Features
- Liquid ready-to-use
- Monthly reporting
- Submit results and view reports online via RIQAS.Net
- Suitable for POCT
Liquid ready-to-use
The liquid stable formulation requires no preparation making the samples extremely easy and convenient to use.
Consolidation
Covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.
RIQAS
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories.
Analytes
- Carboxyhaemoglobin (COHb / HbCO)
- Methaemoglobin (MetHb)
- Oxygen Content (O₂CT)
- Oxygen Saturation (sO₂ / Vol O₂)
- Oxyhaemoglobin (O₂Hb / HbO₂)
- Total Haemoglobin (tHb)
- Reduced / Deoxyhaemoglobin (RHb / HHb)
Related Products
RIQAS Blood Gas EQA
Suitable for monitoring the performance of 10 blood gas parameters.
- Accredited to ISO/IEC 17043
- Liquid ready-to-use
- Aqueous material
- Monthly reporting
- Submit results and view reports online via RIQAS.Net
- Suitable for POCT
Download some of our related brochures below and broaden your understanding.
References
Chatburn, R. (2014). To co-ox or not to co-ox. Acutecaretesting.org. Retrieved 19 February 2018, from https://acutecaretesting.org/en/articles/to-coox-or-not-to-coox
The Benefits of True Third Party Controls
In the clinical laboratory, Quality Control (QC) refers to the process of detecting analytical errors to ensure both the reliability and accuracy of patient test results. Poor performance can result in misdiagnosis, delayed/inappropriate treatment, increased costs and may even be potentially life threatening for the patient. Third party controls offer a better solution to ensure optimum performance and accuracy, read on to learn how.
1. Dependent / First Party Controls
Dependent controls refer to any control material that has been produced by the instrument or reagent manufacturer for use on a specific test system. Such controls are often manufactured from the same raw materials as the calibrator, making them less sensitive to subtle changes in performance.
As dependent controls are generally optimised for use with the manufacturer’s test system, these controls can mask weaknesses, and therefore, are increasingly considered less effective than independent controls.
2. Semi-Dependent Controls
Semi-dependent control material, although produced independently of the instrument or reagent, is often supplied or recommended by the instrument/reagent manufacturer. It is this manufacturing relationship between the two that requires close scrutiny when considering if these controls are fit-for-purpose.
Although the control material is not produced by the instrument manufacturer, it is produced according to their exact specifications and therefore, optimised to work with a specific platform.
3. Independent / Third Party Controls
Independent or third party quality control material has not been designed or optimised for use with any instrument, kit or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provide an unbiased, independent assessment of analytical performance across multiple platforms.
Third party controls have been designed to deliver an independent, unbiased assessment of performance with any instrument or method helping you gain accreditation. Below are some of the key benefits of third party controls:
- Values assigned using a large number of independent laboratories ensuring statistically valid targets.
- Highly consolidated controls allow for space, time, and ultimately, cost savings.
- Boosted shelf life ensures continuity of supply and reduced costs
- Reduced preparation times by removing the need for multiple instrument controls
Regulatory Requirements
Third party controls are growing in popularity across the globe. More and more laboratories are beginning to use third party controls as part of their daily QC strategy. The benefits of such controls are widely accepted and recommended by both key opinion leaders and regulatory bodies in the field of Quality Control.
“Use of independent third party control materials should be
considered, either instead of, or in addition to, any control
materials supplied by the reagent or instrument manufacturer”
ISO 15189:2012 Section 5.6.2.2
ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence
The benefit of running third party controls in your laboratory cannot be underestimated. The following case studies highlight their many benefits and how they have helped laboratories across the world to provide more accurate and reliable test results.
Case Study One: Identifying Lot-to-Lot Variability with Third Party Controls
A laboratory in the UK contacted Randox Technical Services, reporting higher than expected QC results for
Thyroglobulin. When using a third party control (Acusera Immunoassay Premium Plus) the results were four
times higher on their main analyser compared to other systems. However, when they ran the instrument
manufacturer’s control alongside the third party control it did not show the same problem.
After reviewing EQA data, the Technical Services team confirmed there was a significant difference in results
compared to other instruments, and set about helping the laboratory troubleshoot. After an exhaustive
review of procedures and processes, the customer contacted the instrument manufacturer, who advised of a
positive bias with several batches of reagent, including the batch the laboratory was using.
Conclusion: By using a third party control the laboratory was able to detect a shift in results after changing
reagent batch that the instrument manufacturer’s control did not.
Case Study Two: Overcoming Instrument Errors with Third Party Controls
A laboratory using the Acusera Assayed Chemistry Premium Plus control contacted Randox Technical Services
after observing a consistent negative bias for ALT which was not replicated by the instrument control. They
had previously contacted their instrument manufacturer who advised that the problem was with the control
and not the reagent or instrument.
Randox investigated the problem and demonstrated that patient results were also wrongly reported low. This
later led the instrument manufacturer to recommend a wash stage to eliminate any interference.
Conclusion: The use of a third party control in this instance enabled the identification of a procedural error
with the instrument that the recommended control did not.
Explore the benefits of Randox Acusera third party controls below.
Our extensive range of assayed quality controls are supplied with highly accurate target values for a wide range of instruments and methods. Our unique value assignment process utilises thousands of independent laboratories globally ensuring target values won’t change throughout the shelf life of the control and eliminates the need to spend time and money performing value assignment in-house.
Accuracy coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.
We take quality seriously, that’s why all QC products are manufactured to the highest possible standard delivering control products of unrivalled quality. Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot to lot. You can therefore be sure of receiving the same standard of product time and time again.
Regular shifts in QC results when a reagent batch is changed can be both costly and frustrating for many labs, resulting in a frequent need to reassign target values. Designed to be commutable, the Acusera range of Internal Quality Controls will react to the test system in a manner as close as possible to the patient sample helping you to meet ISO 15189:2012 requirements while ultimately ensuring accurate & reliable instrument performance. Furthermore our lyophilized controls contain no added preservatives or stabilisers ensuring a sample matrix that closely matches the patient sample.
ISO 15189:2012 states, “The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
All controls for use with immunoassay/immunology based methods are manufactured using only 100% human components demonstrating our commitment to quality and eliminating costly QC shifts when reagent batch is changed.
Working stability and product shelf life are important considerations for any lab when choosing which internal quality control material is best suited to their needs. Labs often spend up to one month validating new material, a process which can be minimised by opting for a control with an extended shelf life. At Randox our lyophilised controls have a shelf life of up to four years and our liquid controls a shelf life of up to two years from the date of manufacture ensuring continuity of lot supply and ultimately reducing the need for expensive new lot validation studies.
Each of our third party controls will have its own reconstituted or open vial stability, some of the analytes will have limitations, however we pride ourselves on not misleading customers with false claims. The extended open vial and reconstituted stabilities will help laboratories to minimise waste and reduce costs.
Randox is a leading provider of multi-analyte, third party controls designed to allow any lab to carry out highly accurate QC using fewer controls. In an industry where budgets and resources are increasingly under pressure, highly consolidated controls will ensure high levels of throughput without compromising on accuracy. Uniquely comprising up to 100 analytes in a single control product, costs, preparation time and storage space are dramatically reduced without sacrificing on quality.
The presence of analytes at key decision levels in all Acusera controls will not only ensure accurate test system performance across the clinical range, but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional high or low level controls, which are often expensive.
Available in multiple levels, the Acusera range of third party controls are designed to challenge laboratory instruments throughout the patient reportable range. The presence of analytes at clinically relevant decision levels not only helps to ensure accurate instrument performance but maximizes laboratory efficiency by eliminating the need to purchase additional low/high concentration controls at extra expense.
Randox also employs easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.
ISO 15189:2012 states, “The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any lab – regardless of their size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189:2012 recommendations.
ISO 15189:2012 states that the “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”
Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.
The European parliament and council directive 98/79 EC require values assigned to both calibrators and control materials on in vitro diagnostic medical devices to be traceable to a recognised reference material or reference measurement procedure of higher order, e.g. SI units.
Guidelines have been set for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability. These guidelines were set by the European standards EN/ISO 17511 and also EN/ISO 18153. The Randox traceability pathway has been established with reference to standards ISO 17511 and ISO 18153. The pathway has been followed to establish traceability for Randox calibrators allowing all patient results to be traced right back to the source.
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.
Custom Controls
Randox is a market leader in the manufacture of customised quality controls designed to meet the individual and unique requirements of even the most specialised laboratories.
Acusera Third Party Controls
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Product Spotlight: Liquid Urinalysis Control
Liquid Urinalysis Quality Control
The Randox Acusera Urinalysis Quality Control is designed primarily to ensure accurate test system performance however offer the laboratory additional benefits that will help them to meet regulatory requirements whilst also reducing costs and time.
Background
It is estimated that 1 in 2 people will be affected by a urological condition at some point in their lifetime. Conditions and diseases related to kidneys, bladder and prostate, among others, are commonplace and can be devastating for millions of men, women and children across the globe.
Urological conditions can be common, such as urinary tract infections, or they can be much more serious, for example, prostate or testicular cancer.
Urinalysis is used as a screening or diagnostic tool because it can detect kidney and metabolic disorders. Often, substances such as glucose or protein will appear in the urine before a patient is aware that they have a problem. In some conditions, urinalysis also provides an easy and economical test to track patient progress, for example, if you want to know if a condition is improving.
Key Benefits & Features
- Liquid ready-to-use
- 100% human urine
- Assayed ranges provided for 13 parameters
- Suitable for use in POC testing
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 25°C (20 immersions for UC5033/5034)
Consolidation
As a leading provider of multi-analyte, third party controls, Randox helps busy laboratories significantly reduce the number of controls needed to cover their test menu. The Randox Liquid Urinalysis Control combines multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality. Analytes at key decision levels will ensure test system performance across the clinical range. It can also be used in monitoring the performance of both automated and manual methods of urine test strip analysis.
Liquid Stable
Samples are conveniently supplied ready-to-use requiring no preparation as such they can save valuable laboratory time. The Acusera Liquid Urinalysis Control can be used for POCT as well as laboratory based testing.
True third party quality control
The Acusera Liquid Urinalysis Quality Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.
“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”.
Analytes
- Albumin
- Bilirubin
- Blood
- Creatinine
- Glucose
- hCG
- Ketones
- Leukocytes
- Nitrate
- pH
- Protein
- Specific Gravity
- Urobilinogen
Complete QC solution
The combining of the Acusera Liquid Urinalysis Quality Control, RIQAS Urinalysis EQA programme, and our Acusera 24•7 software will provide a complete QC solution for laboratories of all sizes.
Download some of our related brochures below and broaden your understanding.