Detection of influenza A and B with the Alere™ i Influenza A & B: a novel isothermal nucleic acid amplification assay
Detection of influenza A and B with the Alere™ i Influenza A & B: a novel isothermal nucleic acid amplification assay
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DOI：
10.1111/irv.12303
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发表时间：
2015-05-01
影响因子：
4.4
通讯作者：
Kok, Jen
中科院分区：
文献类型：
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作者：
Hazelton, Briony;Gray, Timothy;Kok, Jen
背景：快速流感诊断试验（RIDTs）在临床决策中具有重要作用；然而，目前可用的测定方法的性能差异很大。目的：我们评估了Alere i Influenza A&B （Alere iNAT）的性能，这是一种最近获得FDA批准的快速等温核酸扩增试验，用于检测2013年澳大利亚流感季节的甲型和乙型流感病毒。将结果与平行测试的其他两种rct进行比较；Quidel Sofia（(R)）流感A+B荧光免疫分析（FIA）和Alere BinaxNOW（(R)）流感A+B免疫层析（ICT）检测。方法收集来自16岁流感样疾病（ILI）患者的202份配对鼻咽拭子，用2ml通用运输介质（UTM）洗脱，用于并行进行所有3次RIDTs。以逆转录聚合酶链反应（RT-PCR）作为对照标准。结果与RT-PCR相比，Alere iNAT的检出率为778%，Quidel Sofia((R)) influenza A+B FIA和BinaxNOW((R)) influenza A & B ICT检测的检出率分别为714%和444%。对于乙型流感，Alere iNAT检测到75%的RT-PCR阳性，而Sofia（(R)）和BinaxNOW（(R)）分别为333%和250%。Alere iNAT对甲型流感的特异性为100%，对乙型流感的特异性为99%。结论Alere i甲型流感和乙型流感是一种有前景的新型流感快速诊断方法，具有潜在的临床应用前景。
BackgroundRapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; however, the performances of currently available assays vary widely.ObjectivesWe evaluated the performance of the Alere i Influenza A&B (Alere iNAT), a rapid isothermal nucleic acid amplification assay that has recently received FDA clearance, for the detection of influenza A and B viruses during the Australian influenza season of 2013. Results were compared to two other RIDTs tested in parallel; Quidel Sofia((R)) Influenza A+B fluorescent immunoassay (FIA) and Alere BinaxNOW((R)) Influenza A & B immunochromatographic (ICT) assay.MethodsA total of 202 paired nasopharyngeal swabs collected from patients 16years old with an influenza-like illness (ILI) were eluted in 2ml of universal transport medium (UTM) that was used to perform all three RIDTs in parallel. Reverse-transcription polymerase chain reaction (RT-PCR) was used as the reference standard.ResultsCompared to RT-PCR, Alere iNAT detected 778% influenza A positive samples versus 714% and 444% for the Quidel Sofia((R)) Influenza A+B FIA and BinaxNOW((R)) Influenza A & B ICT assay, respectively. For influenza B, Alere iNAT detected 75% of those positive by RT-PCR, versus 333% and 250% for Sofia((R)) and BinaxNOW((R)), respectively. The specificity of Alere iNAT was 100% for influenza A and 99% for influenza B.ConclusionsAlere i Influenza A&B is a promising new rapid influenza diagnostic assay with potential point-of-care applications.