Clinical Evaluation of the Healgen Rapid COVID-19 Antigen Test as a
Point-of-Care Diagnostic Tool
Abstract
Development of readily available Rapid COVID-19 Antigen tests are
essential for promptly identifying SARS-CoV2 infection and preventing
its spread. 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 symptoms onset. The
results from the Healgen test were compared to the results from
Emergency Use Authorization (EUA) approved SARS-CoV-2 RT-PCR tests. 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 sensitivity of the test.
The Healgen Rapid COVID-19 antigen detection test demonstrated good
performance in terms of sensitivity and specificity when compared to the
EUA RT-PCR assays and has potential as a diagnostic tool for SARS-CoV-2.