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对比 Panther Fusion 呼吸道病毒检测试剂盒与 R-Gene 和实验室自建检测方法在上下呼吸道诊断和卫生筛查标本中的性能。

Comparison of the performance of the Panther Fusion respiratory virus panel to R-Gene and laboratory developed tests for diagnostic and hygiene screening specimens from the upper and lower respiratory tract.

机构信息

Institute for Medical Virology, University Hospital Tuebingen, Tuebingen, Germany.

Institute for Virology, Hannover Medical School, Hannover, Germany.

出版信息

J Med Microbiol. 2020 Mar;69(3):427-435. doi: 10.1099/jmm.0.001133.

DOI:10.1099/jmm.0.001133
PMID:32118531
Abstract

Diagnosis of acute respiratory infections (ARIs) can be facilitated by the Panther Fusion (PF) automatic, random access PCR system for the detection of influenzavirus A (Flu A) and B (Flu B), parainfluenzavirus (Paraflu), respiratory syncytial virus (RSV), human metapneumovirus (hMPV), rhinovirus (RV) and human adenovirus (AdV) in nasopharyngeal swabs. To evaluate the performance of PF in comparison with established methods, including subsets of (1) lower respiratory tract (LRT) specimens and (2) upper respiratory tract (URT) hygiene screening specimens of patients without ARI symptoms. The performance characteristics of PF were compared with bioMérieux R-Gene and laboratory-developed PCR tests (LDTs). Overall, 1544 specimens with 6658 individual diagnostic requests were analysed. The overall concordances of PF and LDTs for Flu A, Flu B and AdV were 98.4, 99.9 and 96.1%, respectively; by re-testing of discrepant specimens concordances increased to 99.4, 99.9 and 98.0%, respectively. Initial concordances of PF and R-Gene assays for RSV, Paraflu, hMPV and RV were 98.4, 96.3, 99.3 and 96.0%, respectively, and retest concordances were 99.7, 97.9, 99.9 and 98.9%, respectively. No differences to the overall performance were found for the subgroups of LRT and hygiene screening specimens. PCR cycle threshold (Ct) values correlated very well between methods, indicating that a semi-quantitative diagnostic approach using Ct values (e.g. highly vs. weakly positive) could augment the diagnostic information. PF performed similar to R-Gene and LDTs not only for its intended use but also for LRT and hygiene screening specimens with shorter hands-on and turnaround times.

摘要

Panther Fusion(PF)自动随机存取 PCR 系统可用于检测鼻咽拭子中的流感病毒 A(Flu A)和 B(Flu B)、副流感病毒(Paraflu)、呼吸道合胞病毒(RSV)、人偏肺病毒(hMPV)、鼻病毒(RV)和人腺病毒(AdV),有助于急性呼吸道感染(ARI)的诊断。为了评估 PF 与包括(1)下呼吸道(LRT)标本和(2)无 ARI 症状患者上呼吸道(URT)卫生筛查标本亚组的既定方法相比的性能,对其进行了评估。PF 的性能特征与生物梅里埃 R-Gene 和实验室开发的 PCR 检测(LDT)进行了比较。总共分析了 1544 个标本和 6658 个单独的诊断请求。PF 和 LDT 对 Flu A、Flu B 和 AdV 的总体一致性分别为 98.4%、99.9%和 96.1%;通过对不一致标本的重新检测,一致性分别提高到 99.4%、99.9%和 98.0%。PF 和 R-Gene 检测 RSV、Paraflu、hMPV 和 RV 的初始一致性分别为 98.4%、96.3%、99.3%和 96.0%,重测一致性分别为 99.7%、97.9%、99.9%和 98.9%。对于 LRT 和卫生筛查标本的亚组,没有发现与整体性能的差异。PCR 循环阈值(Ct)值在方法之间非常吻合,表明使用 Ct 值(例如高度阳性与弱阳性)的半定量诊断方法可以增加诊断信息。PF 的性能不仅与 R-Gene 和 LDT 相似,而且与 LRT 和卫生筛查标本的性能相似,操作时间和周转时间更短。

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