Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2022 Nov 7;37(43):e310. doi: 10.3346/jkms.2022.37.e310.
Antigen rapid diagnostic tests (RDTs) became the most important tool for the diagnosis of the coronavirus disease 2019 (COVID-19), however there have been very few evaluations of the accuracy of the RDTs in actual use. In this study, we investigated the performance accuracy of the RDT, the STANDARD Q COVID-19 Ag (STANDARD Q), in the Republic of Korea. We collected a total of 5,792 results that underwent both RDT and reverse transcription polymerase chain reaction simultaneously, and overall sensitivity and specificity of the STANDARD Q were 57.6% and 99.9%, respectively. With binomial logistic regression analysis, we estimated that about half of the COVID-19 patients with a cycle threshold value of 25 for and were RDT-negative. These results suggest that the clinical sensitivity of RDTs against severe acute respiratory syndrome coronavirus 2 is considerably low in a real-world setting, and we recommend that limitations of RDTs should be considered when setting up COVID-19 test strategies.
抗原快速诊断检测（RDT）成为了诊断 2019 冠状病毒病（COVID-19）的最重要工具，但对于 RDT 在实际使用中的准确性评估却非常少。在这项研究中，我们在韩国调查了 RDT（STANDARD Q COVID-19 Ag，STANDARD Q）的性能准确性。我们共收集了 5792 份同时进行 RDT 和逆转录聚合酶链反应的结果，STANDARD Q 的总体灵敏度和特异性分别为 57.6%和 99.9%。通过二项逻辑回归分析，我们估计约有一半的 COVID-19 患者的 循环阈值 值为 25 ，RDT 结果为阴性。这些结果表明，在现实环境中，RDT 对严重急性呼吸综合征冠状病毒 2 的临床灵敏度相当低，我们建议在制定 COVID-19 检测策略时应考虑 RDT 的局限性。
