@article{adae3cd65bc64e8cbfe64f84d16e22de,
title = "Susceptibility of cardiac troponin assays to biotin interference",
abstract = "Objectives To investigate biotin interference on three cardiac troponin (cTn) assays and demonstrate a method to overcome biotin interference. Methods cTn levels were measured in (1) plasma from healthy volunteers on 10-mg daily biotin supplementation mixed with a plasma with known elevated troponin, (2) plasmas with known elevated cTn after mixing in reagent biotin to simulate supplementation, and (3) biotin-spiked plasma specimens pretreated with streptavidin-agarose beads. Results Daily biotin ingestion (10 mg) and studies simulating daily biotin use resulted in significant interference in the Gen5 cardiac troponin T (cTnT) assay; the contemporary Gen 4 cTnT and high-sensitivity cardiac troponin I (hs-cTnI) assays were unaffected. The biotin interference threshold was 31, 315, and more than 2,000 ng/mL for Gen5 cTnT, cTnT, and hs-cTnI assays, respectively. Streptavidin pretreatment blocked biotin interference in cTn assays. Conclusions Biotin interference is possible at plasma concentrations achievable by ingestion of over-the-counter supplements that may lead to delayed or missed diagnosis of myocardial injury with the Gen5 cTnT assay.",
keywords = "Biotin, Interference, Myocardial infarction, Troponin",
author = "Frame, {Ithiel J.} and Joshi, {Parag H.} and Caroline Mwangi and Ian Gunsolus and {De Lemos}, {James A.} and Das, {Sandeep R.} and Ravi Sarode and Jyoti Balani and Apple, {Fred S.} and Alagarraju Muthukumar",
note = "Funding Information: Corresponding author: Alagarraju Muthukumar, PhD; Alagarraju.Muthukumar@UTSouthwestern.edu. *First author. This work was supported by an institutional grant from the Department of Pathology, UT Southwestern Medical Center. Disclosures: P.H.J. reports serving as a noncompen-sated site principal investigator (PI) for studies funded by AstraZeneca, Pfizer, Regeneron/Sanofi, and Novo Nordisk, as well as modest consulting income from Regeneron. I.G. reports receiving a speaking honorarium from Abbott Diagnostics. J.A.D. reports grant support from Roche Diagnostics and Abbott Diagnostics, as well as consulting income from Roche Diagnostics and Ortho Clinical Diagnostics, and served on end-point review committees for Alere, Radiometer, and Siemen{\textquoteright}s Health Care Diagnostics. S.R.D. reports consulting income from Roche Diagnostics. F.S.A. reports serving on the Board of Directors for HyTest, the Advisory Board for Instrumentation Laboratory and LumiraDx, as an associate editor for Clinical Chemistry, and as noncompensated PI for studies funded by the Minneapolis Medical Research Foundation from the following cardiac biomarker companies: Siemens, Abbott Diagnostics, Abbott POC, Ortho-Clinical Diagnostics, Singulex, Beckman Coulter, Qorvo, and Alere/ Quidel. A.M. reports serving as an Advisory Committee member for Roche Diagnostics and noncompensated PI for studies funded by Abbott Diagnostics. All other authors have no disclosures. Parts of this work was presented at two national/international meetings: (1) Academy of Clinical Laboratory Physicians and Scientists Annual Meeting, May 30, 2018, Houston, TX (Young Investigator Award to I.J.F.) and (2) American Association of Clinical Chemistry Annual Scientific Meeting, July 31, 2018, Chicago, IL (Distinguished Abstract Award to I.G.). Publisher Copyright: {\textcopyright} American Society for Clinical Pathology, 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.",
year = "2019",
month = apr,
day = "2",
doi = "10.1093/ajcp/aqy172",
language = "English (US)",
volume = "151",
pages = "486--493",
journal = "American Journal of Clinical Pathology",
issn = "0002-9173",
publisher = "American Society of Clinical Pathologists",
number = "5",
}