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Bioanalysis ; 14(6): 325-340, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1726396

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.


Subject(s)
COVID-19 Serological Testing/methods , Reagent Kits, Diagnostic , Antibodies, Viral/blood , Automation, Laboratory , COVID-19 Serological Testing/instrumentation , COVID-19 Serological Testing/standards , Enzyme-Linked Immunosorbent Assay/instrumentation , Enzyme-Linked Immunosorbent Assay/methods , Humans , Immunoglobulin G/blood , Japan , SARS-CoV-2/immunology
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