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

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 co...

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Autores principales: Park, Younhee, Hong, Ki Ho, Lee, Su-Kyung, Hyun, Jungwon, Oh, Eun-Jee, Lee, Jaehyeon, Lee, Hyukmin, Song, Sang Hoon, Kee, Seung-Jung, Kwon, Gye Cheol, Kim, Su Hwan, Do, Hyeon-Nam, Kim, Ah-Ra, Lee, June-Woo, Kim, Sung Soon, Kim, Hyun Soo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society for Laboratory Medicine 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8368235/
https://www.ncbi.nlm.nih.gov/pubmed/34374351
http://dx.doi.org/10.3343/alm.2022.42.1.71
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author Park, Younhee
Hong, Ki Ho
Lee, Su-Kyung
Hyun, Jungwon
Oh, Eun-Jee
Lee, Jaehyeon
Lee, Hyukmin
Song, Sang Hoon
Kee, Seung-Jung
Kwon, Gye Cheol
Kim, Su Hwan
Do, Hyeon-Nam
Kim, Ah-Ra
Lee, June-Woo
Kim, Sung Soon
Kim, Hyun Soo
author_facet Park, Younhee
Hong, Ki Ho
Lee, Su-Kyung
Hyun, Jungwon
Oh, Eun-Jee
Lee, Jaehyeon
Lee, Hyukmin
Song, Sang Hoon
Kee, Seung-Jung
Kwon, Gye Cheol
Kim, Su Hwan
Do, Hyeon-Nam
Kim, Ah-Ra
Lee, June-Woo
Kim, Sung Soon
Kim, Hyun Soo
author_sort Park, Younhee
collection PubMed
description 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.
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spelling pubmed-83682352022-01-01 Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies Park, Younhee Hong, Ki Ho Lee, Su-Kyung Hyun, Jungwon Oh, Eun-Jee Lee, Jaehyeon Lee, Hyukmin Song, Sang Hoon Kee, Seung-Jung Kwon, Gye Cheol Kim, Su Hwan Do, Hyeon-Nam Kim, Ah-Ra Lee, June-Woo Kim, Sung Soon Kim, Hyun Soo Ann Lab Med Original Article 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. Korean Society for Laboratory Medicine 2022-01-01 2022-01-01 /pmc/articles/PMC8368235/ /pubmed/34374351 http://dx.doi.org/10.3343/alm.2022.42.1.71 Text en © Korean Society for Laboratory Medicine https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Park, Younhee
Hong, Ki Ho
Lee, Su-Kyung
Hyun, Jungwon
Oh, Eun-Jee
Lee, Jaehyeon
Lee, Hyukmin
Song, Sang Hoon
Kee, Seung-Jung
Kwon, Gye Cheol
Kim, Su Hwan
Do, Hyeon-Nam
Kim, Ah-Ra
Lee, June-Woo
Kim, Sung Soon
Kim, Hyun Soo
Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title_full Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title_fullStr Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title_full_unstemmed Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title_short Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
title_sort performance comparison of five sars-cov-2 antibody assays for seroprevalence studies
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8368235/
https://www.ncbi.nlm.nih.gov/pubmed/34374351
http://dx.doi.org/10.3343/alm.2022.42.1.71
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