Keywords
SARS-CoV-2
serology
evaluation
diagnosis
sensitivity
specificity
How to Cite
Abstract
Introduction: In response to the COVID-19 pandemic, a large number of serological tests for the detection of antibodies against SARS-CoV-2, in different formats, have been rapidly developed and approved. Given the large offer and variability between assays, independent evaluation of their performance is essential. Objectives: The objective of this work was to analyze and compare the diagnostic performance of three anti-SARS-CoV-2 IgG antibody detection methods available in our environment. Materials and methods: Three types of serological assays were evaluated, a chemiluminescent immunoassay (Access ® SARS-CoV-2 IgG), an enzyme immunoassay (COVIDAR IgG) and a lateral flow immunoassay (SARSCoV- 2 Antibody Test), using serum samples from individuals with overcome SARS-CoV-2 infection, and sera collected before the start of the pandemic. Results: A total of 168 samples were processed, 94 sera from individuals with overcome SARS-CoV-2 infection and 74 pre-pandemic sera. The sensitivities of the methods tested varied between 71.3% and 89.4%. The sensitivity of the COVIDAR IgG assay was found to be significantly higher than that of the other two methods (p < 0.05). The specificities varied between 95.9% and 100%, with no significant differences between the three methods. Substantial agreement was found between the COVIDAR IgG assay and the Access® SARS-CoV-2 IgG assay (kappa coefficient: 0.74) and almost perfect agreement between the SARS-CoV-2 Antibody Test and the other two assays (kappa coefficients: 0.80 and 0.89). Conclusions: This study demonstrates adequate performance of the three assays in our population and the existence of concordance between them.
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