Comparison of various serological assays for novel SARS-COV-2

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ORIGINAL ARTICLE

Comparison of various serological assays for novel SARS-COV-2 María Simón Sacristan 1 & Ana Collazos-Blanco 1 & Maria Isabel Zamora Cintas 1 & Alicia Serrano García 1 & Carmen Ybarra de Villavicencio 1 & María Mateo Maestre 1 Received: 2 June 2020 / Accepted: 28 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), is associated with severe morbidity and mortality. The aim of our study was to compare different immunoassays. We evaluated three immunochromatographic test (The StrongStep®SARS-CoV-2 IgG/IgM kit, AllTest COV-19 IgG/IgM kit, and Wondfo® SARS-CoV-2 Antibody) and two chemiluminescence immunoassays (CMIA) (Covid-19 VIRCLIA® IgM+IgA/ IgG monotest and the Abbott SARS-CoV-2 IgG assay) in COVID-19 patients. The assays were performed using serum samples of three group patients, i.e., healthy controls, patients with SARS-CoV-2 PCR positive, and patients with SARS-CoV-2 PCR negative clinically diagnosed of COVID-19 infection. The detection percentages of IgG with the StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit were similar in both groups (83.3% and 80.6%, respectively in group 2, p = 0.766) and (42.9% and 50.0%, respectively in group 3, p = 0.706). There were some differences on IgM detection between StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit (11.1% and 30.6%, respectively in group 2, p = 0.042 and 0.0% and 28.6%, respectively in group 3, p = 0.031). The positive rate of IgG in group 2 is higher compared to group 3 with the two immunoassays tested. We observe the same positive rates of IgG with the two CMIA. Our study shows excellent performance of CMIA compared to immunochromatographic test and confirms its potential use in the diagnosis of the new SARS-CoV-2. Keywords Antibodies . Chemiluminescence immunoassays . IgG . IgM . Immunochromatographic tests . SARS-CoV-2

Introduction

María Simón Sacristan, Ana Collazos Blanco and Maria Isabel Zamora Cintas contributed equally to this work. * María Simón Sacristan [email protected] * Ana Collazos-Blanco [email protected] Maria Isabel Zamora Cintas [email protected] Alicia Serrano García [email protected] Carmen Ybarra de Villavicencio [email protected] María Mateo Maestre [email protected] 1

Servicio de Microbiología y Parasitología, Hospital Central de la Defensa Gómez Ulla, Madrid, Spain

Severe acute respiratory syndrome coronavirus (SARS-CoV2) [1] was discovered in December 2019 in the city of Wuhan, China. It soon spread to other cities and countries, and on 11 March 2020 was proclaimed a pandemic by WHO. The clinical symptoms of most patients are fever, sore throat, cough, and shortness of breath [2]. RT-PCR (reverse transcription polymerase chain reaction) remained the gold standard for the diagnosis of infection due to SARS-CoV-2, which has led to 974,449 coronavirus disease-19 (COVID19) cases and 33,992