Biotin Supplementation Interference in Health Diagnostic Testing
Continuing our theme of Biotin (Vitamin B7) this month, we turn our attention to its role in diagnostic testing.
With as many as 20% of people taking biotin-containing supplements, including high profile celebrities such as Kylie Jenner, Kim Kardashian and Vanessa Hudgens, it is important to know the effects it can have on particular blood tests, should you visit your GP or local hospital.
Whilst there are various diagnostic health tests out there, including fertility hormone tests, prostate tests, and tests for troponin – a marker released into the blood during a heart attack – that are known to be affected by elevated levels of biotin, there are other tests available, including those provided by Randox, that are not impacted.
The reason that so many non-Randox tests are impacted by biotin is that biotin is widely used throughout the biotechnology industry in the development of diagnostic tests.
ELISA tests in particular (tests that measure the reaction of antibodies to identify a substance) often make use of antibodies labelled with biotin, to detect toxins or other foreign substances within the body.
In most instances, the biotin will bind with high affinity to a protein called streptavidin. This affinity of streptavidin for biotin is the strongest non-covalent biological interaction known, and is therefore particularly useful in binding antibodies within diagnostic tests.
But with more and more people exceeding the recommended daily dosage for biotin (30 micrograms) by taking up to 10,000 micrograms of biotin in supplements marketed for beauty reasons, many diagnostic tests are being measured inaccurately. Excess biotin in the blood can block the binding of biotin-labelled antibodies to streptavidin within the tests, and the substance being tested won’t be measured accurately.
Laboratory professionals have known about this potential problem for some time. In late November 2017, the FDA (Food and Drug Administration) published a safety notice to make the public and healthcare practitioners more aware that biotin can “significantly interfere with certain lab tests and cause incorrect test results.”
The FDA even reported on one particular case in which a patient died following falsely low troponin (marker of a heart attack) results when the troponin test used was known to have biotin interference. Biotin supplements masked the true diagnosis of a heart attack.
Many patients taking biotin supplements have also been misdiagnosed with a condition called Graves’ disease, an autoimmune condition characterised by an overactive thyroid. In these cases, biotin supplementation led to falsely low levels of thyroid stimulating hormones, and falsely high levels of other thyroid hormones. This particular profile of hormones led to a Graves’ disease diagnosis, in spite of a lack of symptoms, which in Graves’ disease would usually include muscle weakness, a quickened heartbeat, sleeping problems, diarrhoea, weight loss and poor tolerance of heat.
In pregnant women, tests that are impacted by biotin interference may produce falsely low levels of beta HCG, more commonly known as the ‘pregnancy hormone’ as it released by the placenta after conception. With low levels of beta HCG, and therefore no confirmation of pregnancy, pregnant women could be exposed to X-rays and CT scans that may harm the developing foetus.
So, what can be done? Suggestions have been made that patients taking biotin supplements should be made to wait before any diagnostic testing is conducted, so that the biotin clears from their system.
But this “Wait and Watch” approach certainly would not work in emergencies. In the case of a heart attack, testing must be conducted as soon as possible to allow for diagnosis, immediate medical intervention and follow-up testing.
At Randox, we are convinced that the risk of analytic interference by biotin supplementation is a serious problem that needs to be more widely recognised and promptly addressed.
In the GP setting, general practitioners must ask their patients if they are taking any biotin supplements and inform the testing laboratory if interference from biotin is a possibility. They should also consider that lab results not matching with a patient’s signs and symptoms may be caused by biotin interference.
In the acute care setting however, it is imperative that biotin technology is not used in diagnostic testing to protect patients from misdiagnosis and subsequently, further health problems.
This is why Randox’s patented Biochip Array Technology does not use biotin technology in its development. This revolutionary methodology, free from Biotin-Streptavidin is not impacted by elevated levels of biotin from biotin supplementation in the same way as Biotin-Streptavidin tests.
So if you have been taking biotin supplements for hair or nail growth, to ease symptoms associated with Multiple Sclerosis, for epilepsy or for a range of other health conditions, and your diagnostic testing has been conducted using Randox Biochip Array Technology, you can rest assured of true, accurate, and reliable results.
Randox Biochip Array Technology is interference-proof.
For further information on the Randox Biochip, visit https://www.randox.com/multiplex-testing/
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Randox Laboratories and Ulster University have launched a £5 million skills development initiative to support up to 10 individuals annually through PhD level study in the Life Sciences sector.
The Randox-Ulster University-Industrial PhD Academy, which aims to encourage the development of advanced, higher level skills in key industry sectors, will further reinforce Ulster University’s position as one of the top universities for biomedical related research impact and, enhance Randox’s competitiveness in the growing global healthcare sector.
Up to ten PhD researchers will be supported annually, including Randox employees and individuals from the wider sector, who are working on a range of scientific projects, with the ultimate goal of new product development. They will have the opportunity to work on new research projects, driven by industry and jointly supervised by Ulster University and Randox, to enhance their own individual skill sets whilst delivering groundbreaking advances in the life sciences sector. Ulster University and Randox will each fully fund up to five PhD researchers annually.
To date PhD researchers enrolled in this new programme of Industrial Research have started exciting projects in areas of medicine including mental health, diabetes and cancer, with more projects being developed. All projects share the common goal of delivering new diagnostic approaches for early detection of disease and earlier intervention where possible.
Professor Alastair Adair Deputy Vice-Chancellor Ulster University said:
“Ulster University is renowned globally for research in personalised medicine, cancer, diabetes and mental health and this makes us the perfect fit for a global industry leader like Randox. Ulster University and Randox have a longstanding partnership built around research, knowledge sharing and collaboration which has placed both organisations at the forefront of diagnostics and health research globally.”
Ulster University Professor of Personalised Medicine Tara Moore, said:
“The life sciences sector is of critical importance to our economy and health. To truly maximise our contribution to the economy and to fully exploit new advances in science and technology we must focus on advancing the skills of our workforce, ensuring the most talented people reach their full potential by working with partners to tackle new challenges and drive new discoveries. A strong and growing life sciences sector ensures patients will continue to benefit from new technologies which will help to improve diagnosis getting them the treatment they need quickly.”
“This new Industrial PhD Academy is a further step forward in our commitment to respond to national priorities such as the Industrial Strategy, aligning the research community with industry to drive innovation, building on the world-leading reputation of Randox and supporting a new generation of researchers in this strategically important sector.”
Dr Peter FitzGerald, Managing Director of Randox Laboratories, said;
“At this time of rapid and significant change in the UK, it is critical that the next-generation can meet industry’s ever-changing demands. The current STEM skills shortage costs the economy £1.5bn/year and will only be resolved if all companies in the sector recognise they have a role to play now too.
“In the last 4 months, we have made significant investments within Northern Ireland, in both R&D infrastructure and now in helping aspirational scientists at Ulster University to develop the critical skills to make a positive difference to patient healthcare around the world. We are unapologetically ambitious in our determination to cement Northern Ireland’s reputation as a global hub for life sciences and our own position as a worldwide leader.”
For further information about the Randox UU PhD Academy please contact Randox PR by email: firstname.lastname@example.org or by phone: 028 9442 2413
A record £50 million investment which will deliver cutting-edge technologies to diagnose conditions like cancer, heart conditions and infectious diseases has been announced by Northern Ireland diagnostics company Randox Laboratories and Invest Northern Ireland.
This major project involves the establishment of three Centres of Excellence, enabling Randox R&D scientists to work collaboratively with colleagues from Queen’s University Belfast and Ulster University. The centres are being officially launched today at the Randox Science Park. The ceremony will include a keynote address from Sir John Bell, who chaired the UK Government’s Life Sciences Industrial Strategy Board.
Advanced diagnostics have been identified as key to delivering sustainable improvement to healthcare systems struggling to cope with increasing levels of chronic and preventable conditions. Having been focused in this field for over 36 years, Randox has a successful track record of developing new and innovative tests – examples include assessing those at risk of Alzheimer’s disease and genetic cardiac conditions, to promote and enable preventive treatment, and a new clinically-approved test to diagnose prediabetes.
Managing Director of Randox Laboratories, Dr Peter FitzGerald, who today launched the three Centres of Excellence, said;
“When almost a quarter of the deaths of people under 75 in the UK are considered preventable, we need to ask ourselves what can be done to improve healthcare outcomes. There is an undeniable case for radical change in the way healthcare is delivered, and sophisticated diagnostics will be at the fore of this revolution.
“Enabling earlier and more accurate diagnosis, to identify those at the earliest stages of illness, ideally before the onset of any symptoms, is a game-changer. Through early intervention we can restrict the development of chronic conditions and improve people’s lives. Our view of the future is one where people are empowered through earlier diagnosis to stay healthier for longer, and where healthcare systems are freed to deliver quality services to patients. Our announcement today demonstrates our continuing commitment in this field.
“We are grateful for the support offered by Invest NI and look forward to addressing these pressing healthcare needs.”
The Centres of Excellence will focus respectively on clinical diagnostics, engineering for biosciences and quality control. The project, which will strengthen collaborative partnerships between Randox, Queen’s University Belfast and Ulster University, will accelerate the development of new technologies and drive healthcare improvements regionally, nationally and across the globe.
Of the £23m of support offered by Invest NI, £5m will go toward research projects at Ulster University and Queen’s University Belfast.
Welcoming the investment, Alastair Hamilton, Chief Executive of Invest NI said;
“Randox has a long history of investing heavily in innovation and R&D which has enabled it to create a globally competitive export driven business, capable of developing world leading research. This major investment will enable Randox to perform cutting-edge R&D which has the potential to revolutionise the global healthcare industry. This is excellent news for Northern Ireland’s life and health sciences sector. Northern Ireland is enjoying a growing international reputation as a region of expertise and knowledge in key areas such as Diagnostics, Precision Medicine and Advanced Manufacturing. The three new Centres of Excellence will help build on this and enhance Northern Ireland’s credibility, provide supply chain opportunities, and encourage knowledge transfer with our universities.”
Sir John Bell, commenting on the potential for the UK Life Sciences sector said;
“The life sciences industry represents one of the dominant economic sectors in the UK, and one with considerable potential for growth. However, whilst we have many natural strengths we cannot afford to be complacent. We must strive to optimise our science base, to encourage collaboration across academia, industry and the NHS, and grow our industrial capabilities. To do so we need to use our extensive data sets to best effect, and have in place a strong skills strategy. Success requires vision and drive. To that end I would like to congratulate Dr FitzGerald and Randox in the establishment of these three R&D collaborative Centres of Excellence – these are assets of national standing and will have a meaningful impact in enabling earlier and more accurate diagnosis, driving improvements in patient care, regionally, nationally and globally. They are leaders in this field, committed to innovation, and I wish them every success.”
Professor Jim McLaughlin, Director of Ulster University’s Nanotechnology and Integrated Bioengineering Centre, added;
“This very welcome investment enables pioneering Randox-inspired engineering capacity at Ulster University and reflects our research commitment to the life sciences industry. From nanotechnology to the development of systems that will enable large scale laboratory capability to be produced in the palm of your hand, the partnership brings shared industry and academic research excellence from the lab into the marketplace. Life sciences is a vital economic sector locally and this collaboration will advance diagnostics and ultimately enhance patient health outcomes.”
Dr David Jess, Senior Lecturer at Queen’s University Belfast School of Mathematics and Physics, added;
“The Randox Centres of Excellence will allow Queen’s University Belfast to continue to deliver cutting-edge and world leading research. We look forward to collaborating further with industry to develop pioneering research, focused on the needs of society.”
Invest NI’s R&D support is part funded by ERDF under the EU Investment for Growth and Jobs Programme 2014 – 2020.
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Randox Laboratories and Qnostics have today announced that they have entered into a strategic partnership. The partnership will provide Randox Laboratories with access to the Qnostics molecular range of products for sales and distribution purposes, complementing the established Randox Laboratories portfolio.
Access to the Randox Laboratories commercial capabilities will enhance Qnostics’ market penetration, whilst also maintaining their presence as an independent provider of molecular quality controls and custom services.
MD of Randox Laboratories, Dr Peter FitzGerald said;
“We are delighted to have agreed a strategic partnership with Qnostics, an arrangement we see as mutually beneficial. We look forward to working together to strengthen the molecular service we provide to our global markets whilst enhancing the Qnostic brand and market penetration.”
Dr Frank Opdam, Head of Commercial of Qnostics said;
“We believe this is an ideal partnership. We look forward to working with Randox Laboratories and the growth that will result from the global access this partnership will provide to Qnostics for its expanding range of molecular quality control products.”
For further information please contact the Randox PR Team: phone 028 9442 2413 or email firstname.lastname@example.org
Randox Clinical Laboratory Services is built upon Randox’s 35 years as an invitro diagnostics company, and is on hand to assist your drug discovery ensuring the toxicity and efficacy of your drug before proceeding to Phase 1 of your clinical trial.
RCLS currently has four state of the art, fully functional ISO12025 accredited laboratories across the UK. They are situated in Liverpool, London and two in Northern Ireland, Hollywood and Randox Science Park in Antrim.
RCLS looks to expand their team of experienced scientists, working towards further accreditations and furthermore setting up two additional labs in Dubai and Los Angeles. The addition of these purpose-built labs will give RCLS the ability to increase output to both the pharmaceutical, health and research market.
The RCLS laboratories offer unrivalled sample management and workflow with a unique identifier and sample traceability allowing patient history to be 100% accurate and guaranteed. The storage locations of sample are located separately with a duration of 15-25 years in fire proof cabinets. The sample rejection criteria and sample destruction processes are different from diagnostics standards as we offer multiple bar coding, sample manifests dictated by LIMS and double blinding of samples undergoing genomic testing.
A variety of analysers are situated across all RCLS laboratories not only including our RX Series and Evidence Series of multiplex immunoassay analysers but also third party analysers ensuring the testing abilities are diverse. The equipment covers chemistry, haematology, urinalysis and immunoassay testing capabilities.
With a greater understanding of human complexity, pharmaceutical companies are now focusing on developing safer drugs tailored to specific patient groups or sub-groups and the expansion plans in motion at RCLS will help these organisations bring new drugs to the market quicker.
If you would like more information on RCLS please contact email@example.com
Today, the National Institute for Health and Care Excellence has published guidelines that state doctors should not prescribe precious antibiotics for most people with sore throats and should instead recommend drugs like paracetamol.
The guidelines from NICE and Public Health England, which aim to limit the use of antibiotics, said doctors should only be prescribing the medicines for more severe cases that are most likely to have been caused by a bacterial infection.
This is despite recent research that suggests antibiotics are prescribed in 60% of sore throat cases, for which doctors are unable to tell if the infection is viral or bacterial.
The National Institute for Health and Care Excellence said most sore throats were caused by viral infections, which cannot be treated by antibiotics.
At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which indicates the cause of the infection and whether a patient needs antibiotics or not. This helps to limit the number of patients who are prescribed antibiotics unnecessarily.
The Randox test, which can rapidly detect and identify the cause of 21 respiratory infections in just 5 hours, assists the clinician in prescribing the appropriate antibiotic.
John Lamont, Lead Scientist at Randox Laboratories, said;
“Current diagnostic testing for respiratory infections takes at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way our new respiratory test can.”
This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics. It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.
This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes.
The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.
Find out more about the Cough, Cold & Flu Respiratory test here.
Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.
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The Evidence Investigator is a compact, semi-automated benchtop analyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, research, toxicology and food diagnostics.
Renowned for its versatility, robustness and effective reporting methods, the Evidence Investigator has been used in a wide range of laboratory settings for over 15 years. This highly advanced yet simple to use analyser has only one moving part, giving the user peace of mind.
The Evidence Investigator contains a host of innovative on-board data analysis features ensuring manual processes are kept to a minimum.
By utilising the same multiplex technology as the other Evidence Series analysers, the Evidence Investigator can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour. Offering efficiency without compromising on accuracy, the Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space.
Accurate and Robust
Like all the Evidence Series analysers, what sets it apart is technology. The Evidence Investigator is extremely well equipped to provide reliable results, while simultaneously robust enough to withstand frequent, heavy use.
Results are generated using a Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. This light measures the degree of binding between the patient sample and specific biochip bound ligands, generating highly accurate and reliable results.
The Evidence Investigator is the world’s first platform allowing consolidation of immunoassay and molecular diagnostics. This is achieved through utilising protein and DNA based biochips. By giving the user the ability to consolidate tests, the Evidence Investigator improves laboratory efficiency and reduces costs.
The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentration. This removes the need for any manual processing of data.
Previously unreported tests can also be retrieved, so they can be tested retrospectively. This saves time, labour costs and reduces any reagents wastage. All data is then analysed on-board, removing issues related to human error and result manipulation.
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 recent report by the Independent discussed how buying drugs has become as easy as buying ice cream. The report comes after experts named London as a city where cocaine is now delivered faster than pizza. According to the NHS, in the UK 2.7 million people between the ages of 16 and 59 took an illicit drug in 2015 and 2016 (roughly one in 12 adults). As a result, the Global Drug Survey are now looking at the impact of encrypted mobile phone messaging services and other methods that have enabled quick drug deliveries.
However, the drug problem is worldwide. In the US, life expectancy has fallen for the second consecutive year amid concerns of increased drug related deaths, the first multi-year drop since 1962 and 1963 according to the US National Centre for Health Statistics (NCHS). The NCHS documented that more than 63,600 US deaths in 2016 were due to drug related overdoses, a number that continues to increase.
MDMA has continued to appear in the news, after the deadly substance was responsible for the recent deaths of multiple teenagers in the UK. Also known as Ecstasy, MDMA is often described as the original designer drug due to its link with the dance culture in the late 80s and early 90s. Randox Toxicology’s DoA II panel tests for common drugs of abuse, including MDMA and generic opioids.
With the use of Biochip Array Technology, we have made multiplex testing capabilities possible. Our level of expertise in toxicology research and development allows us to adapt quickly to the ever-changing drug market influences and develop assays for current and novel drug trends.
|Analyte||Compound||Cross Reactivity %|
Purity is a concern with MDMA, which is regularly sold containing other fatal drugs. Newshub released information from Wendy Allison at KnowYourStuffNZ, who stated that only 20 percent of the drugs they tested in New Zealand contained MDMA. KnowYourStuffNZ’s website advises people to avoid certain pressed pills containing large amounts of MDMA. Theses pills include “Green Guccis”, a rectangular green pill with the Gucci logo and “Yellow Rolexes”, a yellow pill shaped like the Rolex crown logo. The comedown of Ecstasy can cause users to feel depression, whilst long term users can suffer from memory problems and anxiety. The use of the Class A drug has also been linked to liver, kidney and heart problems.
Our Randox Biosciences division is a trusted partner in supplying quality diagnostic solutions to the Clinical, Life Science, Pharmaceutical, Research and BioPharma industries.
Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infections (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD).
Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The arrays are optimised for use with the Randox Evidence Investigator semi-automated, medium throughput bench-top biochip analyser.
One test, 10 results.
Our STI multiplex array II simultaneously detects 10 bacterial, viral and protozoan infections including primary, secondary and asymptomatic co-infections for a complete infection profile. The assay is based on a combination of multiplex, PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets. A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).
The combination of priming and spatially organised biochip array technology enables enhanced specificity of the assay. Analysis can be completed from template DNA through PCR to data readout in less than 6 hours. The array is validated for urine and swab sample matrices with up to 53 patient samples being processed simultaneously. The array is CE marked for routine clinical use.
Our STI Multiplex Array II includes tests for the following STIs;
Neisseria Gonnorrhoea (NG) Mycoplasma Genitalium (MG)
Ureaplasma Urealyticum (UU) Chlamydia Trachhomatis (CT)
Tricomonas Vaginalis (TV) Haemophilus Ducreyi (HD)
Mycoplasma Hominis (MH) Treponema Pallidum (TP)
Herpes Simplex virus I (HSV-1) Herpes Simplex Virus 2 (HSV-2)
Randox Biosciences also offer four additional Molecular arrays.
For more information on our Molecular arrays please contact us by sending an email to Info@randoxbiosciences.com
In 2002, Randox invented a worlds first; Biochip Array Technology, instantly changing the landscape of diagnostic testing forever. Biochip Array Technology is a multi-analyte platform which provides an unrivalled increase in patient information per sample. Instead of a patient sample needing to be subdivided for each test result, or in some cases re-collected, Biochip Array Technology offers a diagnostic patient profile with each patient sample.
How does it work?
Biochip Array Technology is a precision multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.
The biochip detection system is based on a chemiluminescent reaction. This is the emission of light, without heat, as a result of a chemical reaction. An enzyme is used to catalyse the chemical reaction on the biochip which generates the chemiluminescent signal. The light emitted from the chemiluminescent reaction that takes place in each DTR is simultaneously detected and quantified using a Charge-Coupled Device (CCD) Camera.
Each biochip has up to 49 Discrete Test Regions (DTR). This means that up to 44 tests can be carried out simultaneously. The additional DTR are reserved for internal quality control and visual reference, a unique Biochip Array Technology feature.
How is the technology applied?
With over £250 million invested into Biochip Array Technology research and development, Randox have launched a range of Biochip Array Technology immunoanalysers – The Evidence Series. This includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser is developed with boundary pushing engineering, designed to make financial, labour and time savings for the end user.
The Evidence Series has truly revolutionised 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.