Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients
Cláudia Serre-Miranda, Cláudia Nóbrega, Susana Roque, João Canto-Gomes, Carolina S. Silva, Neide Vieira, Palmira Barreira‐Silva, Pedro Alves-Peixoto, Jorge Cotter, Ana Batalha Reis, Mariana Formigo, Helena Sarmento, Olga Pires, Alexandre Carvalho, Dmitri Y. Petrovykh, Lorena Diéguez, João Carlos Sousa, Nuno Sousa, Carlos Capela, Joana Almeida Palha, Pedro Cunha, Margarida Correia‐Neves
Abstract
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.