Randox Food Diagnostics offers innovative multiplex technology for mycotoxin screening within varieties of farmed crops
Mycotoxins are poisonous chemical compounds produced by certain fungi. There are many such compounds, but only a few of them are regularly found in food, farmed crops and end product animal feeds. Since they are produced by fungi, mycotoxins are associated with diseased or mouldy crops. Those that do occur in food may have an impact on livestock and the health of humans and have been associated with conditions such as asthma, respiratory infections and chronic fatigue. The main causes of mycotoxins within stored grains are when the grain is damp, damaged or cracked and kept in insufficient storage conditions.
The formation of mycotoxins is climate-dependent, with temperature and moisture levels directly impacting fungal growth. Evidence shows that climate change is causing increasing temperatures and altered rainfall patterns. Additionally, extreme weather incidents have increased. As a consequence of these changes, increased levels of mycotoxins have been observed in some European crops.
Mycotoxins occur, and exert their toxic effects, in extremely small quantities in foodstuffs. Their identification and quantitative assessment therefore generally require sophisticated sampling, sample preparation, extraction, and analytical techniques. Under practical storage conditions, the aim should be to monitor for the occurrence of fungi. If fungi cannot be detected then there is unlikely to be any mycotoxin contamination. The presence of fungi indicates the potential for mycotoxin production, and the need to consider the fate of the batch of commodity affected.
In order to help the industry Randox Food Diagnostics developed the Evidence Investigator analyser. The Investigator uses Biochip Array Technology (BAT), a technology that was developed by Randox, to detect multiple residues (up to 45) from a single sample. Within farmed crops Randox Food Diagnostics provide testing for different matrices such as: Maize silage, maize, Barley, grass seed, rice, wheat, oats, soya, DDGS, rapeseed as well as livestock and pet foods including premixed feed.
Randox Food Diagnostics offer a mycotoxin screening array on Biochip called Myco 10 which can detect 10 mycotoxins per sample including aflatoxins G1/G2 & B1/B2, ergot alkaloids, fumonisins, paxilline, ochratoxin A, diacetoxyscirpenol, deoxynivalenol (DON), T2 toxin & zeralenone. Also offered is a range of ELISA test kits including ergot alkaloids.
Randox Food Diagnostics is a regular participant in the FAPAS proficiency testing scheme which provides an independent check of a laboratory’s procedures to ensure the delivery of quality results. To read our study on: Biochip Array Technology for the reliable performance of multi-mycotoxin determination in animal feed materials” click here: http://www.randoxfooddiagnostics.com/docs/default-source/randox-fd/posters/bat-mycotoxins-in-animal-feed-materials.pdf?sfvrsn=4
Supported by Global Sponsor Randox Laboratories, internationally renowned pianist and Gold Medal winner at the Tchaikovsky International Piano Competition Barry Douglas returned to India last night with Camerata Ireland. Barry founded Camerata Ireland in 1999 with a vision to create a chamber orchestra of excellence to match the best in the world. Since its formation the group has travelled the world to wide critical acclaim.
Over Tuesday 24th and Wednesday 25th April 2018, Camerata Ireland and Barry Douglas performed all five of Beethoven’s piano concertos with Douglas as pianist and conductor to wide critical acclaim. Taking place in the National Centre for the Performing Arts in Mumbai, the concerts marked Randox Laboratories’ commitment to the Indian market and supported the continued development of their manufacturing and R&D facilities in Bangalore.
Managing Director of Randox Laboratories, Dr Peter FitzGerald, commented;
Randox, now celebrating over 36 years of innovation in healthcare diagnostics, is proud of its association with Barry Douglas & Camerata Ireland. As global sponsors we salute this all-Ireland organisation which has a tremendous international reputation, provides world class performances, commits to the development and improvement of the next generation and brings true energy and innovation to their field.
We at Randox truly value this partnership with Barry Douglas & Camerata Ireland as, in our field of endeavour, we strive to improve healthcare and extend life across the globe. Our energies and skills are focused upon the development and provision of world-leading Research and Development in heath diagnostics. We are passionate about what we do and are committed to better healthcare for all which not only improves global healthcare but will significantly extend lives. We believe that innovative diagnostics, with increasingly preventative capabilities, hold the key to improved healthcare for the future.
Randox has four key international sites – in Antrim, Northern Ireland; Dungloe, Ireland; West Virginia in the US and Bangalore, India. Based among other high-tech industries in the capital of the Indian state of Karnataka, Randox’s base in India is a hub for not only world-leading diagnostic research, but also a base for the many Randox sales, logistics, administration and finance teams who service the Indian market.
Barry Douglas, founder of Camerata Ireland, also commented on the historic trip;
“I’m thrilled to be back in India and to be able to bring Camerata Ireland with me. Music connects us all universally and transcends gender, nationality, race and orientation. We are excited to bring our own special taste of Ireland to India and be able to share in this experience with Randox Laboratories, who continue to help the growth and development of our orchestra. We couldn’t have achieved our internationally-acclaimed reputation without them.”
Paul Turnbull, Global Business Manager at Randox, said of the company’s continued investment in the Indian market;
“Randox have been providing the highest quality In-Vitro Diagnostic products into the Indian market for over 20 years. As a business we are very excited about the next 12 months in particular as our business continues to expand and we invest in growing the team at our India base. We continue to build on our world-leading International EQA scheme RIQAS, our niche and high performance reagents, and over the coming months we will be adding revolutionary molecular diagnostic products to our portfolio. Randox continues to lead global diagnostic innovation in one of the world’s fastest growing and most quality-conscious markets.”
For more information on Barry Douglas and Camerata Ireland please contact the Randox PR team at RandoxPR@randox.com
With Lab Week occurring this week, RCLS wants to take the opportunity to draw recognition to their dedicated and experienced team of scientists who enable you to meet the time sensitive, bespoke requirements of your research and clinical projects globally. Lab Week occurs annually to celebrate medical laboratory professionals and pathologists who play a vital role in health care and patient advocacy.
Specialising in biomarker and multiplex testing in addition to standard safety and clinical testing, RCLS provides a full laboratory service to accelerate your project to completion. Our experienced project management teams are available to provide support and guidance from initial biomarker selection through to the design of a comprehensive results data package to deliver against your project aims and timelines.
Flexibility and quality are at the core of our service offering. Our in-house biotechnology group enables custom development and scale up monoclonal and polyclonal antibodies, antibody fragments (Fab’s, ScFv’s, sdAb’s) and recombinant proteins to meet your laboratory needs.
Currently, there are four state of the art, fully functional ISO12025 accredited laboratories, located in Liverpool, London, Holywood and the Randox Science Park in Antrim. In addition, two laboratories are underway in Los Angles and Dubai. These additions will give RCLS the ability to increase output to both the pharmaceutical, health and research market.
Renowned for quality and reliability, the RX Series and Evidence series are utilised by all RCLS Laboratories, guaranteeing real cost savings, highly accurate and flexible testing solutions. Furthermore, RCLS perform sample testing on numerous third party analysers situated in our laboratories dependent upon the testing which is required by the customer.
Overall, the RCLS team aim to save your laboratory time and money. By utilising our multiplex panels, RCLS can offer labour saving, time reducing and cost effective solutions for all your laboratory testing. Providing your laboratory with the best solution to outsource your testing.
Medical Laboratory Professionals Week is taking place this year from 22nd– 28th April 2018. 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 Aidan Murphy, one of our laboratory analysts at Randox to find out more about what his job in the lab entails day-to-day. Aidan works with the RX series of clinical chemistry analysers and Randox QC on a daily basis.
We asked Aidan a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis …
1. What attracted you to a career in laboratory science?
Science has always interested me in both my academic and personal life, I always aspired to get a science based degree and after achieving this I now hope to improve my laboratory skills to increase my employability.
2. What were your stronger subjects at school?
My strongest subjects in school were biology, chemistry, music and politics. Some of which are more applicable to my current role than others.
3. What does your job in Randox entail?
My job entails a variety of roles ranging from testing Randox diagnostic kits before they’re released to customers as well as maintenance and precision checks of the machines in our lab.
4. What aspects of your job do you enjoy the most?
The independence in my job is great. Knowing what I have to do at the start of each week and the deadlines to do these jobs requires me to organise and prioritise my work accordingly.
5. What are some common preconceived ideas the public have about what laboratory staff do?
From my friends’ ideas of what I do in the lab I have found that a stereotypical image of a lab is one of a dark quiet lab full of strange equipment and even stranger people. However fortunately my lab is a lively one and thankfully with normal people.
6. In your opinion, what are the most important aspects of laboratory work?
Following correct protocols and procedures are imperative in an efficient laboratory. As well as this, good lab practice and good hygiene can have a massive effect on the accuracy of our results.
7. What’s in your lab coat pocket?
My lab coat pockets are quite boring. I have a pair of safety goggles, some post-its and some pens and markers.
8. In what ways does your work make a difference to people’s lives?
Randox is dedicated to improving the quality of diagnostics globally, so knowing that the kits that I have tested are then sent to customers to be used in patient diagnosis gives me a level of job satisfaction that I haven’t got from previous jobs.
Aidan is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through his work. 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.
Having developed the patented Biochip Array Technology following £250 million investment in diagnostic research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series.
The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.
Have a read below of the overview of each analyser in the Evidence Series
The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.
As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.
The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.
The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.
About the Randox Evidence Series
The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.
A partnership between Randox Laboratories, the UK’s largest manufacturer of in-vitro diagnostics, and the German technology giant Bosch is changing the way doctors will treat patients with antibiotics, with the launch of a revolutionary product – the Vivalytic.
It’s estimated that 20% of antibiotics currently prescribed are unnecessary, and fuel the growing threat of global antibiotic resistance. This threatens the ability to treat common infectious diseases, and a growing number are becoming harder, and in some cases impossible, to treat. The World Health Organisation warns that without action, we are heading towards a post-antibiotic era.
This problem is being addressed by the Vivalytic. The result of a decade of R&D, it is an intuitive point-of-care analyser that, depending on the complexity of the test, will deliver results from 30 minutes: enabling doctors to select the right course of therapy faster than before. In some cases, this will be life-saving.
The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections*.
Using Randox’s patented Biochip Array Technology, the Respiratory Multiplex Array simultaneously reports on 22 viral and bacterial pathogens including Bordetella pertussis and parapertussis which causes whooping cough – without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI array enables the detection of 10 STIs from a single sample. Every day more than 1 million STIs are acquired, and many have mild if any symptoms at all. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use.
The Managing Director of Randox Dr Peter FitzGerald commented:
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. This partnership is ideal, combining our expertise in molecular laboratory diagnostics with Bosch’s cutting-edge engineering. The Vivalytic is a game-changer for clinicians and patients: never before has there been this level of accessibility to this range of molecular diagnostics.”
Marc Meier, General Manager of Bosch Healthcare Solutions, a wholly owned subsidiary of Bosch Group, said:
“We are enthusiastic about having gained Randox as the first partner on our platform with two initial panels available from the start. It´s the beginning of jointly expanding the Vivalytic test portfolio for our clients. In this partnership the core competencies of Bosch in automation, miniaturization, and networking are complemented by Randox’s expertise in developing and commercializing innovative diagnostic solutions.”
Vivalytic and the panels will be presented to industry professionals for the first time at the ECCMID 2018 Congress in Madrid, Spain, in hall 10, booth 55A between 21st – 24th April.
*CE pending and FDA planned.
For further information about the Vivalytic, please contact firstname.lastname@example.org
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://dev.randox.com/clinical-chemistry-analysers/
A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?
What is diabetes?
Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin. Currently, diabetes is classified into two main forms, type 1 and type 2.
Type 1 diabetes is an autoimmune disease which manifests in childhood. In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas. As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.
Type 1 diabetes affects 10 percent of individuals with diabetes. 96 percent of children diagnosed with diabetes have type 1. Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14. The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).
Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced. As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.
Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden. The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014. It is expected to rise to 592 million by 2035. In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths. 43 percent of these deaths occurred before 70 years of age. Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well. In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).
In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.
The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study
This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.
This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications. The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.
Cluster One – Severe autoimmune diabetes (SAID)
SAID is similar to type 1 diabetes. SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA. 6% of individuals studied in the ANDIS study were identified with having SAID.
Cluster Two – Severe insulin-deficient diabetes (SIDD)
SIDD is similar to SAID, however, GADA is negative. This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present. Patients have a higher risk of diabetic retinopathy. 18% of subjects in the ANDIS study were identified with having SIDD.
Cluster Three – Severe insulin-resistant diabetes (SIRD)
SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI. Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease. 15% of subjects in the ANDIS study were identified as having SIRD.
Cluster Four – Mild obesity-related diabetes (MOD)
MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal. 22% of subjects in the ANDIS study were identified as having MOD.
Cluster Five – Mild age-related diabetes (MARD)
MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters. Patients with MARD have mild problems with glucose regulation, similar to MOD. 39% of subjects in the ANDIS study were identified with having MARD.
This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels. This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).
The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.
Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes. For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.
Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].
Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].
Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].
Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].
NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].
The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].
World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.
Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.
Some key benefits include:
- Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
- Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
- Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.
To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).
In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).
ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.
Meeting ISO Requirements
Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.
Review of QC data
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”
– ISO 15189:2012
Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.
Calculation of MU
“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.”
– ISO 15189:2012
Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”
– ISO 15189:2012
Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.
Medical decision levels
“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”
– ISO 15189:2012
Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.
Comparison of results across instruments
“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
– ISO 15189:2012
Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.
Third Party Control
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”
– ISO 15189:2012
Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.
At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.
Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.
CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf
Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014
Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology, 134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf
Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE, 11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856
A recent study completed by the Narcotics Control Bureau (NCB) reported an all-time high of 3.6 lakh kg narcotic drugs seized in India in 2017, this was an increase of over 300 percent in the last five years. Known as ganja, cannabis is the most widely abused drug in India, increasing from 40,113 in 1999 to 352,379 by 2017, according to The Times of India.
(Sourced: The Times of India: Drug abuse on the rise in India, Ganja most in demand)
A prevalent issue in the north of India is pharmaceutical drug abuse, both over the counter and prescription drugs. The Times of India reported that 566,450 bottles of cough syrup, 58,463 injections and more than 6,300,000 tablets were recovered across India in 2017. Among the drugs being smuggled out of India and into countries such as America and Canada is the opioid painkiller Tramadol, which is not covered under the Narcotic Drugs and Psychotropic Substances Act.
With daily drug seizures across the country, the situation in India has been described as akin to the US national opioid emergency. Therefore, it has been suggested that a harm-reduction approach be taken to educate the young and tackling substance abuse.
Using our revolutionary Biochip Array Technology, the Evidence MultiSTAT is a fully automated analyser that enables on-site simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single sample. Designed to work across a variety of matrices and generate results in under 20 minutes, Randox Toxicology have changed the landscape of drug detection forever.
For further information about the Evidence MultiSTAT and our cutting-edge multiplex testing capabilities, contact email@example.com to be put in touch with a sales member or visit www.randoxtoxicology.com
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