Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan.
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Reagent Kits, Diagnostic
/
COVID-19 Serological Testing
Type of study:
Diagnostic study
/
Experimental Studies
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Bioanalysis
Year:
2022
Document Type:
Article
Affiliation country:
BIO-2021-0254
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