Take control of your heart health with Randox

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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.

The niche Adiponectin assay allows for the early assessment of CVD.  Adiponectin levels are inversely correlated with abdominal visceral fat which has proven to be a strong predictor of T2DM.  Body-Mass Index (BMI) is a common method for determining which patients are classified as underweight, healthy, overweight or obese, however, BMI does not take into account gender, ethnicity or activity levels.  For example, measuring the BMI of athletes who have a high BMI due to muscle weighing heavier than fat would classify them as obese which is inaccurate.  Measuring adiponectin levels is therefore a much more reliable indicator of at-risk patients compared to BMI.

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

cardiac

 


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:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. 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

  1. 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
  2. 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
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. 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
  5. 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
  6. 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
  7. 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.


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?

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.

Respondent Map - Westgard QC Survey

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 – 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
HbA1cmmol/mol%
NormalBelow 42 mmol/molBelow 6.0%
Prediabetes42 to 47 mmol/mol6.0% to 6.4%
Diabetes48 mmol/mol or over6.5% 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.

World Diabetes Day

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


Celebrate Christmas with Randox Quality Control

T’was the week before Christmas and all through the lab not a thing could be heard not even a sound. The analyser lay silent asleep in the corner, the lab staff at home dreaming of a few days’ rest, only a few more days to go before the big day!

The big man in red, what will he bring those who already have everything? Peace, happiness and health for their loved ones throughout the festive break, that would be the wish for everyone to make. And what better way to ensure they stay healthy, well it all begins in the laboratory…

An important consideration to remember when choosing your lab Quality Control (QC) is that approximately 70% of clinical decisions are based on laboratory test results. It is therefore essential that the results gained from laboratory testing are accurate and reliable in order to provide the appropriate treatment and avoid or prevent potential misdiagnosis.

Patient results are of the utmost importance for a laboratory and therefore running the best Quality Control material should be at the top of their agenda. QC material should have a number of features that allow a lab to judge the overall quality of their output. These features include the controls ability to be commutable (which means how well it reacts as a replicate of a patient sample), is it a true third party control that has been manufactured to provide an independent and unbiased assessment of performance, does your control come with clinically relevant levels and does it have a long shelf life as well as a good open vial or reconstituted stability? These are the questions lab staff will be asking themselves when deciding on what QC is the right QC.

So stay off Santa’s naughty list by providing accurate and reliable patient test results, do this by employing Randox QC in your laboratory. Our controls have been designed to deliver significant cost savings without sacrificing on quality. With consolidated controls (combining up to 100 analytes in a single vial) your lab can reduce QC costs and preparation time, the inclusion of analytes present at clinical decision levels will eradicate the need for additional controls and because of our long shelf life (2 years for liquid controls, 4 years for lyophilised) and excellent stability claims your laboratory can be sure that expensive lot changes will be a thing of the past! Our controls can be described as true third party and this, combined with the commutable nature of the controls, leads to us being able to claim that we have the best Quality Control material around.

So this Christmas when deciding what QC to choose – make sure you look no further than Randox Quality Control. Our QC family is known as Acusera and our product offering includes QC and calibrator material, Interlaboratory Data Management Program (Acusera 24.7), the world’s largest international EQA/PT scheme better known as RIQAS and the newest addition to the family, Linearity or Calibration Verification material.

We have packages for every lab regardless of size and budget and we guarantee you will become ho-ho-hooked on Randox QC.

Wishing you all season’s greetings and a prosperous New Year from everyone at Randox QC.


ISO 22870- Are you meeting expectations?

Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.

There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.

POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;

  • Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
  • Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
  • Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
  • Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
  • Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
  • Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
  • Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel

In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.

Our Acusera liquid ready-to-use controls include:

  1. Blood Gas ControlA liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
  2. Liquid Cardiac ControlThis is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
  3. Liquid Urinalysis ControlLiquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
  4. Liquid HbA1c ControlThis is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.

Complementary EQA programmes are also available to meet the needs of ISO 22870.


IQCP: Where Are We Now?

What is IQCP?

IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.

IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.

Where are we now?

As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?

In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.

Opinions were mixed regarding the effectiveness of IQCP:

Positive Opinions of IQCP

  • Some users found that IQCP decreased the number of QC materials required
  • There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
  • Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
  • Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
  • Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff

Negative Opinions of IQCP

  • Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
  • Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
  • Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
  • Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.

ISO 15189:2012 requirements

As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.

We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.

References:
  1. Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.

Does Your QC Cover Clinically Relevant Ranges?

Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.

Measuring the Complete Clinical Range

It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.

Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”

What are Medical Decision Levels?

Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.

For example, the MDL of Glucose can indicate a certain diabetic status:

Analyte Medical Decision Level Diagnostic Status
Glucose (fasting) <100 mg/dL Non-Diabetic
100–125 mg/dL Pre-Diabetic
>125 mg/dL Diabetic

Competitor QC

Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:

Competitor Chemistry Control Level 1 – 68 mg/dL

Competitor Chemistry Control Level 2 – 134 mg/dL

Competitor Chemistry Control Level 3 – 386 mg/dL

In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).

Randox QC

Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:

Level 1 – 57 mg/dL

Level 2 – 114 mg/dL

Level 3 – 236 mg/dL

The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.

Immunoassay Medical Decision Levels

Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:

Analyte Medical Decision Level Randox Level 1 IA Control Competitor Level 1 IA Control
TSH 0.1 or 0.27 uU/mL 0.15uU/mL 0.37 uU/mL
Vitamin B12 190 pmol/L 174 pmol/L 327 pmol/L
Ferritin 12 ng/mL 11.1 ng/mL 49.6 ng/mL

In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.


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