Cargando…
Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients
Serological testing is recommended to support the detection of undiagnosed coronavirus disease 2019 (COVID-19) cases. However, the performance of serological assays has not been sufficiently evaluated. Hence, the performance of six severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binding...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9048255/ https://www.ncbi.nlm.nih.gov/pubmed/35495639 http://dx.doi.org/10.3389/fmicb.2022.881038 |
_version_ | 1784695892557692928 |
---|---|
author | Choi, Hyun-Woo Jeon, Chae-Hyeon Won, Eun Jeong Kang, Seung-Ji Lee, Seung Yeob Kee, Seung-Jung |
author_facet | Choi, Hyun-Woo Jeon, Chae-Hyeon Won, Eun Jeong Kang, Seung-Ji Lee, Seung Yeob Kee, Seung-Jung |
author_sort | Choi, Hyun-Woo |
collection | PubMed |
description | Serological testing is recommended to support the detection of undiagnosed coronavirus disease 2019 (COVID-19) cases. However, the performance of serological assays has not been sufficiently evaluated. Hence, the performance of six severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binding antibody assays [three chemiluminescence (CLIAs) and three lateral flow immunoassays (LFIAs)] and a surrogate virus neutralization test (sVNT) was analyzed in a total of 988 serum samples comprising 389 COVID-19-positives and 599 COVID-19-negatives. The overall diagnostic sensitivities of CLIAs and LFIAs ranged from 54.2 to 56.6% and from 56.3 to 64.3%, respectively. The overall diagnostic specificities of CLIAs and LFIAs ranged from 98.2 to 99.8% and from 97.3 to 99.0%, respectively. In the symptomatic group (n = 321), the positivity rate increased by over 80% in all assays > 14 days after symptom onset. In the asymptomatic group (n = 68), the positivity rate increased by over 80% in all assays > 21 days after initial RT-PCR detection. In LFIAs, negatively interpreted trace bands accounted for the changes in test performance. Most false-positive results were weak or trace reactions and showed negative results in additional sVNT. For six binding antibody assays, the overall agreement percentages ranged from 91.0 to 97.8%. The median inhibition activity of sVNT was significantly higher in the symptomatic group than in the asymptomatic group (50.0% vs. 29.2%; p < 0.0001). The median times to seropositivity in the symptomatic group were 9.7 days for CLIA-IgG, 9.2 and 9.8 days for two CLIAs-Total (IgM + IgG), 7.7 days for LFIA-IgM, 9.2 days for LFIA-IgG, and 8.8 days for sVNT-IgG, respectively. There was a strong positive correlation between the quantitative results of the four binding antibody assays and sVNT with Spearman ρ-values ranging from 0.746 to 0.854. In particular, when using LFIAs, we recommend using more objective interpretable assays or establishing a band interpretation system for each laboratory, accompanied by observer training. We also anticipate that sVNT will play an essential role in SARS-CoV-2 antibody testing and become the practical routine neutralizing antibody assay. |
format | Online Article Text |
id | pubmed-9048255 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-90482552022-04-29 Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients Choi, Hyun-Woo Jeon, Chae-Hyeon Won, Eun Jeong Kang, Seung-Ji Lee, Seung Yeob Kee, Seung-Jung Front Microbiol Microbiology Serological testing is recommended to support the detection of undiagnosed coronavirus disease 2019 (COVID-19) cases. However, the performance of serological assays has not been sufficiently evaluated. Hence, the performance of six severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binding antibody assays [three chemiluminescence (CLIAs) and three lateral flow immunoassays (LFIAs)] and a surrogate virus neutralization test (sVNT) was analyzed in a total of 988 serum samples comprising 389 COVID-19-positives and 599 COVID-19-negatives. The overall diagnostic sensitivities of CLIAs and LFIAs ranged from 54.2 to 56.6% and from 56.3 to 64.3%, respectively. The overall diagnostic specificities of CLIAs and LFIAs ranged from 98.2 to 99.8% and from 97.3 to 99.0%, respectively. In the symptomatic group (n = 321), the positivity rate increased by over 80% in all assays > 14 days after symptom onset. In the asymptomatic group (n = 68), the positivity rate increased by over 80% in all assays > 21 days after initial RT-PCR detection. In LFIAs, negatively interpreted trace bands accounted for the changes in test performance. Most false-positive results were weak or trace reactions and showed negative results in additional sVNT. For six binding antibody assays, the overall agreement percentages ranged from 91.0 to 97.8%. The median inhibition activity of sVNT was significantly higher in the symptomatic group than in the asymptomatic group (50.0% vs. 29.2%; p < 0.0001). The median times to seropositivity in the symptomatic group were 9.7 days for CLIA-IgG, 9.2 and 9.8 days for two CLIAs-Total (IgM + IgG), 7.7 days for LFIA-IgM, 9.2 days for LFIA-IgG, and 8.8 days for sVNT-IgG, respectively. There was a strong positive correlation between the quantitative results of the four binding antibody assays and sVNT with Spearman ρ-values ranging from 0.746 to 0.854. In particular, when using LFIAs, we recommend using more objective interpretable assays or establishing a band interpretation system for each laboratory, accompanied by observer training. We also anticipate that sVNT will play an essential role in SARS-CoV-2 antibody testing and become the practical routine neutralizing antibody assay. Frontiers Media S.A. 2022-04-14 /pmc/articles/PMC9048255/ /pubmed/35495639 http://dx.doi.org/10.3389/fmicb.2022.881038 Text en Copyright © 2022 Choi, Jeon, Won, Kang, Lee and Kee. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Microbiology Choi, Hyun-Woo Jeon, Chae-Hyeon Won, Eun Jeong Kang, Seung-Ji Lee, Seung Yeob Kee, Seung-Jung Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title | Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title_full | Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title_fullStr | Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title_full_unstemmed | Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title_short | Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients |
title_sort | performance of severe acute respiratory syndrome coronavirus 2 serological diagnostic tests and antibody kinetics in coronavirus disease 2019 patients |
topic | Microbiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9048255/ https://www.ncbi.nlm.nih.gov/pubmed/35495639 http://dx.doi.org/10.3389/fmicb.2022.881038 |
work_keys_str_mv | AT choihyunwoo performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients AT jeonchaehyeon performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients AT woneunjeong performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients AT kangseungji performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients AT leeseungyeob performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients AT keeseungjung performanceofsevereacuterespiratorysyndromecoronavirus2serologicaldiagnostictestsandantibodykineticsincoronavirusdisease2019patients |