Celebrating the Randox Reagents R&D Team this Medical Laboratory Professionals Week!
Medical Laboratory Professionals Week (MLPW) is a week dedicated to increasing public understanding and appreciation for the clinical laboratory profession. During this week, we are taking the opportunity to celebrate the hard work of our Research and Development team. Allow us to provide you an insight into the life changing work of our scientists in the laboratories.
At Randox, our scientists work tirelessly to develop revolutionary diagnostic tests that are used in hospital and research laboratories across the globe.
We spoke to one of our biochemistry R&D Scientists to gain an insight into what working in a clinical chemistry laboratory entails. Emmett Donnelly, Clinical Chemistry R&D Scientist, is involved in the development of new reagents and the improvement of existing reagents. Emmett commented, “[My] role also involves the transfer and testing of existing chemistries onto new analyser platforms. Troubleshooting and resolving customer queries also forms part of a clinical analyst’s role”. Emmett’s work is vital to ensure that patient tests are performing correctly, and to develop ground-breaking new technologies leading to better patient outcomes. To find out more about the work Emmett does, watch this video below.
Our scientists are committed to research and development and thrive knowing that their novel research is putting them at the forefront of clinical diagnostics.
In fact, prior to beginning work at Randox, Scott Paulin, Clinical Chemistry R&D team, took part in a three month expedition to Antarctica to intensely study human response-based research in athletes. A number of papers have been published in peer reviewed journals as a result of Scott’s research, as the findings have provided a useful insight into the physiological stress and responses associated with an Antarctic ultra-endurance race and nutritional counterstrategies to help maintain immune responses, function body weight and reduce stress markers. Read the full article here.
At Randox, our scientists are of the highest calibre, with vast experience and expertise which ensures we are producing the highest quality range of clinical diagnostic tests.
Excitingly as a result, American astronauts have enlisted our help to test their antioxidant levels before they go to space! This is essential as it ensures astronauts can survive long periods of time away from earth. To find out more about how important our Total Antioxidant Status (TAS) test is for astronauts, read our blog post here.
The invaluable work our scientists undertake in the laboratory is vital to ensure healthcare is advanced globally. Thanks to those in our Research and Development team, we are proud to be able to offer the widest range of clinical chemistry reagents and unique tests for medical diagnosis. Due to our scientist’s dedication to research, a continual focus is placed on developing tests that assess the risk of diseases, rather than diagnosing the illness after it has occurred. As a result, Randox are helping to change healthcare, as patients are provided the ability to take preventative action early. In the words of our R&D scientist Emmett Donnelly, “for me, my work supports the old saying prevention is better than cure”.
We hope you have enjoyed reading about our fantastic team of R&D Scientists! If you would like to find out more about the work of Randox Reagents, please get in contact by emailing: firstname.lastname@example.org or click here to view our homepage.
With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. Over 16% of turnover is reinvested in R&D, and therefore, we have more new tests in development than any other diagnostic company.
Of our 1400-strong workforce, almost 400 are research scientists and engineers. Over the past year alone these highly-skilled specialists have developed a new test for Alzheimer’s disease, a bladder cancer test and a test with the ability to stratify Acute Myeloid Leukemia (AML) patients, to determine patient response before chemotherapeutic treatment.
We were also the first company in the world to bring to market a test to detect ‘Flakka’, a dangerous and highly addictive new psychoactive substance.
Most recently we announced the official opening of our new research and testing laboratory, Randox Clinical Laboratory Services (RCLS), at the Randox Science Park in Antrim, Northern Ireland.
Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations.
Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.
Our R&D projects are known across the world for their ingenuity and relevance to current health issues.
Both our Bladder Cancer project and our Acute Myeloid Leukemia projects were awarded Innovate UK Research Awards, which enabled economic studies to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative. These DECs will investigate the economic benefits of the new diagnostic tests for The National Health Service, and their role in the current patient care pathway.
Our revolutionary Alzheimer’s disease test was presented with a NACB / AACC Distinguished Abstract Award at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia.
We have also recently established a collaborative agreement with Dr. Carl Novina at the Dana-Farber Cancer Institute and Harvard Medical School. The goal of this collaboration is to develop therapeutic antibodies that will be incorporated into a platform technology that can reprogram patients’ immune systems to attack cancers.
Our research and development programme at Randox is continuously evolving to address the most pressing health issues. We are committed to improving health worldwide and as such will continue to focus our R&D efforts where they are most needed.
Please see below for some examples of our latest research and development news stories.
QC Material Stability
Stability has a number of different definitions, however, the most relevant to clinical diagnostics, and indeed quality control sera, is the “resistance to chemical change or physical disintegration”. Much like a chain, your quality control system is only as strong as its weakest link, or in this case analyte.
Whilst we appear to be stating the obvious here, this might not be as straightforward as it first appears. The product literature you peruse will help you decide what control best suits your needs, whilst many companies will state their control stability in the literature there are some instances where all may not be as it first appears. It is also important to note that some manufacturers may not make stability claims for some of the analytes listed in their control material. In such instances, you are required to validate these in-house, taking up precious time and resources.
Dig a Little Deeper
Whilst we understand that some analytes do have limitations due to their inherent nature, misleading analyte claims can cost the laboratory both time and money. In a recent survey conducted by Randox, 65.5% of respondents indicated that they felt stability was a ‘Very Important’ QC feature. As such it’s important that you look beyond the sales literature when it comes to control stability. Look out for exceptions in the small print of the control kit inserts. For example, if a control has a stability claim of 7 days at 2-8oC and a routine analyte like Cholesterol has a stability claim of just 2 days at 2-8oC then the true stability of the control is only 2 days. In such instances, there is a lot of potential for waste, as laboratories will be required to prepare a new vial of QC material every 2 days leading to increased costs and time. However, if you dig a little deeper into the controls and always read the small print, you could avoid such issues.
How can Randox Acusera benefit you?
For more than 30 years Randox has been shaping the future of clinical diagnostics with our pioneering high quality, cost effective laboratory solutions. Quality Control is our passion, we believe in producing high-quality material that can help streamline procedures, whilst saving money for laboratories of all sizes and budgets. We pride ourselves in not misleading our customers with false stability claims for our controls. With controls such as our Liquid Cardiac and Specific Proteins Controls, you could benefit from a 30-day open vial stability for all analytes, without exception.
By employing our Randox Acusera quality control materials you could benefit from;
Commutable controls, ensuring a matrix that reacts to the test system in the same manner as a patient sample, enabling an accurate and reliable assessment of instrument performance.
Accurate target values that won’t shift throughout the shelf life of the controls, eliminating the need to spend valuable time and money assigning values in-house.
Consolidation of test menu with controls comprising up to 100 analytes, reducing preparation time and storage space required.
Analytes present at clinically relevant levels ensuring accurate test system performance across the clinical range, maximising laboratory efficiency by eliminating the need to purchase additional high or low-level controls at extra expense.
True third party controls designed to provide an unbiased assessment of performance, our Acusera controls have not been manufactured in line with or optimised for use with any particular reagent, method or instrument.
For more information on any of our products, or to request a consultation from one of our QC Consultants, contact us via email@example.com.
The countdown to the Randox Health Grand National continues, with only two weeks to go before the first day of the Festival.
And there’s no one who knows the history of the race better than Aintree Racecourse Chairman, Rose Paterson. Today she shares her memories of her favourite horse, Foinavon, and why his unexpected Grand National win in 1967 has become an iconic moment in the history of the great race.
Foinavon is the Forrest Gump of Grand National history, the horse who became immortal despite his best endeavours.
Bred in the purple by the great stallion Vulgan, he was bought as a youngster by Anne, Duchess of Westminster, one of the pre-eminent National Hunt owners of her generation and sent to Tom Dreaper, the Willie Mullins of his day, along with another young horse, Arkle. Both horses were named after mountains on the Westminsters’ Invernesshire estate.
However, while Arkle went on to win three Cheltenham Gold Cups and become the benchmark for NH greatness, Foinavon’s trajectory was in a different direction. Pat Taaffe, Dreaper’s stable jockey, said of him “I never came across a horse with less ambition.”
The final straw was when after a heavy fall, Taaffe scrambled to his feet, desperately worried for Foinavon, who had failed to rise. He found him sitting comfortably on the ground, eating grass.
It was a short journey from this incident to Doncaster sales, where he was snapped up by small time trainer and part-time farrier John Kempton, entirely because he had qualified for the Grand National and one of his few owners, Cyril Watkins, was desperate for a runner. By this time, Foinavon had acquired a white goat named Suzie as a companion, who travelled everywhere with him and with whom he developed a love/hate relationship.
A year later, after 17 consecutive losing runs, Foinavon was ready to have a go. He had already run in the Gold Cup three weeks earlier, at 500-1 and no less than twice since then, without distinction. His jockey, John Buckingham, was the trainer’s third choice and neither owner or trainer could be bothered to make the five hour journey to Aintree.
When the disaster caused by loose horses Popham Down and April Rose unfolded at the smallest fence on the course, universally described as “the one after Becher’s,” Foinavon was so far behind the leaders that he was able to pop a gap in the fence and trundle on to the Canal Turn, leaving a scene of mayhem in his wake.
It was the combination of an intelligent, experienced jockey and an unusually placid horse that probably won him the race.
At the time, the result was seen as a disaster and an embarrassing fiasco. 50 years on, Foinavon’s win seems an iconic moment in the history of the great race.
It was about luck, fate, the victory of the outsider, the 100 – 1 dream come true.
Not for nothing was the first winner of the Grand National called Lottery and there is an equally good reason why the 7th and 23rd fence is now known as Foinavon.
For more information about Randox Horse Tales please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com
With less than three weeks’ to go before the Randox Health Grand National, we’re really starting to feel the excitement!
Those who’ve ridden over the famous fences at Aintree never forget it. The most successful female jockey of all time, Katie Walsh, shares her memories of Seabass in the 2012 Grand National, when she came third.
I remember every single bit of it. You don’t forget things like that.
It was a fantastic time and I had some brilliant months in the lead up to it. I won a couple of good races in the build up to the Grand National.
And for Seabass to be the horse that I rode that day, made it all the more magical. This is definitely at the top of my list.
He’d been trained by my father and we’ve been involved with horses for so long that we know how hard it is to have a horse for the Grand National – things can change every day. It’s like someone saying, “I’m going to be President.” That’s how slim the chances are for it to all work out, so I really appreciate how lucky we were to be there.
Seabass is a gorgeous horse and I absolutely love him.
The biggest difficulty we had was keeping him sound. Seabass was a lovely horse but he wasn’t the easiest to keep sound. You see that a lot in elite athletes – sometimes it’s just incredibly difficult to stay fit. And to be in with a shot of getting into the National, you have to keep a horse high enough in the handicaps so it’s constant work – you’ve got to be really careful what you do and how you treat them.
If you look back at his record, Seabass was off for a couple of seasons simply because he has legs of glass, he’s really fragile. There were many different problems over the years which had to be treated and we did a lot of swimming with him. A lot a lot of work went into minding his legs!
The actual race – I could tell you every moment. It was like a dream, the whole ride was fantastic and everything worked out super! Seabass travelled so well – it was a competitive year that year and on another he might have won.
But I was over the moon when we crossed the line in third.
It meant a lot to people that a female jockey had done so well. It featured heavily in the interviews I did afterwards and still does to be honest.
The whole family were there– Ruby wasn’t actually riding himself that day, he’d had a fall earlier. So they were all watching. We’re a pretty special unit – very close – and they were thrilled for us.
Once it was over though, I went straight into the usual routine. In fact I jumped in the car and went to Newmarket. Life goes on!
But once you’ve achieved something like that in the Grand National life does change. Off the back of it I became an Aintree ambassador which is a huge honour and something that I absolutely love.
I can’t wait for the Randox Health Grand National this year!
For more information about Randox Horse Tales please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com
The theme this year for British Science Week is change. At Randox, our R&D Scientists are helping to change healthcare. By investing heavily into research and development to develop unique diagnostics tests, Randox provide doctors with the ability to identify disease risk sooner- offering the opportunity to prevent illness, rather than the need to find a cure.
One unique test by Randox, adiponectin, is becoming an increasingly significant biomarker for health professionals. Low levels have been linked with several illnesses including metabolic syndrome, cancer and cardiovascular disease.
What is adiponectin?
Adiponectin is a protein hormone produced and secreted by fat cells called adipose tissue. Adiponectin is normally found in relatively high concentrations in healthy individuals. Its role in the body is to regulate the metabolism of lipids and glucose, which influences the body’s response to insulin and inflammation.
Adiponectin and abdominal visceral fat
Adiponectin levels are inversely correlated with abdominal visceral fat, meaning that lower levels of adiponectin are related to higher amounts of visceral fat in the body.¹ Visceral fat is stored around vital organs and higher levels of this type of fat can be associated with a range of conditions including insulin resistance, high blood pressure and high levels of cholesterol. These factors can subsequently increase a patient’s chance of developing metabolic syndrome, diabetes, cardiovascular disease and in some cases cancer. In fact, it has been found that patients with high abdominal visceral fat or low adiponectin levels have a three-fold increased risk of insulin resistance, with a combination of both doubling this probability.2
Adiponectin as a biomarker
Due to the protective properties of adiponectin, for example in increasing insulin sensitivity or preventing atherosclerosis, adiponectin has been classified as novel and important for a number of reasons.3 A range of studies have demonstrated why adiponectin levels should be considered as a routine test.
Adiponectin and Type 2 Diabetes
Increasing evidence suggests adiponectin is a valid biomarker related to type 2 diabetes. In fact, one study suggests that adiponectin is a powerful marker of diabetes risk in subjects at high risk.4 Decreased adiponectin has been found to be an independent risk factor for the progression of type 2 diabetes.5
Other evidence shows that adiponectin is also a beneficial measure of diabetes treatment response. A recent study has emerged which has found that dipeptidyl peptidase-4 inhibitors, which are used for the treatment of type 2 diabetes, increase adiponectin levels and have a stronger effect in comparison to traditional oral antidiabetic drugs.6
Adiponectin and Gestational Diabetes
Adiponectin levels are also of interest during pregnancy. If a woman has lower adiponectin concentration during the first trimester of pregnancy, they are 3.5 times more likely to develop gestational diabetes.7,8
Adiponectin and Cardiovascular Disease
A range of evidence exists linking serum adiponectin concentration and cardiovascular diseases. Studies have found low levels of adiponectin can have an adverse effect, for example one study suggests adiponectin levels are an independent predictor of CHD in Caucasian men with no previous history of CHD.9 Low adiponectin concentrations have also been associated with myocardial infarction (a heart attack) in individuals below the age of 60, and also been linked with increased risk of new-onset hypertension in men and postmenopausal women.10,11
Adiponectin and Benign Prostatic Hyperplasia (BPH)
Studies have also been conducted to examine the relationship between adiponectin and BPH. BPH is a common condition which is usually associated with men over 50 years of age and causes enlargement of the prostate. Higher adiponectin levels have been associated with reduced risk of BPH, as adiponectin has a protective effect in the progression of BPH.12,13,14
Adiponectin and Cancer
Lower levels of adiponectin have been found to increase the risk of endometrial cancer in women, and also prostate and pancreatic cancer in men.14,15 Researchers have been able to identify that serum adiponectin is inversely linked to the risk of obesity-associated cancers including endometrial cancer, renal cancer, postmenopausal breast cancer, colon cancer and leukaemia.16,17, 18
Why measure adiponectin?
As demonstrated above, the clinical significance of adiponectin is widely studied and has been linked to a range of diseases in which overweight or obese patients are proven to be at higher risk of developing. Measuring serum concentration of adiponectin to determine visceral fat levels is proven to be a more reliable indicator of at-risk patients in comparison to conventional methods of determining whether a patient is overweight or obese, such as body mass index (BMI) or measuring waist circumference.19
Our commitment to research and development ensures that unique tests, such as adiponectin, are available for use by health professionals. Scientists at Randox are continuing to change healthcare every day with their research to develop revolutionary diagnostic solutions. By placing a continual focus on assessing the risk of diseases rather than diagnosing the illness after it has occurred and providing patients with the tools to take preventative action, Randox are helping to change healthcare globally.
For more information, email: firstname.lastname@example.org
- Kishida, K., Kim, K. K., Funshashi, T., Matsuzawa, Y., Kang, H. C., Shimomura, I. Relationships between circulating adiponectin levels and fat distribution in obese subjects. Journal of Atherosclerosis and Thrombosis. 18(7):592-595 (2011)
- Medina-Urrutia, A., Posadas-Romero, C., Posadas-Sánchez, R., Jorge-Galarza, E., Villarreal-Molina, T., González-Salazar, M. C., Cardoso-Saldaña, G., Vargas-Alarcón, G., Torres-Tamayo, M. and Juárez-Rojas, J. G. Role of adiponectin and free fatty acids on the association between abdominal visceral fat and insulin resistance. Cardiovascular Diabetology, vol. 14, no. 20 (2015).
- Chandran, M., Phillips, S. A., Ciaraldi, T., Henry, R. R. Adiponectin: More than just another fat cell hormone? Diabetes Care. 26(8): 2442-2450 (2003)
- Daimon, M., Oizumi, T., Saitoh, T., Kameda, W., Hirata, A., Yamaguchi, H., Ohnuma, H., Igarashi, M., Tominaga, M., Kato, T. and Funagata Study. Decreased serum levels of adiponectin are a risk factor for the progression to type 2 diabetes in the Japanese population. Diabetes Care, vol. 26, no. 7, p. 2015-2020 (2003).
- Mather, K. J., Funahashi, T., Matsuzawa, Y., Edelstein, S., Bray, G. A., Kahn, S. E., Crandall, J., Marcovina, S., Goldstein, B., Goldberg, R. and Diabetes Prevention Program. Adiponectin, change in adiponectin, and progression to diabetes in the Diabetes Prevention Program. Diabetes, vol. 57, no. 4, p. 980-986 (2008).
- Liu, X., Men, P., Wang, Y., Zhai, S., Liu, G. Impact of dipeptidyl peptidase-4 inhibitors on serum adiponectin: a meta-analysis. Lipids in Health and Disease. 15:204 (2016)
- Lacroix, M., Battista, M.C., Doyon, M., Ménard, J., Ardilouze, J.L., Perron, P. and Hivert M. F. Lower adiponectin levels at first trimester of pregnancy are associated with increased insulin resistance and higher risk of developing gestational diabetes mellitus. Diabetes Care, vol. 36, no. 6, p. 1577-83 (2013).
- Hedderson, M. M., Darbinian, J., Havel, P. J., Quesenberry, C. P., Sridhar, S., Ehrlich, S. and Ferrara, A. Low prepregnancy adiponectin concentrations are associated with a marked increase in risk for development of gestational diabetes mellitus. Diabetes Care, vol. 36, no. 12, p. 3930-7 (2013).
- Tsimikas, S., Mallat, Z., MD, Talmud, P. J., Kastelein, J. J. P., Wareham, N. J., Sandhu, M. S., Miller, E. R., Benessiano, J., Tedgui, A., Witztum, J. L., Khaw, K. T. and Boekholdt, S. M. (2010). Oxidation-Specific Biomarkers, Lipoprotein(a), and Risk of Fatal and Nonfatal Coronary Events. JACC. 56:12, p. 946-955.
- Ai, M., Otokozawaw, S., Asztalos, B. F., White, C., Cupples, L. A., Nakajima, K., Lamon-Fava, S., Wilson, P. W., Matsuzawa, Y. and Schaefer, E. J. Adiponectin: an independent risk factor for coronary heart disease in men in the Framingham Offspring Study. Atherosclerosis. Vol. 217, p. 543-548 (2011)
- Persson, J., Lindberg, K., Gustafsson, T. P., Eriksson, P., Paulsson-Berne, G. and Lundman, P. Low plasma adiponectin concentration is associated with myocardial infarction in young individuals. Journal of Internal Medicine. Vol. 268, no. 2, p. 194-205 (2010).
- Fu, S., Xu, H., Gu,M., Liu, C., Wang, Q., Wan, X., Chen, Y., Chen, Q., Peng, Y., Cai, Z., Zhou, J. and Wang, Z. Adiponectin deficiency contributes to the development and progression of benign prostatic hyperplasia in obesity. Available from: 10.1038/srep43771
- Schenk, J. M., Kristal, A.R., Neuhouser, M.L., Tangen, C.M., White, E., Lin, D.W., Thompson, I.M. Serum adiponectin, C-peptide and Leptin and Risk of Symptomatic Benign Prostatic Hyperplasia: Results from the Prostate Cancer Prevention Trial. The Prostate, Vol 69 Issue 12 pp.1-15 (2009) Available from: 10.1002/pros.2097
- Izadi, V., Farabad, E., Azadbakht, L. Serum adiponectin level and different kinds of cancer: a review of recent evidence. ISRN Oncology Vol. 2012, (2012) Available from: 10.5402/2012/982769
- Messier V, Karelis AD, Prud’homme D, Primeau V, Brochu M, Rabasa-Lhoret R. Identifying metabolically healthy but obese individuals in sedentary postmenopausal women. Obesity, vol. 18, pp. 911-7 (2010).
- Dalamaga, M., Diakopoulos, K.N. and Mantzoros, C.S. The Role of Adiponectin in Cancer: A Review of Current Evidence. Endocrine Reviews. 2012 Aug; 33 (4): 547-594 (2012) Available from: 10.1210/er.2011-1015
- Kelesidis, I., Kelesidis, T. and Mantzoros, CS. Adiponectin and cancer: a systematic review. British Journal of Cancer (2006) 94, 1221-1225 Available from: 10.1038/sj.bjc.6603051
- Katira, A. and Tan, P.H. Evolving role of adiponectin in cancer-controversies and update. Cancer Biol Med 2016. Pp.101-119 (2016) Available from: 10.28092/j.issn.2095-3941.2015.0092
- Messier V, Karelis AD, Prud’homme D, Primeau V, Brochu M, Rabasa-Lhoret R. Identifying metabolically healthy but obese individuals in sedentary postmenopausal women. Obesity, vol. 18, pp. 911-7 (2010).
In celebration of British Science Week 2017, we will be giving you an introduction to diagnostics, and exploring how Randox Scientists are helping to change healthcare.
You may or may not already know that Randox are one of the leading diagnostics companies globally. But what exactly does clinical diagnostics involve? It is one of the fundamental steps of finding out what is wrong with a person when they are ill. Read on to find out a bit more about diagnostics, and how the Randox Reagents R&D Scientists are helping to change healthcare globally!
What is a diagnostic test?
A diagnostic test is any kind of analysis performed on a patient sample (a sample is typically blood, urine or cerebrospinal fluid (CSF)), to aid in the diagnosis or detection of disease. The information found from a test can be used to:
- Diagnose disease
- Assess the extent of damage
- Monitor the effectiveness of treatment
- Confirm a person to be free from disease
Examples of substances that may be tested for the blood include proteins, nutrients, waste products, antibodies, hormones, salts, trace elements or vitamins. These are sometimes referred to as ‘analytes’, ‘markers’ or ‘biomarkers’.
This is where reagents come in…
A reagent is a substance which is mixed with the patient sample to create a chemical reaction to detect the biomarker. These reactions are analysed by machines known as analysers.
Using data gathered from both clinical symptoms and laboratory tests, the doctor will follow a sometimes painstaking process of analysis and elimination to perform a successful diagnosis!
On 9 March 2017, Randox Reagents are celebrating World Kidney Day! World Kidney Day is a global campaign aimed at raising awareness of the importance of our kidneys to our overall health. It aims to reduce the frequency and impact of kidney disease and its associated health problems worldwide.
This year, the World Kidney Day promotes education on the harmful consequences of obesity and its association with kidney disease, advocating healthy lifestyle and health policy measures that make preventive behaviours an affordable option.
With this in mind, throughout the week we have been sharing on social media some interesting facts on diagnostic tests which can help aid an early risk assessment of kidney disease in obese patients, allowing preventative action to be taken before any serious damage occurs. The tests of focus this week included cystatin C, adiponectin and microalbumin…
The creatinine test is routinely run for patients who are suspected for deteriorating kidney function, however this test has limitations. Cystatin C is an alternative test, and is particularly useful in patients where creatinine measurements are not suitable e.g. individuals who are obese, malnourished, have liver cirrhosis or reduced muscle mass. Importantly, unlike creatinine, cystatin C does not have a ‘blind area’ – up to 50% of kidney function can be lost before significant creatinine elevation occurs. Cystatin C is extremely sensitive to very small changes in kidney function and is therefore capable of detecting early stage kidney dysfunction. The cystatin C test therefore allows preventative measures to be taken much earlier and before significant kidney function decline.
There is substantial evidence that excess visceral fat is the main driving force for almost all of the disorders associated with the metabolic syndrome, including CKD.1,2 The adiponectin test from Randox can accurately assess levels of abdominal visceral fat, independent of age, race or fitness level.3,4 Assessing adiponectin, and therefore visceral fat levels, can help assess risk of CKD, as well as a range of other illnesses such as pre-diabetes, CVD and various cancers.
The microalbumin test detects very low levels of a blood protein called albumin, in urine. The detection of albumin in urine can be an indicator of kidney injury and can result in irreversible damage if left untreated. Low albumin concentrations in the urine are the earliest marker of kidney damage and therefore enable preventative measures to be taken. Microalbumin testing can identify individuals with diabetic nephropathy approximately 5-10 years earlier than proteinuria tests helping reduce the frequency of end stage renal disease.
Both World Kidney Day and Randox are working towards improving healthcare worldwide. With continuous investment in R&D, Randox are helping with the risk assessment and earliest detection of renal function problems. By assessing one’s risk of kidney problems (with the adiponectin test), it can give patients (obese and other) the tools to prevent kidney problems further on down the line. With early diagnosis (through the cystatin C and microalbumin tests) it will be possible to keep kidney problems from getting worse, therefore lowering the number of those diagnosed with CKD worldwide.
Laboratory professionals are well aware that for every test run, there will always be an element of uncertainty regarding the result produced. For this reason, it is key to ensure that any change identified in a patient’s test result is due to a change in the sample concentration, not variation within the test system.
Measurement Uncertainty (MU) relates to the margin of doubt that exists for the result of any measurement, as well as how significant the doubt is. For example, a piece of string may measure 20 cm plus or minus 1 cm, at the 95% confidence level. As a result, this could be written: 20 cm ±1 cm, with a confidence of 95%. Therefore, we are 95% sure that the piece of string is between 19 cm and 21 cm long.
Standards such as ISO 15189 require that the laboratory must determine uncertainty for each test. However, they have not specified how this should be done.
How do we calculate Measurement Uncertainty using QC data?
Employing your QC data to calculate uncertainty makes several assumptions; your test system is under control, the patient samples are treated in the same manner as your controls and gross outliers have been removed. If you choose to use your QC data to calculate this you should ensure that you use a commutable control with a matrix similar to that of a patient sample, with analytes present at clinically relevant levels
To calculate MU, labs must look at the intra-assay precision and inter-assay precision of their test.
Intra-assay precision: Sometimes known as ‘within run’ precision, is where 20 or more replicates of the same sample are run at the same time, under the same conditions (calculated from a single experiment). Intra-assay precision helps to assess systematic uncertainties
Inter-assay precision: Sometimes known as ‘between run’ precision, is where 20 or more replicates are run at different times – e.g. 1 replicate every day for 20 days (can be calculated from routine IQC data). Inter-assay precision can help identify random uncertainties within the test system.
*The Australian Association of Clinical Biochemists (AACB) recommends that at least 6 months’ worth of QC data are used when calculating the inter-assay precision1.
Once the data is collected, you must calculate the standard error of the mean (SEM) of the intra-assay precision (A) and the SD of the inter-assay precision (B) in order to measure the uncertainty (u). Once A and B have been calculated, they need to be squared, added together and the square root of the sum found:
As uncertainty is calculated as SD and 1SD is equal to 68% confidence on a standard Gaussian curve, we can conclude that if we multiply using a coverage factor of 2, we can attain 2SD confidence of 95%. This is known as the Expanded Uncertainty (U):
What is the Advantage of Measurement Uncertainty for a lab?
Labs need to carry out MU as it is a requirement of ISO 15189. It states: “The laboratory shall determine measurement uncertainty for each measurement procedure, in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty”.
MU also helps determine whether the difference between two results is negligible due to uncertainty or significant due to a genuine change in condition of the patient; giving labs a greater confidence in reported results.
How can Randox help?
Our new Acusera 24.7 Live Online software provides automatic calculation of MU, saving valuable time and helping labs meet ISO 15189 requirements with ease.
Contact email@example.com to find out how your lab can benefit from Acusera 24.7 Live Online
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 18.104.22.168 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
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’.
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 performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.