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Clinical Evaluation of the Healgen Rapid COVID-19 Antigen Test as a Point-of-Care Diagnostic Tool
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  • Stephen Young,
  • Hua Zhang,
  • Jose Rodriguez,
  • David Mishkin,
  • Ward Paine,
  • Li Seyfried,
  • LaTisha Hargrove,
  • Dennis L. Broyles,
  • Chermaen Lindberg,
  • Anurag Purushothaman,
  • Stacey House
Stephen Young
TriCore Reference Laboratories
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Hua Zhang
Zhejiang Orient Gene Biotech Co Ltd
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Jose Rodriguez
Golden Research
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David Mishkin
Proactive Clinical Research- Fort Lauderdale
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Ward Paine
LLC-Morgantown
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Li Seyfried
Healgen Scientific LLC
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LaTisha Hargrove
Healgen Scientific LLC
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Dennis L. Broyles
CovarsaDx
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Chermaen Lindberg
CovarsaDx
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Anurag Purushothaman
Healgen Scientific LLC

Corresponding Author:[email protected]

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Stacey House
Washington University in St Louis School of Medicine
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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.