Su Xiaosong, Zhou Jiaye, Liu Ling, Gao Hongzhi, Lin Yan, Wang Zhile, Zhang Xin, Pan Baishen, Wang Beili, Zhang Chunyan, Guo Wei
Department of Clinical Laboratory, Zhongshan Hospital, Fudan University, Xiamen Branch, 668 Jinhu Road, 361015, Xiamen, China.
Department of Clinical Laboratory, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Pract Lab Med. 2024 Jun 7;40:e00416. doi: 10.1016/j.plabm.2024.e00416. eCollection 2024 May.
Rapid antigen test (RAT) and polymerase chain reaction (PCR) using nasopharyngeal (NP) or oropharyngeal (OP) swab specimens are the two main testing techniques used for laboratory diagnosis of influenza in clinical practice. However, performance variations have been observed not only between techniques, but also between different specimens. This study evaluated the differences in performance between specimens and testing techniques to identify the best combination in clinical practice.
Both NP and OP samples from suspected influenza patients collected in the 2023/4-2023/5 Flu-season in Xiamen, China, were tested for RAT and quantitative PCR. The testing performance of the different specimens and testing techniques were recorded and evaluated.
Compared to PCR, RAT showed 58.9 % and 10.3 % sensitivity for NP and OP swabs, respectively. The Limit of Detection (LoD) was 28.71 the Median Tissue Culture Infectious Dose (TCID)/mL. Compared with PCR using NP swabs, PCR with OP swabs showed 89.5 % sensitivity and 95.4 % specificity.
There were no significant differences in performance between the specimens when PCR was used to test for influenza. However, a decrease in sensitivity was observed when the RAT was used, regardless of the specimen type. Therefore, to avoid false-negative results, PCR may be a better choice when OP swabs are used as specimens. In contrast, NP swabs should be the recommended specimens for RAT.
快速抗原检测（RAT）和使用鼻咽（NP）或口咽（OP）拭子样本的聚合酶链反应（PCR）是临床实践中用于流感实验室诊断的两种主要检测技术。然而，不仅在技术之间，而且在不同样本之间都观察到了性能差异。本研究评估了样本和检测技术之间的性能差异，以确定临床实践中的最佳组合。
对2023年4月至2023年5月在中国厦门流感季节收集的疑似流感患者的NP和OP样本进行RAT和定量PCR检测。记录并评估不同样本和检测技术的检测性能。
与PCR相比，RAT对NP和OP拭子的敏感性分别为58.9%和10.3%。检测限（LoD）为28.71中位数组织培养感染剂量（TCID）/mL。与使用NP拭子的PCR相比，使用OP拭子的PCR敏感性为89.5%，特异性为95.4%。
当使用PCR检测流感时，样本之间的性能没有显著差异。然而，无论样本类型如何，使用RAT时均观察到敏感性下降。因此，为避免假阴性结果，当使用OP拭子作为样本时，PCR可能是更好的选择。相比之下，NP拭子应是RAT的推荐样本。
