Take control of your heart health with Randox
Take control of your heart health with Randox
Your heart is amazing. Not only is it your most critical organ but also one of the most hard-working. The average adult heart beats around 100,000 times a day, acting as a giant pump for all the blood in your body. Indeed, every day your heart pumps over nine litres of blood through a system of blood vessels over 60,000 miles long – it’s little wonder, then, the importance placed on looking after such a vital muscle.
The heart works 24/7, only taking a rest when you sleep with the natural drop of heart rate and blood pressure. Over time, and influenced by lifestyle choices, the heart grows weaker, needing to work harder to fulfil its function. Crucial lifestyle changes now could limit your risk of developing serious cardiac conditions, such as Cardiovascular Disease (CVD) in the future. Factors which can contribute to your CVD risk include genes inherited from parents or grandparents, smoking, an unhealthy diet, excessive alcohol consumption and low physical activity levels.
You can’t change your DNA, but you can find out what it means to you and your family. One of our advanced tests can identify people living with a common but often hidden disorder – Familial Hypercholesterolemia (FH). Fewer than 12% of people in the UK know they have this potentially fatal condition. It is characterised by dangerously high levels of cholesterol which can lead to early onset cardiovascular disease.
While lifestyle changes may help to limit your risk of CVD, and related heart condition, it is impossible to eradicate it completely for everyone. Accounting for 31% of deaths worldwide, CVD is the number one cause of death globally but early screening could lower this figure significantly. That’s why it’s vitally important to detect CVD early before a coronary event like a heart attack occurs.
Today in the UK, 530 people will go to the hospital with a suspected heart attack. Only a fifth of these people will actually be having a heart attack. According to a team from King’s College London, as reported by the BBC, a faster, more accurate diagnosis of whether chest pain is caused by a heart attack would save the health service millions of pounds each year by sending well patients home and freeing up beds. Yet current testing methods do not efficiently differentiate between high-risk patients and the estimated 80% of patients who are not having a heart attack.
Randox’s revolutionary test for Heart-Type Fatty Acid-Binding Protein (H-FABP), when combined with current testing, is able to rule out a heart attack for patients who present at A&E with chest pain which is caused by other conditions such as respiratory issues, meaning they may not need emergency admission.
When measured at the time a patient presents to A&E with chest pain, H-FABP enables doctors to triage patients suffering with a heart attack more efficiently than before, making sure those at high-risk are given medical intervention earlier.
Early screening in the form of a comprehensive health check is essential to detect cardiac irregularities before they become serious problems. Heart damage builds up over time, meaning that when detected early enough, lifestyle changes can help to reduce cardiac risk and potentially even prevent a cardiac event occurring.
Therefore, it is vitally important that individuals are tested for CVD to detect them in the earliest stages to reduce damage, prevent further damage, or even death. Furthermore, many people suffer from inherited cardiac risk factors, which stresses the need for accurate testing.
Randox offer the complete laboratory solution to cardiac risk assessment information to doctors and hospitals, and also directly to the public at Randox Health. Our range of both traditional and novel cardiac risk biomarkers, along with our technologically-advanced range of analysers, serves to allow us to offer the most advanced, most accurate health check available on the planet.
As well as your cardiovascular risk score, a Randox Health check will also assess your cholesterol levels, FH risk, triglycerides, creative kinase, myoglobin, troponin levels and many more heart health indicators. In total, a Randox Health check can assess up to 350 different markers of irregularity or disease in the whole body, from heart to hormone health and skin to stomach.
Many serious future health issues are preventable now with action. Find out more about our health check programmes here.
About Randox Health
Randox Health is a global leader in healthcare diagnostics; today more than 5% of the world’s population – in excess of 370 million people across 145 countries – receives medical diagnosis using Randox products each year.
After investing over £220 million in the invention and production of revolutionary blood-science technology, a single Randox Health check will deliver a complete picture of your health – as it is now and, crucially, how it is likely to develop in the future.
Randox Health has proven that signs of disease or irregularity can be caught at their earliest stage. This means that, with early action, some cases of illness can even be prevented altogether. Our health checks include, but are not limited to, cancer surveillance, fertility monitoring, heart health, nutrition, digestive and diabetes health.
In other words, from one health check, you’ll receive up to 350 results and afterwards avail of expert advice from the Randox scientists or a Randox Health GP. Not only that, but a complete 12-month programme and repeat testing come as standard so you can have full confidence that you are really taking care of yourself.
Find out more information about Randox Health checks here: https://www.randoxhealth.com/our-packages/
RX Series
Randox has developed the RX series range of clinical chemistry analysers for high-quality semi-automated and fully automated testing. Choose between the RX misano, RX monaco, RX daytona+, RX imola, and the RX modena depending on the throughput of your laboratory. The RX series offers a suitable analyser for your laboratory’s needs. For more information on the Randox RX series, please click here or email therxseries@randox.com
Reagents
Randox offers an extensive range of third party diagnostic reagents which are internationally recognised as being of the highest quality; producing accurate and precise results. We have the largest test menu of 118 assays, covering over 100 disease markers including specific proteins, lipids, therapeutic drug monitoring, drugs of abuse, antioxidants, coagulation, diabetes and veterinary testing. A wide range of formats and methods are available providing greater flexibility and choice for any laboratory size. In addition to flexible pack sizes and a comprehensive list of analyser applications, we can also provide dedicated reagent packs (Randox Easy Read and Easy Fit regents) for a wide range of chemistry analysers providing you with freedom of choice from an independent manufacturer.
For more information on Randox Reagents, please click here or email reagents@randox.com
Acusera – Internal Quality Control
The Acusera cardiac controls have been designed to cover a wide range of cardiac markers at clinical decision levels, eliminating the extra expense of an additional low level control. The controls are available in a both liquid ready-to-use and lyophilized formats making them ideal for all situations and manufactured from 100% human serum a matrix similar to that of the patient is guaranteed. For more information on the Randox Acusera internal quality control, please click here or email acusera@randox.com
RIQAS – External Quality Control
The RIQAS Liquid Cardiac EQA programme is designed to monitor the performance of up to 9clinically significant cardiac markers including: CK-MB mass, D-dimer, Digoxin, homocysteine, hsCRP, myoglobin, NT proBNP, troponin I, and troponin T. RIQAS is ISO/IEC 17043 accredited and allows the registration of up to five instruments at no extra cost. All samples are 100% human serum and provided in a liquid ready-to-use format for enhanced convenience. Submit your results bi-weekly and view reports online via RIQAS.Net. For more information on RIQAS, the world’s largest international EQA scheme, please click here or email acusera@randox.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
The Complete Solution to Cardiac Risk Assessment
“CVDs are the number 1 cause of death globally: more people die annually from CVDs than from any other cause”. In 2015, roughly 17.7 million people died from CVD, representing 31% of all global deaths: 7.4 million were due to coronary heart disease and 6.7 million were due to stroke. (WHO, 2017)
Cardiac health and regular cardiovascular screening is important to enable risk factors to be detected in their earliest stages. There are a few factors which contribute to CVD. These include: smoking, unhealthy diet, excessive alcohol consumption, low physical activity levels. Whilst there are only a few factors contributing to CVD, these can be maintained by the patient through living a healthy lifestyle including: quitting smoking, consuming no more than the recommended allowance of alcohol, cutting out junk food, and exercising for 30 minutes a day, 3 – 5 days a week. In a perfect world, this would be easy and CVD would not be a global problem. However, due to busy lifestyles, cravings, reduced willpower, and convenience, not all individuals in today’s world will be able to avoid CVDs. Therefore, it is vitally important that individuals are tested for CVDs to detect them in the earliest stages to reduce damage, prevent further damage, or even death. Furthermore, many individuals suffer from inherited cardiac risk factors, which stresses the need for accurate testing of both traditional and novel cardiac risk biomarkers.
Randox offer the complete solution to cardiac risk assessment including: RX analysers, traditional and novel reagents, internal quality control (Acusera), and external quality control (RIQAS).
RX Series
Randox has developed the RX series range of clinical chemistry analysers for high-quality semi-automated and fully automated testing. Choose between the RX misano, RX monaco, RX daytona+, RX imola, and the RX modena depending on the throughput of your laboratory. The RX series offers a suitable analyser for your laboratory’s needs. For more information on the Randox RX series, please click here or email therxseries@randox.com
Reagents
As previously mentioned, early assessment of cardiac risk is vital. Randox offer a range of novel risk biomarkers for both very early and the genetic assessment of cardiac risk.
LDL cholesterol is often referred to as the ‘bad cholesterol’. High concentrations of LDL-cholesterol is considered to be the most important clinical predictor, of all single parameters, with respect to coronary atherosclerosis. However, sLDL is a smaller, more dense subfraction of LDL-cholesterol. sLDL particles more readily permeate the inner arterial wall and are more susceptible to oxidation. Individuals with a predominance of sLDL have a 3-fold increased risk of myocardial infarction. Measurement of sLDL allows the clinician to get a more comprehensive picture of lipid risk factors and tailor treatment accordingly.
Elevated levels of Lp(a) are considered to be both a casual risk factor and independent genetic marker of atherosclerotic disorders. The major challenge associated with Lp(a) measurement is the size variation of apo(a) within Lp(a). Dependent upon the size of apo(a) in the assay calibrator, many assays under or overestimate apo(a) size in the patient sample. Numerous commercially available products suffer apo(a) size related bias, resulting in an over estimation of Lp(a) in samples with large apo(a)molecules and an under estimation in samples with small apo(a) molecules. The antibody used in the Randox method detects the complete Lp(a) molecule providing accurate and consistent results. This was proven by the IFCC who developed a gold standard ELISA reference assay and compared 22 commercially available tests. The Randox Lp(a) method displayed the least (minimal) amount of apo(a) size related bias, proving it be a superior offering.
HDL3 Cholesterol is a smaller and more dense subfraction of the HDL particle. HDL is the scavenger of cholesterol within arterial walls and the levels of HDL3 is too low, the ability to remove this cholesterol is reduced. Therefore, it is widely accepted that there is an inverse correlation between HDL3 and CVD risk.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information on Randox Reagents, please click here or email reagents@randox.com
Acusera – Internal Quality Control
The Acusera cardiac controls have been designed to cover a wide range of cardiac markers at clinical decision levels, eliminating the extra expense of an additional low level control. The controls are available in a both liquid ready-to-use and lyophilized formats making them ideal for all situations and manufactured from 100% human serum a matrix similar to that of the patient is guaranteed. For more information on the Randox Acusera internal quality control, please click here or email acusera@randox.com
RIQAS – External Quality Control
The RIQAS Liquid Cardiac EQA programme is designed to monitor the performance of up to 9clinically significant cardiac markers including: CK-MB mass, D-dimer, Digoxin, homocysteine, hsCRP, myoglobin, NT proBNP, troponin I, and troponin T. RIQAS is ISO/IEC 17043 accredited and allows the registration of up to five instruments at no extra cost. All samples are 100% human serum and provided in a liquid ready-to-use format for enhanced convenience. Submit your results bi-weekly and view reports online via RIQAS.Net. For more information on RIQAS, the world’s largest international EQA scheme, please click here or email acusera@randox.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
Reconstituting Lyophilised Controls
What is Lyophilisation?
Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:
- Freezing
- Primary Drying (Sublimation)
- Secondary Drying (Desorption)
There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.
Reconstituting Lyophilised QC Material
The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.
Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:
- If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
- If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
- If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected
If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.
Materials and Methods Required
The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:
- Calibrated volumetric pipettes
- Sterile, appropriately sized pipette tips
- Distilled water, or other reconstitution fluid as specified
- Technician with good pipetting technique
- Lyophilised QC stored according to manufacturer’s specifications
How to Reconstitute Lyophilised QC Material
Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example
- Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
- Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
- Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
- After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
- Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
- Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
- Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4
Additional Considerations
It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.
Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.
If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.
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.
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
Download Third Party Benefits Brochure
Contact Us
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 – http://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!
Mythbusting: āUsing 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.
Got a question?
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.
(Click to enlarge)
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.
(Click to enlarge)
The laboratory’s performance is summarised in various charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by Concentration.
(Click to enlarge)
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.
(Click to enlarge)
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.
(Click to enlarge)
Acusera Internal Quality Control Analyte List
Quality Control is our passion; we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With an extensive product offering comprising third party controls and calibrators, interlaboratory data management, external quality assessment, and calibration verification, you can count on Randox to deliver trustworthy results time and time again. Just ask one of our 60,000 users worldwide.
Our Acusera Internal Quality Control A – Z analyte list highlights how comprehensive our Acusera product portfolio is. Search through the list to see if we have the analyte you require.
Acusera Parameter List
#
5-HIAA
17-OH-progesterone
17β Clostebol
1-25-(OH₂)-Vitamin D
25-OH-Vitamin D
A
α-1-Acid Glycoprotein
α-1-Antitrypsin
α-1-Globulin (Electrophoresis)
α-2-Globulin (Electrophoresis)
α-2-Macroglobulin
α-Fetoprotein (AFP)
α-HBDH
ACE (Angiotensin Converting Enzyme)
Acetaminophen Acid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACTH
Active Vitamin B12 (Holotranscobalamin/HoloTC)
Activated Partical Thromboplastin Time(APTT)
AHD Albumin
Albumin (Electrophoresis)
Aldolase x Aldosterone
Alkaline Phosphatase (ALP)
ALT (GPT)
AMH
Amikacin
Ammonia
AMOZ Amylase
Amylase (Pancreatic)
Androstenedione
Anti-HAV
Anti-HBc
Anti-HBe
Anti-HBs
Anti-HCV
Anti-HIV 1 / 2
Anti-HTLV 1 / 2
Anti-Streptolysin (ASO)
Anti-Thyroglobulin (Anti-TG)
Anti-Thyroperoxidase (Anti-TPO)
Anti-Thrombin III (AT III)
AOZ Apolipoprotein A-I
Apolipoprotein A-II
Apolipoprotein B
Apolipoprotein C-II
Apolipoprotein C-III
Apolipoprotein E
AST (GOT)
β-Globulin (Electrophoresis)
β-2-Microglobulin
BASO-X
BASO-Y
Basophils (BASO)
Basophils % (% BASO)
Bicarbonate
Bile Acids
Bilirubin (Direct)
Bilirubin (Total)
Blood Bone Alkaline Phosphatase (B-ALP)
Borrelia burgdorferi IgG
Borrelia burgdorferi IgM
Brain Natriuretic Peptide (BNP)
C-Peptide
C-Telopeptide
CA 15-3
CA 19-9
CA 72-4
CA 125
Caffeine
Calcitonin
Calcium
Carbamazepine
CEA
Ceftiofur
Ceruloplasmin
Chloramphenicol
Chloride
Cholesterol (HDL)
Cholesterol (LDL)
Cholesterol (Total)
Cholinesterase
CK-MB
CK (Total)
Complement C3
Complement C4
Copper
Cortisol
CRP
Creatinine
Cyclosporine
Cytomegalovirus (CMV) IgG
Cytomegalovirus (CMV) IgM
CYFRA 21
Cystatin C
D-3-Hydroxybutyrate
D-dimer
Deoxypyridinoline
DHEA-Sulphate
DIFF-X
DIFF-Y
Digoxin
Dopamine
E-Selectin (E-SEL)
Eosinophils (EOS)
% Eosinophils (% EOS)
Epidermal Growth Factor (EGF)
Epinephrine
Epstein Barr Virus (EBV) EBNA IgG
Epstein Barr Virus (EBV) IgM
Epstein Barr Virus (EBV) VCA IgG
Estriol
Ethanol
Ethinylestradiol
Ethosuximide
Factor II
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Fructosamine
FSC-X
FSH
G-6-PDH
γ-Globulin (Electrophoresis)
γGT
Gastrin
Gentamicin
Gestagens (Generic)
GLDH
Glucose
Glutamate
Glutathione Peroxidase (Ransel)
Glutathione Reductase
Glycerol
GM-CSF
Growth Hormone (GH)
Haematocrit (HCT)
Haemoglobin (HGB)
Haemoglobin (Total)
Haemolysis (H)
Haemopioetic Progenitor Cell (HPC)
Haptoglobin
HAV IgM
HbA1c
HBc IgM
HBeAg
HBsAg
hCG
Free β-hCG
Total β-hCG
HDL-3
Helicobacter pylori IgG
Herpes Simplex Virus 1 (HSV-1) IgG
Herpes Simplex Virus 1 (HSV-1) IgM
Herpes Simplex Virus 2 (HSV-2) IgG
Herpes Simplex Virus 2 (HSV-2) IgM
HIV-1 P24Ag
Homocysteine
hsCRP
Icterus (I)
IMIDC
IMIRF
Immature Granulocytes (IG)
% Immature Granulocytes (% IG)
Immature Myeloid Information (IMI)
Immature Platelet Fraction (IPF)
Immunoglobulin A (IgA)
High Sensitivity Immunoglobulin A (hsIgA)
Immunoglobulin E (IgE)
Immunoglobulin G (IgG)
High Sensitivity Immunoglobulin G (hsIgG)
Immunoglobulin M (IgM)
High Sensitivity Immunoglobulin M (hsIgM)
Inhibin A
Insulin
Insulin Like Growth Factor (IGF 1) x
Intercellular Adhesion Molecule-I (ICAM-I)
Interferon-γ (IFN-γ)
Interleukin-Ia (IL-la)
Interleukin-1β (IL-1β)
Interleukin-2 (IL-2)
Interleukin-4 (IL-4)
Interleukin-5 (IL-5)
Interleukin-6 (IL-6)
Interleukin-8 (IL-8)
Interleukin-10 (IL-10)
Interleukin-15 (IL-15)
Iron
Iron (TIBC)
Iron (UIBC)
Kappa Light Chain
Ketones
L-Selectin (L-SEL)
Lactate
Lactate Dehydrogenase (LDH)
Lambda Light Chain
Lambda Light Chain (Free)
LAP
Leptin
Leukocytes
Lipase
Lipemia (L)
Lipoprotein (a)
Lithium
Luteinising Hormone (LH)
Lymphocytes (LYMPH)
% Lymphocytes (% LYMPH)
Magnesium
Matrix Metalloproteinase-9 (MMP-9)
Measles IgG
Mean Corpuscular Haemoglobin (MCH)
Mean Corpuscular Haemoglobin Concentration (MCHC)
Mean Corpuscular Volume (MCV)
Mean Platelet Volume (MPV)
Metanephrine
Methandriol
Methotrexate
Methyltestosterone
Microalbumin
Macrophage Inflammatory Protein-1a(MIP-1a)
Monocytes (MONO)
Monocytes % (% MONO)
Monocyte Chemoattractant Protein-1 (MCP-1)
Mumps IgG
Myoglobin
N-MID Osteocalcin (OC)
N-Telopeptide
NEFA
Neuron-Specific Enolase (NSE)
Neutrophils (NEUT)
Neutrophils % (% NEUT)
Neutrophil Gelatinase-associated Lipocalin (NGAL)
Nitrite
Norepinephrine
Normetanephrine
NT-proBNP
Nucleated Red Blood Cells (NRBC)
Nucleated Red Blood Cells % (% NRBC)
Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y)
Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxyhaemoglobin
P-Selectin (P-SEL)
Paracetamol
PAPP-A
pCO2
pH
Phenobarbital
Phenobarbitone
Phenytoin
Phosphate (Inorganic)
PIGF
Plasminogen
Plasminogen Activator Inhibitor
Platelet Distribution Width (PDW)
Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT)
Platelet (PLT)
Platelet Optical Count (PLT-O)
pO2
Potassium
Prealbumin
Primidone
Procalcitonin
Procollagen Type 1 N-Terminal Propeptide (P1NP)
Progesterone
Prolactin
Protein C
Protein S
Protein (Total)
Prothrombin Time (PT)
Pyridinium Crosslinks
Pyridinoline
PSA (Free)
PSA (Total)
PTH (Parathyroid Hormone)
PTH (Intact)
Quinolones (Generic)
Red Blood Cell Y (RBC-Y) x
Red Blood Cell Distribution Width CV (RDW-CV) x
Red Blood Cell Distribution Width SD (RDW-SD) x
Renin
Resistin
Retinol Binding Protein (RBP)
Rheumatoid Factor (RF)
Rubella IgG
Rubella IgM
Salicylate
Semicarbazine (SEM)
Sex Hormone Binding Globulin (SHBG)
sFlt-1
sLDL
Sodium
Soluble IL-2 Receptor a (sIL-2Ra)
Soluble IL-6 Receptor (sIL-6R)
Soluble Transferrin Receptor (sTfR)
Soluble Tumour Necrosis Factor Receptor 1 (sTNFR I)
Soluble Tumour Necrosis Factor Receptor 11 (sTNFR I1)
Specific Gravity
Streptomycin
Superoxide Dismutase (Ransod)
T Uptake
T3 (Free)
T4 (Free)
T3 (Total)
T4 (Total)
Testosterone
Testosterone (Free)
Tetracyclines (Generic)
Theophylline
Thiamphenicol
Thrombin Time (TT)
Thyroglobulin
Tobramycin
Total Antioxidant Status (TAS)
Toxoplasma gondii IgG
Toxoplasma gondii IgM
Transferrin
Treponema pallidum (Syphilis) IgG
Triglycerides
Trimethoprim
Troponin I
Troponin T
TSH
Tumour Necrosis Factor a (TNFa)
Tylosin
Unconjugated Oestriol
Urea
Uric Acid (Urate)
Urine Osmolality
Urobilinogen
Valproic Acid
Vancomycin
Vanillylmandelic Acid (VMA)
Varicella Zoster Virus (VZV) IgG
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Vitamin B12
White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)
Zinc
Westgard’s Great Global QC Survey 2017
In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.
Read on as we take a summarised look at our favourite bits.
Setting control Limits
Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.
Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.
The types of Controls used by labs
More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.
Frequency of QC
The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.
The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.
The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.
“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard
QC Frequency Influences
Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.
Managing QC
Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.
Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.
A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.
More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.
Managing QC Costs
Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.
Conclusion
Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.
How Randox Can Help
Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits – this is where Randox comes in.
Acusera Third Party Controls offer the highest quality solution for any lab – regardless of 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 recommendations. Unrivaled consolidation allows for significant cost savings.
Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.
Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results
To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.
Diabetes ā World Diabetes Day (14th Nov 2017)
World Diabetes Day
With World Diabetes Day on Tuesday 14th November 2017, we take a look at what diabetes is and why quality control is so important.
What is Diabetes?
Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.
Type 1 Diabetes
Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.
Type 2 Diabetes
A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.
Role of Quality Control
Quality control plays a crucial role in ensuring accurate and reliable diabetes monitoring. 70% of medical decisions are based on a laboratory test result and QC is vital in ensuring the results the laboratory report are both accurate and reliable.
Want to know what makes a good HbA1c control? Read on to find out.
Clinically Relevant Levels
In the diagnosis of diabetes, glycated haemoglobin (HbA1c) in blood provides an indication of average blood glucose levels in the previous three months. HbA1c is the recommended standard of care for type 2 diabetes monitoring. HbA1c is measured using the range below:
HbA1c – Clinically Relevant Levels
| HbA1c | mmol/mol | % |
|---|---|---|
| Normal | Below 42 mmol/mol | Below 6.0% |
| Prediabetes | 42 to 47 mmol/mol | 6.0% to 6.4% |
| Diabetes | 48 mmol/mol or over | 6.5% or over |
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. 48 mmol/mol is the cut-off for diabetes diagnosis, it is crucial that this can be measured accurately because any inaccuracy could mean the difference between being diagnosed and treated and not.
In terms of accreditation, 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’.
Benefits of Third Party Controls
The importance of third party controls is evident. Third party controls can help identify instrument, reagent, and procedural errors. Unchecked these errors could lead to incorrect patient results, further leading to misdiagnosis.
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.
Again, in terms of accreditation, ISO 15189 states – “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.”
Many laboratories perform HbA1c testing on a dedicated machine and as a result, are not always using a third party control.
Controlling Waste
Wastage is a common issue when running HbA1c due to the pre-treatment step required for many HbA1c controls and poor stability of some controls on the market. Look out for controls with an extended open vial stability to help reduce waste and keep costs low.
How can Randox help?
To help you get your QC in check for World Diabetes Day, Randox Acusera HbA1c control contains both HbA1c and Total Haemoglobin, with a reconstituted stability of 4 weeks to reduce waste and reduce costs. To find out more about our HbA1c control visit the page using the button below or fill out the form above.
References
Diabetes: The basics. (2017). Diabetes UK. Retrieved 3 November 2017, from https://www.diabetes.org.uk/diabetes-the-basics
Khan, H et al. (2016). Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights, 95. http://dx.doi.org/10.4137/bmi.s38440