Evaluation of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection: Single Italian Center Study

The need for timely establishment of diagnostic assays of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is demanded in laboratories worldwide. We evaluated the performance of a flow immunoassay which can detect IgM an IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 min. Among the 132 positive novel Coronavirus Disease 19 (COVID-19) cases, 126 tests were consistent with previous quantitative Real Time PCR (qRT-PCR) assays. Among the 62 negative cases, 60 were consistent with qRT-PCR assays except for 2 cases. In this study, 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device showed 95.5% sensitivity and 96.8% specificity. In conclusion, Rapid IgM-IgG Combined Antibody Test showed high detection consistency among all analysed samples. Suggesting that could be used for the rapid screening of SARS-CoV-2 carriers, either symptomatic or asymptomatic.