Recent studies and case reports are driving awareness that Biotin can interfere with labo-
ratory testing. Patients, laboratories and physicians may not know about the presence of
Biotin, so education and awareness can help reduce the potential for diagnostic errors.
In 2015 a 55-year-old man with multiple sclerosis was referred to a hospital thyroid unit because the screening thyroid
function tests showed markedly elevated FT4 and FT3 results nd low (apparently suppressed) levels of TSH
1
. This pat-
tern of results typically suggests a severe form of Graves’ disease. However a thyroid scan with 123-Iodine showed a
normal thyroid gland with normal radioiodine uptake. The patient showed no symptoms of hyperthyroidism. As the
biochemical results were discordant with the patient’s clinical assessment, investigations for assay interference from
drugs or other compounds were conducted.
It emerged that the patient had taken very high doses of biotin (300 mg daily, roughly 1,000 times the recommended
daily intake) as a study had suggested that biotin might be beneficial for multiple sclerosis patients. The discontinua-
tion of biotin supplements resulted in the FT4, FT3 and TSH results returning to within reference range values in just
a few days.
Just a few months ago, the U.S Food and Drug Administration (FDA) issued a Safety Communication
2
to alert the pub-
lic, health care providers and laboratory personnel that Biotin can interfere with certain lab tests (including troponin)
and cause incorrect lab test results which in one case reported to the FDA was linked to the death of a patient.
Abbott has recently conducted an evaluation and no on-market ARCHITECT assay formulations use the free capture
streptavidin/biotin assay format referenced
3.
5 steps to help reduce laboratory errors caused by biotin
1. Raise Awareness
2. Know your assays and the impact biotin can have on them
3. Educate your health care providers and patients
4. Have a contingency plan for acute care settings
5. Recognise there are laboratory methods that are not impacted by biotin
that can provide an alternative option for your patients
References
1. Barbesino Thyroid 2016; 26: 860–863.
2.
MedicalProducts/ucm586641.htm
3. Abbott Product Information Letter PI1011-2017.
For more information
T: +45 39770008
E:
Biotin beware – why?
GORDON AVERY MSC, MANAGER
MEDICAL AFFAIRS IN ABBOTT,
GIVES A BRIEF OVERVIEW OF BIOTIN
INTERFERENCE IN SOME IMMUNOASSAYS
