Clinical Evaluation of the Healgen Rapid COVID‐19 Antigen Test as a Point‐of‐Care Diagnostic Tool
ABSTRACT 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...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-07-01
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| Series: | Immunity, Inflammation and Disease |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/iid3.70228 |
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| Summary: | ABSTRACT 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. |
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| ISSN: | 2050-4527 |