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Alere i甲型和乙型流感检测法及mariPOC检测法用于快速检测甲型和乙型流感病毒的性能。

Performance of the Alere i influenza A&B assay and mariPOC test for the rapid detection of influenza A and B viruses.

作者信息

Jokela Pia, Vuorinen Tytti, Waris Matti, Manninen Raija

机构信息

Laboratory Services (Satadiag), Satakunta Central Hospital, 28500 Pori, Finland; Department of Clinical Virology, Division of Microbiology and Genetics, Turku University Hospital, 20521 Turku, Finland.

Department of Clinical Virology, Division of Microbiology and Genetics, Turku University Hospital, 20521 Turku, Finland; Department of Virology, University of Turku, 20520 Turku, Finland.

出版信息

J Clin Virol. 2015 Sep;70:72-76. doi: 10.1016/j.jcv.2015.07.294. Epub 2015 Jul 17.

Abstract

BACKGROUND

Timely detection of influenza viruses is required to facilitate infection control measures and appropriate patient management. The Alere™ i Influenza A&B assay for detection of viral RNA and multianalyte mariPOC(®) test for detection of viral antigens enable rapid detection of influenza viruses with little hands-on time.

OBJECTIVES

To evaluate the performance of the Alere i Influenza A&B assay and the mariPOC test in comparison to the Xpert(®) Flu A/B assay and laboratory-developed real-time reverse transcription-polymerase chain reaction.

STUDY DESIGN

A total of 140 and 108 nasopharyngeal specimens were analysed for evaluation of the Alere i and mariPOC, respectively.

RESULTS

The sensitivity and specificity of the Alere i Influenza A&B assay for detection of influenza A virus was 80.0% and 98.1%, and for influenza B virus 45.2% and 98.2%, respectively. For the mariPOC test, a sensitivity and specificity of 53.1% and 98.7%, respectively, for detection of influenza A virus was achieved.

CONCLUSIONS

The mariPOC test proved insensitive for detection of influenza A virus and therefore unsuitable for individual patient diagnosis without confirmatory testing. In contrast, the Alere i Influenza A&B assay was reasonably sensitive and specific for detection of influenza A and B virus, although decreased detection of specimens with low viral load was observed particularly for detection of influenza B virus. Taken together with its rapidity and ease of use, the Alere i influenza A&B assay is a welcome alternative to immunochromatographic rapid influenza detection tests and may provide timely results that enable appropriate patient care and management of patient flow during high-prevalence seasons.

摘要

背景

及时检测流感病毒对于促进感染控制措施和恰当的患者管理至关重要。用于检测病毒RNA的Alere™ i甲型和乙型流感检测法以及用于检测病毒抗原的多分析物即时检验(mariPOC(®))能够在几乎无需人工操作时间的情况下快速检测流感病毒。

目的

与Xpert(®)甲型/乙型流感检测法和实验室研发的实时逆转录聚合酶链反应相比较,评估Alere i甲型和乙型流感检测法以及mariPOC检测法的性能。

研究设计

分别对140份和108份鼻咽标本进行分析,以评估Alere i检测法和mariPOC检测法。

结果

Alere i甲型和乙型流感检测法检测甲型流感病毒的灵敏度和特异性分别为80.0%和98.1%,检测乙型流感病毒的灵敏度和特异性分别为45.2%和98.2%。对于mariPOC检测法,检测甲型流感病毒的灵敏度和特异性分别为53.1%和98.7%。

结论

mariPOC检测法被证明对甲型流感病毒检测不敏感,因此在没有确诊检测的情况下不适合用于个体患者诊断。相比之下,Alere i甲型和乙型流感检测法对甲型和乙型流感病毒检测具有合理的灵敏度和特异性,尽管观察到对低病毒载量标本的检测率有所下降,尤其是对乙型流感病毒的检测。鉴于其快速性和易用性,Alere i甲型和乙型流感检测法是免疫层析快速流感检测试验的一个受欢迎的替代方法,并且可能提供及时的结果,从而在高流行季节实现恰当的患者护理和患者流程管理。

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