Best practices in mitigating the risk of biotin interference with laboratory testing

Bowen, Raffick A.R.; Benavides, Raul; Colón-Franco, Jessica M; Katzman, Brooke M.; Muthukumar, Alagarraju; Sadrzadeh, Hossein; Straseski, Joely A.; Klause, Ursula; Tran, Nam K.

doi:10.1016/j.clinbiochem.2019.08.012

Cited by 47 publications

(69 citation statements)

References 75 publications

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“…Multivitamin formulations (containing biotin in microgram amounts) do not elevate plasma biotin concentrations sufficiently to interfere with immunoassays. However, high-dose biotin supplements or novel treatments with very high biotin doses for patients with multiple sclerosis have increased concerns about biotin interference [80]. In streptavidin-biotin binding immunoassays using a sandwich format, such as hs-cTn assays, the presence of biotin may decrease the signal intensity producing falsely low results that may go undetected and lead to potentially serious clinical implications such as inappropriate patient discharge.…”

Section: Understanding the Impact Of Pre-analytical And Analytical Inmentioning

confidence: 99%

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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A number of assay-related issues can affect the performance of cardiac troponin (cTn) measurement in everyday practice. In this respect, it is vital that all information on cTn assays is known and that the performance characteristics of assays are objectively assessed and adequately described. The advent of the latest generation of more sensitive cTn assays has heralded a new wave of information about low concentrations of cTn in blood. These recent generation assays have improved analytical sensitivity and corresponding performance at low cTn concentrations when compared to their predecessors, providing a convincing goal for laboratory medicine in helping clinicians in the diagnosis of acute myocardial infarction. Crucial to the clinical utility of highly sensitive cTn assays is the laboratorians’ role in closely scrutinizing proposed assays and defining their value in relation to available evidence. Analytical, as well as pre-analytical and post-analytical, aspects must be documented. In this review, we describe what laboratory professionals should know about their cTn assay performance characteristics and the pre-analytical prerequisites for robustness to ensure optimal post-analytical reporting.

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Section: Understanding the Impact Of Pre-analytical And Analytical Inmentioning

confidence: 99%

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Several independent studies have already confirmed much higher-than-manufacturer-reported interference thresholds in other assays. 36 To our knowledge, no other work group has evaluated biotin interference in Elecsys assays for toxoplasma IgM and toxoplasma IgG. Additional investigation will be required to further evaluate the results obtained for FT3, FT4, cortisol, toxoplasma IgM, and toxoplasma IgG.…”

Section: Discussionmentioning

confidence: 97%

“…32 Alternatives to biotin depletion for the evaluation of discrepant assay results in non-time-critical situations include discontinuation of biotin supplementation and repeated analysis after biotin clearance, serial dilution of samples, and repeat testing on an alternate platform. 36 As described above, each of these approaches suffers from specific drawbacks: serial dilutions can be time-consuming and overdilution can lead to inaccurate results, whereas repeat testing on an alternate platform usually requires sending samples to a reference laboratory for testing. Repeated analysis after biotin discontinuation and clearance might not be possible, because patients may not be available upon recognition of potential biotin interference.…”

Section: Discussionmentioning

confidence: 99%

“…Repeated analysis after biotin discontinuation and clearance might not be possible, because patients may not be available upon recognition of potential biotin interference. 36 Regardless of the chosen evaluation method, direct measurement of biotin concentrations should be performed to confirm biotin as the likely cause of interference. 36…”

Section: Discussionmentioning

confidence: 99%

“…36 Regardless of the chosen evaluation method, direct measurement of biotin concentrations should be performed to confirm biotin as the likely cause of interference. 36…”

Section: Discussionmentioning

confidence: 99%

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Interference From High-Dose Biotin Intake in Immunoassays for Potentially Time-Critical Analytes by Roche

Mrosewski

Urbank

Stauch

et al. 2020

Archives of Pathology &Amp; Laboratory Medicine

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Context.— Immunoassays using the interaction between streptavidin and biotin are used for clinical chemical analytes on platforms by many different manufacturers. The design can be susceptible to interference from high-dose biotin intake in patients, which remains an often-overlooked confounder despite recently increased awareness. Objective.— To evaluate an easily implementable method of in vitro biotin depletion for the removal of biotin interference in immunoassays for potentially time-critical analytes. Design.— A biotin stock solution was made and de-identified patient samples were spiked to reach a biotin concentration of 1.126 × 106 pg/mL, the maximum reported biotin concentration 1 to 2 hours after a single oral dose of 300 mg biotin. Then, the resulting interference in Elecsys immunoassays for cortisol, cyclosporine A, tacrolimus, digitoxin, thyroid-stimulating hormone, free triiodothyronine, free thyroxine, C-peptide, insulin, N-terminal pro-B–type natriuretic peptide, troponin T high sensitive, human immunodeficiency virus, procalcitonin, β human chorionic gonadotropin, toxoplasma immunoglobulin M, and toxoplasma immunoglobulin G was evaluated before and after biotin depletion using streptavidin particles. Results.— All tested immunoassays, with the exception of toxoplasma immunoglobulin M and toxoplasma immunoglobulin G, suffered from significant biotin interference. The depletion protocol removed assay interference due to biotin and produced results that were close or identical to initial prespike measurements. Conclusions.— Despite an increase in turnaround times, biotin adsorption is a feasible countermeasure for biotin interference in Elecsys immunoassays. Until test kits with an increased resistance to the interference from high-dose biotin intake are distributed, the evaluated protocol can provide results properly reflecting the patient's clinical condition.

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The biotin interference within interference suppressed immunoassays

Kabiri

Weiskirchen

Helden

2021

Clinical Laboratory Analysis

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Background Reports of false laboratory findings due to a biotin supplementation have raised concerns about the safety of immunoassays. According to current research, biotin is known to cause interference in immunoassays. Since up to 70% of medical decisions are based on laboratory results and the significantly increased intake of biotin supplements in the recent years, the reliability of immunoassays is essential. Methods To evaluate this reliability two experiments were conducted. In the first experiment 59 interference suppressed immunoassays of the manufacturer Roche Diagnostics were examined regarding their sensitivity to a biotin interference. In the second experiment the pharmacokinetic of biotin was examined by supplementing volunteers with biotin. Results A combination of the results of both experiments suggests that a biotin interference in laboratory findings is probable. Contrary to the current state of research on sandwich immunoassays, falsely elevated test results occur more frequently than falsely low results. Conclusion The interference suppressed immunoassays have shown in the experiment that they are susceptible to a biotin interference. Therefore, laboratory institutions, medical staff and patients must be aware of the possibility of a biotin interference. As a result, Roche Diagnostics may consider reviewing the interference suppression and their indications of the tests.

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Best practices in mitigating the risk of biotin interference with laboratory testing

Cited by 47 publications

References 75 publications

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Interference From High-Dose Biotin Intake in Immunoassays for Potentially Time-Critical Analytes by Roche

The biotin interference within interference suppressed immunoassays

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