Clinical Evaluation of the Healgen Rapid COVID‐19 Antigen Test as a Point‐of‐Care Diagnostic Tool

BACKGROUND: Development of readily available Rapid COVID-19 Antigen tests essential for promptly identifying SARS-CoV2 infection and preventing its spread. METHODS: This study evaluated the clinical performance of the Healgen Rapid COVID-19 antigen test as a point-of-care diagnostic tool with 806 evaluable subjects who were within 6 days post-symptom onset. The results from the Healgen test were compared to the results from Emergency Use Authorization (EUA) approved SARS-CoV-2 RT-PCR tests. RESULTS: Out of the 806 evaluable subjects, 140 tested positive and 640 tested negative for SARS-CoV-2 with the Healgen COVID-19 test, showing good agreement with the EUA RT-PCR results. There were 26 subjects with discordant results, of which 24 were negative according to the Healgen test but positive according to the RT-PCR test, while 2 were positive by the Healgen test but negative by the EUA-PCR test. The positive percent agreement (PPA) and negative percent agreement (NPA) were 85.4% and 99.7%, respectively. Additionally, the Healgen COVID-19 test detected 34 cases (60.7%) out of 56 weak positive cases (based on Ct values of ≥ 30 by the EUA PCR test), demonstrating good detection capability of the test. CONCLUSIONS: The Healgen Rapid COVID-19 antigen detection test demonstrated good performance in terms of PPA and NPA when compared to the EUA RT-PCR assays and has potential as a diagnostic tool for SARS-CoV-2.