Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies

• DOI: 10.1007/s10096-020-04092-3
• Publication Date: 2020-11-24T23:07:02Z
• Authors: Ainhoa Gutiérrez-...; Sara Gómez de Frutos; Diego Domingo García; Eva Navarro Lara; Ayla Yarci Carrión; Leticia Fontán Ga...; Arturo Manuel Fra...; Laura Cardeñoso D...
• Keywords: Gold standard (test); Medical microbiology

Antibody detection is essential to establish exposure, infection, and immunity SARS-CoV-2, as well perform epidemiological studies. The worldwide urge for new diagnostic tools control the pandemic has led a quick incorporation in clinical practice of recently developed serological assays. However, only few comparative studies have been published, there lack data about accuracy currently available We evaluated detect Ig G, M+A, and/or IgA anti SARS-CoV-2 10 different assays: lateral flow card immunoassays, 4 enzyme-linked immunosorbent assay (ELISA), 3 chemiluminescent particle immunoassays (CMIA). Using reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 gold standard, sensitivity, specificity, PPV, NPV were determined. Each was tested 2 groups, namely, positive control, formed by 50 sera from patients with pneumonia RT-PCR; negative respiratory infection non-COVID-19. Sensitivity range assays RT-PCR 40-77% (65-81% considering IgG plus IgM). Specificity ranged 83-100%. VPP VPN respectively 81-100% 61.6-81%. Among highest sensitivity specificity results found Wondfo® Test. ELISA EUROIMMUN® most sensitive ELISA. poor obtained isolated IgG. similar Architect Abbott® Vircell®. Results varied widely among evaluated. Due better overall higher case result. On other side, antibody should be taken care because low described. Highest CMIAs, but they last much longer.