Damien Jacot1, Milo Moraz2, Alix T Coste1, Christele Aubry1, Jilian A Sacks3, Gilbert Greub1, Antony Croxatto4. 1. Institute of Microbiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland. 2. Institute of Microbiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland; Department of Infectious Diseases, Valais Hospital, Central Institute, Sion, Switzerland. 3. Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland. 4. Institute of Microbiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland. Electronic address: Antony.Croxatto@chuv.ch.
Abstract
BACKGROUND: In response to the current COVID-19 pandemic, multiple companies marketed serological tests. Rigorous, independent and comparative performances of these assays on defined clinical specimens are needed. METHODS: In a first preliminary phase, we investigated 16 IgG, IgM, IgA and pan Ig serological ELISA using a panel of 180 sera, comprising 97 sera from patients with a positive RT-PCR, and 83 negative sera sampled before November 1, 2019. In a second phase and to complete the evaluation on the full panel (100 positive and 300 negative), tests that passed pre-defined exclusion criteria of 90% sensitivity and 97% specificity were further evaluated on 220 additional sera chosen to assess possible cross-reactivity with other human viral infections. RESULTS: Among the 16 tests evaluated in the preliminary phase, two were excluded due to insufficient sensitivity at 15 days post-symptom onset and one was excluded due to poor specificity. Of the 13 tests evaluated using the full panel comprised of a diverse pool of sera including those reactive against known respiratory viruses, no systematic cross-reactivity was observed. However, heterogeneities across tests were found. Consistent with kinetics of antibody expression, maximal sensitivity was found two weeks post-symptom onset. CONCLUSION: In this independent evaluation, we compared the performance of 16 SARS-CoV-2 serological tests using well-characterized sera and found 13 tests with more than 90% sensitivity at 15 days post-symptom onset and 97% specificity across a diverse range of negative samples.
BACKGROUND: In response to the current COVID-19 pandemic, multiple companies marketed serological tests. Rigorous, independent and comparative performances of these assays on defined clinical specimens are needed. METHODS: In a first preliminary phase, we investigated 16 IgG, IgM, IgA and pan Ig serological ELISA using a panel of 180 sera, comprising 97 sera from patients with a positive RT-PCR, and 83 negative sera sampled before November 1, 2019. In a second phase and to complete the evaluation on the full panel (100 positive and 300 negative), tests that passed pre-defined exclusion criteria of 90% sensitivity and 97% specificity were further evaluated on 220 additional sera chosen to assess possible cross-reactivity with other humanviral infections. RESULTS: Among the 16 tests evaluated in the preliminary phase, two were excluded due to insufficient sensitivity at 15 days post-symptom onset and one was excluded due to poor specificity. Of the 13 tests evaluated using the full panel comprised of a diverse pool of sera including those reactive against known respiratory viruses, no systematic cross-reactivity was observed. However, heterogeneities across tests were found. Consistent with kinetics of antibody expression, maximal sensitivity was found two weeks post-symptom onset. CONCLUSION: In this independent evaluation, we compared the performance of 16 SARS-CoV-2 serological tests using well-characterized sera and found 13 tests with more than 90% sensitivity at 15 days post-symptom onset and 97% specificity across a diverse range of negative samples.
Authors: Gustavo Martins; Jeferson L Gogola; Lucas H Budni; Maurício A Papi; Maritza A T Bom; Maria L T Budel; Emanuel M de Souza; Marcelo Müller-Santos; Breno C B Beirão; Craig E Banks; Luiz H Marcolino-Junior; Márcio F Bergamini Journal: Anal Chim Acta Date: 2022-10-04 Impact factor: 6.911