ArticleImmunity, inflammation and disease2025
Clinical Evaluation of the Healgen Rapid COVID-19 Antigen Test as a Point-of-Care Diagnostic Tool.
Article in Immunity, inflammation and disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDevelopment of readily available Rapid COVID-19 Antigen tests essential for promptly identifying SARS-CoV2 infection and preventing its spread.
methodsThis 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.
resultsOut 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.
conclusionsThe 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.
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