Xiaosong Su , Jiaye Zhou , Ling Liu , Hongzhi Gao , Yan Lin , Zhile Wang , Xin Zhang , Baishen Pan , Beili Wang , Chunyan Zhang , Wei Guo
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The testing performance of the different specimens and testing techniques were recorded and evaluated.</p></div><div><h3>Results</h3><p>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<sub>50</sub>)/mL. Compared with PCR using NP swabs, PCR with OP swabs showed 89.5 % sensitivity and 95.4 % specificity.</p></div><div><h3>Conclusions</h3><p>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. 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引用次数: 0
摘要
目的使用鼻咽(NP)或口咽(OP)拭子标本进行快速抗原检测(RAT)和聚合酶链反应(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,不仅不同技术之间存在性能差异,不同标本之间也存在性能差异。本研究评估了不同标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。方法对中国厦门 2023/4-2023/5 流感季节采集的疑似流感患者的 NP 和 OP 标本进行 RAT 和定量 PCR 检测。结果与 PCR 相比,RAT 对 NP 和 OP 拭子的灵敏度分别为 58.9% 和 10.3%。检测限(LoD)为 28.71 中位组织培养感染剂量(TCID50)/毫升。与使用 NP 涂片进行 PCR 相比,使用 OP 涂片进行 PCR 的灵敏度为 89.5%,特异度为 95.4%。然而,使用 RAT 时,无论标本类型如何,灵敏度都会下降。因此,为避免出现假阴性结果,在使用 OP 拭子作为标本时,PCR 可能是更好的选择。相反,NP拭子应作为 RAT 的推荐标本。
Performance evaluation of influenza a rapid antigen test and PCR among nasopharyngeal and oropharyngeal samples
Objectives
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.
Methods
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.
Results
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 (TCID50)/mL. Compared with PCR using NP swabs, PCR with OP swabs showed 89.5 % sensitivity and 95.4 % specificity.
Conclusions
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.
期刊介绍:
Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.