Randox celebrate British Science Week 2018

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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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RIQAS Serology Report

The Serology report is available within ten days of the final submission date. The results for each parameter are displayed on a single page report. There are two types of Serology report – one for qualitative reporting and one for quantitative reporting. Each of these report ensure quick and easy performance assessment.

RIQAS EQA Reports

The Qualitative report comprises three subsections including a text section, Histogram and method summary. The text section conveniently displays your laboratory’s result to the correct result for your method. The Histogram visually displays your laboratory’s result in relation to all of the results submitted for your method group and the all method group. Finally, the method summary provides a breakdown of the results for all methods registered with RIQAS.

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The Quantitative report comprises four subsections including a text section, Histogram, Levey-Jennings chart and method summary. The text section conveniently displays your laboratory’s result to the mean for comparison, the histogram visually displays your laboratory’s result to the mean for comparison, the Levey-Jennings chart displays the SD for the last 20 samples ensuring instant identification of performance over time and finally the method summary provides a breakdown of the results submitted for all methods registered with RIQAS.

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RIQAS Urinalysis Report

RIQAS Urinalysis reports have been designed specifically for participants of the RIQAS Urinalysis programme (RQ9138). Report features include;

  • Scoring system
  • Ability to rate performance and visualise historical performance data
  • Visual representation of performance
  • Peer group comparison levels

To find out more on the range of features available with the report, see the table below.

RIQAS EQA Reports

The Urinalysis Report scoring system, scores participants based on a spread of results over each category and how far a participant is away from the consensus, which is referred to as the Target Category.

The score calculated is based on how close to the target category a participant’s result falls. A score of 0 refers to a result which falls within the target category and therefore, the comment “acceptable” will be given. A laboratory’s performance is described as being acceptable or unacceptable based on this calculated score.

A laboratory must achieve a score of between -6 and +6 for their performance to be deemed acceptable. Scores can fall between the values of -10 and +8.

  1. If a participant’s result matches the target category then they will receive the score of 0 and the comment “acceptable” given.
  2. Where a participant returns a negative result and the target category is positive (category 9), the participant score will be -10. The comment “unacceptable” will be given.
  3. Where a participant returns a positive result (category 9) and the target category is negative, the participant score will be +8 and the comment “unacceptable” given.

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Current Sample

The score achieved for the current reported sample together with the associated comment of acceptable, unacceptable or borderline will be listed in the comments box located towards the top of the results page for each registered parameter. The percentage (%) of results from the selected peer group which fall within the target category are also stated.

Potential Historical Information

The number of correct scores (i.e. scores of 0) that have been submitted in the last “n” samples, up to a maximum of 6 previous samples. The number of acceptable assessments that have been submitted in the last “n” samples, up to a maximum of 6 previous samples.

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Charting of Current & Historical Information

Results of scoring for each sample are displayed on a Levey-Jennings style chart with “0” score in the middle and scoring categories positioned on either side for 2, 4, 6, 8 and 10. The chart is shaded into bands depending on the scores.

Acceptable scores (0-6) have no shading, Borderline scores (6-8) have light red shading and unacceptable scores (8-10) are shaded a darker red.

Scores for each of the last 12 samples are plotted against the appropriate sample number and the chart also indicates whether the participant’s reported result category is higher or lower than the target category.

The target categories are stated along the top of the chart and if there are no target categories due to a lack of numbers then an “X” is plotted to show that a result has been submitted but could not be scored.

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Reporting – Summary Page

The summary page at the end of the report lists all of the parameters that a participant has registered for.

For each parameter the following information is stated:

  1. Target Category, which is dependent on the unit registered
  2. The result which has returned by the participant
  3. The score achieved for the current sample
  4. The comment of Acceptable / Unacceptable / Borderline
  5. Where the comment is “Unacceptable” it is highlighted in bold italics and underlined
  6. The number of “Acceptable” assessments that have been achieved over the previous 6 samples

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RIQAS Urine Toxicology Report

A dedicated report is provided for the Urine Toxicology programme. The report is divided into two subsections; the screening (qualitative) and the quantitative section, allowing for visual performance assessment at-a-glance.

RIQAS EQA Reports

Your laboratory’s result is displayed along with the correct response. A visual chart is also provided displaying performance of the last 20 samples. A breakdown of the screening results submitted by other laboratories in your method group and all method groups for the current sample is also provided at a variety of cut-offs. A further breakdown is provided for various methods at your specific cut-off.

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The Quantitative section of the Urine Toxicology report is further broken down into a text section comparing your laboratory’s performance to the mean for comparison, a Histogram chart indicating your laboratory’s performance in relation to the method group and the all method group and a multi-method section highlighting the performance of other methods.

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This Christmas, treat your laboratory to the “gift” of Randox Quality Control

At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.

With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.

Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.

With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!

User-friendly, one page per parameter reports are available within 72 hours of the submission deadline.  These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report  summarising laboratory performance for each cycle and helping to identify progress over time.

Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.

All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.

Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!

So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.

To find out more on any of our RIQAS programmes visit our website – https://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com

Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!


Meeting ISO 15189:2012 Requirements for Multiple Instruments

Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.

About ISO 15189:2012

ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.

Gaining Accreditation

ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.

A particular requirement of ISO 15189:2012 is:

“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”

How Randox can help labs with multiple instruments?

Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.

RIQAS

Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.

Multi-Instrument Reports

All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.

The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.

Acusera 24.7 Live Online

Our stress free QC analysis software is designed to assist in the management of daily QC activities.

Support for multiple instruments

Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.

Helping you get accredited

Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.

To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.

Meet ISO 15189 Requirements for Multiple Instruments

Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’

Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.

It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.

IQC and EQA in Laboratory Quality Management

IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.

EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.

Is there any disadvantage to using IQC and EQA material from the same provider?

The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.

For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.

However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.

Conclusion

ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).

No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.

Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.

How can we help?

To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.

References

Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.

Mythbusting QC Bias
Got a question?

RIQAS Instrument Group Report

All RIQAS participants are entitled to register up to five separate instruments per programme at no extra cost.

Individual reports for each instrument are supplied as normal in addition to a complimentary instrument group report allowing the performance of each instrument to be uniquely compared and assessed easily.

RIQAS EQA Reports

The multi-instrument group report displays the %Deviation for the last 10 samples along with the RM%Dev across all registered laboratory instruments. The %Dev for each instrument is plotted on a user-friendly, colour coded chart for instant identification of poor performing instruments.

As an ISO requirement, the Multi-Instrument Report is an extremely useful and beneficial tool for laboratories – “Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers” – ISO 15189:2012.

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RIQAS Inter-Laboratory Group Report

A unique group reporting facility is available allowing laboratory groups or chains to effectively monitor the performance of satellite sites.

All laboratories within a group will receive their RIQAS sample packs, analyse the samples, return results to RIQAS and receive their individual RIQAS reports as normal. In addition to this a separate group report will be sent to the group manager or supervisor allowing relative performance of all laboratories within the group to be assessed.

RIQAS EQA Reports

For each laboratory in the group, the interlaboratory group report displays the %Dev for the last 10 samples along with the RM%Dev. The %Dev for each laboratory is plotted on a user-friendly, colour coded chart for instant identification of poor performing labs.

inter-laboratory group report

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RIQAS End-of-Cycle Report

RIQAS End-of-Cycle reports are sent to all participants who receive the standard report. Therefore, participants who are enrolled in RIQAS Urinalysis, RIQAS Urine Toxicology and RIQAS Serology programmes will not receive an End-of-Cycle report.

The RIQAS End-of-Cycle report provides laboratories with a complete summary of their External Quality Assessment performance. Performance is also compared to that of the previous cycle providing an indication of progress and improvement over time. Data is presented in both written and graphical format allowing a visual assessment of overall performance.

The RIQAS End-of-Cycle report is split into 3 sub-sections. These sub-sections are designed to allow performance assessment at a glance.

RIQAS EQA Reports

RIQAS End-of-Cycle Report Features

The Parameter Cycle Summary section provides an overview of the results returned for each sample in the cycle. The text section summarises the laboratory’s result compared to the Mean for Comparison. Laboratory performance for the current cycle is also compared to that of the previous cycle. A variety of charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by concentration are also presented allowing a visual assessment of laboratory performance over the cycle.

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The text section provides a summary of the laboratory’s results and statistics including Mean for Comparison, SDPA, %CV, Uncertainty, SDI, Target Score and % Deviation. An additional table comparing performance for the current cycle to the previous cycle is also provided.

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The laboratory’s performance is summarised in various charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by Concentration.

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The absolute SDI summary report compares current performance for all parameters to the previous cycle and indicates whether performance is better or worse. Performance is compared to other RIQAS participants in your country and worldwide.

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A certificate of performance is provided listing all parameters, for which the laboratory achieved an acceptable level of performance (Average Absolute SDI <2). Although the End-of-Cycle Report is issued for all registered parameters, the certificate of performance will only be available for parameters where results for at least 50% of samples in the cycle have been returned.

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