Kakhki Reza Kamali, Neshani Alireza, Kakhki Mohammad Kamali, Zare Hosna
Mashhad Gene Azma Inc., Mashhad, Iran.
Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
Infect Dis Clin Microbiol. 2023 Jun 23;5(2):113-117. doi: 10.36519/idcm.2023.224. eCollection 2023 Jun.
This study aimed to evaluate the sensitivity, specificity, and accuracy of the commercial HARDSON COVID-19 Antigen Rapid Test Kit for diagnosing COVID-19 among the Iranian population by compared with the results of commercial RT-PCR.
Two nasopharyngeal swabs were collected from each patient. One swab was tested with HARDSON COVID-19 Antigen Rapid Test Kit, and the second swab was placed in 3 mL of a virus-transmitted inactivated media for RT-PCR testing. Then, the results of both tests were compared to investigate the diagnostic accuracy of the rapid antigen test.
A total of 275 suspected COVID-19 patients' samples were collected to investigate the diagnostic accuracy of HARDSON COVID-19 Antigen Rapid Test Kit. In this study, 162 positive and 113 negative samples were evaluated. As a result, the sensitivity, specificity, and accuracy of HARDSON COVID-19 Antigen Rapid Test Kit were 90%, 100%, and 94%, respectively.
The diagnostic kit analyzed in this study indicated excellent specificity and a relatively good overall sensitivity for the diagnosis of COVID-19 when compared with the RT-PCR detection kit. Based on the result of this study, COVID-19 Antigen Rapid Test Kit indicated a good sensitivity (96%) in low cycle threshold (Ct) value, and it would be recommended to be integrated into routine diagnostic laboratories and used as an at-home rapid antigen test.
本研究旨在通过与商业逆转录聚合酶链反应（RT-PCR）结果相比较，评估商业哈德森新冠病毒抗原快速检测试剂盒在伊朗人群中诊断新冠病毒的敏感性、特异性和准确性。
从每位患者采集两份鼻咽拭子。一份拭子用哈德森新冠病毒抗原快速检测试剂盒进行检测，另一份拭子置于3毫升病毒运输灭活培养基中用于RT-PCR检测。然后，比较两种检测的结果以研究快速抗原检测的诊断准确性。
共收集了275份疑似新冠病毒患者的样本，以研究哈德森新冠病毒抗原快速检测试剂盒的诊断准确性。在本研究中，评估了162份阳性样本和113份阴性样本。结果，哈德森新冠病毒抗原快速检测试剂盒的敏感性、特异性和准确性分别为90%、100%和94%。
与RT-PCR检测试剂盒相比，本研究中分析的诊断试剂盒在诊断新冠病毒时显示出优异的特异性和相对良好的总体敏感性。基于本研究结果，新冠病毒抗原快速检测试剂盒在低循环阈值（Ct）值时显示出良好的敏感性（96%），建议将其纳入常规诊断实验室并用作居家快速抗原检测。
