4.7 Article

Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients

期刊

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
卷 104, 期 -, 页码 661-669

出版社

ELSEVIER SCI LTD
DOI: 10.1016/j.ijid.2021.01.038

关键词

COVID-19; Serological tests; Qualitative and semiquantitative tests; Sensitivity; Specificity; Clinical presentation

资金

  1. Foundation for Science and Technology (FCT) [596694995, POCI-01-0145-FEDER-016428, UIDB/50026/2020, UIDP/50026/2020]
  2. Norte Portugal Regional Operational Programme (NORTE 2020), under the PORTUGAL 2020 Partnership Agreement, through the European Regional Development Fund (ERDF) [NORTE-01-0145FEDER-000013, NORTE-01-0145-FEDER-000023]
  3. FCT [DL57/2016, PD/BD/137433/2018, PD/BDE/142976/2018]
  4. Fundação para a Ciência e a Tecnologia [PD/BDE/142976/2018, PD/BD/137433/2018] Funding Source: FCT

向作者/读者索取更多资源

The study found the specificity and sensitivity of serological tests for SARS-CoV-2, providing important insights for epidemic monitoring and diagnosis.
Background: Commercial availability of serological tests to evaluate immunoglobulins (Ig) targeting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has grown exponentially since the start of the coronavirus disease 2019 (COVID-19) outbreak. Thorough validation of these tests is important before use as epidemiological tools to infer seroprevalence in specific populations and as diagnostic tools to complement molecular approaches (e.g., quantitative reverse transcription-polymerase chain reaction). Methods: Commercial serological tests from 11 suppliers were assayed side-by-side using 126 samples from SARS-CoV-2-infected inpatients and 36 from healthy and HIV-infected individuals. Results: The majority of the tests assayed have > 95% specificity. For the sensitivity calculation, samples were stratified by days since symptoms onset; sensitivity peaks at 16-21 days for IgM and IgA (maximum 91.2%, Euroimmun) and, dependant on the test, at 16-21 or > 21 days for IgG (maximum 94.1%, Snibe). Data from semiquantitative tests show that patients with a severe clinical presentation have lower levels of Ig targeting SARS-CoV-2 at < 10 days since symptoms onset and higher levels at > 21 days, compared to patients with a non-severe presentation. Conclusions: This study highlights the heterogeneity of sensitivity and generally high specificity of the serological tests and establishes a basis for their usefulness to complement diagnostic techniques and population seroprevalence studies. (c) 2021 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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