The rapid antigen test (RAT) for coronavirus disease (COVID-19) represents a potent diagnostic method in situations of limited molecular testing resources. However, considerable performance variance has been reported with the RAT. We evaluated the clinical performance of Standard Q COVID-19 RAT (SQ-RAT; SD Biosensor, Suwon, Korea), the first RAT approved by the Korean Ministry of Food and Drug Safety. In total, 680 nasopharyngeal swabs previously tested using real-time reverse-transcription PCR (rRT-PCR) were retested using SQ-RAT. The clinical sensitivity of SQ-RAT relative to that of rRT-PCR was 28.7% for all specimens and was 81.4% for specimens with RNA-dependent RNA polymerase gene (RdRp) threshold cycle (Ct) values ≤23.37, which is the limit of detection of SQ-RAT. The specificity was 100%. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis was assessed based on the Ct distribution at diagnosis of 33,294 COVID-19 cases in Korea extracted from the laboratory surveillance system of Korean Society for Laboratory Medicine. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis in the Korean population was 41.8%. Considering the molecular testing capacity in Korea, use of the RAT for COVID-19 diagnosis appears to be limited.

中文翻译：

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标准 Q COVID-19 快速抗原测试的临床性能及其在韩国的实际应用模拟。

在分子检测资源有限的情况下，冠状病毒病 (COVID-19) 的快速抗原检测 (RAT) 是一种有效的诊断方法。但是，已经报告了 RAT 的相当大的性能差异。我们评估了标准 Q COVID-19 RAT（SQ-RAT；SD 生物传感器，韩国水原）的临床性能，这是韩国食品和药物安全部批准的第一个 RAT。总共使用 SQ-RAT 重新测试了先前使用实时逆转录 PCR (rRT-PCR) 测试的 680 份鼻咽拭子。SQ-RAT 相对于 rRT-PCR 的临床敏感性对于所有标本为 28.7%，对于具有 RNA 依赖性 RNA 聚合酶基因 ( RdRp) 的标本为 81.4%) 阈值循环 (Ct) 值≤23.37，这是 SQ-RAT 的检测限。特异性为100%。根据从韩国检验医学会实验室监测系统中提取的韩国 33,294 例 COVID-19 病例诊断时的 Ct 分布评估 SQ-RAT 对 COVID-19 诊断的临床敏感性。SQ-RAT 在韩国人群中诊断 COVID-19 的临床敏感性为 41.8%。考虑到韩国的分子检测能力，使用 RAT 诊断 COVID-19 似乎很有限。