Communication: Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection

Objective . We assessed the performance of the Humasis COVID-19 AgHS Test (Humasis, Korea), a novel antigen rapid diagnostic test (Ag-RDT) based on lateral fl ow immunoassay. Methods . 85 SARS-CoV-2-positive and 155 SARS-CoV-2-negative nasopharyngeal swab specimens con fi rmed by rRTPCR were tested using the Humasis and PBCheck Ag-RDTs. Th e analytical speci fi city of the Humasis AgRDT was evaluated using 27 strains of human respiratory pathogens. Results . Th e overall sensitivity and speci fi city were 72.9% and 99.4% for the Humasis Ag-RDT and 64.7% and 100% for the PBCheck AgRDT, respectively. Th e sensitivity for specimens with Ct <= 25 was 100% for both Ag-RDTs. Th e Humasis Ag-RDT showed no cross -reactivity with other respiratory pathogens. Conclusion . Our data suggests that the Humasis Ag-RDT can be a useful diagnostic tool for the detection of SARS-CoV-2 infection.