Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan

Author:

Shibata Hiroko1,Nishimura Kazuko1,Maeda Takuya2,Honma Masamitsu3,Goda Yukihiro3,Ishii-Watabe Akiko1,Saito Yoshiro4ORCID

Affiliation:

1. Division of Biological Chemistry & Biologicals, National Institute of Health Sciences, Kanagawa, 210-9501, Japan

2. Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, 350-0495, Japan

3. National Institute of Health Sciences, Kanagawa, 210-9501, Japan

4. Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, 210-9501, Japan

Abstract

Background: With the spread of COVID-19, anti-SARS-CoV-2 antibody tests have been utilized. Herein we evaluated the analytical performance of anti-SARS-CoV-2 antibody test kits using a new reference standard prepared from COVID-19 patient sera. Methods: Fifty-seven kits in total (16 immunochromatography types, 11 ELISA types and 30 types for automated analyzers) were examined. By measuring serially diluted reference standards, the maximum dilution factor showing a positive result and its precision were investigated. Results: The measured cut-off titers varied largely depending on the antibody kit; however, the variability was small, with the titers obtained by each kit being within twofold in most cases. Conclusion: The current results suggest that a suitable kit should be selected depending on the intended purpose.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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