Young Stephen A, Zhang Hua, Rodriguez Jose, Mishkin David, Paine Ward, Seyfried Li, Hargrove LaTisha, Broyles Dennis L, Lindberg Chermaen, Purushothaman Anurag, House Stacey
TriCore Reference Laboratories, Albuquerque, New Mexico, USA.
Zhejiang Orient Gene Biotech Co. Ltd., Zhejiang, China.
Immun Inflamm Dis. 2025 Jul;13(7):e70228. doi: 10.1002/iid3.70228.
Development of readily available Rapid COVID-19 Antigen tests 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-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.
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.
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.
开发易于获得的新型冠状病毒快速抗原检测对于及时识别严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染并防止其传播至关重要。
本研究评估了Healgen新型冠状病毒快速抗原检测作为即时诊断工具的临床性能，研究对象为806名症状出现后6天内的可评估受试者。将Healgen检测结果与紧急使用授权（EUA）批准的SARS-CoV-2逆转录聚合酶链反应（RT-PCR）检测结果进行比较。
在806名可评估受试者中，Healgen新型冠状病毒检测结果显示，140人SARS-CoV-2检测呈阳性，640人检测呈阴性，与EUA RT-PCR结果显示出良好的一致性。有26名受试者结果不一致，其中24人Healgen检测为阴性，但RT-PCR检测为阳性，2人Healgen检测为阳性，但EUA-PCR检测为阴性。阳性百分一致性（PPA）和阴性百分一致性（NPA）分别为85.4%和99.7%。此外，Healgen新型冠状病毒检测在56例弱阳性病例（基于EUA PCR检测Ct值≥30）中检测出34例（60.7%），显示出该检测具有良好的检测能力。
与EUA RT-PCR检测相比，Healgen新型冠状病毒抗原检测在PPA和NPA方面表现良好，具有作为SARS-CoV-2诊断工具的潜力。
