Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies.

Abstract:

Background:Seroprevalence studies of coronavirus disease 2019 (COVID-19) cases, including asymptomatic and past infections, are important to estimate the scale of the disease outbreak and to establish quarantine measures. We evaluated the clinical performance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody assays available in Korea for use in seroprevalence studies. Methods:The sensitivity, specificity, cross-reactivity, and interference of five SARS-CoV-2 antibody assays were evaluated using the following: 398 serum samples from confirmed COVID-19 patients, 510 negative control samples from before 2018 (pre-pandemic), 163 serum samples from patients with SARS, Middle East respiratory syndrome (MERS), and other viral infections, and five samples for the interference study. Results:The sensitivities of the five assays ranged from 92.2% to 98%, and their specificities, including cross-reactivity and interference, ranged from 97.5% to 100%. The agreement rates were excellent (kappa >0.9). Adjustment of the cutoff values could be considered through ROC curve analysis. The positive predictive values of the individual assays varied from 3.5% to 100% at a 0.1% prevalence but were as high as ≥95% when two assays were combined. Conclusions:The prevalence of COVID-19 in Korea is considered to be exceptionally low at present; thus, we recommend using a combination of two or more SARS-CoV-2 antibody assays rather than a single assay. These results could help select SARS-CoV-2 antibody assays for COVID-19 seroprevalence studies in Korea.

journal_name

Ann Lab Med

authors

Park Y,Hong KH,Lee SK,Hyun J,Oh EJ,Lee J,Lee H,Song SH,Kee SJ,Kwon GC,Kim SH,Do HN,Kim AR,Lee JW,Kim SS,Kim HS

doi

10.3343/alm.2022.42.1.71

keywords:

["Antibody","COVID-19","SARS-CoV-2","Seroprevalence"]

subject

Has Abstract

pub_date

2022-01-01 00:00:00

pages

71-78

issue

1

eissn

2234-3806

issn

2234-3814

pii

alm.2022.42.1.71

journal_volume

42

pub_type

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