Abstract

Early detection of SARS-CoV-2 is essential for a timely update of health policies and allocation of resources. Particularly, serological testing may allow individuals with low-risk of being contagious of SARS-CoV-2 to return to daily activities. Both private and academic initiatives have sought to develop serological assays to detect anti-SARS-CoV-2 antibodies. Herein, we compared five different assays in active healthcare personnel exposed to SARS-CoV-2 in a large center in Madrid, Spain, in a retrospective study. Median time lapse between polymerase chain-reaction (PCR) and serological testing was 11 days (7–21). All tests assessed IgM/IgG titers except for Euroimmun (IgA/IgG) and The Binding-Site (IgA/IgM/IgG). The highest concordance rate was observed between Dia.Pro and Euroimmun (75.76%), while it was lowest between The Binding-Site and Euroimmun (44.55%). The Binding-Site assay showed the highest concordance (85.52%) with PCR results. Considering PCR results as reference, Dia.Pro was the most sensitive test, although The Binding-Site assay exhibited the highest area under the curve (AUC; 0.85). OrientGene and MAGLUMI tests were performed in a smaller cohort with confirmed infection and thus were not adequate to estimate sensitivity and specificity. The Binding-Site assay presented the best joint sensitivity and specificity among all the tests analyzed in our cohort. Likewise, this serological assay presents a greater repertoire of antibodies and antigen-regions tested, which is why each individual’s humoral immunity is more accurately reflected. The better the immunity test, the most adequate the health strategy to take in terms of organization of consultations, surgery, and treatments in vulnerable patients. The three antibody classes (IgG/IgM/IgA) were determined jointly, which translates to an economic impact on healthcare. While their role in the protection status remains elusive, serological tests add a valuable tool in the early management of SARS-CoV-2 after known exposition.

Highlights

  • The COVID-19 pandemic represents a global health concern with unprecedented social and economic repercussions

  • Both antibody detection methods were proposed as valid tools for detecting antibodies against SARS-CoV-2 in the Report for analytical techniques in COVID-19 presented by the Spanish Society of Immunology

  • We evaluated specific antibodies against SARS-CoV-2 using ELISA or lateral flow assay in 258 serum samples from individual active health workers

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Summary

Introduction

The COVID-19 pandemic represents a global health concern with unprecedented social and economic repercussions. Viral RNA can be detected in swab samples until approximately day 14 post infection [4,5]. IgM SARS-CoV-2 specific antibodies have been detected from day 3 post illness onset and/or initial exposure [2] in asymptomatic patients (Figure 1). IgM reaches a maximum peak between weeks 2 and 3, and it can be detected up to 1 month following exposure to the virus [6,7,8]. Both IgA and IgG SARS-CoV-2 specific antibodies are detected from day 4 post illness onset, increasing gradually until reaching a peak after

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