김 and Kim: Clinical Usefulness of SARS-CoV-2 Antibody Test

Hyun Soo Kim1*

1Department of Laboratory Medicine, Hallym University College of Medicine, Chuncheon, Korea


*Corresponding author: E-mail: hskim0901@empas.com


ABSTRACT

SARS-CoV-2 antibody assay is a test that checks whether an antibody against the SARS- CoV-2 virus has been formed in the blood after SARS-CoV-2 infection or vaccination. SARS- CoV-2 antibody is detected 1–2 weeks after infection, and antibodies are produced in more than 90% of infected patients. The duration for the formation of antibodies differs by individual and by type of antibody. In the case of IgG, it is at least several months or longer, and the relationship between antibodies and immunity is being studied. As test methods, enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CIA), immunochromatographic assay, and neutralizing antibody assay have been developed and used. The target antibody to be detected differs depending on the type of recombinant antigen and the type of secondary antibody in reagents. Many kinds of commercialized SARS-CoV-2 antibody assays are currently being developed, and the S (spike) protein, N (nucleocapsid) protein, S1 or RBD (receptor binding domain) part of the S protein, and a mixture of these antigens are used as recombinant antigens of reagents. IgG, IgM, IgA, or total immunoglobulin antibodies in patients’ blood that react with these reagent antigens are detected. In this review, the types and performance of SARS-CoV-2 antibody tests and the guidelines for COVID-19 antibody tests published domestically and abroad were investigated.

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Table 1

Seroprevalence of SARS-CoV-2 IgG in healthcare workers, COVID-19 patients, and community-based population

Country

Sensitivity

Specificity

US FDA

90% overall, 70% IgM, 90% IgG

95% (overall - total)

UK MHRA (the Medicines and

Healthcare products Regulatory Agency)

> 98% (95% CI 96%-100%) on specimens collected

20 days or more after the first appearance of symptoms

> 98% (95% CI 96%-100%)

Health Canada

95% for IgG or total antibodies in samples collected

2 weeks or more after symptom onset.

98%

Abbreviations: FDA, Food and Drug Administration; CI, confidence interval.