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

• Published in: International journal of infectious diseases 2021-03, Vol.104, p.661-669
• Main Authors: Serre-Miranda, C., Nobrega, C., Roque, S., Canto-Gomes, J., Silva, C.S., Vieira, N., Barreira-Silva, P., Alves-Peixoto, P., Cotter, J., Reis, A., Formigo, M., Sarmento, H., Pires, O., Carvalho, A., Petrovykh, D.Y., Diéguez, L., Sousa, J.C., Sousa, N., Capela, C., Palha, J.A., Cunha, P.G., Correia-Neves, M.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Clinical presentation; COVID-19; COVID-19 - diagnosis; COVID-19 Serological Testing - methods; Female; Hospitalization; Humans; Male; Middle Aged; Qualitative and semiquantitative tests; SARS-CoV-2 - immunology; Sensitivity; Sensitivity and Specificity; Seroepidemiologic Studies; Serological tests; Specificity
• ISSN: 1201-9712; 1878-3511
• DOI: 10.1016/j.ijid.2021.01.038

•Sensitivity heterogeneity of severe acute respiratory syndrome coronavirus-2 serological tests.•Maximum sensitivity achieved 21 days from symptoms onset.•COVID-19 clinical outcome is associated with different immunoglobulins levels. 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). 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. 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 21 days, compared to patients with a non-severe presentation. 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.