Evaluation of the Cepheid Xpert Flu Assay for Rapid Identification and Differentiation of Influenza A, Influenza A 2009 H1N1, and Influenza B Viruses
Evaluation of the Cepheid Xpert Flu Assay for Rapid Identification and Differentiation of Influenza A, Influenza A 2009 H1N1, and Influenza B Viruses
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DOI：
10.1128/jcm.06520-11
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发表时间：
2012-05-01
影响因子：
9.4
通讯作者：
Robinson, C. C.
中科院分区：
文献类型：
--
作者：
Novak-Weekley, S. M.;Marlowe, E. M.;Robinson, C. C.
Xpert流感检测试剂盒是下一代核酸扩增系统，可在大约70分钟内以最少的实际操作时间提供甲型流感、甲型流感2009 H1N1和乙型流感B病毒的多重PCR检测。六个实验室参与了一项临床试验，将新型Cepheid Xpert Flu Assay的结果与使用存档和前瞻性采集的儿童和成人鼻抽吸液-洗液（NA-W）标本和鼻咽（NP）拭子进行培养或实时PCR的结果进行比较。通过DNA序列分析解决不一致结果。差异结果分析后，Xpert Flu Assay对含甲型流感病毒、甲型流感病毒2009 H1 N1和流感病毒B的前瞻性NA-W标本的灵敏度与培养物相比分别为90.0%、100%和100%，而对前瞻性NP拭子的灵敏度与培养物相比分别为100%、100%、100%和100%。分别为100%。Xpert Flu Assay对存档NA-W标本的灵敏度与Gen-Probe ProFlu+ PCR对甲型流感病毒、甲型流感病毒2009 H1N1和B流感病毒的灵敏度相比分别为99.4%、98.4%和100%，而Xpert Flu Assay对存档NP拭子的灵敏度与ProFlu+的灵敏度相比分别为98.1%、100%、和93.8%。Xpert Flu Assay对存档NP标本的灵敏度与培养物对三种靶标的灵敏度相比分别为97.5%、100%和93.8%。我们得出结论，Cepheid Xpert Flu Assay是一种准确、快速的方法，适用于按需检测流感病毒感染。
The Xpert Flu Assay cartridge is a next-generation nucleic acid amplification system that provides multiplexed PCR detection of the influenza A, influenza A 2009 H1N1, and influenza B viruses in approximately 70 min with minimal hands-on time. Six laboratories participated in a clinical trial comparing the results of the new Cepheid Xpert Flu Assay to those of culture or real-time PCR with archived and prospectively collected nasal aspirate-wash (NA-W) specimens and nasopharyngeal (NP) swabs from children and adults. Discrepant results were resolved by DNA sequence analysis. After discrepant-result analysis, the sensitivities of the Xpert Flu Assay for prospective NA-W specimens containing the influenza A, influenza A 2009 H1N1, and influenza B viruses compared to those of culture were 90.0%, 100%, and 100%, respectively, while the sensitivities of the assay for prospective NP swabs compared to those of culture were 100%, 100%, and 100%, respectively. The sensitivities of the Xpert Flu Assay for archived NA-W specimens compared to those of Gen-Probe ProFlu+ PCR for the influenza A, influenza A 2009 H1N1, and influenza B viruses were 99.4%, 98.4%, and 100%, respectively, while the sensitivities of the Xpert Flu Assay for archived NP swabs compared to those of ProFlu+ were 98.1%, 100%, and 93.8%, respectively. The sensitivities of the Xpert Flu Assay with archived NP specimens compared to those of culture for the three targets were 97.5%, 100%, and 93.8%, respectively. We conclude that the Cepheid Xpert Flu Assay is an accurate and rapid method that is suitable for on-demand testing for influenza viral infection.