Cepheid Xpert Xpress对在clia认可和放弃clia的环境中检测的鼻和鼻咽标本的CoV-2/Flu/RSV plus的评估

IF 3.4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-08-07 DOI:10.1016/j.jcv.2025.105851

Erin McElvania , Deepa Rao , Alexander L. Greninger , Glenn Harnett , Allan Larcena , Amrish Patel , Brian Webster , Christina Ulen , Dallas F. Green , Dana King , Deepesh Rubin Patel , Imad Jandali , Jane Gibson , Jennifer Killion , Jibran Atwi , Kelly R. Bergmann , Lance Slade , Mary Allen Staat , Matthew Faron , Megan Washington , Xiaohong Liu

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引用次数: 0

摘要

背景：呼吸道病毒每年导致数百万人就医。2019冠状病毒病的不可预测的周期性以及流感和呼吸道合胞病毒的季节性模式导致这些病毒同时传播，具有非特异性和重叠的临床症状。本研究使用3011份鼻咽拭子（NPS）和2943份前鼻拭子（NS）标本对造父变星Xpert Xpress CoV-2/Flu/RSV plus检测进行了评估。该检测在经过实验室培训的clia认可（CA）实验室和非实验室人员的clia豁免（CW）环境中进行评估。将结果与BioFire Respiratory Panel 2.1检测SARS-CoV-2和Hologic Panther Fusion Flu A/B/RSV检测甲型流感、乙型流感和RSV进行比较。造父变星Xpert Xpress CoV-2/Flu/RSV + NPS和NS标本检测结果与参考检测结果具有高度的阳性和阴性一致性。结果NPS对SARS-CoV-2、甲型流感、乙型流感和RSV的总体符合率分别为98.8%、99.1%、99.9%和100%。对于NS， SARS-CoV-2、甲型流感、乙型流感和RSV的总体一致性分别为98.7%、99.3%、99.9%和99.9%。在CA和CW地点进行的标本测试也与参考测试高度阳性和阴性一致。对于SARS-CoV-2、甲型流感、乙型流感和RSV， CA检测的总体一致性分别为97.7%、99.6%、100%和100%。对于连续波检测，SARS-CoV-2、甲型流感、乙型流感和RSV的总体一致性分别为98.8%、99.0%、99.9%和99.9%。结论本研究表明，无论工作人员是否具有分子检测经验，Xpert Xpress CoV-2/Flu/RSV plus都能在CA和CW检测设施中对NPS和NS标本提供快速准确的结果。

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Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings

Background

Respiratory viruses are responsible for millions of healthcare visits annually. The unpredictable periodicity of Coronavirus disease 2019 and seasonal patterns of influenza and respiratory syncytial virus result in concurrent circulation of these viruses with non-specific and overlapping clinical symptoms.

Study design

This study evaluated the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test using 3011 nasopharyngeal swab (NPS) and 2943 anterior nasal (NS) specimens. The assay was evaluated in CLIA-accredited (CA) laboratories with laboratory trained operators and CLIA-waived (CW) settings with non-laboratory personnel. Results were compared to the BioFire Respiratory Panel 2.1 for SARS-CoV-2 and Hologic Panther Fusion Flu A/B/RSV for influenza A, influenza B, and RSV. Cepheid Xpert Xpress CoV-2/Flu/RSV plus testing of NPS and NS specimens had high positive and negative agreement with reference testing.

Results

Overall agreement for NPS was 98.8 %, 99.1 %, 99.9 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For NS, overall agreement was 98.7 %, 99.3 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. Specimen testing performed at CA and CW locations also had high positive and negative agreement with reference testing. Overall agreement for CA testing was 97.7 %, 99.6 %, 100 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For CW testing, overall agreement was 98.8 %, 99.0 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively.

Conclusions

This study demonstrates that Xpert Xpress CoV-2/Flu/RSV plus provides rapid and accurate results from NPS and NS specimens in CA and CW testing facilities regardless of staff experience with molecular testing.

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)