Laboratory Quality Control – Acusera
Laboratory Quality Control – Acusera
Acusera true third party quality controls offer complete test menu consolidation for laboratory Internal Quality Control.
Providing accurate and reliable sample material and delivering results you can trust.
Key Benefits of Acusera
Commutability
A commutable sample matrix increases confidence that performance mimics that of patient samples.
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.
Traceability
The values assigned to both our calibrators and control materials are traceable to a recognised reference material or reference measurement procedure meeting ISO 17511 and ISO 18153 requirements.
Accurate Target Values
Our process utilises thousands of independent labs globally, ensuring availability of highly accurate, robust target values for a wide range of instruments and methods, ultimately eliminating the need to spend time and money assigning in-house.
True Third Party Controls
Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2022 requirements whilst eliminating the need for multiple instrument dedicated controls.
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.
Consistency
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.
Shelf Life Longevity
With a shelf life of up to four years for lyophilised controls and two years for liquid controls, you can benefit from continuity of lot supply whilst reducing the frequency of new lot validation studies, thus saving time and money.
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.
Acusera Internal Quality Control Range
With over 390 parameters, choice and flexibility is guaranteed.
Browse the controls below
What Are The Benefits of Third Party Controls?
Customer Testimonials
Continue Reading
Controls Brochure
Importance of Third Party
Acusera 24•7 Online
Contact Us
Acusera Verify
Laboratory Quality Control – Acusera
Acusera true third party quality controls offer complete test menu consolidation for laboratory Internal Quality Control.
Providing accurate and reliable sample material and delivering results you can trust.
Key Benefits of Acusera
Commutability
A commutable sample matrix increases confidence that performance mimics that of patient samples.
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.
Traceability
The values assigned to both our calibrators and control materials are traceable to a recognised reference material or reference measurement procedure meeting ISO 17511 and ISO 18153 requirements.
Accurate Target Values
Our process utilises thousands of independent labs globally, ensuring availability of highly accurate, robust target values for a wide range of instruments and methods, ultimately eliminating the need to spend time and money assigning in-house.
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 eliminating the need for multiple instrument dedicated controls.
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.
Consistency
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.
Shelf Life Longevity
With a shelf life of up to four years for lyophilised controls and two years for liquid controls, you can benefit from continuity of lot supply whilst reducing the frequency of new lot validation studies, thus saving time and money.
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.
Acusera Internal Quality Control Range
With over 390 parameters, choice and flexibility is guaranteed.
Browse the controls below
What Are The Benefits of Third Party Controls?
Customer Testimonials
Sixth People’s Hospital of Zhengzhou City, Henan Province
‘Our laboratory continues to use Randox’s IQC products, including HN1530, HE1532, IA3110, IA3111, CG5021, CG5023, UC5033, UC5034. Compared with the previous use of original quality control, we can now find the quality control deviation caused by the change of reagent batch number in time. Later, we can timely pass the calibration and the calibration to return the laboratory results to the correct level. Randox products have brought us more convenience in our work. We are very satisfied with Acusera series products.’
Patrick Else, Nuffield Health
‘Randox Acusera 24/7 has enabled me to effectively manage 13 separate hub sites effectively through the use of the integrated reports that can be generated. The system allows for routine day to day monitoring of IQC results as well as long term tracking and trending. The Uncertainty of Measurement report has allowed me to free up a large amount of time as this report can be generated whenever for a particular date range meaning no more manual number crunching. The support from Randox has been first class from the initial install through to current working practices and the company are very open to improvements to the system. On the whole I am very happy with the programme. ‘
Continue Reading
Controls Brochure
Importance of Third Party
Acusera 24•7 Online
Contact Us
Acusera Verify
Measurement Uncertainty Vs Total Error
In a recent article, Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred, James Westgard comments on the latest developments in the debate on the use of analytical total error (TE) and measurement uncertainty (MU), a debate which has been regularly revisited for the last twenty years. This blog aims to briefly explore the benefits of MU and TE and attempt to draw a conclusion on which is most beneficial in the clinical laboratory.
Many things can undermine a measurement. Measurements are never made under perfect conditions and in a laboratory, errors and uncertainties can come from (Good Practice Guide No. 11, 2012):
- The measuring instrument – instruments can suffer from errors including bias, changes due to ageing, wear, poor readability, and noise.
- The item being measured – the sample may be unstable.
- The measurement process – the analyte may be difficult to measure
- ‘Imported’ uncertainties – calibration of the instrument.
- User error – skill and judgement of the operator can affect the accuracy of a measurement.
- Sampling issues – the measurements you make must be properly representative of the process you are trying to assess. I.e. not using fully commutable controls will mean your quality control process is not reflective of a true patient sample.
Random and systematic errors
The effects that give rise to uncertainty in a measurement can be either random or systematic, below are some examples of these in a laboratory.
- Random – bubbles in reagent, temperature fluctuation, poor operator technique.
- Systematic – sample handling, reagent change, instrument calibration (bias), inappropriate method.
Total Error (TE) or Total Analytical Error (TAE) represents the overall error in a test result that is attributed to imprecision (%CV) and inaccuracy (%Bias), it is the combination of both random and systematic errors. The concept of error assumes that the difference between the measured result and the ‘true value’, or reference quantity value, can be calculated (Oosterhuis et al., 2017).
TE is calculated using the below formula:
TE = %BIAS + (1.96 * %CV)
Measurement Uncertainty is the margin of uncertainty, or doubt, that exists about the result of any measurement.
There is always margin of doubt associated with any measurement as well as the confidence in that doubt, which states how sure we are that the ‘true value’ is within that margin. Both the significance, or interval, and the confidence level are needed to quantify an uncertainty.
For example, a piece of string may measure 20 cm plus or minus 1 cm with a 95% confidence level, so we are 95% sure that the piece of string is between 19 cm and 21 cm in length (Good Practice Guide No. 11, 2012).
Standards such as ISO 15189 require that laboratories must determine uncertainty for each test. Measurement Uncertainty is specifically mentioned in section 5.5.8.3:
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
Uncertainty is calculated using the below formula:
u = √A2+B2
U = 2 x u
Where:
A = SD of the Intra-assay precision
B = SD of the Inter-assay precision
u = Standard Uncertainty
U = Uncertainty of Measurement
Error methods, compared with uncertainty methods, offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine (Oosterhuis et al., 2018).
It is important not to confuse the terms ‘error’ and ‘uncertainty’.
- Error is the difference between the measured value and the ‘true value’.
- Uncertainty is a quantification of the doubt about the measurement result.
Whenever possible we try to correct for any known errors: for example, by applying corrections from calibration certificates. But any error whose value we do not know is a source of uncertainty (Good Practice Guide No. 11, 2012).
While Total Error methods are firmly rooted in laboratory medicine, a transition to the Measurement Uncertainty methods has taken place in other fields of metrology. TE methods are commonly intertwined with quality assurance, analytical performance specifications and Six Sigma methods. However, Total Error and Measurement Uncertainty are different but very closely related and can be complementary when evaluating measurement data.
Whether you prefer Measurement Uncertainty, Total Error, or believe that they should be used together, Randox can help. Our interlaboratory QC data management software, Acusera 24•7, automatically calculates both Total Error and Measurement Uncertainty. This makes it easier for you to meet the requirements of ISO:15189 and other regulatory bodies.
This is an example of the type of report generated by the 247 software. MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets.
Fig. A
Fig. B
Fig. A and Fig. B above are examples of report generated by the 24•7 software. Fig.A shows how MU is displayed for each test and each lot of control in use therefore eliminating the need for manual calculation and multiple spreadsheets. Fig. B shows TE displayed for each test.
Acusera Third Party Controls
The Importance of ISO 15189
Good Practice Guide No. 11. (2012). Retrieved from http://publications.npl.co.uk/npl_web/pdf/mgpg11.pdf
Hill, E. (2017). Improving Laboratory Performance Through Quality Control.
Oosterhuis, W., Bayat, H., Armbruster, D., Coskun, A., Freeman, K., & Kallner, A. et al. (2017). The use of error and uncertainty methods in the medical laboratory. Clinical Chemistry and Laboratory Medicine (CCLM), 56(2). http://dx.doi.org/10.1515/cclm-2017-0341
Westgard, J. (2018). Error Methods Are More Practical, But Uncertainty Methods May Still Be Preferred. Clinical Chemistry, 64(4), 636-638. http://dx.doi.org/10.1373/clinchem.2017.284406
The Importance of Meeting ISO 15189 Requirements
Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.
Some key benefits include:
- Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
- Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
- Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.
To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).
In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).
ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.
Meeting ISO Requirements
Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.
Review of QC data
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”
– ISO 15189:2012
Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.
Calculation of MU
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
– ISO 15189:2012
Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.
More about Measurement Uncertainty and how Acusera 24∙7 can help
Commutability
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”
– ISO 15189:2012
Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.
Medical decision levels
“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”
– ISO 15189:2012
Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.
Comparison of results across instruments
“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
– ISO 15189:2012
Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.
Third Party 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
Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.
At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.
Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.
Fig. A
Fig. B
Acusera Third Party Controls
Interlaboratory Data Management
CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf
Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014
Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology, 134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf
Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE, 11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856
Benefits of High-Sensitivity Troponin I (hs-TnI)
Benefits of High-Sensitivity Troponin I (hs-TnI)
Chest pain is a common symptom; 20% to 40% of the population will experience chest pain during their lifetime. There are many causes of chest pain, some of which are benign, while others are potentially life threatening. Importantly, in patients with chest pain caused by an acute coronary syndrome (ACS) or angina, there are effective treatments to improve symptoms and prolong life, emphasising the importance of early diagnosis in patients where chest pain may be of cardiac origin (Skinner et al, 2010). Chest pain is one of the most common reasons for emergency admission to hospital and is a heavy burden on health-care resources. A strategy to identify low-risk patients suitable for immediate discharge would have major benefits (Shah et al., 2015).
RIQAS Liquid Cardiac Programme
Interlaboratory data Management
Ford, C. (2017). Benefits of High Sensitivity Cardiac Troponin I at Admission. Clinical Laboratory Management Association, (July/August 2017), 22-24.
Shah, A., Anand, A., Sandoval, Y., Lee, K., Smith, S., & Adamson, P. et al. (2015). High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. The Lancet, 386(10012), 2481-2488. http://dx.doi.org/10.1016/s0140-6736(15)00391-8
Skinner, J., Smeeth, L., Kendall, J., Adams, P., & Timmis, A. (2010). NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart, 96(12), 974-978. http://dx.doi.org/10.1136/hrt.2009.190066
Randox Quality Control Celebrate British Science Week 2018!
This British Science Week 2018, Randox Quality Control are celebrating the hard work our team puts in every day, to help bring the best Quality Control products to the market.
We caught up with Edward Hill, QC Product Specialist, to explain a bit about what his role involves and how Randox QC are impacting on global healthcare!
What is your position and what does it involve?
I am a QC Product Specialist at Randox Laboratories. This is a hugely varied role, and some of my general duties involve; creating educational material for laboratory professionals, conducting competitor comparisons to ensure we are always one step ahead of the competition, staying up-to-date with the latest industry trends and thinking of new and innovative ways to interact with our customer-base.
For those of us who aren’t in the industry, can you give us a brief snapshot of what Quality Control is and why we use it?
When a patient has their blood/urine/serum etc. taken, it must be sent to the laboratory for analysis. Laboratory professionals run the patient sample on a clinical instrument, which gives a quantitative result for each analyte. However, the laboratory professional does not know whether the value given by the instrument is correct or not. For this reason, the laboratory professional must use a Quality Control – which is a material designed to mimic the patient sample, and has a known concentration of each analyte.
When the laboratory professional runs the QC material on their instrument, they can compare the obtained result with the expected result. If these values are comparable, then the laboratory professional can be confident that their instrument is reporting accurately. Essentially, QC is a ‘practice run’ to ensure the testing system is working correctly.
How does your teams’ work impact on global healthcare?
Quality Control is a hugely important part of laboratory quality. Around 70% of clinical decisions are made based on laboratory results, so it is plain to see how significant Quality Control practices can be in relation to global health care. My work, as well as the work of the wider Quality Control team, is focused on making end-users aware of the importance of Quality Control. We aim to provide advice and recommendations to optimise accuracy and efficiency.
As a company, Randox prioritizes quality above all else, and this ethos is perfectly reflected by the Quality Control team. We work tirelessly to provide quality products and simplify the entire testing process – giving the laboratory professionals more time to do what they do best; provide accurate results time and time again.
What is your favourite Randox QC product and why?
My favourite QC product is the Acusera Liquid Cardiac Control. It’s my favourite control because it perfectly displays all the advantages of Acusera in a single product:
- Highly consolidated analyte list without any unnecessary extras, keeping costs low
- True third party
- Manufactured with 100% human serum, giving full commutability
- Liquid ready-to-use and suitable for POC testing
- Clinically relevant ranges, with ultra-low levels of Troponin I
- Long open vial stability of 30 days
Competitors often offer additional low level Troponin I controls. The thing I like most about the Acusera Liquid Cardiac Control is that the Troponin I levels are still lower than the ‘ultra-low level’ competitor controls – showing that Acusera gets it right the first time, rather than supplementing weak QC products with additional products at an extra cost.
Listen to our 24.7 podcast with QC Product Specialist, Edward Hill.
Find out more about British Science Week 2018.
If you would like further information on our Quality Control Products, contact acusera@randox.com.
Randox celebrate British Science Week 2018
The theme this year for British Science Week is exploration & discovery. Randox Laboratories was established in 1982 with the aim to revolutionise healthcare through continuously improving diagnostic solutions as diagnostics are vital to improving healthcare and disease diagnosis. To achieve this, 28% of the total annual revenue is reinvested in R&D.
Did you know?
The RX series have analyser placements in over 120 countries worldwide
5th largest manufacturer of clinical chemistry reagents in the world.
3rd largest manufacturer of QC and calibrators globally, supplying to 60,000 labs worldwide.
Largest international EQA scheme, with more than 45,000 lab participants in 133 countries.
Patient care is the primary focus of clinical chemistry testing and Randox has developed the RX series of clinical chemistry analysers for high quality semi-automated and fully automated testing. The RX series combines robust hardware and intuitive software with the world leading RX series test menu, including routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing.
Renowned for quality and reliability, the RX series has one of the most extensive dedicated clinical chemistry test menus on the market guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform. This extensive dedicated test menu of high quality reagents guarantees excellence in patient care ensuring unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
The RX series offers both semi-automated and fully automated clinical chemistry analysers to suit your laboratory needs. Choose from the RX misano, RX monaco, RX daytona+, RX imola and RX modena to start your journey with the RX series today.
The market-leading reagents portfolio from Randox is internationally recognised as being of the highest quality, offering rapid and reliable results. With 118 assays, covering over 100 disease markers, Randox offers the most comprehensive product portfolio in the diagnostic market incorporating antioxidants, cardiology, diabetes, drugs of abuse, hepatic function, lipids, renal function, specific proteins, therapeutic drug monitoring and veterinary testing. Randox assays are available in a wide range of formats and methods providing greater flexibility and choice for your laboratory. In addition to flexible pack sizes, a comprehensive list of 13,000 applications for 195 clinical chemistry analysers can be provided as dedicated reagent packs (Easy Read & Easy Fit Reagents).
Through continued exploration to expand the clinical test panels, Randox discovered numerous high performing and unique tests. These tests are either unique to Randox or offer a superior methodology for more accurate results. Such tests include:
– Adiponectin is a protein hormone secreted by adipocytes which has an important role in a number of metabolic processes. Adiponectin is a diabetes biomarker as adiponectin levels are inversely correlated with abdominal visceral fat (AVF) levels, which has proven to be a strong predictor of several pathologies including metabolic syndrome, type 2 diabetes mellitus (T2DM), some cancers and cardiovascular disease (CVD).
– Cystatin C is a small cysteine proteinase inhibitor that is produced at a constant rate by all nucleated cells. Cystatin C is a more sensitive marker of renal function than creatinine as up to 50% of renal function can be lost before significant creatinine levels become detectable. Cystatin C is also useful in patients where creatinine measurements are inconclusive or unreliable, such as patients who are obese, malnourished, have liver cirrhosis or reduced muscle mass.
– 5th Generation Bile Acids is a highly sensitive marker of hepatic function, enabling the early detection of liver disease. The Randox 5th Generation Bile Acids assay utilises an advanced enzyme cycling method which displays outstanding sensitivity and precision when compared to traditional enzymatic based tests.
The Randox High Performance and Unique Tests brochure can be downloaded here for further information.
As the aim of British Science Week 2018 is to inspire innovation and celebrate science, Randox Quality Control are celebrating the fact that we have evolved into one of the principal manufacturers of quality controls and calibrators in the world. With approximately 70% of clinical decisions based on laboratory test results, it is clear to see the significant role laboratory testing plays. Our extensive range of Acusera Controls help labs to find and correct flaws in their analytical processes before potentially incorrect patient results are released, ultimately helping to improve health worldwide.
With more than 390 analytes available across the range, labs can significantly reduce costs without compromising on quality. We specialise in consolidation, our range of multi-analyte controls is designed to cover your test menu, ultimately reducing costs, preparation and storage space for any lab.
Manufactured independently, our third-party range of controls delivers unbiased performance assessment with any instrument or method, furthermore our commutable materials are designed to mimic the patient sample and ensures accurate and reliable test results. Designed to complement our range of third party controls the Acusera 24•7 software is the only peer group program to offer automatic calculation of measurement uncertainty helping laboratories to meet ISO 15189 requirements. Peer group statistics are also uniquely updated live, in real-time giving you access to the most up-to-date information possible enabling rapid and effective troubleshooting.
As the largest EQA scheme in the world, RIQAS (Randox International Quality Assessment Scheme) is used by more than 45,000 laboratory participants in 133 countries worldwide. Comprising 33 programmes a wide range of clinical testing is covered. Each RIQAS programme delivers high quality samples spanning clinically relevant levels to allow identification of concentration related biases; our frequent, user-friendly reporting enables early identification of system errors and our report turnaround time of less than 72 hours from the submission deadline, ensures corrective action can be implemented earlier, reducing costly errors with patient results.
Diagnostics is the key enabler to improve healthcare, patient outcomes and reduce the burden on healthcare; 80% of all medical decisions are based on diagnostic tests. In 1982, we had meagre resources, but we felt we could develop and manufacture world class diagnostic tests. Through continuously improving diagnostic solutions through exploration and discovery, Randox are a world leading manufacturer of diagnostic solutions.
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Our commitment to Research and Development at Randox
With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. Over 16% of turnover is reinvested in R&D, and therefore, we have more new tests in development than any other diagnostic company.
Of our 1400-strong workforce, almost 400 are research scientists and engineers. Over the past year alone these highly-skilled specialists have developed a new test for Alzheimer’s disease, a bladder cancer test and a test with the ability to stratify Acute Myeloid Leukemia (AML) patients, to determine patient response before chemotherapeutic treatment.
We were also the first company in the world to bring to market a test to detect ‘Flakka’, a dangerous and highly addictive new psychoactive substance.
Most recently we announced the official opening of our new research and testing laboratory, Randox Clinical Laboratory Services (RCLS), at the Randox Science Park in Antrim, Northern Ireland.
Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations.
Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.
Our R&D projects are known across the world for their ingenuity and relevance to current health issues.
Both our Bladder Cancer project and our Acute Myeloid Leukemia projects were awarded Innovate UK Research Awards, which enabled economic studies to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative. These DECs will investigate the economic benefits of the new diagnostic tests for The National Health Service, and their role in the current patient care pathway.
Our revolutionary Alzheimer’s disease test was presented with a NACB / AACC Distinguished Abstract Award at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia.
We have also recently established a collaborative agreement with Dr. Carl Novina at the Dana-Farber Cancer Institute and Harvard Medical School. The goal of this collaboration is to develop therapeutic antibodies that will be incorporated into a platform technology that can reprogram patients’ immune systems to attack cancers.
Our research and development programme at Randox is continuously evolving to address the most pressing health issues. We are committed to improving health worldwide and as such will continue to focus our R&D efforts where they are most needed.
Please see below for some examples of our latest research and development news stories.
