Performance evaluation of in-house developed Covid-19 IgG/IgM antibody rapid diagnostic kit

Abstract

Abstract In the interest of preventing the Coronavirus Disease 2019 (COVID-19) pandemic from spreading, it is crucial to promptly identify and confine afflicted patients. Serological antibody testing is a significant diagnostic technique that is increasingly employed in clinics, however its clinical use is still being investigated. A meta-analysis was carried out to scrutinize how well Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibody testing using in-house developed rapid antibody assay worked for diagnosing COVID-19 patients against the chemiluminescence (CLIA) assay. IgG- positive but IgM-negative (IgG-, IgM+); IgG-positive but IgM-negative (IgG+, IgM-); IgM+ IgG+; both IgM-positive and IgG-positive (IgM+IgG+); and either IgM-positive or IgG-positive (IgM+ or IgG+) have been evaluated. A total of 300 samples with diverse age and sexual identity data were included. The combined sensitivities for IgG+IgM+, IgM+IgG-, IgG+IgM- and negative were evaluated. More accurate diagnostic results may be obtained using molecular diagnostic tools. The Antibody Rapid Diagnostic kit's (in-house developed) performance was satisfactory for determining the presence of Covid-19 infection with IgG and IgM positivity. The IgG and IgM positivity helped evaluate the immune response in the individual for the COVID-19 infection. These results lend support to the additional utilisation of serological antibody tests in the COVID-19 diagnosis.