The RX series celebrate Medical Laboratory Professional Week
The RX series celebrate Medical Laboratory Professional Week
Medical Laboratory Professionals Week is taking place this year from 24th-30th April 2017. This is an annual celebration of professionals working in the laboratory, highlighting and recognising their contributions to medicine and healthcare.
To celebrate Medical Laboratory Professionals Week the RX series interviewed Emmett Donnelly, one of our R&D Scientists at Randox to find out more about what his job in the lab entails day-to-day. Emmett works with the RX series of clinical chemistry analysers and Randox reagents on a daily basis to develop or improve new tests for the market.
We asked Emmett a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis …
What attracted you to a career in laboratory science?
I have always been interested in science and around the time of GCSEs I had a fantastic science teacher that made the subject interesting and easy, so from there I wanted to follow some kind of Science related career. When I learned about the role of Biology and Chemistry in pharmaceuticals and diagnostics I wanted to become more involved in that area.
What were you good at in school?
I was always interested in science so did well in these subjects. I also did well in maths and loved technology class. I took sciences to A’ level and liked languages so took French at A level too. I was never really that interested in history or arts so these were never my strong points come exam times.
What do you do in your job for Randox?
I am primarily involved in the Development and improvement of new reagents making sure that they work to a high standard on our automated analysers. I am also involved in troubleshooting product and customer queries, transfer work onto new analysers and some formulation of products.
Can you tell us an example of your daily routine as an R&D scientist?
I’m usually involved in a project so I work through all the data that needs to be generated for that. However product and customer queries may come through the lab and this would take priority. Other studies such as stress studies and stability may need done at the same time every week and is therefore scheduled. I am dealing with emails, calls throughout the day and more recently mentoring of graduate and placement students.
What is your favourite test to perform & why?
I like several tests. I like simple tests such as ALP, AST and Creatinine designed to monitor the health of our vital organs. I also like tests such as IGs designed to test for infection and Therapeutic Drug tests like Valproic acid and Theophylline used to monitor patient response to therapies.
What aspects of your job do you enjoy the most?
I generally like being involved in an area that improves people’s wellbeing. It’s nice to develop a new product and get it performing to a point that can be used in the market especially if it is something that has never been produced before.
What are some common preconceived ideas the public have about what laboratory staff do?
I think the public have little knowledge of what happens in a lab. They have an interest but tend not to question in detail what staff do because they perhaps think that the work is too complex for them to understand. I also think that the public isn’t aware that practically everything they use in daily life has been developed in a laboratory environment and fail to see the link between primary testing and the final product.
In your opinion, what are the most important aspects of laboratory work?
It is important that all work is carried out in accordance to Standard Operating Procedures to keep in line with Regulatory criteria. It is also important that the analyst knows their exact aims and have the right technical knowledge to achieve these aims. It is especially important to keep with deadlines as well if the Laboratory work is business based.
What are common errors of pipetting?
FinnPipettes require routine maintenance so it’s important that they are calibrated and maintained properly. When using them it’s important that liquid is removed and dispensed slowly to avoid air bubbles. Too fast and air will be introduced into the plastic tip resulting in inaccurate volumes. It’s also important that with viscous liquids not to forget to remove excess liquid from the tip. Users also sometimes place pipettes on the bench horizontally with the tip on resulting in material finding its way into the pipette. Slow adjustment of the volume control will prolong the life of the pipette. With normal pipetting it’s important to always read the liquid meniscus at the required reading.
What’s in your lab coat pocket?
I have a calculator, a couple of pens and a marker though I have a habit of losing mine so they probably belong to my work mates.
In what ways does your work make a difference to people’s lives?
For me my work supports the old saying Prevention is better than cure. The use of Diagnostic reagents help detect the development of disease at an early stage and therefore enable something to be done about it early. In addition, the reagents can be used to monitor treatment during illness as the results will tell if treatment is working.
Emmett is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through research and development of new tests. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible.
To find out more about Randox products contact us at theRXseries@randox.com.
Check out our social media sites for more on Medical Laboratory Professionals Week.
Our commitment to Research and Development at Randox
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 – Dig a Little Deeper
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 acusera@randox.com.
Randox celebrates British Science Week 2017
Randox celebrates British Science Week 2017
Last week was British Science Week 2017, an annual campaign that aims to inspire innovation and celebrate science. To mark the occasion, Randox Laboratories got involved by celebrating the innovation of each Randox product group. The product groups within Randox shared a series of posts, videos and blogs showcasing the #ScienceBehindRandox throughout British Science Week.
Randox
To initiate the Randox British Science Week campaign, Randox shared this video, which highlights the company’s dedication to improving health worldwide. The video provides an introduction about each product group, however throughout British Science Week, each product group has gone into further detail about the #ScienceBehindRandox.
Randox Careers, the RX series, Randox Reagents, Randox Quality Control, Randox Toxicology, Randox Biosciences, Randox Testing Services, & Randox Food Diagnostics all got involved in the British Science Week Campaign. You can read a snippet of each product groups post below, with videos and links to the full content also provided. We hope you enjoy learning about the #ScienceBehindRandox.
Randox – Dedicated to improving health wordwide.
Randox Careers
Joanne Darragh spent some time with Randox Careers to discuss her role as R&D Toxicology Manager.
“Working in this area has been both challenging and exciting as we are at the cutting edge of assay development. We work in a great team and we work along very closely alongside other departments such as Marketing & Sales so that we are in close contact with what the customer needs, which means we are producing relevant tests very quickly and effectively. Every day brings a new challenge.”
– Joanne Darragh, R&D Toxicology Manager
Listen to what Joanne had to say on the video above
Randox RX series
As part of British Science Week, the RX series caught up with Daniel Melly, one of our very talented Mechanical Design Engineers based in Randox Teoranta in Dungloe, Ireland.
Daniel was an integral part of the team involved in the design of our new semi-automated analyser, the RX misano. The RX series asked Daniel a few questions about why Randox created this analyser, the design process involved in creating such a unique system, and what his favourite features are.
“Randox set out in creating the RX misano with the philosophy of supplying the customer with a more modern, reliable, and aesthetically pleasing analyser than those that are currently available on the market. Robust part selection was always at the fore of any design decisions, and we feel that we have delivered on all of these requirements.”
– Daniel Melly, Randox Mechanical Design Engineer
Read the full interview the RX series had with Daniel here
The RX misano is currently unavailable to purchase in Germany
Randox Reagents
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.
At Randox, our R&D Scientists are helping to change healthcare. By investing heavily into research and development to develop unique diagnostics tests, such as the adiponectin test, 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.
Read the full Randox Reagents blog entry here
Randox Quality Control
One Simple Change to Randox Quality Control can save your laboratory time and money.
Randox Quality Control are a world leading manufacturer of true third party controls with over 390 analytes covering Antioxidants, Blood Gas, Cardiac Markers, Routine Chemistry, Coagulation, Haematology, Diabetes, Immunoassay, Immunology, Lipids, POCT, Therapeutic Drugs, Toxicology and Urine Chemistry, providing complete test menu consolidation. Randox Quality Control produces the most consistent material available with the most accurate target values.
Randox Quality Control guarantee to simplify QC practice in any laboratory, just ask one of their 60,000 users worldwide.
Find out more information about Randox Quality Control in the video above
Randox Toxicology
Randox Toxicology provides trusted solutions for the screening for drugs of abuse. With significant reinvestment in Research and Development, we persistently stay ahead of this ever challenging market. Being the first to develop New Psychoactive Substances tests such as fentanyl, bath salts and flakka allows us to maintain our position as a global leader.
Our pioneering technology has created a number of advancements in the field of toxicology. In particular, our patented Biochip Array Technology which can simultaneously screen from a multi-analyte testing platform, achieving a complete immunoassay profile from the initial screening phase.
Read the full Randox Toxicology blog post here
Randox Biosciences
During British Science Week, we are delighted to introduce you to our latest development utilising this technology; our Gastropanel Array,* a multiplex test engineered to diagnose those at risk of developing peptic ulcers and gastric cancer using non-invasive methods.
Our Gastropanel Array encompasses two quantitative assays, a H. pylori assay for the detection of antibodies produced in response to a H. pylori infection, a common cause of gastric cancer1 as well as a 3plex Gastropanel assay, for the detection of pepsinogen I (PGI), pepsinogen II (PGII) and gastrin 17 (G17).
Currently recorded as the world’s 5th most common cancer, the majority of gastric cancer cases are diagnosed after presenting as an emergency, when treatment may be less effective due to the cancer being at an advanced stage, highlighting the need for the availability of diagnostics tests like our Gastropanel Array to enable practitioners to administer prompt treatment and ultimately increase survival rates on a global scale.
Read the full Randox Biosciences blog here
Randox Testing Services
Randox Testing Services have shown how they are at the forefront of continually reacting and developing tests for NPS. NPS (formerley known as Legal Highs) have had devastating effects on users since emerging in the UK in 2008. These substances are highly dangerous and have caused unnecessary deaths. This is due to the effects from different elements used in production. Legislation concerning the substances changed in 2016 with the implementation of the Psychoactive Substance Act.
How have Randox Testing Services implemented change? Find out in the video above
Randox Food Diagnostics
Of the 41 antibiotics that are approved for use in food-producing animals by the FDA, 31 are medically important for human health. Randox Food Diagnostics provides advanced screening solutions for 94% of these antibiotics including beta-lactams, quinolones and tetracyclines, allowing you to ensure the integrity of your end product without compromising quality. Randox Food provides multiplex screening solutions validated across a range of matrices including urine, serum, tissue, milk, honey and feed.
The Evidence Investigator matched with Biochip Array Technology (BAT) provide the end user with fast, reliable results to aid in ensuring your produce is antibiotic free. BAT provides a platform for the simultaneous determination of multiple drug residues from a single sample using miniaturised immunoassays with implications in the reduction of sample/reagent consumption and an increase in the output of test results.
To read Randox Food Diagnostics full blog click here
We hope you enjoyed our informative British Science Week content from each of our Product Groups.
Look out for our Quiz later this week to test your knowledge on the #ScienceBehindRandox
Randox Horse Tales | Katie Walsh on the partnership with Seabass that made her the most successful female jockey of all time
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
How Randox R&D Scientists are helping to change healthcare: An introduction to diagnostics for BSW 2017
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
Blood flows through all parts of the body, coming into direct contact with every organ and tissue. Therefore a blood sample’s appearance and composition provide important information on what is happening in the various parts of the body!
Examples of substances that may be tested for the blood include proteins, nutrients, waste products, antibodies, hormones, salts, trace elements or vitamins.Ā These are sometimes referred to as āanalytesā, āmarkersā or ābiomarkersā.
This is where reagents come inā¦
A reagent is a substance which is mixed with the patient sample to create a chemical reaction to detect the biomarker.Ā These reactions are analysed by machines known as analysers.
Finallyā¦
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!
Randox Reagents celebrate World Kidney Day 2017
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…
Cystatin C
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.
Adiponectin
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.
Microalbumin
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.
For health professionals
If you are a clinician or lab interested in running renal function assays, Randox offers a large range of high quality routine and niche assays including: Cystatin C, Creatinine Enzymatic and Jaffe, Microalbumin, Urinary Protein, Urea, Sodium, Potassium, Albumin, Ammonia, β2- Microglobulin, Calcium, Chloride, Glucose, HbA1c, IgG, LDH, Magnesium, Phosphorus (Inorganic), and Uric Acid. These can be run on most automated biochemistry analysers.
For more information, download our Diabetes Brochure or email reagents@randox.com.
References
- Hall JE, Henegar JR, Dwyer TM, et al. Is obesity a major cause of chronic renal disease?Adv Ren Replace Ther. 2004;11(1):41–54. [PubMed]
- Tchernof A, Després JP. Pathophysiology of human visceral obesity: an update.Physiol Rev. 2013;93(1):359–404. [PubMed]
- Matsuzawa, Y. The role of fat topology in the risk of disease. Int J Obes. 2008;32:s83-s92.
- Frederiksen, L., Nielsen, T. L., Wraae, K., Hagen, C., Frystyk, J., Flyvbjerg, A., Brixen, K. and Andersen, M. Subcutaneous Rather than Visceral Adipose Tissue Is Associated with Adiponectin Levels and Insulin Resistance in Young Men. JCEM, (2009) 94 (10): 4010-4015.
Further reading:
What is Measurement of Uncertainty?
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 marketing@randox.com to find out how your lab can benefit from Acusera 24.7 Live Online
Take steps to prevent incorrect patient results by making one simple change
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 5.6.2.2 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.
Extensive study confirms the benefit of testing apolipoproteins E, C-II and C-III to assess cardiac risk
A study published on 21st February 2017 in the Journal of the American College of Cardiology has found that measuring apolipoproteins E, C-II and C-III can offer earlier detection of cardiovascular risk in comparison to routine apolipoprotein A-I and B tests.1
The lead author of the study, Professor Manuel Mayr, from King’s College London has said, “We directly compared the association of a broad panel of apolipoproteins to new onset of cardiovascular disease over a 10-year observation period, and found that while apoB was predictive, other apolipoproteins, namely apoE, apo C-II and apo C-III, were even better”. Professor Mayr further implied that the findings provide support that expanding current cardiac screening tests to include apolipoproteins could reduce risk of cardiovascular diseases.2
What are apolipoproteins?
Apolipoproteins are proteins that bind to lipids to form lipoproteins. Lipoproteins are made of proteins and fats, and serve the function of transporting insoluble fats, such as cholesterol and triglycerides, to be used by different cells. 3
There are six major types of apolipoprotein: A, B, C, D, E and H and the lipoproteins within these categories can vary in size, density and lipid composition. The study found that apolipoproteins E, C-II and C-III are linked to very low-density lipoproteins (vLDL) and have a stronger association with cardiovascular diseases in comparison to apolipoprotein A-I and apolipoprotein B.4
vLDL is strongly associated with the development of atherosclerosis, the build-up of fatty material inside the arteries, which is a major risk factor of cardiovascular diseases as it can lead to angina, heart attack, stroke or peripheral arterial disease.5
Why measure apo C-II, apo C-III and apo-E?
As highlighted by the authors of the study, cardiovascular risk assessment is commonly associated with only a few lipids within established lipoprotein classes, such as LDL.1 This emphasises the importance of carrying out detailed lipid testing to identify all subgroups to provide a complete cardiovascular risk assessment, as traditional biomarkers for lipids may only provide a limited overview. This can then allow for effective treatment to be provided at an earlier stage, which could subsequently reduce the risk of death by cardiovascular diseases.
Randox offer a range of routine and novel cardiac assays to provide a complete cardiac risk assessment, including: Apolipoprotein C-II / C-III / E / A-I / A-II / B, Adiponectin, HDL Cholesterol, HDL3 Cholesterol, LDL Cholesterol, sLDL Cholesterol, Total Cholesterol, TxBCardio™, H-FABP, Homocysteine, hsCRP, Lipoprotein (a), sPLA2-IIA, and Triglycerides. For more information, email: reagents@randox.com.
References
1. Mayr, M. et al., Very-low-density lipoprotein-associated apolipoproteins predict cardiovascular events and are lowered by inhibition of APOC-III., Journal of the American College of Cardiology. Vol. 69, No. 7, 2017.
2. NIHR Biomedical Research Centre at Guy’s and St Thomas’ and King’s College London, Discovery could help doctors to spot cardiovascular disease at an earlier stage: Advanced technologies provide researchers with new insights into the warning signs for cardiovascular disease, ScienceDaily (2017) Available from: https://goo.gl/XkC23R [Accessed: 21 February 2017]
3. Kingsbury, K. J., Understanding the Essentials of Blood Lipid Metabolism, Medscape, (2017) Available from: https://goo.gl/AApW6S [Accessed: 23 February 2017]
4. Wallace, A., New technique could aid in earlier diagnosis of heart disease, UPI, (2017) Available from: https://goo.gl/xzxLdf [Accessed: 23 February 2017]
5. British Heart Foundation, Atherosclerosis, (2017) Available from: https://goo.gl/1qHxpk [Accessed: 23 February 2017}
