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Alere i甲型和乙型流感核酸扩增检测与Xpert Flu/RSV检测的前瞻性评估

Prospective evaluation of the Alere i Influenza A&B nucleic acid amplification versus Xpert Flu/RSV.

作者信息

Nguyen Van J C, Caméléna F, Dahoun M, Pilmis B, Mizrahi A, Lourtet J, Behillil S, Enouf V, Le Monnier A

机构信息

Unité de Microbiologie Clinique, Groupe Hospitalier Paris Saint Joseph, Paris, France.

Unité de Microbiologie Clinique, Groupe Hospitalier Paris Saint Joseph, Paris, France.

出版信息

Diagn Microbiol Infect Dis. 2016 May;85(1):19-22. doi: 10.1016/j.diagmicrobio.2015.11.012. Epub 2015 Dec 1.

Abstract

The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic acid assay. We prospectively evaluated the performance of the Alere i Influenza A&B assay in comparison with our routine Xpert Flu/RSV assay. Positive samples were subtyped according to the protocol from the National Influenza Center (Paris, France). A total of 96 respiratory nasal swab samples were analyzed: with both methods, 38 were positive and 56 were negative. Samples were prospectively collected from January 20 to April 8, 2015, from patient (86 adult and 10 pediatric patients) presenting with an influenza-like illness through the French influenza season. In comparison with the Xpert Flu/RSV assay, the overall sensitivity and specificity of the Alere i Influenza A&B assay were 95% and 100%, respectively. Our results indicate that the Alere i Influenza A&B assay has a good overall analytical performance and a high degree of concordance with the PCR-based Xpert Flu/RSV assay. The Alere i Influenza A&B isothermal nucleic acid amplification test is a powerful tool for influenza detection due to its high sensitivity and specificity as well as its ability to generate results within 15min.

摘要

为了对急性呼吸道感染患者进行最佳管理,需要快速准确地检测呼吸道标本中的流感病毒。由于症状的变异性以及引起流感样疾病的其他众多原因,仅根据临床标准无法做出流感诊断。因此,已经开发了快速流感诊断测试,如Alere i甲型和乙型流感等温核酸检测。我们前瞻性地评估了Alere i甲型和乙型流感检测与我们常规的Xpert Flu/RSV检测相比的性能。根据法国国家流感中心(巴黎)的方案对阳性样本进行亚型分类。共分析了96份呼吸道鼻拭子样本:两种方法检测,38份为阳性,56份为阴性。样本于2015年1月20日至4月8日前瞻性收集,来自在法国流感季节出现流感样疾病的患者(86名成人和10名儿科患者)。与Xpert Flu/RSV检测相比,Alere i甲型和乙型流感检测的总体敏感性和特异性分别为95%和100%。我们的结果表明,Alere i甲型和乙型流感检测具有良好的总体分析性能,并且与基于PCR的Xpert Flu/RSV检测具有高度一致性。Alere i甲型和乙型流感等温核酸扩增检测因其高敏感性和特异性以及在15分钟内得出结果的能力,是一种强大的流感检测工具。

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