评估赛沛Xpert Xpress CoV-2/流感/呼吸道合胞病毒检测试剂在经临床实验室改进修正案（CLIA）认证和CLIA豁免的环境中对鼻拭子和鼻咽拭子样本的检测情况。
Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings.
作者信息
McElvania Erin, Rao Deepa, Greninger Alexander L, Harnett Glenn, Larcena Allan, Patel Amrish, Webster Brian, Ulen Christina, Green Dallas F, King Dana, Patel Deepesh Rubin, Jandali Imad, Gibson Jane, Killion Jennifer, Atwi Jibran, Bergmann Kelly R, Slade Lance, Staat Mary Allen, Faron Matthew, Washington Megan, Patel Rahul, Annamalai Rajasekaran, Ackerman Ronald, Stewart William P, Mora Amador Yuliet, Raman Aarthi, Liu Xiaohong
机构信息
Department of Pathology and Laboratory Medicine, Endeavor Health, Evanston, IL, USA; Department of Pathology, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.
Cepheid, CA, USA.
出版信息
J Clin Virol. 2025 Oct;180:105851. doi: 10.1016/j.jcv.2025.105851. Epub 2025 Aug 7.
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.
背景
呼吸道病毒每年导致数百万次医疗就诊。2019冠状病毒病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，伴有非特异性且重叠的临床症状。
研究设计
本研究使用3011份鼻咽拭子（NPS）和2943份前鼻拭子（NS）样本对赛沛Xpert Xpress CoV-2/流感/呼吸道合胞病毒联合检测进行了评估。该检测在经临床实验室改进修正案（CLIA）认可（CA）的实验室中由经过实验室培训的操作人员进行评估，并在由非实验室人员操作的CLIA豁免（CW）环境中进行评估。将结果与用于检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的BioFire呼吸病原体检测板2.1以及用于检测甲型流感、乙型流感和呼吸道合胞病毒的豪洛捷Panther Fusion甲型/乙型流感/呼吸道合胞病毒检测进行比较。对NPS和NS样本进行赛沛Xpert Xpress CoV-2/流感/呼吸道合胞病毒联合检测与参考检测具有高度的阳性和阴性一致性。
结果
对于NPS，SARS-CoV-2、甲型流感、乙型流感和呼吸道合胞病毒的总体一致性分别为98.8%、99.1%、99.9%和100%。对于NS，SARS-CoV-2、甲型流感、乙型流感和呼吸道合胞病毒的总体一致性分别为98.7%、99.3%、99.9%和99.9%。在CA和CW地点进行的样本检测与参考检测也具有高度的阳性和阴性一致性。对于CA检测，SARS-CoV-2、甲型流感、乙型流感和呼吸道合胞病毒的总体一致性分别为97.7%、99.6%、100%和100%。对于CW检测，SARS-CoV-2、甲型流感、乙型流感和呼吸道合胞病毒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，无论工作人员在分子检测方面的经验如何，Xpert Xpress CoV-2/流感/呼吸道合胞病毒联合检测都能在CA和CW检测设施中从NPS和NS样本中提供快速准确的结果。
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