TY - JOUR
T1 - Best practices in mitigating the risk of biotin interference with laboratory testing
AU - Bowen, Raffick
AU - Benavides, Raul
AU - Colón-Franco, Jessica M.
AU - Katzman, Brooke M.
AU - Muthukumar, Alagarraju
AU - Sadrzadeh, Hossein
AU - Straseski, Joely
AU - Klause, Ursula
AU - Tran, Nam
N1 - Funding Information:
This work was supported by Roche Diagnostics . The sponsor was involved in the interpretation of data, preparation of the article, and the decision to submit the article for publication.
Funding Information:
This work was supported by Roche Diagnostics. The sponsor was involved in the interpretation of data, preparation of the article, and the decision to submit the article for publication.Medical writing support, under the guidance of the authors, was provided by Louise Kelly, BSc (Gardiner-Caldwell Communications, Macclesfield, UK) and funded by Roche Diagnostics International Ltd.
Publisher Copyright:
© 2019
PY - 2019
Y1 - 2019
N2 - Dietary biotin intake does not typically result in blood biotin concentrations that exceed interference thresholds for in vitro diagnostic tests. However, recent trends of high-dose biotin supplements and clinical trials of very high biotin doses for patients with multiple sclerosis have increased concerns about biotin interference with immunoassays. Estimates of the prevalence of high biotin intake vary, and patients may be unaware that they are taking biotin. Since 2016, 92 cases of suspected biotin interference have been reported to the US Food and Drug Administration. Immunoassays at greatest risk from biotin interference include thyroid and reproductive hormones, cardiac, and immunosuppressive drug tests. Several case studies have highlighted the challenge of biotin interference with thyroid hormone assays and the potential misdiagnosis of Graves' disease. Biotin interference should be suspected when immunoassay test results are inconsistent with clinical information; a clinically relevant biotin interference happens when the blood biotin concentration is high and the assay is sensitive to biotin. We propose a best practice workflow for laboratory scientists to evaluate discrepant immunoassay results, comprising: (1) serial dilution; (2) retesting after biotin clearance and/or repeat testing on an alternate platform; and (3) confirmation of the presence of biotin using depletion protocols or direct measurement of biotin concentrations. Efforts to increase awareness and avoid patient misdiagnosis should focus on improving guidance from manufacturers and educating patients, healthcare professionals, and laboratory staff. Best practice guidance for laboratory staff and healthcare professionals would also provide much-needed information on the prevention, detection, and management of biotin interference.
AB - Dietary biotin intake does not typically result in blood biotin concentrations that exceed interference thresholds for in vitro diagnostic tests. However, recent trends of high-dose biotin supplements and clinical trials of very high biotin doses for patients with multiple sclerosis have increased concerns about biotin interference with immunoassays. Estimates of the prevalence of high biotin intake vary, and patients may be unaware that they are taking biotin. Since 2016, 92 cases of suspected biotin interference have been reported to the US Food and Drug Administration. Immunoassays at greatest risk from biotin interference include thyroid and reproductive hormones, cardiac, and immunosuppressive drug tests. Several case studies have highlighted the challenge of biotin interference with thyroid hormone assays and the potential misdiagnosis of Graves' disease. Biotin interference should be suspected when immunoassay test results are inconsistent with clinical information; a clinically relevant biotin interference happens when the blood biotin concentration is high and the assay is sensitive to biotin. We propose a best practice workflow for laboratory scientists to evaluate discrepant immunoassay results, comprising: (1) serial dilution; (2) retesting after biotin clearance and/or repeat testing on an alternate platform; and (3) confirmation of the presence of biotin using depletion protocols or direct measurement of biotin concentrations. Efforts to increase awareness and avoid patient misdiagnosis should focus on improving guidance from manufacturers and educating patients, healthcare professionals, and laboratory staff. Best practice guidance for laboratory staff and healthcare professionals would also provide much-needed information on the prevention, detection, and management of biotin interference.
KW - Biotin
KW - Biotin interference
KW - Biotin supplements
KW - Immunoassay
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U2 - 10.1016/j.clinbiochem.2019.08.012
DO - 10.1016/j.clinbiochem.2019.08.012
M3 - Review article
C2 - 31473202
AN - SCOPUS:85071568724
SN - 0009-9120
JO - Clinical Biochemistry
JF - Clinical Biochemistry
ER -