Field Performance and Public Health Response Using the BinaxNOWTM Rapid Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Assay During Community-Based Testing

Abstract

Among 3302 persons tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by BinaxNOWTM and reverse transcription polymerase chain reaction (RT-PCR) in a community setting, rapid assay sensitivity was 100%/98.5%/89% using RT-PCR cycle thresholds of 30, 35, and no threshold. The specificity was 99.9%. Performance was high across ages and those with and without symptoms. Rapid resulting permitted immediate public health action.

Keywords: asymptomatic SARS-CoV-2 infection; community-based SARS-CoV-2 testing.

Figure 1.

RT-PCR Ct values and BinaxNOW rapid antigen test results of participants, stratified according to COVID-19 symptoms. Average viral Ct values of all individuals with positive RT-PCR and/or rapid antigen test results (N = 245 total) plotted in ascending order of Ct. Each point represents 1 individual. Blue points are individuals whose samples were positive for both rapid antigen test (BinaxNOW) and RT-PCR test. Yellow circles represent individuals who were RT-PCR positive, but rapid antigen test negative. Red circles represent individuals with a positive rapid antigen test and a negative RT-PCR test result. Abbreviations: COVID-19, coronavirus disease 2019; Ct, cycle threshold; RT-PCR, reverse transcription polymerase chain reaction.