The biotin interference within interference suppressed immunoassays

Journal of Clinical Laboratory Analysis, vol. 35, pp. e23940

Abstract

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.

Authors 2

1. Ralf Weiskirchen Aachen Institute for Molecular Pathobiochemistry Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC)

   RWTH Aachen University · Universitätsklinikum Aachen

   Affiliation as printed

   Institute for Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC) University Hospital RWTH Aachen Germany

   Institute for Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC), University Hospital RWTH, Aachen, Germany

2. Josef van Helden corresponding Aachen Institute for Molecular Pathobiochemistry Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC)

   RWTH Aachen University · Universitätsklinikum Aachen

   Affiliation as printed

   Institute for Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC) University Hospital RWTH Aachen Germany

   Laboratory Dr. Stein and Colleagues Mönchengladbach Germany

   Institute for Molecular Pathobiochemistry, Experimental Gene Therapy and Clinical Chemistry (IFMPEGKC), University Hospital RWTH, Aachen, Germany