PDF(Pubmed)
Abstract：
Point-of-care tests for coronavirus disease 2019 (COVID-19) antigen detection have been widely used for rapid diagnosis in various settings. However, research on the diagnostic performance of the COVID-19 antigen test performed by non-laboratory personnel is limited. In this study, we aimed to elucidate the diagnostic performance of GenBody COVID-19 rapid antigen between laboratory professionals and non-laboratory staff. We retrospectively analyzed the data of patients who underwent both GenBody COVID-19 rapid antigen testing and reverse transcription polymerase chain reaction (RT-PCR) between November 01, 2021, and June 30, 2022. The diagnostic performance of the antigen test was compared between laboratory and non-laboratory operators, using RT-PCR as the gold standard. Sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, positive predictive value, negative predictive value, and accuracy were calculated and sensitivity analysis was performed based on the PCR cycle threshold (Ct) value. Of the 11,963 patients, 1273 (10.6%) tested positive using real-time RT-PCR. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, positive predictive value, negative predictive value, and accuracy of the GenBody COVID-19 rapid antigen test with 95% confidence interval were 79.92% (77.26%-82.39%), 99.23% (98.73%-99.57%), 103.25 (62.31-171.11), 0.2 (0.18-0.23), 510.18 (299.81-868.18), 98.11% (96.91%-98.85%), 90.75% (89.64%-91.75%) and 92.76% (91.76%-93.67%), respectively, for non-laboratory staff and 79.80% (74.78%-84.22%), 99.99% (99.94%-100.00%), 6983.92 (983.03-49617.00), 0.2 (0.16-0.25), 34566.45 (4770.30-250474.46) 99.58% (97.09%-99.94%), 99.32% (99.15%-99.46%), and 99.33% (99.13%-99.48%), respectively, for laboratory staff. Notably, when the PCR Ct value exceeded 25, the sensitivity of both the groups decreased to < 40%. The diagnostic performance of GenBody COVID-19 rapid antigen performed by non-laboratory staff was comparable to that of laboratory professionals. However, it should be noted that the sensitivity of the antigen tests decreased when the PCR Ct value exceeded 25. Overall, the GenBody COVID-19 antigen test is a viable option for non-laboratory staff during an epidemic.
摘要：
2019年冠状病毒病(COVID-19)抗原检测的即时检测已被广泛用于各种环境的快速诊断。然而,非实验室人员进行的COVID-19抗原检测的诊断性能研究有限。在这项研究中,我们旨在阐明GenBodyCOVID-19快速抗原在实验室专业人员和非实验室人员之间的诊断性能。我们回顾性分析了2021年11月1日至2022年6月30日同时接受GenBodyCOVID-19快速抗原检测和逆转录聚合酶链反应（RT-PCR）的患者数据。在实验室和非实验室操作人员之间比较了抗原测试的诊断性能,使用RT-PCR作为金标准。灵敏度,特异性，正似然比，负似然比，诊断赔率比，正预测值，负预测值，并根据PCR循环阈值(Ct)值计算准确度,进行敏感性分析.在11963名患者中，1273(10.6%)使用实时RT-PCR检测为阳性。敏感性,特异性，正似然比，负似然比，诊断赔率比，正预测值，负预测值，95%置信区间的GenBodyCOVID-19快速抗原检测准确率为79.92%(77.26%-82.39%),99.23%（98.73%-99.57%），103.25(62.31-171.11),0.2（0.18-0.23），510.18(299.81-868.18),98.11%（96.91%-98.85%），90.75%（89.64%-91.75%）和92.76%（91.76%-93.67%），分别,非实验室工作人员和79.80%(74.78%-84.22%)，99.99%（99.94%-100.00%），6983.92(983.03-49617.00)，0.2（0.16-0.25），34566.45（4770.30-250474.46）99.58%（97.09%-99.94%），99.32%（99.15%-99.46%），和99.33%（99.13%-99.48%），分别,实验室工作人员。值得注意的是,当PCRCt值超过25时,两组的灵敏度均降低至<40%。非实验室工作人员对GenBodyCOVID-19快速抗原的诊断性能与实验室专业人员相当。然而,应该注意的是,当PCRCt值超过25时,抗原测试的灵敏度降低。总的来说,GenBodyCOVID-19抗原检测是流行病期间非实验室工作人员的可行选择。
