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Research Articles

Biotin interference in routine IDS-iSYS immunoassays for aldosterone, renin, insulin-like growth factor 1, growth hormone and bone alkaline phosphatase

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Pages 6-11 | Received 18 Jun 2021, Accepted 26 Oct 2021, Published online: 03 Dec 2021

References

  • Zempleni J, Mock DM. Biotin biochemistry and human requirements. J Nutr Biochem. 1999;10(3):128–138.
  • Cree BAC, Cutter G, Wolinsky JS, et al. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2020;19(12):988–997.
  • Li D, Rooney MR, Burmeister LA, et al. Trends in daily use of biotin supplements among US adults, 1999–2016. JAMA. 2020;324(6):605–607.
  • Li D, Ferguson A, Cervinski MA, et al. AACC guidance document on biotin interference in laboratory tests. J Appl Lab Med. 2020;5(3):575–587.
  • Katzman BM, Lueke AJ, Donato LJ, et al. Prevalence of biotin supplement usage in outpatients and plasma biotin concentrations in patients presenting to the emergency department. Clin Biochem. 2018;60:11–16.
  • Trambas CM, Liu KC, Luu H, et al. Further assessment of the prevalence of biotin supplementation and its impact on risk. Clin Biochem. 2019;65:64–65.
  • Sanders A, Gama R, Ashby H, et al. Biotin immunoassay interference: a UK-based prevalence study. Ann Clin Biochem. 2021;58(1):66–69.
  • Ijpelaar A, Beijers A, van Daal H, et al. Prevalence of detectable biotin in The Netherlands in relation to risk on immunoassay interference. Clin Biochem. 2020;83:78–80.
  • The FDA warns that biotin may interfere with lab tests: FDA safety communication. 2017 [accessed 23 March 2021]. Available from: https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication
  • Piketty ML, Polak M, Flechtner I, et al. False biochemical diagnosis of hyperthyroidism in streptavidin-biotin-based immunoassays: the problem of biotin intake and related interferences. Clin Chem Lab Med. 2017;55(6):780–788.
  • Li D, Radulescu A, Shrestha RT, et al. Association of biotin ingestion with performance of hormone and nonhormone assays in healthy adults. JAMA. 2017; 318(12):1150–1160.
  • CLSI. Interference testing in clinical chemistry. CLSI guideline EP07. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institute; 2018.
  • Arendt JFH, Hansen AT, Ladefoged SA, et al. Existing data sources in clinical epidemiology: laboratory information system databases in Denmark. Clin Epidemiol. 2020;12:469–475.
  • Livaniou E, Evangelatos GP, Ithakissios DS, et al. Serum biotin levels in patients undergoing chronic hemodialysis. Nephron. 1987;46(3):331–332.
  • Grimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. Int J Pharmacokinet. 2017;2(4):247–256.
  • Peyro Saint Paul L, Debruyne D, Bernard D, et al. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12(3):327–344.
  • Haslam S, Hall C, Penny P, et al. Assessment of biotin interference in four routine IDS iSYS immunoassays. Clin Chim Acta. 2019;/06/01/493:S74.
  • Trambas C, Lu Z, Yen T, et al. Characterization of the scope and magnitude of biotin interference in susceptible roche elecsys competitive and sandwich immunoassays. Ann Clin Biochem. 2018;55(2):205–215.
  • Kit Insert. Immunodiagnostic systems-iSYS renin assay 7 June 2017.
  • Kit Insert. Immunodiagnostic systems-iSYS aldosterone assay 19 May 2015.
  • Kit Insert. Immunodiagnostic systems-iSYS human growth hormone assay 9 May 2019.
  • Kit Insert. Immunodiagnostic systems-iSYS insulin-like growth factor assay 28 March 2019.
  • Kit Insert. Immunodiagnostic systems-iSYS bone alkaline phosphatase assay 27 February 2017.
  • Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(5):1889–1916.
  • Subbarayan SK, Fleseriu M, Gordon MB, et al. Serum IGF-1 in the diagnosis of acromegaly and the profile of patients with elevated IGF-1 but normal glucose-suppressed growth hormone. Endocrin Pract. 2012;18(6):817–825.
  • Fleseriu M, Hashim IA, Karavitaki N, et al. Hormonal replacement in hypopituitarism in adults: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(11):3888–3921.
  • Mock DM, Nyalala JO, Raguseo RM. A direct streptavidin-binding assay does not accurately quantitate biotin in human urine. J Nutr. 2001;131(8):2208–2214.

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