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Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study
BACKGROUND: Virological detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through RT-PCR has limitations for surveillance. Serological tests can be an important complementary approach. We aimed to assess the practical performance of RT-PCR-based surveillance protocols and det...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Ltd
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816573/ https://www.ncbi.nlm.nih.gov/pubmed/33495759 http://dx.doi.org/10.1016/S2666-5247(20)30200-7 |
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author | Zhang, Zhen Bi, Qifang Fang, Shisong Wei, Lan Wang, Xin He, Jianfan Wu, Yongsheng Liu, Xiaojian Gao, Wei Zhang, Renli Gong, Wenfeng Su, Qiru Azman, Andrew S Lessler, Justin Zou, Xuan |
author_facet | Zhang, Zhen Bi, Qifang Fang, Shisong Wei, Lan Wang, Xin He, Jianfan Wu, Yongsheng Liu, Xiaojian Gao, Wei Zhang, Renli Gong, Wenfeng Su, Qiru Azman, Andrew S Lessler, Justin Zou, Xuan |
author_sort | Zhang, Zhen |
collection | PubMed |
description | BACKGROUND: Virological detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through RT-PCR has limitations for surveillance. Serological tests can be an important complementary approach. We aimed to assess the practical performance of RT-PCR-based surveillance protocols and determine the extent of undetected SARS-CoV-2 infection in Shenzhen, China. METHODS: We did a cohort study in Shenzhen, China and attempted to recruit by telephone all RT-PCR-negative close contacts (defined as those who lived in the same residence as, or shared a meal, travelled, or socially interacted with, an index case within 2 days before symptom onset) of all RT-PCR-confirmed cases of SARS-CoV-2 detected since January, 2020, via contact tracing. We measured anti-SARS-CoV-2 antibodies in serum samples from RT-PCR-negative close contacts 2–15 weeks after initial virological testing by RT-PCR, using total antibody, IgG, and IgM ELISAs. In addition, we did a serosurvey of volunteers from neighbourhoods with no reported cases, and from neighbourhoods with reported cases. We assessed rates of infection undetected by RT-PCR, performance of RT-PCR over the course of infection, and characteristics of individuals who were seropositive on total antibody ELISA but RT-PCR negative. FINDINGS: Between April 12 and May 4, 2020, we enrolled and collected serological samples from 2345 (53·0%) of 4422 RT-PCR-negative close contacts of cases of RT-PCR-confirmed SARS-CoV-2. 1175 (50·1%) of 2345 were close contacts of cases diagnosed in Shenzhen with contact tracing details, and of these, 880 (74·9%) had serum samples collected more than 2 weeks after exposure to an index case and were included in our analysis. 40 (4·5%) of 880 RT-PCR-negative close contacts were positive on total antibody ELISA. The seropositivity rate with total antibody ELISA among RT-PCR-negative close contacts, adjusted for assay performance, was 4·1% (95% CI 2·9–5·7), which was significantly higher than among individuals residing in neighbourhoods with no reported cases (0·0% [95% CI 0·0–1·1]). RT-PCR-positive individuals were 8·0 times (95% CI 5·3–12·7) more likely to report symptoms than those who were RT-PCR-negative but seropositive, but both groups had a similar distribution of sex, age, contact frequency, and mode of contact. RT-PCR did not detect 48 (36% [95% CI 28–44]) of 134 infected close contacts, and false-negative rates appeared to be associated with stage of infection. INTERPRETATION: Even rigorous RT-PCR testing protocols might miss a substantial proportion of SARS-CoV-2 infections, perhaps in part due to difficulties in determining the timing of testing in asymptomatic individuals for optimal sensitivity. RT-PCR-based surveillance and control protocols that include rapid contact tracing, universal RT-PCR testing, and mandatory 2-week quarantine were, nevertheless, able to contain community spread in Shenzhen, China. FUNDING: The Bill & Melinda Gates Foundation, Special Foundation of Science and Technology Innovation Strategy of Guangdong Province, and Key Project of Shenzhen Science and Technology Innovation Commission. |
format | Online Article Text |
id | pubmed-7816573 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-78165732021-01-21 Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study Zhang, Zhen Bi, Qifang Fang, Shisong Wei, Lan Wang, Xin He, Jianfan Wu, Yongsheng Liu, Xiaojian Gao, Wei Zhang, Renli Gong, Wenfeng Su, Qiru Azman, Andrew S Lessler, Justin Zou, Xuan Lancet Microbe Articles BACKGROUND: Virological detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through RT-PCR has limitations for surveillance. Serological tests can be an important complementary approach. We aimed to assess the practical performance of RT-PCR-based surveillance protocols and determine the extent of undetected SARS-CoV-2 infection in Shenzhen, China. METHODS: We did a cohort study in Shenzhen, China and attempted to recruit by telephone all RT-PCR-negative close contacts (defined as those who lived in the same residence as, or shared a meal, travelled, or socially interacted with, an index case within 2 days before symptom onset) of all RT-PCR-confirmed cases of SARS-CoV-2 detected since January, 2020, via contact tracing. We measured anti-SARS-CoV-2 antibodies in serum samples from RT-PCR-negative close contacts 2–15 weeks after initial virological testing by RT-PCR, using total antibody, IgG, and IgM ELISAs. In addition, we did a serosurvey of volunteers from neighbourhoods with no reported cases, and from neighbourhoods with reported cases. We assessed rates of infection undetected by RT-PCR, performance of RT-PCR over the course of infection, and characteristics of individuals who were seropositive on total antibody ELISA but RT-PCR negative. FINDINGS: Between April 12 and May 4, 2020, we enrolled and collected serological samples from 2345 (53·0%) of 4422 RT-PCR-negative close contacts of cases of RT-PCR-confirmed SARS-CoV-2. 1175 (50·1%) of 2345 were close contacts of cases diagnosed in Shenzhen with contact tracing details, and of these, 880 (74·9%) had serum samples collected more than 2 weeks after exposure to an index case and were included in our analysis. 40 (4·5%) of 880 RT-PCR-negative close contacts were positive on total antibody ELISA. The seropositivity rate with total antibody ELISA among RT-PCR-negative close contacts, adjusted for assay performance, was 4·1% (95% CI 2·9–5·7), which was significantly higher than among individuals residing in neighbourhoods with no reported cases (0·0% [95% CI 0·0–1·1]). RT-PCR-positive individuals were 8·0 times (95% CI 5·3–12·7) more likely to report symptoms than those who were RT-PCR-negative but seropositive, but both groups had a similar distribution of sex, age, contact frequency, and mode of contact. RT-PCR did not detect 48 (36% [95% CI 28–44]) of 134 infected close contacts, and false-negative rates appeared to be associated with stage of infection. INTERPRETATION: Even rigorous RT-PCR testing protocols might miss a substantial proportion of SARS-CoV-2 infections, perhaps in part due to difficulties in determining the timing of testing in asymptomatic individuals for optimal sensitivity. RT-PCR-based surveillance and control protocols that include rapid contact tracing, universal RT-PCR testing, and mandatory 2-week quarantine were, nevertheless, able to contain community spread in Shenzhen, China. FUNDING: The Bill & Melinda Gates Foundation, Special Foundation of Science and Technology Innovation Strategy of Guangdong Province, and Key Project of Shenzhen Science and Technology Innovation Commission. Elsevier Ltd 2021-02 /pmc/articles/PMC7816573/ /pubmed/33495759 http://dx.doi.org/10.1016/S2666-5247(20)30200-7 Text en © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Articles Zhang, Zhen Bi, Qifang Fang, Shisong Wei, Lan Wang, Xin He, Jianfan Wu, Yongsheng Liu, Xiaojian Gao, Wei Zhang, Renli Gong, Wenfeng Su, Qiru Azman, Andrew S Lessler, Justin Zou, Xuan Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title | Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title_full | Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title_fullStr | Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title_full_unstemmed | Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title_short | Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study |
title_sort | insight into the practical performance of rt-pcr testing for sars-cov-2 using serological data: a cohort study |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816573/ https://www.ncbi.nlm.nih.gov/pubmed/33495759 http://dx.doi.org/10.1016/S2666-5247(20)30200-7 |
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