Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies
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ORIGINAL ARTICLE
Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies Ainhoa Gutiérrez-Cobos 1 & Sara Gómez de Frutos 1 & Diego Domingo García 1 & Eva Navarro Lara 1 & Ayla Yarci Carrión 1 & Leticia Fontán García-Rodrigo 1 & Arturo Manuel Fraile Torres 1 & Laura Cardeñoso Domingo 1 Received: 4 August 2020 / Accepted: 28 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Antibody detection is essential to establish exposure, infection, and immunity to SARS-CoV-2, as well as to perform epidemiological studies. The worldwide urge for new diagnostic tools to control the pandemic has led to a quick incorporation in clinical practice of the recently developed serological assays. However, as only few comparative studies have been published, there is a lack of data about the diagnostic accuracy of currently available assays. We evaluated the diagnostic accuracy to detect Ig G, Ig M+A, and/or IgA anti SARS-CoV-2 of 10 different assays: lateral flow card immunoassays, 4 enzyme-linked immunosorbent assay (ELISA), and 3 chemiluminescent particle immunoassays (CMIA). Using reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19 as gold standard, sensitivity, specificity, PPV, and NPV were determined. Each assay was tested in 2 groups, namely, positive control, formed by 50 sera from 50 patients with SARS-CoV-2 pneumonia with positive RT-PCR; and negative control, formed by 50 sera from 50 patients with respiratory infection non-COVID-19. Sensitivity range of the 10 assays evaluated for patients with positive COVID-19 RT-PCR was 40–77% (65–81% considering IgG plus IgM). Specificity ranged 83–100%. VPP and VPN were respectively 81–100% and 61.6–81%. Among the lateral flow immunoassays, the highest sensitivity and specificity results were found in Wondfo® SARS-CoV-2 Antibody Test. ELISA IgG and IgA from EUROIMMUN® were the most sensitive ELISA. However, poor results were obtained for isolated detection of IgG. We found similar sensitivity for IgG with SARS-CoV-2 for Architect by Abbott® and ELISA by Vircell®. Results obtained varied widely among the assays evaluated. Due to a better specificity, overall diagnostic accuracy of the assays evaluated was higher in case of positive result. On the other side, lack of antibody detection should be taken with care because of the low sensitivity described. Highest diagnostic accuracy was obtained with ELISA and CMIAs, but they last much longer. Keywords Antibody assays . Diagnostic accuracy . SARS-CoV-2
Introduction A new coronavirus from the betacoronavirus family (subgenus Sarbecovirus) has emerged in the last few months. It has been denominated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) because of a high phylogenetic similarity to the SARS-CoV, first identified in China’s Guangdong province in 2002[1]. The disease caused by
* Ainhoa Gutiérrez-Cobos [email protected] 1
Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28
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