Biotin, also known as vitamin B7, is involved with fatty acid metabolism, amino acid degradation, and gluconeogenesis. The recommended daily intake for biotin is roughly 30-70µg, which is extremely low, meaning that biotin deficiency is rare. Recently, there has been a surge in biotin supplementation mainly for beauty reasons, including: stronger nails and healthier skin and hair, resulting in the biotin craze on Instagram. Currently 162K posts are attributed to the biotin hashtag (#biotin) on Instagram. Whilst biotin supplementation is beneficial for numerous health conditions, including: multiple sclerosis (MS), diabetes, elevated cholesterol, and metabolic dysfunction, the increasing use of biotin by patients has created a problem with in vitro diagnostic testing.
With numerous manufacturers using biotin-streptavidin technology to develop in vitro diagnostic tests, combined with the rise in biotin supplementation use, the FDA (food and drug administration) issued an alert regarding the potential for erroneous results triggered by high levels of biotin in patient samples, at the end of 2017. Clinical decisions based on these false results from biotin technology can lead to inaccurate diagnosis and inappropriate treatment prescribed. The FDA confirmed that a patient, who was consuming high levels of biotin, died when a troponin tested was skewed and failed to show that the patient was having a heart attack. Other tests that can produce erroneous results include: cardiac, pregnancy, cancer and iron-deficiency tests.
(Halasey, 2018)
The image above highlights that in biotin-free patient samples, the analyte to be tested successfully binds to the biotinylated antibody and the labelled antibody ultimately ensuring accurate measurement. In the patient sample containing high levels of biotin, the biotin inhibits streptavidin’s ability to capture the analyte-antibody complex, generating falsely lowered results.
As 70% of all clinical decisions are based on results from in vitro diagnostic tests, it is vital that laboratories are selecting in vitro diagnostic tests that do not adopt the biotin-streptavidin technology to ensure accurate patient testing.
Randox do not utilise the biotin-streptavidin technology in the development of the Biochip Array Technology (BAT).
The Randox Biochip facilitates multiplex testing for faster, more comprehensive patient testing. This technology, free from biotin-streptavidin, uses capture antibodies bound to a solid substrate (biochip surface) as opposed to biotinylated antibodies used by other manufacturers. The Biochip also utilises enzyme labelled conjugate to enable chemiluminescent detection of the target in the patient sample.
Biochip test menu
The Biochip Array Technology (BAT) from Randox is capable of simultaneous multi-analyte diagnostic testing within the fields of clinical research and drugs of abuse testing. The technology works through combining a panel of related assays on a single biochip with a single set of reagents, controls and calibrators. An extensive range of Biochip panels are available, each optimised to provide the best performance.
Evidence
The evidence analyser is the world’s first protein Biochip Array Technology system and has truly transformed laboratory diagnostics worldwide. As the first of its kind, the Evidence has introduced higher standards of quality efficiency and reliability to numerous sectors including hospitals and clinical laboratories, forensic and clinical toxicology, pharmaceutical/CRO applications, as well as veterinary laboratories.
Evidence Evolution
The world’s first fully automated random access Biochip testing platform. The Evidence Evolution is set to revolutionise current diagnostic testing. With the capability to process up to 2,640 tests per hour, the Evidence Evolution utilises multiplexing technology, offering advanced test consolidation, patient profiling, a complete system integration, as well as the most comprehensive test menu on the market.
Investigator
The #1 choice for research, clinical, forensic, and veterinary testing. Using the multiplexing technology, the semi-automated benchtop immunoanalyser Evidence Investigator is suitable for medium throughput laboratories. In addition to the current test menu for this analyser, Randox have new tests in development.
In 2002, Randox invented a world first, Biochip Array Technology (BAT), instantly changing the landscape of diagnostic testing forever. BAT is a multi-analyte platform which provides an unrivaled 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. So now the patient’s needs become the focus, as BAT delivers the multiple results needed for improved diagnosis.
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 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. Utilising this technology, the Evidence series guarantees cost-effective, highly accurate and flexible testing solutions.
Click on the immunoanalysers below for more information
Evidence Investigator
Evidence MultiSTAT
Evidence
Why choose the Evidence Series?
Biochip Array Technology has a proven high standard of precise test results with CVs <10%
Multiplex testing reduces the amount of time and labour spent on individual tests and associated laboratory costs
Simultaneous testing represents greater value for money as fewer patient samples are able to deliver more in-depth analysis
Testing for multiple markers simultaneously increases the amount of patient information rapidly available to the clinician, allowing for more informed diagnosis
Randox has the world's most innovative test development program, ensuring that with Biochip Array Technology you are able to offer improved options from your laboratory
Multiple sample types can be used on one immunoanalyser including serum, plasma, whole blood, urine and oral fluid
Vast Biochip Array Technology test menu allows clinicians to detect routine and novel markers for advanced analysis
Through utilising a smaller sample volume, more assays can be run without needing further collections
