Multicenter evaluation of the Alere™ i influenza A&B assay using respiratory specimens collected in viral transport media

被引:8
作者
Hassan, Ferdaus [1 ]
Crawford, Jordan [1 ]
Bonner, Aleta B. [2 ]
Ledeboer, Nathan A. [3 ]
Selvarangan, Rangaraj [1 ]
机构
[1] Childrens Mercy Hosp, Dept Pathol & Lab Med, Kansas City, MO 64108 USA
[2] Veritas PA, Belton, TX USA
[3] Med Coll Wisconsin, Milwaukee, WI 53226 USA
关键词
Influenza virus; Molecular method; Clinical trial; Point-of-care testing; Turn-around time; Alere i Influenza MB assay; VIRUSES; PCR; IMPACT; TESTS; IDENTIFICATION; DIAGNOSIS; SYSTEM; PANEL; FLU;
D O I
10.1016/j.diagmicrobio.2018.07.002
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Rapid and accurate detection of influenza virus is critical for proper patient management. The Alere (TM) i Influenza A&B assay is an isothermal nucleic acid amplification test capable of detecting influenza A and B viruses directly from respiratory specimens. In this multicenter clinical trial conducted in the US, we evaluated the clinical performance of the Alere (TM) i Influenza A&B assay against that of the Prodesse ProFlu+ assay. A total of 1243 fresh, leftover nasal or nasopharyngeal swabs eluted in viral transport medium were tested by both assays. Sensitivity and specificity of the Alere (TM) i Influenza A&B assay were 97.8% (95% CI 94.6-99.2) and 96.6% (95% CI 95.2-97.5) for influenza A and 92.9% (95% CI 85.5-96.9) and 983% (95% CI 97.4-98.0) for influenza B. The Alere (TM) i Influenza A&B assay is an ideal molecular assay for influenza virus detection due to its high sensitivity and specificity with minimal hands-on and turn-around-time. (C) 2018 Elsevier Inc. All rights reserved.
引用
收藏
页码:294 / 298
页数:5
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