Meeting Accreditation Guidelines with Acusera 24.7

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Meeting Accreditation Guidelines with Acusera 24.7

At Randox Quality Control, we are never finished shouting about how great our interlaboratory comparison and peer group reporting software is. If you’ve had a look yourself, you’ll know exactly why. Acusera 24.7 is full of fetching, interactive charts, and useful, detailed reports, including measurement uncertainty, to help you streamline your QC procedure.

But Acusera 24.7 is so much more than this. Our team are constantly looking for innovative ways to update and improve our live, cloud-based software. Much of this comes from talking to our subscribers and finding out what they want and how they want to do it. Our team also happens to include some serious accreditation enthusiasts. So, we decided to put their passion to work. We’re regularly coming up with new measures to make meeting the guidelines set out by various accreditation bodies, including ISO15189, as simple for you as we can.

In this article, we’ll look at some of the accreditation requirements and the features we’ve included in Acusera 24.7 to simplify the process for you.

QC management tools

Its one thing to look at the features of Acusera 24.7, but what do the various guidelines have to say about QC management tools? Let’s look at some of the major accreditation literature.

ISO15189:2022

The new version of ISO15189 includes updates which aim to place more emphasis on risk management and mitigating risk to the patient. Here’s what the 2022 version has to say about QC management tools:

“e) the resulting data shall be recorded in such a way that trends and shifts are detectable and, where applicable, statistical techniques shall be applied to review the results.

f) IQC data shall be reviewed with defined acceptability criteria at regular intervals, and in a timeframe that allows a meaningful indication of current performance.”

ISO15189:2022 section 7.3.7.2

The Clinical Laboratory Improvement Amendments 1988 (CLIA)

CLIA ’88 regulations are federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. These regulations state the following related to QC management:

“Lab surveys by CLIA accreditation bodies will request quality control records including:

a) Remedial action information; …

c) Statistical limits; and

d) Instrument maintenance and function checks records.”

4.93.1105 Standard: Retention requirements (a)(3) Analytical system records.

“Retain quality control and patient test records (including instrument printouts, if applicable) … for at least 2 years. The records must include charts, graphs, printouts, transcribed data, and manufacturers’ assay information sheets for control and calibration materials.”

CLIA Amendments 1988

COLA Accreditation

The Commission on Office Laboratory Accreditation (COLA) is another recognised laboratory accreditation in the U.S. and is a third-party accreditation organisation that ensures laboratories comply with federal regulations, including those set by CLIA. I’m sure you’re catching the trend here:

“Identification of individuals performing QC should be available in the QC records.”

“The Surveyor will review QC records, corrective action logs, reagent logs and maintenance or service records to make sure that controls were tested and acceptable. Documentation should include date of testing, initials of the individual performing, actual results and indication of acceptability.”

“The Surveyor will look for QC in a graphic format. Data may be graphed as Levey-Jennings Chart or similar graphic representation and reviews of graphs should be performed at least every 5-7 days of testing. The graphs do not have to be printed.”

“If there are shifts or trends demonstrated in the data, the Surveyor will expect to see notation by the staff and should be able to follow the documentation trail to corrective action that is taken, as required by the laboratory’s QC policies.”

“Control charts, graphs, or statistical  parameters (i.e. mean, SD and CV) should be maintained for all quantitative tests performed by the laboratory. This data should be reviewed weekly or following every 5-7 data points if performed infrequently to detect changes such as shifts or trends that may be indicators of test system problems that need to be addressed.”

“The Surveyor will review QC records for evidence of review – including initials/signature and date of the review. Reviews should take place at least on a monthly basis. If data point(s) fall outside the acceptable ranges, notation, and corrective action, if necessary according to the laboratory’s QC procedures, needs to be include in the review.

Corrective actions may include such actions as opening a new bottle of QC, replacing the reagent, or recalibration. Trends and shifts in QC should be noted as well.”

COLA Accreditation Manual, Section 3 – QC

Meeting accreditation with Acusera 24.7

Acusera 24.7 offers a flexible approach to help laboratories meet all the QC accreditation requirements detailed above, including CLIA, COLA, CAP, and ISO15189.

Our user-friendly, cloud-based software allows users to effortless run statistical analysis including Coefficient of Variation Index (CVI), Standard Deviation Index (SDI), % Bias, Total Error, Sigma Metrics and more! Find out more about how we can aid you in your statistical analysis in our blog, Advanced Statistics with Acusera 24.7.

Acusera 24.7 can also create fully interactive Levey-Jennings charts, and a selection of histograms to provide a wide range of options for the graphical representation of your data. The interactive features of our charts allow you to record events such as lot changes and calibration events directly on to the chart, helping you achieve not just accreditation, but a better understanding of what is going on in your laboratory. You can read more about our charts and the insights you can gain from them at our blog, Charting the course to laboratory excellence

Acusera 24.7 can also provide you with a variety of reports to help you effortlessly achieve accreditation. From our Statistical Analysis and Exception reports to our Personalised Performance Summary Reports, we can help your laboratory to efficiently identify and document trends or shifts in performance. You can read all about our reports in our blog, Effortless Data Management: Acusera 24.7 Reports

Measurement Uncertainty

Anyone involved in laboratory quality control will be aware of measurement uncertainty (MU), although that doesn’t mean everyone understands this tricky requirement. MU is defined as a parameter associated with the result of a measurement that characterises the dispersion of values that could reasonably be attributed to the measured quantity.

In other words, MU provides medical laboratories with an estimate of the overall variability in the values they report. The goal of MU is to quantify the doubt or range of possible values around the measurement result, helping to provide an understanding of the reliability and limitations of measurements. This helps ensure measured results are useful and not wildly inaccurate, allows meaningful comparisons with medical decision limits and previous results of the same kind in the same individual and finally, it’s a requirement of ISO15189:2022:

“a. The measurement uncertainty (MU) of measured quantity values shall be evaluated and maintained for its intended use. The MU shall be compared against performance specifications and documented.

b. MU evaluations shall be regularly reviewed.”

ISO15189:2022 Section 7.3.4

Calculating MU is no simple task and not one that can even be attempted without in depth know-how. These calculations can take a single member of staff 2 full working days to complete. That’s a lot of time away from their normal duties, especially if MU is to be reviewed regularly, as per ISO15189:2022.

Lucky for you, Acusera 24.7 can calculate you MU in seconds, rather than days, and provide you with a report. This report can be shown to your accreditation surveyor, and you can consider the MU box ticked. You can read more about Acusera 24.7 and MU in our Advanced Statistics blog, or in our educational guide How to Measure Uncertainty.

Peer Group Reporting

The peer group reporting features of Acusera 24.7 are much more than just an added extra. Peer group reporting can help speed up the troubleshooting process, allowing you to determine whether an issue you are seeing is unique to you, or evident in the QC data of your peers. It can also provide you with more confidence in assigned target values and help make significant savings by improving your analytical performance, and therefore, your EQA performance.

A peer group reporting programme can also help meet regulatory requirements, like ISO15189:2022:

“ a. The laboratory shall monitor its performance of examination methods by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods.”

“f. When an EQA programme is either not available, or not considered suitable, the laboratory shall use alternative methodologies to monitor examination methods performance.

NOTE Acceptable alternatives include:

– Interlaboratory comparisons of the results of the examination of identical IQC materials, which evaluates individual laboratory IQC results against pooled results from participants using the same IQC material.”

ISO15189:2022 Section 7.3.7.3 External quality assessment (EQA)

So, if you’re struggling to find a suitable EQA programme for your analytes, you might just be able to meet your accreditation with the peer group reporting features included in Acusera 24.7.

We’ve only begun to cover the features of this intuitive and efficient software. If you still aren’t convinced that Acusera 24.7 is right for QC data management in your laboratory, reach out to us today at marketing@randox.com. We’re always delighted to hear from you, and we’ll be happy to discuss any of the features of Acusera 24.7, or any reservations you may have.

Our customers can’t believe the gulf in class between Acusera 24.7 and other QC data management programmes.

Don’t get left behind.

Reach out to us today!


International Day of Women and Girls in Science 2024

For the 9th consecutive year, the field of science has taken this day to celebrate women in the STEM industries and their achievements. The representation of women in STEM is climbing, however it remains low, with estimates claiming women make up only around 26% of the workforce. By celebrating the accomplishments of women in these fields, we hope to encourage more girls to enter the world of science and engineering and challenge the adversity women in STEM all too often face.

In honour of International Day of Women and Girls in Science 2024, we’ve looked at some of the most important achievements in the life sciences. Some of the names you’ll be familiar with, others may be new. We’ll travel to Ancient Greece where we will learn about the first female science writer and surgeon, before coming back to today to recognise some of the most groundbreaking innovations in medicine. For far too long the door to a career in the life sciences has been all but closed for women, as you will discover in this article. Yet some of the discoveries and triumphs over adversity we’ll look at are arguably some of the most important achieved by humanity.

Metrodora

In Ancient Greece, it was believed that science was derived directly from the gods. This meant, like other divine disciplines, women were not allowed to practice medicine. However, such a technicality did not stop our first heroine of science. Before her exploits in Greece, Metrodora was likely born and educated in Egypt where men and woman were equals, unlike much of the ancient world. In fact, some believe Metrodora to be an alias of the famous Cleopatra VII, Queen of Egypt. There is some debate about when Metrodora lived; some say between 200-400 CE, others claim it was more likely to be during the 7th century CE. The name Metrodora is particularly fitting for a woman of her accolades. In Greek, metro can be translated as womb, and dora means gift.

Metrodora was the author of a textbook, making her the first female science writer, spanning 2 volumes and 108 chapters entitled On the Disease and Cures of Women, in which she describes in detail her theories and findings on the topics of female health and the reproductive system. She is thought to have devised treatments for sterility, infections of the female reproductive system, menorrhagia (heavy periods) as well as a method for determining sexual abuse in women. Not to be limited by writing and medicine, Metrodora was also a surgeon, cited as removing dead embryos to save the lives of mothers who miscarried, removing cancers of the breast and uterus and was even among the first to perform cosmetic surgery. Metrodora reconciled this with her Hippocratic duty to help women who had been abused through aesthetic facial and breast reconstruction and the restructuring of the hymen of women who had suffered this fate.

Her pioneering work, however, was quite nearly forgotten forever as she was largely overlooked by her contemporaries. But thankfully, some of her texts are preserved in the Laurentian Library in Florence. Metrodora’s commitment to medicine and female health is summed up perfectly in the opening words of her text, “some of them are intricate to treat and others are fatal, by these notes we will recognise each one”.

 

 

 

Elizabeth Blackwell (1821-1910)

Elizabeth Blackwell was always destined to shake the status quo. Her father, Samuel, was a Quaker and an antislavery activist. Among her siblings are Henry, an abolitionist and women’s suffrage supporter; her sister, Emily, who followed Elizabeth into medicine; and her sister-in-law, Antoinette Brown Blackwell, who was the first female minister in mainstream Protestantism.

She was inspired into a life of medicine after a close friend had confessed embarrassment of her treatment by male doctors and suggested she’d have been more comfortable if attended to by a female physician. After a series of rejections from numerous medical schools, Elizabeth was finally accepted to Geneva College, New York. However, this acceptance was intended as a practical joke. Not to be discouraged, Elizabeth proved them all wrong, graduating top of her class in 1849 and becoming the first woman to graduate medical school. Dr Blackwell then practiced in London and Paris and was one of the first advocates for the importance of hygiene in medicine, noting that male doctors frequently failed to wash their hands, which led to the spread of epidemics.

In 1851, Elizabeth made the trip back to New York where discrimination was still rife. Once again, her persistence led to the opening of the New York Infirmary for Women and Children in 1857 with Dr Emily Blackwell and Dr Marie Zakrzewska. This institution was a haven for women who needed medical treatment but were often too poor to afford it, and for female physicians struggling to get work in the field. Among her laurels, she played a role in the inception of the National Health Society, established in 1871, which aimed to spread knowledge of public health, and is considered the predecessor to the National Health Service.

 

 

Marie Curie (1867-1934)

Marie Curie is among the most famous of the women in science, so we won’t spend too much time on her life and accomplishments here. However, its impossible to have the discussion without mentioning her invaluable contribution to science. In often poor laboratory conditions with worse equipment, she, and her husband Pierre Curie, made some pivotal discoveries including the isolation of polonium and radium. Marie Curie developed techniques to separate radium from radioactive residues which allowed it to be studied extensively and eventually, its use as a therapeutic agent.

In 1903, Marie and Pierre Curie were awarded half of the Nobel Prize for Physics for their work on spontaneous radiation. Then, in 1911, Marie Curie was given a second Nobel Prize, this one for chemistry, for her work on radioactivity. In recognition of her groundbreaking work leading to novel cancer therapies, the charity Marie Curie was named in her honour, immortalising her and her contributions to the field.

Marie Curie, 1867-1934

Gerty Cori (1896-1957)

Here we find another woman whose name outshines that of her husband, Carl, with whom she collaborated for most of her scientific career. Gerty graduated from medical school in 1920, along with her husband, before they emigrated to America in 1922. Here, they initially delved into the fate of sugar within the animal body, exploring the impacts of insulin and epinephrine. They made groundbreaking discoveries, including the demonstration of glycolysis in tumours in vivo. Their research on carbohydrate metabolism evolved from whole animal studies to experiments on isolated tissues, and eventually to tissue extracts and isolated enzymes, including some in crystalline form. In a pivotal moment in 1936, they isolated glucose-1-phosphate, known as “Cori ester,” and linked its formation to the activity of phosphorylase, which plays a crucial role in the breakdown and synthesis of polysaccharides. This discovery paved the way for the enzymatic synthesis of glycogen and starch in vitro.

Their research extended into the realm of hormone action mechanisms, with several studies focusing on the pituitary gland. They observed significant changes in rats that have had their pituitary gland removed, including a marked decrease in glycogen and a drop in blood sugar levels, accompanied by an increased rate of glucose oxidation. Further investigations into the effects of hormones on hexokinase revealed that certain pituitary extracts could inhibit this enzyme both in vivo and in vitro, while insulin was found to counteract this inhibition.

Beyond their groundbreaking research, the Cori’s served as an endless source of inspiration to their peers in the vibrant hubs of biochemical research they led. Their contributions to The Journal of Biological Chemistry and numerous other scientific journals have left an indelible mark on the field, showcasing their innovative work and collaborative spirit throughout their careers.

 

 

 

 

https://www.nlm.nih.gov/changingthefaceofmedicine/gallery/photo_69_3.html

Gertrude Belle Elion (1918-1999)

Gertrude provides us with another tale of the triumph over adversity. After graduating with a degree in biochemistry in 1937, she failed to obtain a graduate position because she was a woman. After roles in laboratories and teaching, she joined the Burroughs Wellcome Laboratories in 1944 and became the assistant to Dr George Hitchings. Over the following 40 years, the pair were successful in the development of a vast array of new drugs and treatments. Much of their success is attributed to their methods. At the time, normal practice is best described as trial and error. However, Hitchings and Elion studied and intimately understood the difference between normal and pathogenic biochemistry, allowing them to envision and create targeted treatments for, to name just a few, leukaemia, urinary-tract infection, gout, malaria and viral herpes.

Although she never achieved her doctorate, in 1967 Elion was promoted to Head of the Department of Experimental Therapy, where she remained until her retirement in 1983. But Elion didn’t let a silly old thing like retirement get in her way. She remained at the Burroughs Wellcome Laboratories as a Scientist Emeritus and Consultant, including overseeing the development of azidothymidine, the first drug used to treat AIDS. Elion also became a Research Professor of Medicine and Pharmacology at Duke University, working with medical students in the field of tumour biochemistry and pharmacology, while continuing to write and lecture. Gertrude B. Elion passed away in 1999, bringing an end to a happy and fruitful career as one of the most influential women in science.

 

GSK Heritage Archives

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GSK Heritage Archives https://creativecommons.org/licenses/by/4.0/

Rosalind Franklin (1920-1958)

Rosalind Franklin, another well-known name and one synonymous with the discovery of the DNA double helix, was an exceptional scientist whose meticulous work in X-ray crystallography laid the groundwork for one of the 20th century’s most significant scientific discoveries. Franklin graduated from Cambridge University in 1941, where she initially delved into the study of coal, gases, and carbon compounds, significantly contributing to the understanding of the molecular structures of these materials. Her early research not only showcased her exceptional skills in physical chemistry but also set the stage for her pioneering work in biology.

In 1951, Franklin joined King’s College London, where she was tasked with improving the X-ray crystallography unit. It was here that Franklin embarked on her most famous work: the study of the structure of DNA. Using her expertise in X-ray diffraction techniques, she captured Photograph 51, a critical piece of evidence revealing the helical structure of DNA. This image was crucial in identifying the double helix structure, although her contributions were not fully acknowledged until after her death.

Franklin’s research extended beyond DNA to the study of viruses, making significant strides in understanding the polio virus and the tobacco mosaic virus. Her work in virology, much like her work on DNA, was pioneering, employing her crystallography skills to uncover the detailed structure of viral particles. This work provided valuable insights into how viruses replicate and infect cells, contributing to the broader field of virology and paving the way for future research in virus structure and function.

Despite facing considerable challenges as a woman in a predominantly male scientific community, Franklin’s contributions were profound. Her relentless pursuit of scientific truth, combined with her exceptional experimental skills, left a legacy in the fields of chemistry, virology, and genetics. Beyond her scientific achievements, Franklin is remembered as a trailblazer who paved the way for future generations of women in science, demonstrating the critical role of perseverance and dedication in the pursuit of knowledge.

 

 

 

 

 

 

The Editors of Encyclopaedia Britannica. "Rosalind Franklin, British Scientist," Encyclopaedia Britannica (article created 20 Jul 1998, accessed 08 Jan 2024); https://www.britannica.com/biography/Rosalind-Franklin : https://cdn.britannica.com/30/99730-050-E68F62FF/Rosalind-Franklin.jpg
The Editors of Encyclopaedia Britannica. "Rosalind Franklin, British Scientist," Encyclopaedia Britannica (article created 20 Jul 1998, accessed 08 Jan 2024); https://www.britannica.com/biography/Rosalind-Franklin : https://cdn.britannica.com/30/99730-050-E68F62FF/Rosalind-Franklin.jpg

Françoise Barré-Sinoussi (1947-)

When discussing women who changed science, it’s impossible not to mention Françoise Barré-Sinoussi. She was born in Paris in 1947 and attended university there. Her passion for science saw her skip class to work at the Pasteur Institute, participating in investigations of retroviruses that caused leukaemia in mice. Although, this didn’t seem to affect her exams scores, and she received her PhD in 1974.

Françoise Barré-Sinoussi is hailed as the woman who discovered the viral cause of the AIDS epidemic. In 1982, the Pasteur Institute was approached by a virologist from a hospital in Paris, seeking help in identifying the cause of a worrying new epidemic. In a mere 2 weeks, Barré-Sinoussi, and her colleagues at the Pasteur Institute, isolated and grew a retrovirus from a biopsied lymph node of a patient at risk of AIDS. The virus, later named HIV-1, was found to be the cause of the AIDS epidemic.

Barré-Sinoussi has been contributing to virology research ever since, including areas such as the function of the host’s innate immune defences in managing HIV/AIDS, the elements contributing to the transmission of HIV from mother to child, and traits enabling a select group of HIV-positive individuals to restrain HIV replication without the need for antiretroviral medications. In 1992, Barré-Sinoussi was appointed Head of the Biology of Retrovirus Unit, renamed the Regulation of Retroviral Infections Unit in 2005.

However, Barré-Sinoussi didn’t stop at the science. She became a prominent activist for public education about AIDS prevention and helped to establish centres for diagnosing and treating AIDS around the world. In 2006, Barré-Sinoussi was elected to the International AIDS Society (IAS) Governing Council and served as president of the IAS from 2012-2016.

 

https://en.wikipedia.org/wiki/Fran%C3%A7oise_Barr%C3%A9-Sinoussi#/media/File:Fran%C3%A7oise_Barr%C3%A9-Sinoussi-press_conference_Dec_06th,_2008-1.jpg

http://www.gnu.org/licenses/old-licenses/fdl-1.2.html
https://en.wikipedia.org/wiki/Fran%C3%A7oise_Barr%C3%A9-Sinoussi#/media/File:Fran%C3%A7oise_Barr%C3%A9-Sinoussi-press_conference_Dec_06th,_2008-1.jpg http://www.gnu.org/licenses/old-licenses/fdl-1.2.html

Jennifer Douda and Emmanuelle Charpentier

Most people have heard of CRISPR-Cas9. But many aren’t aware that we have women to thank for this scientific innovation. In 2012, Jennifer Douda (left) and Emmanuelle Charpentier (right) discovered the ingenious CRISPR-Cas9 technology – a groundbreaking tool in genetic engineering, which holds the promise of revolutionising medicine and biology. By enabling precise editing of the DNA in the cells of living organisms, CRISPR-Cas9 could lead to cures for genetic disorders, enhance crop resistance to pests and diseases, and advance our understanding of complex genetic conditions. It offers the potential to correct genetic defects, combat infectious diseases, and even manipulate traits in plants and animals, paving the way for significant advancements in therapeutic treatments, agricultural productivity, and the study of genetics. This discovery saw both women share the Nobel Prize in Chemistry in 2020.

 

Photograph by Christopher Michel https://creativecommons.org/licenses/by/4.0/

 

https://upload.wikimedia.org/wikipedia/commons/6/66/Emmanuelle_Charpentier.jpg https://creativecommons.org/licenses/by/4.0/

We’ve only looked at a subsection of science, but one where the importance of the innovations and discoveries is felt by people every day. The scientists we’ve discussed here are only a small sample of the inspirational women that have graced the STEM field. We hope that by elucidating some of their work, we can inspire more girls and women to pursue a career in STEM. Careers in this field are challenging and rewarding, perfect for those with a curious mind and those in whom discovery sparks delight.


David Davis calls for blanket testing to save NHS £3bn a year

 

Ministers are being urged to introduce mass medical testing to cut NHS costs by billions and save thousands of lives.

Former Brexit Secretary David Davis calls for mass medical testing across the whole UK population by companies which he believes will alert the NHS to potential health risks for individuals and allow for lifestyle changes and treatment before problems become serious.

Mr. Davis said, “I bring it back to the reality of individuals. If we delay diagnosis, we delay treatment – we sentence people to death. It’s as harsh as that. So one of the things I would like to see us do is dramatically increase the amount of diagnostic capacity we have.”

“My view is that actually we should break clear of the ideology. We should look to increase dramatically the amount of scans and diagnostic procedures we can create. And when I say dramatically, I mean a multiple of what we currently do and we should use the private sector to do it.

“I know it causes a bridling and a backing off but I the only way we can do it fast enough is to do that. And that will save I think about £3 billion, get the waiting lists down by millions of people but most importantly of all will save thousands of lives.”

Mr. Davis was reacting to a paper drawn up by Northern Ireland medical testing company Randox, one of the private health providers who developed Covid testing during lockdown. The paper has been drawn up by scientists at Randox, scaling up its testing capacity from 300 tests a day to 120,000 a day in less than 12 months. Overall, the firm conducted nearly 27 million tests during the pandemic.

Dr. Peter Fitzgerald, the founder of Randox, said that with the NHS waiting lists not far short of eight million people and with budgets under intense pressure, the time had come for a new partnership between the public and private sectors.

Ministers should start by convening a summit of private diagnostic firms and their NHS counterparts and investigate the potential of the enormous advances in testing technologies developed in recent years. By harnessing the startling progress made by scientists they could revolutionize standards of health care while slashing waiting lists and achieving far greater value for money.

Dr. Fitzgerald added, “Policy-makers need to appreciate the vast potential of the latest diagnostic testing technologies. They can deliver a step-change in the quality of people’s lives. By outsourcing much testing to the private sector – under a rigorous independent tendering process – the NHS can be freed up to  get on with its prime job of treating the sick.”

Under the Randox plan, the public would be invited to visit a private diagnostic clinic every year for a check-up. Results would be monitored in house by scientists who would advise people on next steps. Results would be routinely passed onto their GPs, though in many cases no further action would be needed.

GPs would ultimately decide on medical interventions and possible referral to NHS hospital services. A priority group for such tests would be the 7.7 million on NHS waiting lists. They would be assessed to see if their condition had worsened and whether urgent action was required.

High-tech comprehensive testing of the population would also reduce if not eliminate the many false positives arising from much of the diagnostic services available today.

Taken from Daily Express article by David Maddox, Political Editor.

Randox welcomed the Queen’s University staff Leadership Team to their Antrim based Randox Science Park in Antrim.

Randox were delighted to welcome the Queen’s University Belfast Leadership Team to their Antrim based headquarters, Randox Science Park on Tuesday, October 4th.

President and Vice Chancellor, Sir Ian Greer of Queen’s University was joined by Deputy Vice-Chancellor Professor Stuart Elborn, Head of Careers, Employability and Skills Mr Trevor Johnston, Head of Business Alliance Mr Dermot Leonard, Business Engagement Manager Mrs Joanne Mallon, Executive Director of the Global Innovation Institute Dr. David Quinn, Lead of Queen’s sustainable energy research Professor David Rooney, Dean of Research in Medicine, Health and Life Sciences Professor David Rooney, Dean of Research in Medicine, Health and, Life Sciences Professor Chris Scott, and Dean of Impact and Innovation in Medicine, Health, and Life Sciences.

The team received a presentation on Randox’s capabilities which stimulated multiple discussions in relation to research, improvements in healthcare provision, skills and the exciting future of Life and Health Sciences in Northern Ireland.

The purpose-built facilities at the site, covering research and development, engineering, manufacturing and accredited laboratories provides an unparalleled depth of diagnostic capability within a single site.

Randox employ over 2,200 staff, including 800 research scientists and engineers – all focused on improving life science diagnostic capabilities globally.

More than 5% of the world’s population (over 400 million people) receive medical diagnosis using Randox products each year. Randox have major facilities in the UK, Ireland, India, and the United States, supported by global distribution and supply networks.

 


Secretary of State visit to Randox Science Park

The Rt Hon Chris Heaton-Harris, Secretary of State for Northern Ireland paid a visit to Randox Science Park on Thursday, October 19th, to discuss Randox capabilities and undertake a tour of the facilities at the Antrim site.

As leading diagnostic company from the UK & Ireland, Randox have spent over forty years improving healthcare,  with a focus on the provision of timely and accurate  testing both to improve clinical diagnosis and promote preventative healthcare.

The purpose-built facilities at the site, covering research and development, engineering, manufacturing and accredited laboratories provides an unparalleled depth of diagnostic capability with a single site.

More than 5% of the world’s population (over 400 million people) receive medical diagnosis using Randox products each year.

Randox’s proprietary Biochip Technology is the result of a £350 million investment, allowing many tests to be run simultaneously, greatly improving the diagnostic power available to clinicians. This innovative technology allowed the provision of advanced health  profiling to support both early diagnosis and the transition to preventative healthcare.

Randox Science Park is a central hub of Randox’s life science manufacturing, engineering and research and development. Randox employ over 2,200 staff, including 800 research scientists and

engineers – all focused on improving life science diagnostic capabilities globally.

Randox Science Park is one of four key manufacturing and development sites, with others located in Dungloe, County Donegal; Bangalore, India; and the Greater Washington DC area, USA. Across the UK & Ireland there is also a growing network of Randox Health Clinics.

 

 


Sexual Health Week

September 11th-17th is Sexual Health Week 

Sexual Health is a very important part of our lives, impacting on our wider physical and emotional well-being. In our relationships it is also important to act responsibly and with care – and to reduce the risk of Sexually Transmitted Infections (STIs).

More than one million sexually transmitted infections (STIs) are acquired every day worldwide, the majority of which are asymptomatic. STIs are on the increase, and many show very little to no symptoms.

We want to break the stigma on sexual health testing. Regular testing is what keeps us safe and prevents STI’s spreading. Regular screening can aid in detecting an infection in the early stages and help to reduce the risk of further complications.

Gonorrhoea and Syphilis, which are two of the most common STIs are increasing at alarming rates.

Usually treated easily with antibiotics, many STIs can cause serious health issues if left untreated. Chlamydia and Gonorrhoea can cause infertility and pelvic inflammatory disease, while syphilis can cause serious, irreversible, and potentially life-threatening problems with your brain, heart, or nerves. Sexually transmitted infections are on the increase, many of which present little to no active symptoms.

A Randox Health spokesperson said: ” The screenings we provide are a complete STI screen which discreetly screens for 14 common STIs including HIV, Chlamydia and Gonorrhoea and take control of your sexual health with a complete STI screen which is available in clinic.

“We also offer a Blood Borne STI screen – where you can test for four common blood borne pathogens including HIV and Hepatitis from a sample blood sample. This specific test is highly recommended for pre-IVF treatment.” They added.

“Lastly we offer a Sexually Transmitted Infection (STI) Test. With this you can discreetly screen for ten common sexually transmitted infections. This screening service is also available to anyone who has mild or no STI symptoms and would like to get themselves checked and is also available Inclinic.”

“Our easy to interpret test report will provide a breakdown of your results, what they mean and the next steps. Reports will be sent to the email address provided at the time of your registration.”

Find out more here: https://rb.gy/40gfv


World’s first Xylazine assay

Randox’s newly established ELISA for xylazine is the first immunoassay test in the world for this drug

Xylazine is an analgesic drug primarily used within the veterinary industry as a tranquilizer.

It has not been approved for human use, however, in recent years it has been linked to the USAs illicit drug supply. The United States Drug Enforcement Authority (DEA) recently published a Public Safety alert about xylazine. Its primary use is as a sedative and analgesic in veterinary medicine for horses, cattle, and other large animals. However, xylazine has been reported as an adulterant in an increasing number of illicit drugs mixtures and detected in a growing number of overdose deaths in the USA, according to the DEA.

A report released by the US Centers for Disease Control and Prevention (CDC) on June 30th 2023 found that “Among 21 jurisdictions, the monthly percentage of illicitly manufactured fentanyl-involved deaths with xylazine detected increased 276% from January 2019 (2.9%) to June 2022 (10.9%).” However, they note that because of inconsistent testing, detection is still likely underestimated.

According to the CDC researchers “Medical Examiners and Coroners might differ regarding whether they consider xylazine to increase fatal overdose risk, or they might be unfamiliar with xylazine and therefore not list it on death certificates. This variation highlights the importance of collecting postmortem toxicology data on all drugs detected in overdose deaths, rather than just those listed on the death certificate.

The CDC advises that Expanded postmortem testing for xylazine is needed to clarify prevalence in drug supplies” and that Routine toxicology testing for xylazine in suspected overdose cases is critical for accurate surveillance”.

Studies continue to see the drug reported as an adulterant in an increasing number of illicit drug mixtures. Commonly encountered in combination with fentanyl but xylazine has also been detected in mixtures containing cocaine, heroin, and a variety of other drugs.

Unlike fentanyl, xylazine is not an opioid, naloxone (Narcan) does not reverse its effects. As such this dangerous combination of toxic drugs can lead to fatal accidental overdoses in users.

The severity of its side effects remain a concern: depressed breathing, blood pressure, heart rate and body temperature to critical levels.

Available now on the Evidence MultiSTAT!

Randox Toxicology continue to lead in new test development within the ever-changing drugs of abuse market. Our newly established test for xylazine is the first immunoassay test in the world for this drug of abuse.

Simultaneously screen two samples for up to 29 drugs of abuse, including xylazine, on our ToxPlex Array  in just 31 minutes!

About Randox Toxicology 

With over 40 years’ experience in the diagnostic market, Randox Toxicology is dedicated to advancing forensic, clinical and workplace toxicology.

Placing a heavy focus on new product R&D has led to the development of technology at the forefront of advanced global diagnostics.

A market leader in the development of new assays and technology in the field of toxicology, Randox aim to minimise laboratory workflow constraints whilst maximising the scope of quality drug detection.

With the world’s largest toxicology test menu, screening for over 600 drugs and drug metabolites, our range of versatile analysers provide toxicology solutions for both high and low throughput laboratories.

For more information, contact Randox Toxicology at info@randoxoxicology.com.


Randox Health partners with Team Gb ahead of Paris 2024

The British Olympic Association (BOA) has announced that Randox Health will be the Official Diagnostic Health Partner of Team GB ahead of the Paris 2024 Olympic Games.

Following the success of their previous partnership, which saw Randox provide Team GB with Covid-19 testing services for Tokyo 2020 and Beijing 2022, the new partnership will see the two organisations work to change the way the nation thinks about health.

Together with Team GB, Randox will encourage people to be proactive about their health by using comprehensive diagnostic screening and data to support prevention and early diagnosis of conditions, while Team GB’s athletes will have access to Randox’s in-clinic and home testing services to help them be in the best possible shape for Paris 2024.

Dr Peter FitzGerald, Founder and Managing Director of Randox Health, said: “We are delighted to announce our partnership as the Official Diagnostic Health Partner of the British Olympic Association and Team GB, particularly as every athlete increasingly focuses their preparations on the Paris Olympic Games in 2024, for which we wish them every success.

“Randox are at the forefront of comprehensive diagnostic testing to reduce illness and optimise health and performance – not only for athletes but also in our everyday lives.  Our range of preventative testing programmes, which are widely available through a growing network of Randox Health Clinics and home test kits, provides a data based, analytical approach to move from sickness management to prevention, promoting longer, healthier lives for all.  We know that much more can be done to improve health and well-being across the nation – working with Team GB we aim to change the way the UK thinks about health.’

Andy Anson, Chief Executive of the BOA, said: “We are delighted to be partnering with Randox for the second time following the success of our work together for Tokyo 2020 and Beijing 2022.

“Due to Randox’s expert support we were the only major nation to attend both Tokyo 2020 and Beijing 2022 to not record any positive Covid-19 cases, which was truly remarkable.

“Ensuring we have the best possible performance environment in place for our athletes is critical to the success of the team at an Olympic Games, and sector-leading medical services are key to that strategy.

“Randox share our ambition to support the health and wellbeing of the nation and it’s great that access to their specialist services are open to the general public and athletes alike.”

For further information, please visit TeamGB.com


Randox acquires microfluidic tools and impedence flow cytometer developer, Cellix Limited.

Randox are pleased to announce the acquisition of Cellix Limited, a Dublin-based company that develops microfluidic tools and impedance flow cytometers for cell analysis. 

This acquisition expands Randox’s technical capabilities into the benchtop flow cytometry space aligning with their commitment to personalised medicine and improved preventative healthcare.

Dr. Peter FitzGerald, Managing Director of Randox Laboratories:

“The acquisition of Cellix complements and broadens Randox’s offerings by making flow cytometry more accessible to a wider audience of scientists and clinicians.”

“We are looking forward to bringing together Cellix’s expertise in cytometry with our dedication to diagnostics and believe this combination will enable us to streamline workflows resulting in better outcomes for patients.”

Vivienne Williams, CEO of Cellix:

“Our team is very excited to be joining forces with Randox to scale access to our technology in the broader scientific community.

“Cellix’s dedicated team has worked hard developing impedance-based cytometry for cell analysis supported through programs including the Disruptive Technology Innovation Fund. With Randox’s strong global presence and dedication to R&D, we are looking forward to continuing development of our technology and expanding our customer footprint.”

 

 

 


Biomedical Science Day 2023

This 8th June, Randox is celebrating Biomedical Science Day and our vital role in pro-active healthcare through our Randox Health Clinics.

Biomedical Science Day celebrates the vital role biomedical scientists play in patient care through the diagnosis of infections and diseases. It is a national event organized by the Institute of Biomedical Science (IBMS), the professional body for biomedical scientists and laboratory support staff. The awareness day aims to inform the public and empower patients by telling them about practices in biomedical science and celebrating a profession that is #AtTheHeartOfHealthcare.

Biomedical science is practiced in healthcare laboratories to identify, research, monitor and treat diseases. As one of the broadest areas of modern science, it focuses on the complexity of the human body and underpins much of modern medicine.

Here at Randox we continuously celebrate all our laboratory staff on a global scale – our team consists of over 650 research scientists and engineers who work in four jurisdictions across three continents!

For over forty years, Randox laboratory staff have been contributing to our work in preventative healthcare and research into diagnostics.

Randox has many departments which all work collectively to produce results. Our laboratory and R&D scientists are continuously researching new biomarker discovery. With a driven commitment to improving health worldwide, Randox reinvest up to 25% of turnover into developing disruptive innovations in diagnostics and healthcare – providing earlier diagnosis, prognosis, and improved patient risk to reduce current invasive diagnostic methods.

“Here at Randox we are using cutting edge Research and Technologies with the aim of making a difference in the field of Clinical Diagnostics and preventative healthcare.”

– Dr. Sarah Gildea, Senior R&D Scientist at Randox Teoranta 


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