Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference
Paul Grimsey,Nicolas Frey,Garnet Bendig,Juergen Zitzler,Oliver Lorenz,Dusanka Kasapic,Christian Zaugg +6 more
- Vol. 2, Iss: 4, pp 247-256
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TLDR
The effective half-life of biotin and biotin metabolites is evaluated, and a pharmacokinetic (PK) model is established to simulate the time taken for the biotin concentration to fall below a series of thresholds to avoid false assay results.Abstract:
Aim: Biotin in human serum is a potential interfering factor for streptavidin-biotin-based assays. We aimed to evaluate the effective half-life of biotin and biotin metabolites, and establish a pharmacokinetic (PK) model to simulate the time taken for the biotin concentration to fall below a series of thresholds. Materials & methods: PK properties of biotin (5, 10 and 20 mg daily) were evaluated in healthy participants. Biotin serum concentrations were simulated for high-dose regimens (1 mg daily to 300 mg q.i.d.) using a population PK model. Results: Washout periods required for biotin concentrations to reach thresholds ranging from 10 to 100 ng/ml were successfully simulated. Conclusion: Our simulations provide valuable guidance on biotin washout periods necessary to avoid false assay results.read more
Citations
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Clinical and Analytical Performance of an Automated Serological Test That Identifies S1/S2-Neutralizing IgG in COVID-19 Patients Semiquantitatively.
Fabrizio Bonelli,Antonella Sarasini,Claudia Zierold,Mariella Calleri,Alice Bonetti,Chiara Vismara,Frank Blocki,Luca Pallavicini,Alberto Chinali,Daniela Campisi,Elena Percivalle,Anna Pia DiNapoli,Carlo Federico Perno,Fausto Baldanti +13 more
TL;DR: An automated LIAISON SARS-CoV-2 S1/S2 IgG assay brings efficient, sensitive, specific, and precise serological testing to the laboratory, with the capacity to test large amounts of samples per day; first results are available within 35 min, with a throughput of 170 tests/hour.
Journal ArticleDOI
Prevalence of biotin supplement usage in outpatients and plasma biotin concentrations in patients presenting to the emergency department.
TL;DR: 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.
Posted ContentDOI
Clinical And Analytical Performance Of An Automated Serological Test That Identifies S1/S2 Neutralizing IgG In Covid-19 Patients Semiquantitatively
Fabrizio Bonelli,Antonella Sarasini,Claudia Zierold,Mariella Calleri,Alice Bonetti,Chiara Vismara,Frank Blocki,Luca Pallavicini,Alberto Chinali,Daniela Campisi,Elena Percivalle,Anna Pia DiNapoli,Carlo Federico Perno,Fausto Baldanti +13 more
TL;DR: DiaSorin has developed an automated serology based assay for the measurement of IgG specific to SARS CoV-2 Spike protein, and tested its clinical performance in collaboration with Italian health care professionals who provided access to large numbers of samples from infected and non-infected individuals.
Journal ArticleDOI
Best practices in mitigating the risk of biotin interference with laboratory testing
Raffick A.R. Bowen,Raul Benavides,Jessica M Colón-Franco,Brooke M. Katzman,Alagarraju Muthukumar,Hossein Sadrzadeh,Joely A. Straseski,Ursula Klause,Nam K. Tran +8 more
TL;DR: A best practice workflow for laboratory scientists to evaluate discrepant immunoassay results is proposed, comprising: serial dilution; retesting after biotin clearance and/or repeat testing on an alternate platform; and confirmation of the presence of biotin using depletion protocols or direct measurement ofBiotin concentrations.
References
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Journal ArticleDOI
The biotin-(strept)avidin system: principles and applications in biotechnology.
TL;DR: An overview of the biotin-(strept)avidin system is presented, its components and advantages are described, and how the system is used in various applications, with emphasis on immunological and nucleic acid hybridization assays.
Journal ArticleDOI
MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study
Ayman Tourbah,Christine Lebrun-Frenay,Gilles Edan,Michel Clanet,Caroline Papeix,Sandra Vukusic,Jérôme De Seze,Marc Debouverie,Olivier Gout,Pierre Clavelou,Gilles Defer,David-Axel Laplaud,Thibault Moreau,Pierre Labauge,Bruno Brochet,Frédéric Sedel,Jean Pelletier +16 more
TL;DR: In a double-blind, placebo-controlled study, MD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated.
Journal ArticleDOI
High doses of biotin in chronic progressive multiple sclerosis: a pilot study.
Frédéric Sedel,Caroline Papeix,Agnès Bellanger,Valerie Touitou,Christine Lebrun-Frenay,Damien Galanaud,Olivier Gout,Olivier Lyon-Caen,Ayman Tourbah +8 more
TL;DR: Preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS.
Journal ArticleDOI
False biochemical diagnosis of hyperthyroidism in streptavidin-biotin-based immunoassays: the problem of biotin intake and related interferences
Marie-Liesse Piketty,Michel Polak,Isabelle Flechtner,Laura Gonzales-Briceño,Jean-Claude Souberbielle +4 more
TL;DR: A review of immunoassays for hormone measurement underlines the importance of keeping close interactions between biologists and clinicians to be able to correlate the hormonal assay results with the clinical picture.
Journal ArticleDOI
Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis
TL;DR: Results of randomized, double-blind, placebo-controlled trial in 154 progressive MS patients confirmed the beneficial effect of MD1003 (high-dose biotin) on reversing or stabilizing disability progression, with a good safety profile.