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采用经最低程度培训的非实验室操作人员,在 CLIA 豁免环境中进行赛沛 Xpert Xpress Flu/RSV 检测评估。

Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment.

机构信息

Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, OH, USA.

The Medical College of Wisconsin, Milwaukee, WI, USA.

出版信息

Diagn Microbiol Infect Dis. 2022 Oct;104(2):115764. doi: 10.1016/j.diagmicrobio.2022.115764. Epub 2022 Jul 10.

DOI:10.1016/j.diagmicrobio.2022.115764
PMID:35917666
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9271353/
Abstract

The COVID-19 pandemic highlighted the significance of readily available and easily performed viral testing for surveillance during future infectious pandemics. The objectives of this study were: to assess the performance of the Xpert Xpress Flu and/or RSV test, a multiplex PCR assay for detecting influenza A and B virus and respiratory syncytial virus nucleic acids in respiratory tract specimens, relative to the Quidel Lyra Influenza A+B assay and the Prodesse ProFlu+ assay, and the system's ease of use by minimally trained operators. Overall, the Xpert Xpress Flu/RSV test demonstrated a high positive and negative percent agreement with the comparator assays, and was easy to use and interpret results, based on the operators' feedback. We concluded that the Xpert Xpress Flu/RSV test is sensitive, specific, and easy to use for the diagnosis of influenza and RSV by minimally trained operators and can be a valuable tool in future infectious clusters or pandemics.

摘要

新型冠状病毒肺炎疫情凸显了在未来传染病大流行期间进行易于获得和易于操作的病毒检测的重要性。本研究的目的是:评估 Xpert Xpress Flu 和/或 RSV 检测(一种用于检测呼吸道标本中流感 A 和 B 病毒和呼吸道合胞病毒核酸的多重 PCR 检测)相对于 Quidel Lyra Influenza A+B 检测和 Prodesse ProFlu+检测的性能,以及该系统在经过最低限度培训的操作人员中的易用性。总的来说,根据操作人员的反馈,Xpert Xpress Flu/RSV 检测与比较检测具有很高的阳性和阴性符合率,并且易于使用和解释结果。我们得出结论,Xpert Xpress Flu/RSV 检测对于经过最低限度培训的操作人员诊断流感和 RSV 具有较高的敏感性、特异性和易用性,并且可以成为未来传染病集群或大流行中的一种有价值的工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae42/9271353/5b32b03e29d1/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae42/9271353/5b32b03e29d1/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae42/9271353/5b32b03e29d1/gr1_lrg.jpg

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A critical review of point-of-care diagnostic technologies to combat viral pandemics.应对病毒大流行的即时诊断技术的批判性回顾。
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The burden of respiratory syncytial virus in adults: a systematic review and meta-analysis.成人呼吸道合胞病毒负担:系统评价和荟萃分析。
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