İmmünokimyasal Yöntemlerde Biyotin İnterferansı

Authors

Emiş Deniz Akbulut

Synopsis

In this chapter featured in the book Güncel Biyokimya Çalışmaları II, the study titled "Biotin Interference in Immunochemical Methods" by Specialist Dr. Emiş Deniz Akbulut comprehensively examines the negative effects of biotin (vitamin B7) usage on clinical laboratory tests and its analytical interference mechanisms. Serving as an essential coenzyme in carbohydrate, lipid, and amino acid metabolism, biotin is widely consumed today in cosmetic supplements as well as high to mega doses for treating congenital metabolic and neurological disorders such as biotinidase deficiency and multiple sclerosis. Although the strong biochemical interaction between biotin and streptavidin is widely utilized in immunoassay designs, high biotin concentrations in patient samples disrupt the separation step, leading to falsely low results in sandwich assays and falsely high results in competitive assays. This analytical distortion can generate misleading laboratory profiles mimicking endocrine pathologies like hyperthyroidism or vitamin D toxicity, potentially causing misdiagnoses. The chapter underscores the critical importance of enhancing communication among clinicians, patients, laboratories, and manufacturers, conducting thorough patient histories, utilizing alternative non-interfering assay methods, and fostering analytical awareness to ensure accurate clinical diagnosis and patient safety.

References

Institute of Medicine Standing Committee on the Scientific Evaluation of Dietary Reference I, its Panel on Folate OBV, Choline. The National Academies Collection: Reports funded by National Institutes of Health. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B(6), Folate, Vitamin B(12), Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US) National Academy of Sciences.; 1998.

Katzman BM, Lueke AJ, Donato LJ, Jaffe AS, Baumann NA. Prevalence of biotin supplement usage in outpatients and plasma biotin concentrations in patients presenting to the emergency department. Clin Biochem. 2018;60:11-6.

Trambas CM, Liu KC, Luu H, Louey W, Lynch C, Yen T, et al. Further assessment of the prevalence of biotin supplementation and its impact on risk. Clin Biochem. 2019;65:64-5.

A IJ, Beijers A, van Daal H, van den Ouweland JMW. Prevalence of detectable biotin in The Netherlands in relation to risk on immunoassay interference. Clin Biochem. 2020;83:78-80.

Sanders A, Gama R, Ashby H, Mohammed P. Biotin immunoassay interference: A UK-based prevalence study. Ann Clin Biochem. 2021;58(1):66-9.

Soleymani T, Lo Sicco K, Shapiro J. The Infatuation With Biotin Supplementation: Is There Truth Behind Its Rising Popularity? A Comparative Analysis of Clinical Efficacy versus Social Popularity. J Drugs Dermatol. 2017;16(5):496-500.

Wolf B. Biotinidase deficiency: “if you have to have an inherited metabolic disease, this is the one to have”. Genet Med. 2012;14(6):565-75.

Alfadhel M, Almuntashri M, Jadah RH, Bashiri FA, Al Rifai MT, Al Shalaan H, et al. Biotin-responsive basal ganglia disease should be renamed biotin-thiamine-responsive basal ganglia disease: a retrospective review of the clinical, radiological and molecular findings of 18 new cases. Orphanet J Rare Dis. 2013;8:83.

Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, et al. MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study. CNS Drugs. 2018;32(7):661-72.

Li D, Ferguson A, Cervinski MA, Lynch KL, Kyle PB. AACC Guidance Document on Biotin Interference in Laboratory Tests. J Appl Lab Med. 2020;5(3):575-87.

Barbesino G. Misdiagnosis of Graves’ Disease with Apparent Severe Hyperthyroidism in a Patient Taking Biotin Megadoses. Thyroid. 2016;26(6):860-3.

Elston MS, Sehgal S, Du Toit S, Yarndley T, Conaglen JV. Factitious Graves’ Disease Due to Biotin Immunoassay Interference-A Case and Review of the Literature. J Clin Endocrinol Metab. 2016;101(9):3251-5.

Khieng V, Stevens C. Vitamin D toxicity?: a case study. New Zealand Journal of Medical Laboratory Science. 2010;64(2):44-50.

US FDA (2019) Safety Communication UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests Food and Drug Administration 06/08/2021 tarihinde https://wwwfdagov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication adresinden ulaşılmıştır.

Holmes EW, Samarasinghe S, Emanuele MA, Meah F. Biotin Interference in Clinical Immunoassays: A Cause for Concern. Arch Pathol Lab Med. 2017;141(11):1459-60.

Colon PJ, Greene DN. Biotin Interference in Clinical Immunoassays. J Appl Lab Med. 2018;2(6):941-51.

Samarasinghe S, Meah F, Singh V, Basit A, Emanuele N, Emanuele MA, et al. Biotin Interference with Routine Clinical Immunoassays: Understand The Causes and Mitigate The Risks. Endocr Pract. 2017;23(8):989-98.

Ostrowska M, Bartoszewicz Z, Bednarczuk T, Walczak K, Zgliczyński W, Glinicki P. The effect of biotin interference on the results of blood hormone assays. Endokrynol Pol. 2019;70(1):10221.

Agency EM. PRAC recommendations on signals. Pharmacovigilance Risk Assessment Committee; 2014.

Clevidence BA, Marshall MW, Canary JJ. Biotin levels in plasma and urine of healthy adults consuming physiological doses of biotin. Nutrition Research. 1988;8(10):1109-18.

Chun KY. Biotin Interference in Diagnostic Tests. Clin Chem. 2017;63(2):619-20.

Luong JH, Vashist SK. Chemistry of Biotin–Streptavidin and the Growing Concern of an Emerging Biotin Interference in Clinical Immunoassays. ACS omega. 2019;5(1):10-8.

Meany DL, Jan de Beur SM, Bill MJ, Sokoll LJ. A case of renal osteodystrophy with unexpected serum intact parathyroid hormone concentrations. Clin Chem. 2009;55(9):1737-9.

Piketty ML, Polak M, Flechtner I, Gonzales-Briceño L, Souberbielle JC. 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):780-8.

Testing for Biotin Interference in In Vitro Diagnostic Devices Guidance for Industry. (2020). 06/08/2021 tarihinde https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-biotin-interference-in-vitro-diagnostic-devices adresinden ulaşılmıştır.

Faix JD. Principles and pitfalls of free hormone measurements. Best Pract Res Clin Endocrinol Metab. 2013;27(5):631-45.

Bowen R, Benavides R, Colón-Franco JM, Katzman BM, Muthukumar A, Sadrzadeh H, et al. Best practices in mitigating the risk of biotin interference with laboratory testing. Clin Biochem. 2019;74:1-11.

Piketty ML, Prie D, Sedel F, Bernard D, Hercend C, Chanson P, et al. High-dose biotin therapy leading to false biochemical endocrine profiles: validation of a simple method to overcome biotin interference. Clin Chem Lab Med. 2017;55(6):817-25.

Trambas C, Lu Z, Yen T, Sikaris K. Depletion of biotin using streptavidin-coated microparticles: a validated solution to the problem of biotin interference in streptavidin-biotin immunoassays. Ann Clin Biochem. 2018;55(2):216-26.

Published

October 4, 2021

License

License