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Licensed Unlicensed Requires Authentication Published by De Gruyter April 22, 2020

Biotin interference: evaluation of a new generation of electrochemiluminescent immunoassays for high-sensitive troponin T and thyroid-stimulating hormone testing

  • Samy Mzougui , Julien Favresse ORCID logo , Reza Soleimani ORCID logo , Catherine Fillée and Damien Gruson EMAIL logo

Abstract

Background

Biotin is currently a matter of concern for laboratories using biotin-streptavidin-based immunoassays. Biotin interferences have been reported for high-sensitive troponin T (hsTnT) and thyroid-stimulating hormone (TSH) assays. We aimed to evaluate the new generation of hsTnT and TSH electrochemiluminescent immunoassays announced to be less sensitive to biotin.

Methods

Firstly, we assessed the analytical performances of new generation assays (imprecision, bias, total error, limit of quantification) and compared previous and new generation assays in the absence of biotin. Secondly, we challenged both generations of assays with samples spiked with seven different biotin levels. The efficiency of new generation assays was also compared to the streptavidin beads treatment.

Results

New generation assays presented suitable analytical performances. Previous and new generations of hsTnT and TSH assays were commutable in the absence of biotin. In the presence of biotin, we confirmed that previous generation assays were affected by biotin concentration as low as 40.5 ng/mL and that new generation assays were not affected up to the announced tolerance threshold of 1200 ng/mL. After the streptavidin beads treatment, we observed a higher imprecision for both parameters and a constant 10% negative bias for TSH compared to new generation assays.

Conclusions

New generation of electrochemiluminescent immunoassays appears as a reliable systematic solution to prevent biotin interference for hsTnT and TSH testing.


Corresponding author: Prof. Damien Gruson, Department of Clinical Biochemistry, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Brussels, Belgium; and Pôle de recherche en Endocrinologie, Diabète et Nutrition, Institut de Recherche Expérimentale et Clinique, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Tour Claude Bernard, 54 Avenue Hippocrate, 1200 Brussels, Belgium, Phone: +32-(0)2-7646747, Fax: +32-(0)2-7646930

Acknowledgments

The authors would like to thank the laboratory technicians of the Department of Clinical Biochemistry, Cliniques Universitaires St-Luc, without whom this work would not have been possible.

  1. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: Authors state no conflict of interest.

  6. Informed consent: Informed consent was obtained from all individuals included in this study.

  7. Ethical approval: The research related to human use complied with all the relevant national regulations, institutional policies and in accordance with the tenets of the Helsinki Declaration.

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Received: 2020-02-27
Accepted: 2020-03-20
Published Online: 2020-04-22
Published in Print: 2020-11-26

©2020 Walter de Gruyter GmbH, Berlin/Boston

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