Liquid Controls vs Lyophilised Controls
Liquid Controls vs Lyophilised Controls
Results of our Liquid vs Lyophilised Poll
Having conducted a recent poll on our Social Media platforms (Facebook, LinkedIn & Twitter) asking our customers what format they preferred their quality control material in – liquid or lyophilised – we saw a large preference for liquid controls.
What does this poll result really tell us?
That most people prefer Liquid controls? Yes.
Lyophilised controls are not as popular amongst our social following? Yes.
However, it also tells us that even though most people chose a liquid format there was still almost a quarter of people who prefer to use lyophilised controls. Liquid and lyophilised controls both have their advantages and disadvantages, this blog is designed to help you decide which is the best fit for your lab.
Liquid Controls
Firstly, it is important to note that there are two distinct types of liquid control available on the market;Liquid ready-to-use and Liquid for ease-of-use, better known as Liquid Frozen. Both types of liquid controls reduce the potential for reconstitution errors and prevent contamination from poor quality water.
Liquid frozen controls must be thawed in a refrigerator before use, making them a little less convenient than the liquid ready-to-use alternative. They require no reconstitution so associated errors are removed. Due to the frozen nature of these controls, they are often shipped on dry ice to prevent thawing in transit, as such transportation costs can be significant.
Liquid ready-to-use controls are arguably the most favoured of the three formats and it is easy to understand why. The controls are simple to use, they require no preparation and there is no need to thaw before use.– With zero preparation required, these controls can be removed from the packaging and used right away! What’s more, they can be conveniently stored at 2-8oC minimising expensive shipping costs.
Another major benefit of using a liquid ready-to-use control is the fact that they are ideal for POCT (Point of Care Testing). The ability to use these controls on the spot is extremely beneficial to POC providers.
Lyophilised Controls
Lastly, the choice of 22% of respondents – lyophilised. This is freeze dried material which requires the laboratory professional to reconstitute the sample using sterilised water and mixing before use. Although this format is not as easy to use as either liquid control it does come with benefits. The enhanced stability of this control sees a shelf life of almost double the two years that is normal with a liquid control, however, the potential for reconstitution errors and the fact it is not as simple to use lead to the majority of people opting for a more convenient liquid control.
Randox Quality Control Range
With Randox QC there are a vast array of controls available in liquid ready-to-use and liquid frozen formats. Areas we have liquid frozen formats available in, include; Clinical Chemistry and Immunoassay.
Liquid ready-to-use controls can be found in the following; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c and Liquid Tumour Markers.
Lyophilised controls available with Randox QC can be found within; Chemistry, Immunoassay, Cardiac, Coagulation, HbA1c, Lipids and Therapeutic Drug Monitoring.
To register an interest in any of our controls simply contact us at acusera@Randox.com and let us know how we can help and support you or alternatively click here – where you will be redirected to our contact page.
ISO 22870:2006 in the Point-of-Care Testing (POCT) Market
Point-of-Care Testing (POCT)
The Point-of-Care testing market, better known as POCT, is growing rapidly as the demand for faster patient testing increases. This point is fully backed up through the results of the recent BIVDA (British IN-Vitro Diagnostics Association) survey of 2016. This survey focuses primarily on Point-of-Care Testing and there were a few questions asked that sparked an interest amongst us. The questions can be seen below;
“What are the challenges you face regarding POCT?”
“What do you see in the future for POCT?” (BIVDA, 2016)
Although many answers were put forward there was one (answer) that appeared for both questions. Accreditation. We found this intriguing yet far from surprising. POCT and accreditation go hand-in-hand, with laboratories striving to achieve ISO accreditation with the ultimate aim of allowing patients to have peace of mind that they are being tested properly and effectively.
ISO 22870:2006
The ISO standard that relates to POCT is ISO 22870:2006 Point of Care Testing- Requirements for quality and competence. This standard gives specific requirements applicable to POCT testing and apply when POCT is carried out in a hospital, clinic or a healthcare organisation providing ambulatory care. However, it is important to note and remember that ISO 22870 is not to be seen as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 (medical laboratories – particular requirements for quality & competence).
With accreditation in POCT becoming a major factor to laboratories, it is no surprise to see accreditation as one of the top answers to the two questions asked in the survey.
For laboratories looking to participate in point-of-care testing there are other factors of ISO 22870 that they must be aware of, one of the major factors is as follows;
“ISO 22870:2006 advises that where available, Internal Quality Control and participation in an External Quality Assessment (EQA) scheme is required in the point-of-care setting.”
How can Randox help?
Fortunately for laboratories, Randox are able to help out here. With a vast range of true third party controls and 32 comprehensive RIQAS (EQA) programmes, Randox can aid laboratories as they aim for ISO accreditation.
We have multiple products particularly suited to the POCT market including, Liquid Cardiac, Blood Gas and Urinalysis. These products are available both as internal quality controls and as EQA programmes.
Our Acusera range of true third party controls are conveniently supplied liquid ready-to-use, therefore requiring no preparation. This is a particular advantage in the POC environment were test results are required quickly and also were testing is not always performed by laboratory personnel. Supplied with assayed target values and manufactured from 100% human material, ensuring they act in the same manner as a patient sample, our Acusera controls are ideal for use at the point of care and will therefore aid a laboratory in gaining ISO accreditation.
Similarly, participation in our RIQAS EQA programme will also assist laboratories to meet regulatory requirements and achieve ISO accreditation. With over 40,000 laboratory participants in 123 countries, RIQAS is the largest international EQA scheme worldwide! Our Liquid Cardiac, Blood Gas and Urinalysis programmes are all supplied liquid ready-to-use, complementing their Acusera counterparts perfectly!
By using our Acusera controls and RIQAS EQA programmes side by side, a laboratory can confidently aim for ISO accreditation in the knowledge that they are meeting criteria.
Randox Reagents: Solving the Problem of Heart Attack Misdiagnosis
A report has today revealed that almost a third of patients in England and Wales are being given a misdiagnosis following a heart attack, following a study of 243 NHS hospitals, conducted by researchers at Leeds University.
Timely evaluation of patients with chest pain and subsequently suspected heart attack is a major challenge for hospitals around the world, with chest pain typically representing around 5% of all visits to the Emergency Department (ED) and 25% of ED admissions. One of the biggest challenges facing emergency doctors now is how to prioritise people presenting with chest pain – to primarily deal with those suffering from a heart attack, and to be able to move those who are not, to a different ward, to alleviate the pressures of the overrun A&E departments.
Responding to the escalating misdiagnosis crisis in emergency hospitals across the globe, scientists at Randox Laboratories in the UK have developed a test which could help clinicians rule out heart attacks in patients immediately upon arrival at hospital; allowing clinicians to accurately prioritise those who have truly suffered heart attacks.
This Randox test, for Heart-type fatty acid-binding protein (H-FABP), is a highly sensitive biomarker for use in the earlier diagnosis of patients with suspected Acute Myocardial Infarction (AMI), enabling faster “rule-in” and “rule-out”. H-FABP is detectable as early as 30 minutes after chest pain onset, significantly earlier than traditionally used biomarkers such as Troponin or CK-MB , which typically require 6-12 hours to reach detectable concentrations.
Put simply, given that H-FABP is released earlier than traditional biomarkers used in diagnosing a heart attack, an earlier diagnosis is achievable.
A succession of recent international clinical trials have demonstrated that by combining H-FABP, via this new laboratory assay, with the existing tests already used in hospitals for for Troponin I or Troponin T, the sensitivity and negative predictive value for ruling out AMIs is significantly improved.
Growing evidence indicates that even when one of the newer generation of “highly sensitive” Troponin assays is used, utilising the combination of Troponin and H-FABP is superior to Troponin alone.
The value of H-FABP is not just in positive diagnosis – but doctors are beginning to see it as a means of ‘ruling out heart attack’ when a patient presents at A&E with chest pain.
Please do get in touch if you would like to find out more about our H-FABP test, and how this can go a long way in solving the heart attack misdiagnosis crisis, by emailing reagents@randox.com
How frequently should you run EQA?
There is much debate among clinical laboratories when discussing this common question. With some schemes offering testing as little as 2 times per year, it raises the question, is this really enough?
How frequently an EQA scheme is run will often be dependent on several aspects. Factors such as the diagnostic error rate, number of tests undertaken, experience and turnover of technical staff, and the known stability/instability of the analyte in question should be considered and will all contribute to determine the desired frequency of EQA.
Each EQA programme will vary, where one area, for instance Chemistry, may require bi-weekly testing, another, such as Serology, may only need to be tested every 3 months. Although there is variation between schemes, the benefits of testing more frequently unquestionably outweighs the costs of not testing frequently enough.
Issues with infrequent testing?
If your EQA provider offers infrequent testing, there is likely to be a lengthy period of uncertainty where errors could be happening in the laboratory and consequently incorrect results being released. The outcome of this could be damaging to both patients and laboratories, with credibility and trust in results likely to come under scrutiny. For these reasons, having an infrequent EQA scheme could cause harm to your laboratory and reduce confidence in your test results.
Why should you use a frequent EQA scheme?
To ensure the previously mentioned errors do not occur, laboratories should participate in frequent EQA schemes to guarantee that if incorrect test results do arise, then they will be detected and rectified immediately.
As preventative/corrective actions can be taken sooner through frequent EQA schemes, you will have increased confidence in your test systems performance and may reduce the need for expensive retests. Being able to pinpoint when an error occurred will be much simpler if you are only looking back a matter of weeks or a couple months, as opposed to if you are looking back over a longer period such as 4 to 6 months.
The ability to implement corrective actions sooner and with less disruptions to the lab will help lead to both time and cost savings in the future.
What can Randox Quality Control offer?
Randox International Quality Assessment Scheme (RIQAS), offers bi-weekly, monthly and quarterly reporting options* designed to assist with the early identification of laboratory errors. Not only will RIQAS provide you with extra confidence in test system accuracy, but with 32 flexible programmes you could also make significant cost and time savings through consolidation.
With more than 40,000 participants in 124 countries, RIQAS is the largest international EQA scheme on the market and offers laboratories around the world assurances that the results they are releasing are accurate and reliable. Our many features include; the ability to register up to 5 instruments per programme at no extra cost, easy to read reports, internationally accredited programmes and rapid report turnaround. Why don’t you contact us today and find out how we can support you in maintaining quality control in your laboratory?
*Programme Specific
We Are Randox | Randox Rugby Team Promote Healthy Work-Life Balance at Randox
As a global healthcare diagnostics company, we know a thing or two about health. And we know that taking time out from our busy lives to relax and unwind is important to stay healthy. Whether that’s taking your dog for a walk, meeting up with friends, getting lost in a good book, or playing your favourite sport.
Playing a competitive sport brings a wealth of benefits – it’s the perfect way to socialise and look after your health at the same time! Not only is it good for your physical health, but can go a long way in maintaining your mental wellbeing too.
There is great value in exercise and fresh air. However, it’s an unfortunate fact of life that most 9-5ers just don’t have the opportunity to indulge in this pleasure very often.
Randox, being a company serious about health and wellbeing, like to know we’re giving our employees the best opportunities to be as healthy as they can, and live their lives as fulfilled as possible.
Amongst many sports in which Randox encourages employees to take part, we encourage our employees to regularly take the time to engage in some friendly competition of 5-a-side rugby against each other. The County Antrim countryside, in which our Randox headquarters are located, is the perfect setting for an informal game of rugby – our rugby players can let off some steam and take in the scenery at the same time!
The team was banded together by Randox Founder and Managing Director, Dr. Peter FitzGerald, who occasionally joins in on the games himself! Dr. FitzGerald is a strong advocate of teamwork and camaraderie in the workplace.
Jonathan Acheson, Randox Health Sales Executive, who plays for our Randox Rugby Team, commented;
“At Randox we work hard but we play hard too! Our work can often be very fast-paced and Randox is expanding phenomenally – for example we’re all working towards our 5 year sponsorship of the Randox Health Grand National, beginning in 2017, which is keeping us all very busy. So it’s important that we take time to unwind and recharge our batteries. We’re lucky that we’re able to take advantage of being in such a lovely area of Northern Ireland – right beside Lough Neagh – and so we can get outside after work and have a good run-about!”
Follow Randox Careers on Facebook, Twitter and Instagram to stay up-to-date with the hashtag #WeAreRandox
Careers Tips | Don’t Get Stressed… Deskercise!
Ever wonder how motivated and successful people stay so calm at work? Here at Randox, we know that even the most enjoyable careers can get stressful, even for the most motivated employees!
According to a CIPD Absence Management Survey the number one cause for long term sickness is stress. When the paperwork begins to pile up and to-do lists become longer it can be difficult not to let the mounting pressure get to you. But, there’s good news! Exercise is not only for the body, but the mind too. Exercise at work can improve our mental wellbeing improving our ability to deal with the pressure/stress in our working lives. So, if you want to keep your cool like John from H.R., here’s some tips on how you can make some changes today towards improving your mood (even on Mondays!)
1. Get up a go. We all realise how important exercise is but making the time for it in our busy lives can be difficult. Why not make simple changes increasing the amount of physical activity you can squeeze into your day. Take the stairs whenever you can. Perhaps even park your car in a space further away meaning more time to stretch your legs.
2. Stretch at your desk. Research by the NHS says Adults in the UK are sitting for 7 hours a day! Find yourself staring at your computer screen all day? Alternate your tasks at works. Why not even try the CIPD suggested “chairobics”…stretches you can do without even leaving your chair such as rotating your shoulders. Chairobics is so widely praised there’s even sit-down aerobics classes based on teaching people how to get moving at their desk!
3. Clear your head. Don’t be afraid to take a screen-break every now and again. I know it can seem like you’re wasting your precious work time, but clearing your head of the stresses you accumulate at work will give you a clearer perspective on things ensuring you remain motivated and more productive. There is a long history of research into breaks and the correct amount of time for a computer-break. Employers first began offering the break because of its effects of revival on work quality. Not only does it revive your work, however, it revives you! Physical activity goes a long way contributing to improving your own mental well being. Any activity that makes you feel good does well. Feeling good boosts your productivity in work and as the saying goes “Nothing will work unless you do”.
4. Sit up straight. Good posture at your desk will improve your breathing making you feel calmer and therefore less like likely to get stressed no matter what work related task is thrown your way. Bad posture, on the other hand can cause many problems such as pains, and headaches. Try this. Roll your shoulders back and straighten your spine. Lift you chin up. How much better do you feel? More motivated and ready to take on the world of work? Don’t question the power of good posture on your mood!
In conclusion, we quote Ziggy Marley; “Doing something that is productive is a great way to alleviate emotional stress. Get your mind doing something that is productive.” We all want to be as cool as a cucumber in stressful situations at work so the next time you’re feeling under pressure try some of these tips and smile! It’s Friday, afterall!
For more tips, follow Randox Careers on Facebook, Twitter and Instagram. Take a look at our website to discover the endless job opportunities open to you!
Demand for external support driving growth of EQA
“In Vitro Diagnostics (IVD) Quality Controls Market” recently published by Markets and Markets has highlighted an overall significant growth within the Quality Control Market. Further growth is anticipated in the coming years with the Markets and Markets report estimating that the IVD QC market will be worth $979 million.
One area that is currently experiencing growth within this sector is the EQA segment, which Markets and Markets estimates to command a 6.6% share of the overall IVD market. The report is crediting growth within this segment to you, the customer, stating “…various end users or customers of IVD quality control products mostly prefer external support to run their quality control activities. For this, market players are largely focusing on providing external quality assurance (EQA) support”. As such companies such as Randox are being approached to provide EQA for a range of small, independent laboratories and large laboratory chains alike.
What other factors have contributed to this growth?
The adoption of ISO15189 and other similar standards is becoming mandatory in many countries, as discussed in a previous blog post. Accreditation highlights the accuracy and reliability of the patient results being released. ISO15189 states that “The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment or proficiency testing schemes”. Therefore laboratory managers are employing EQA programmes in their laboratory to meet such requirements. EQA also enables laboratories to meet other accreditation requirements such as peer comparison and clinically relevant testing.
Selecting the right EQA for you
When selecting the right EQA scheme for your laboratory there are a number of considerations to be made; sample frequency, peer group numbers, report format, report turnaround and so on. According to a survey conducted by Randox Quality Control 55% of respondents listed sample frequency as the most important feature to be considered when selecting an EQA scheme. Sample frequency is an ongoing debate regarding EQA. However, schemes with frequent reporting will allow you to easily pinpoint when an error occurred and implement corrective actions with minimal disruption. Also making the top three key factors in this survey were; quality samples and peer group numbers.
What can Randox Quality Control offer?
As the largest international EQA scheme available on the market RIQAS offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With more than 40,000 participant in 124 countries and 32 flexible programmes we are certain that the external support we offer for your quality control activities will provide you with the upmost confidence in your laboratory’s performance. Furthermore with our programmes accepted by national and international accreditation bodies worldwide employing RIQAS can help you gain accredited status providing your end users with peace of mind. With other benefits such as programme consolidation, rapid report turnaround, easy to read at-a-glance reporting and the ability to register up to 5 instruments per programme at no extra cost why don’t you contact us today and find out how we can support your quality control activity?
To request a visit from a QC consultant contact us via acusera@randox.com
What is Visceral Fat?
Visceral fat (or abdominal fat) is body fat which is stored within the abdominal cavity. It wraps around your vital organs including the liver, pancreas and intestines, and as a result can have a negative impact on your health. In fact, visceral fat has been linked to increased risk of health problems such as type 2 diabetes, heart disease and some cancers.
It is important to distinguish the difference between subcutaneous fat and visceral fat…
Subcutaneous fat is the fat we store under our skin. It is the tissue that we can feel when we pinch ourselves, and contains blood vessels in addition to fatty tissues. Visceral fat, on the other hand, cannot be felt in such a way as it is the extra fat stored around our organs. It is the most dangerous type of fat as it much harder to identify.
No matter what your shape or size, you may be carrying excess visceral fat!
Regardless of shape or size an individual can be carrying excess visceral fat. This means that whether your doctor tells you that you’re underweight, overweight, obese or of a healthy weight, you may be carrying excess visceral fat within your abdominal cavity.
That is why BMI is an inaccurate measurement of health…
Body Mass Index (BMI) is used by many as an indicator of health. It involves comparing your weight in relation to your height to give an indication of your weight status i.e. whether you are categorised as underweight, overweight, healthy or obese. It doesn’t take into account muscle mass, age, sex, ethnicity, general level of fitness or visceral fat. Therefore, even if you have a ‘healthy’ BMI you may still be carrying excessive visceral fat, and could still be at risk of the health complications associated with it.
As a result, relying on BMI could put you at risk of countless diseases…
Visceral fat is often referred to as ‘active fat’ due to the effect it has on our hormones and body functions. It can interrupt normal hormone communications between your vital organs, and can lead to insulin resistance and eventually type 2 diabetes. Additionally, it can affect the functions of your organs and puts you at higher risk of developing heart disease or cancers including breast cancer or colorectal cancer.
So, what can you do to protect yourself?
Factors which contribute to visceral fat levels include stress, diet and exercise habits in addition to age, ethnicity and gender. Living a healthy lifestyle will therefore reduce your chances of visceral fat accumulating in your abdominal cavity.
If you are worried about your visceral fat levels the waist-to-hip ratio (found by dividing waist width by hip width) can give an indication of total fat as well as the level of visceral fat, however the most accurate measurement of visceral fat is to measure adiponectin levels in the blood.
Adiponectin (a blood analyte) is closely linked with visceral fat; low levels of adiponectin indicate high levels of visceral fat. The Adiponectin test enables true measurement of visceral fat levels and allows for more accurate measurement of health than traditional BMI; if you have been diagnosed with unhealthy BMI and believe this to be an inaccurate diagnosis, testing your adiponectin levels can help determine your true measurement of health. Simply ask your doctor for the Adiponectin test!
The Secrets of the Aging Process
Age is associated with increases in body weight, body fat, abdominal fat, deterioration of muscles, and arthritis. However, everything in the body happens at the cellular level. Outward signs of aging that you may see, such as wrinkles and grey hair, are only symptoms of what is happening on a microscopic scale.
A study carried out by Raul A Martins, using the RX imola, outlined an experiment, investigating how we can affect our own inner-biological make-up, on a much deeper scale than muscle build-up, through exercise and activity:
“To investigate the training effect of sixteen weeks of moderate intensity, progressive aerobic and strength-based training on metabolic health of old women and men. Sixty three sedentary individuals were randomly assigned to control or exercising groups. The training group was separated to aerobic or strength-based. Training took place 3 times a week. Subjects agreed not to change their diet or lifestyle over the experimental period. Exercising group attained after treatment significant differences on body weight, waist circumference, body mass index, diastolic blood pressure, triglycerides, total cholesterol, HDL cholesterol, LDL-cholesterol, total cholesterol/HDL-cholesterol relationship, high sensitivity C-reaction protein and 6 minute walk distance. The control group only had significant differences on waist circumference” wrote R.A. Martins and colleagues, university of Coimbra.”
As shown in the experiment, exercising does not only affect our muscle mass and body fat index. It does, in fact, affect us on a cellular level.
Before outward aging symptoms are expressed, your cells, your DNA, and everything that makes up you is reacting to your lifestyle and responding appropriately. A particularly lifestyle-sensitive part of your DNA associated with aging are telomeres.
Telomeres are caps at the ends of DNA strands, made up of a combination of DNA and protein. They protect the ends of the chromosome and keep them stable. Telomeres, however, are incredibly sensitive and have a tendency to become damaged and unravel, prompting a process called “telomere shortening”. Telomeres are associated with the changing nature of our bodies, and therefore, are classed as important aging biomarkers – with their length indicating lifespan. Each time our cells divide, our telomeres shorten. After many dozens of years of cell division, these biomarkers have reached a point where they can longer become any shorter. At this point, cell division discontinues and this is where aging will occur, as cells begin to die faster than they are created. Our body begins to break down. Effects such as hair falling out and skin sagging, are all symptoms of telomere damage or shortening. Telomere shortening has not only been associated with aging, but also age-related diseases such as Parkinson’s disease, Alzheimers, cardiovascular disease, Diabetes, and some forms of cancer.
There is good news, Martins noted in his experiment that exercise appears to keep telomeres from unravelling, shortening and becoming damaged, and therefore, can be classed as a natural anti-aging activity.
Through examining white blood cells, scientists can monitor telomere shortening (and damaging) whilst monitoring exercise and lifestyle of subjects. Another group of scientists in Germany conducted a similar experiment, gathering women and men of different ages to examine their lifespans relative to exercising, they noted:
The sedentary older subjects had telomeres that were on average 40 percent shorter than in the sedentary young subjects, suggesting that the older subjects’ cells were, like them, aging. The runners, on the other hand, had remarkably youthful telomeres, a bit shorter than those in the young runners, but only by about 10 percent. In general, telomere loss was reduced by approximately 75 percent in the aging runners. Or, to put it more succinctly, exercise, Dr. Werner says, ‘‘at the molecular level has an anti-aging effect.’’
(Gretchen Reynolds, 2010)
So, to put a number on it, studies show, exercise can reduce the aging process by up to a whopping 75%.
As well as it’s anti-aging properties, there are a surplus of other benefits of exercising, such as increased release of endorphins and relieving of muscular pain. Currently, there’s a good deal of research being conducted into potential drug based approaches for telomere shortening, yet these drugs are still years away. So, for now, exercise and healthy eating is the only known way to stave off aging… As if we needed another healthy reason to get active!
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Read more about the experiment conducted on the RX imola:
Microalbumin shifts when changing reagent batch
A laboratory running a competitors 3rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.
They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.
Competitor Control – Microalbumin | ||
Reagent Batch |
QC Level One |
QC Level Two |
1 | 19.9 | 81.0 |
2 | 29.7 | 90.5 |
3 | 50.4 | 122.4 |
As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.
The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.
Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.
Randox Control – Microalbumin | ||
Reagent Batch |
QC Level One |
QC Level Two |
1 | 33.5 | 158.8 |
2 | 34.9 | 164.9 |
3 | 34.8 | 168.0 |
The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.
This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.