Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study
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Zhang, Z, et al. Insight Into the Practical Performance of Rt-pcr Testing for Sars-cov-2 Using Serological Data: a Cohort Study. Elsevier Ltd, 2021. https://doi.org/10.17615/9m2j-3z95APA
Zhang, Z., Bi, Q., Fang, S., Wei, L., Wang, X., He, J., Wu, Y., Liu, X., Gao, W., Zhang, R., Gong, W., Su, Q., Azman, A., Lessler, J., & Zou, X. (2021). Insight into the practical performance of RT-PCR testing for SARS-CoV-2 using serological data: a cohort study. Elsevier Ltd. https://doi.org/10.17615/9m2j-3z95Chicago
Zhang, Z, Q Bi, S Fang, L Wei, X Wang, J He, Y Wu et al. 2021. Insight Into the Practical Performance of Rt-Pcr Testing for Sars-Cov-2 Using Serological Data: a Cohort Study. Elsevier Ltd. https://doi.org/10.17615/9m2j-3z95- Creator
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Zhang, Z
- Other Affiliation: Department of Public Health Information, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Bi, Q
- Other Affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
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Fang, S
- Other Affiliation: Department of Pathogenic Biology, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Wei, L
- Other Affiliation: Department of Public Health Information, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Wang, X
- Other Affiliation: Department of Pathogenic Biology, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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He, J
- Other Affiliation: Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Wu, Y
- Other Affiliation: Department of Public Health Information, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Liu, X
- Other Affiliation: Department of Public Health Information, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Gao, W
- Other Affiliation: Department of Communicable Diseases Control and Prevention, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Zhang, R
- Other Affiliation: Department of Pathogenic Biology, Shenzhen Center for Disease Control and Prevention, Shenzhen, China
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Gong, W
- Other Affiliation: The Bill & Melinda Gates Foundation, Seattle, WA, United States
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Su, Q
- Other Affiliation: Pediatric Research Institute, Shenzhen Children's Hospital, Shenzhen, China
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Azman, A.S
- Other Affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
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Lessler, J
- Affiliation: Gillings School of Global Public Health, Department of Epidemiology
- Other Affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
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Zou, X
- Other Affiliation: Shenzhen Center for Disease Control and Prevention, Shenzhen, China
- Abstract
- 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.
- Date of publication
- 2021
- DOI
- Identifier
- Resource type
- Article
- Rights statement
- In Copyright
- License
- Attribution 4.0 International
- Journal title
- The Lancet Microbe
- Journal volume
- 2
- Journal issue
- 2
- Page start
- e79
- Page end
- e87
- Language
- English
- Version
- Publisher
- Funder
- Bill and Melinda Gates Foundation, BMGF: INV-006376
- 2020B1111340077
- 202002073000003
- ISSN
- 2666-5247
- Publisher
- Elsevier Ltd
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