Abstract

BackgroundEfficient monitoring and control of coronavirus disease 2019 (COVID-19) require access to diagnostic tests, and serological diagnostic testing is desirable. In the current study, antibodies were investigated in patients recently diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.MethodsCross-sectional data were obtained from 245 patients in whom SARS-CoV-2 infection had been confirmed via real-time reverse transcriptase-polymerase chain reaction between March and October 2020. Serum samples were acquired between 2 and 60 days following the onset of COVID-19 symptoms or the first detection of SARS-CoV-2 in asymptomatic patients. All specimens were tested simultaneously using an IgM/IgG rapid diagnostic test (RDT), IgG nucleocapsid protein-based chemiluminescent microparticle immunoassay (CMIA), IgG, and IgA spike protein-based enzyme-linked immunosorbent assays (ELISAs). Blood donor samples obtained in 2018 were used as negative controls.ResultsThe sensitivity and specificity of the RDT IgG were compared with the IgG immunoassays as standards. The RDT IgG exhibited 97.5% sensitivity and 89.4% specificity compared with a CMIA IgG, 98.4% sensitivity, and 78.8% specificity compared with an ELISA IgG. IgM, IgG, and IgA seropositivity rates were low between 1 and 2 weeks after COVID-19 symptom onset or the detection of SARS-CoV-2 RNA. IgM seropositivity rate began decreasing after 4 weeks, whereas IgG and IgA seropositivity rate remained at appreciable levels over the 8-week study period. No cross-reactivity with seasonal coronaviruses was detected.ConclusionsIgG RDT alone or combined with molecular diagnostic tests may be useful for identifying recent SARS-CoV-2 infection.

Highlights

  • Efficient monitoring and control of coronavirus disease 2019 (COVID-19) require access to diagnostic tests, and serological diagnostic testing is desirable

  • In the current study, the interval between symptom onset or initial SARS-CoV-2 detection and serum sample acquisition for serology testing was assessed by week

  • 167/245 (68.2%) individuals tested seropositive for rapid diagnostic test (RDT) IgM, 198/245 (80.8%) for RDT IgG, 198/245 (80.8%) for chemiluminescent microparticle immunoassay (CMIA) IgG, 189/245 (77.1%) for Enzyme-linked immunosorbent assay (ELISA) IgG, and 196/245 (80.0%) for ELISA IgA

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Summary

Introduction

Efficient monitoring and control of coronavirus disease 2019 (COVID-19) require access to diagnostic tests, and serological diagnostic testing is desirable. Antibodies were investigated in patients recently diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) causes an acute respiratory tract illness known as coronavirus disease 2019 (COVID-19) [1]. Many countries can control morbidity, and asymptomatic SARS-CoV-2 infection does occur. The use of rapid and easy to perform diagnostic methods during the early phase of COVID-19 has facilitated early laboratory diagnosis of infection with high sensitivity, in asymptomatic and/or preclinical patients, and they are a key factor to success [5]. Realtime reverse transcriptase-polymerase chain reaction (RT-PCR)-based methods designed to detect SARSCoV-2 in nasopharyngeal swabs are currently the gold standard for COVID-19 diagnosis [6]. Molecular diagnostic approaches require technical expertise and equipment and can be comparatively costly

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