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/

For any additional questions, please contact Randox PR by email: randoxpr@randox.com or by phoning 028 9442 2413