A rise in adverse events, including one death, due to biotin interference with lab tests overseas has implications for Australia, experts warn.
Biotin (also known as vitamin B7) is found in levels well above the US recommended daily allowance of 0.03 mg in a range of over the counter vitamins and hair, skin and nail growth supplements.
High levels in patient samples can lead to false negative and false positive results in pathology tests – including tests for hormones and troponin – that use biotin technology.
The technology uses biotin due to its ability to bond with specific proteins which can be measured to detect certain health conditions.
Now the FDA is warning of an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.
The recommended daily allowance of 0.03 mg per day will not cause significant interference, but some supplements contain up to 20 mg, while some physicians recommend up to 300 mg per day for conditions like multiple sclerosis, the US agency said.
Given some labs in Australia are highly dependent on biotin technology the warning has implications here in Australia, said Clinical Professor John Burnett, a consultant chemical pathologist at PathWest in Western Australia.
The range of biotin-based tests include hormone tests, serology for hepatitis, tumour markers and troponin, he said.
Pathologists have long been aware of the potential for interference with biotin, which is present in many foods.
“The issue has come about because of these extremely high levels that are being used for health and beauty reasons,” said Professor Burnett, who is chair of the Royal College of Pathologists of Australasia’s chemical pathology advisory committee.
He said given the US experience, local labs should get on the front foot.
“The laboratories that use biotin technology should inform their requesting doctors and the doctors need to inform their patients that if they are on high doses of biotin for whatever reason, that they would need to stop those supplements for at least two days before they have their laboratory testing done.”
A spokesperson for the TGA said it is “considering whether further action is warranted” following the FDA alert.
“Should health professionals have concerns regarding the performance of an in vitro diagnostic medical device in relation to interference from biotin, they can submit a report to the TGA”.