Brooke M Katzman1, Alan J Lueke1, Leslie J Donato1, Allan S Jaffe2, Nikola A Baumann3. 1. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States. 2. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States; Department of Medicine, Mayo Clinic, Rochester, MN, United States. 3. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States. Electronic address: Baumann.nikola@mayo.edu.
Abstract
BACKGROUND: Several cases of biotin interference with laboratory testing have been reported in the literature. However, there are no publications discussing the extent of biotin use or plasma concentrations observed among the patient population. The objective of this study was to determine the prevalence of biotin consumption using two distinct methods: surveying the outpatient population using a questionnaire and quantifying biotin in plasma samples collected from patients presenting to the Emergency Department (ED). METHODS: Survey questionnaires (n = 4000) were distributed to Mayo Clinic outpatients over one week (July 10-14, 2017). Biotin was quantified in residual waste plasma samples collected for physician-ordered electrolyte panels from patients presenting to the ED (March 6-12, 2017 and March 26-April 4, 2017, n = 1442 unique patient samples). RESULTS: 1944 patients (972 female, 963 male, 9 no answer) with a median (interquartile range) age of 62 (49-72) years returned completed questionnaires (48.6%). From the completed surveys, 7.7% (95% CI, 6.6-8.9%) indicated biotin use. Quantitation of biotin in plasma samples from ED patients (n = 1442) revealed that 7.4% (95% CI, 6.2-8.9%) had concentrations at or above the lowest known threshold (10 ng/mL) for biotin interference in Roche Diagnostics immunoassay tests. CONCLUSIONS: According to our survey results, reported use of biotin was common. The range of biotin concentrations in ED patient samples highlights the magnitude of the biotin interference problem and identifies a population at risk for potential harm. These findings should guide laboratorians and clinicians in developing effective strategies to mitigate safety risks and in assessing biotin usage trends within their own patient populations.
BACKGROUND: Several cases of biotin interference with laboratory testing have been reported in the literature. However, there are no publications discussing the extent of biotin use or plasma concentrations observed among the patient population. The objective of this study was to determine the prevalence of biotin consumption using two distinct methods: surveying the outpatient population using a questionnaire and quantifying biotin in plasma samples collected from patients presenting to the Emergency Department (ED). METHODS: Survey questionnaires (n = 4000) were distributed to Mayo Clinic outpatients over one week (July 10-14, 2017). Biotin was quantified in residual waste plasma samples collected for physician-ordered electrolyte panels from patients presenting to the ED (March 6-12, 2017 and March 26-April 4, 2017, n = 1442 unique patient samples). RESULTS: 1944 patients (972 female, 963 male, 9 no answer) with a median (interquartile range) age of 62 (49-72) years returned completed questionnaires (48.6%). From the completed surveys, 7.7% (95% CI, 6.6-8.9%) indicated biotin use. Quantitation of biotin in plasma samples from ED patients (n = 1442) revealed that 7.4% (95% CI, 6.2-8.9%) had concentrations at or above the lowest known threshold (10 ng/mL) for biotin interference in Roche Diagnostics immunoassay tests. CONCLUSIONS: According to our survey results, reported use of biotin was common. The range of biotin concentrations in ED patient samples highlights the magnitude of the biotin interference problem and identifies a population at risk for potential harm. These findings should guide laboratorians and clinicians in developing effective strategies to mitigate safety risks and in assessing biotin usage trends within their own patient populations.
Authors: Chin-Shern Lau; Ya Li Liang; Soon Kieng Phua; Gillian Murtagh; Imo E Hoefer; Ron H Stokwielder; Milica Kosevich; Jennifer Yen; Jaganathan Sickan; Christos Varounis; Tar-Choon Aw Journal: Diagnostics (Basel) Date: 2022-05-08