Metabolism: how Randox is helping to diagnose metabolic conditions
Many people talk about their metabolism as if it is a muscle or organ they can somehow control. In reality, your metabolism refers to a series of chemical processes in each cell that turn the calories you eat into fuel to keep you alive.
Metabolism is the biochemical process of combining nutrients with oxygen to release the energy our bodies need to function. Your resting metabolic rate (RMR) is the number of calories your body burns to maintain vital body functions such as heart rate, brain function and breathing. RMR accounts for up to 75 percent of the calories you burn each day. Knowledge of your individual RMR is a critical piece of information to appropriately establish daily calorie needs.
The body’s major organs — the brain, liver, kidneys, and heart — account for about half of the energy burned at rest, while fat, the digestive system, and especially the body’s muscles account for the rest.
Did you know?
Approximately 20-25% of the world’s adult population have metabolic syndrome?
A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.
There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disordersinclude Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.
Type 2 diabetes is one of the most common types of metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.
Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.
Can you improve your metabolic health?
Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:
- 30 minutes of moderate to intense exercise 5-7 times a week
- Low-dose aspirin to reduce your risk of stroke or heart attack
- Quit smoking
- Medication for blood pressure/cholesterol/ blood sugar
- Limit alcohol intake
- Eat a healthy balanced diet
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.
Metabolic Health Profile
|Alkaline Phosphatase||C02 Total||Sodium|
|AST (GOT)||Glucose||Total Protein|
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
This British Science Week 2018, Randox Quality Control are celebrating the hard work our team puts in every day, to help bring the best Quality Control products to the market.
We caught up with Edward Hill, QC Product Specialist, to explain a bit about what his role involves and how Randox QC are impacting on global healthcare!
What is your position and what does it involve?
I am a QC Product Specialist at Randox Laboratories. This is a hugely varied role, and some of my general duties involve; creating educational material for laboratory professionals, conducting competitor comparisons to ensure we are always one step ahead of the competition, staying up-to-date with the latest industry trends and thinking of new and innovative ways to interact with our customer-base.
For those of us who aren’t in the industry, can you give us a brief snapshot of what Quality Control is and why we use it?
When a patient has their blood/urine/serum etc. taken, it must be sent to the laboratory for analysis. Laboratory professionals run the patient sample on a clinical instrument, which gives a quantitative result for each analyte. However, the laboratory professional does not know whether the value given by the instrument is correct or not. For this reason, the laboratory professional must use a Quality Control – which is a material designed to mimic the patient sample, and has a known concentration of each analyte.
When the laboratory professional runs the QC material on their instrument, they can compare the obtained result with the expected result. If these values are comparable, then the laboratory professional can be confident that their instrument is reporting accurately. Essentially, QC is a ‘practice run’ to ensure the testing system is working correctly.
How does your teams’ work impact on global healthcare?
Quality Control is a hugely important part of laboratory quality. Around 70% of clinical decisions are made based on laboratory results, so it is plain to see how significant Quality Control practices can be in relation to global health care. My work, as well as the work of the wider Quality Control team, is focused on making end-users aware of the importance of Quality Control. We aim to provide advice and recommendations to optimise accuracy and efficiency.
As a company, Randox prioritizes quality above all else, and this ethos is perfectly reflected by the Quality Control team. We work tirelessly to provide quality products and simplify the entire testing process – giving the laboratory professionals more time to do what they do best; provide accurate results time and time again.
What is your favourite Randox QC product and why?
My favourite QC product is the Acusera Liquid Cardiac Control. It’s my favourite control because it perfectly displays all the advantages of Acusera in a single product:
- Highly consolidated analyte list without any unnecessary extras, keeping costs low
- True third party
- Manufactured with 100% human serum, giving full commutability
- Liquid ready-to-use and suitable for POC testing
- Clinically relevant ranges, with ultra-low levels of Troponin I
- Long open vial stability of 30 days
Competitors often offer additional low level Troponin I controls. The thing I like most about the Acusera Liquid Cardiac Control is that the Troponin I levels are still lower than the ‘ultra-low level’ competitor controls – showing that Acusera gets it right the first time, rather than supplementing weak QC products with additional products at an extra cost.
Get your teeth into a Randox commutable control this Halloween
It is that time of year again – when people dress up, children trick-or-treat and many a scary story is told in households around the world. An age-old tradition celebrated globally by millions of people – it can only be Halloween.
Last year Randox QC brought you the truly scary story about a laboratory who chose not to use a third party control, but eventually “treated their laboratory to a true third party control”. This year, we have another scary story for you about a lab manager in Transylvania, Dr. Acula.
It was a normal, busy day in the lab for Dr. Acula. That was until it was time to change reagent batch, after changing batch of reagent Dr. Acula was shocked to find his QC results had shifted by over 20%. This left Dr. Acula very frustrated, having to spend precious time troubleshooting and reassigning QC targets. After troubleshooting showed no apparent root cause, Dr. Acula searched the internet for an answer finally stumbling upon an educational guide from Randox Quality Control on commutability and its many benefits to the lab.
Grinning from ear-to-ear with excitement, Dr. Acula began to read the guide in the hope of finding a solution to his problem – and solutions he found. While reading the guide, Dr. Acula came across a quote from ISO 15189:2012. It read that laboratories “must use quality control materials that react to the examining system in a manner as close as possible to the patient sample”.
Dr. Acula made a decision to look for a commutable control material that met all of his requirements and he didn’t have to search very far. Randox Quality Control were able to supply Dr. Acula and his laboratory with a QC material to meet all his needs – true third party, excellent stability, consistency and consolidation but most importantly of all commutable controls. The fact all Randox immunoassay and immunology controls are manufactured from 100% human material appealed to Dr. Acula a lot. After trialing the Randox control material alongside patient samples and comparing results between reagent batches, Dr. Acula was thrilled with the results.
Labs rely heavily on quality control to detect errors in their test system and to ultimately make critical decisions regarding the accuracy and reliability of patient test results, the use of a control that reacts to the test system in the same manner as a patient sample is therefore essential.
At Randox Quality Control we take quality seriously. All our QC products are manufactured to the highest possible standard ensuring controls of unrivalled quality time and time again. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories meet ISO 15189:2012 requirements.
Just ask Dr. Acula, who likes our 100% human controls so much he has started to drink them himself!
At Randox Quality Control, we strive to meet and exceed customer expectations ensuring high quality products and superior customer service are at the top of our priority list.
How can Randox Quality Control help you?
High Quality QC
The Acusera range of true third party controls boasts an impressive range of benefits ultimately designed to help laboratories reduce costs and time while also ensuring an accurate and reliable test system.
The extended shelf life of our controls allows the same lot of control to be used for a period of up to 2 years keeping costly new lot validation studies to a minimum. We may also be able to sequester lots on your behalf.
The availability of commutable controls designed to react to the test system in the same manner as a patient sample and controls targeted at clinical decision levels will not only help you to meet ISO 15189:2012 requirements but will effectively challenge instrument performance.
Click here to find out more about our QC range.
The Randox global support network are on hand with expert advice to ensure timely, accurate and helpful resolution of any issues or queries you may have. The added benefit of quick delivery of product orders further highlights how we work with and for our customers to provide the best service available.
Don’t believe us? Read a few of the reviews we have received from laboratories around the world;
“I would like to thank the Randox team for the excellent service when helping to reserve and manage our IQC orders, lot numbers and stock.” – Chief Biomedical Scientist, London, 2017.
Request your free QC consultation by contacting us today! Get in touch and we can arrange for your laboratory to have a consultation with one of our Randox QC specialists. Alternatively, if you would like to leave us a review you can do so by emailing firstname.lastname@example.org.
Busy laboratories are not uncommon, in fact, many laboratories are expanding and their workload is increasing as a result. In labs like this, time is limited therefore ease of use and accessibility are valuable traits when it comes to the technology used to monitor daily QC activities.
With this in mind, Randox Quality Control are pleased to announce the launch of a new centralised platform for the management of both daily QC activities and calibration verification.
Convenience is key and that is what we have aimed for with the launch of this new platform. With laboratory professionals at the front of our minds, the platform delivers access to QC data at the click of a button ensuring the review process is as simple as possible.
What is available on the new QC platform?
With the new QC platform users have access to both;
- Acusera 24.7 Live Online for interlaboratory data management
- and, Acusera Verify for calibration verification
By encompassing these two programs onto one easy to use platform, laboratories can save precious time allowing them to focus on other important tasks with the reassurance that their data is easily accessible.
Keep your instrument in check with Acusera Verify
Designed with convenience in mind the Acusera Verify range of linearity sets will help you to easily meet CLIA requirements for calibration verification. The availability of instrument dedicated, liquid ready-to-use materials covering a wide range of cardiac markers, specific proteins and therapeutic drugs enables specific instrument requirements to be met, while challenging the complete reportable range. Complimentary data reduction software is provided with all linearity sets delivering access to:
- Easy-to-interpret charts for at-a-glance performance assessment
- Unique traffic light system indicating pass or fail
- Automatically generated statistics
- Peer group data updated live in real-time
Stress free QC analysis with Acusera 24.7
Acusera 24.7 Live Online is an interlaboratory data management package complementing our Acusera range of true third party controls. With the recent launch of version 2.0, the software is smarter, faster and more powerful than ever before.
Designed to help laboratories efficiently review QC data from all of their laboratory instruments, the software generates a wide range of charts and reports enabling quick & easy identification of QC failures and emerging trends. Unique access to peer group data updated instantly in real-time facilitates comparative performance assessment and helps speed up the troubleshooting process, easily identifying if a problem is unique to your lab or a widespread issue.
From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.
Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care. They perform and interpret billions of laboratory tests every year.
Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory QC for the in vitro diagnostics market, we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.
Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.
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.
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.
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.
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
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.
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 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.
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.
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.
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 firstname.lastname@example.org 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 126.96.36.199 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.