Detection of influenza A and B with the Alere (TM) i Influenza A & B: a novel isothermal nucleic acid amplification assay

作者：Hazelton Briony^*; Gray Timothy; Ho Jennifer; Ratnamohan V Mala; Dwyer Dominic E; Kok Jen

来源：Influenza and Other Respiratory Viruses, 2015, 9(3): 151-154.

DOI：10.1111/irv.12303

• Influenza
• isothermal nucleic acid amplification
• rapid diagnostic test(s)
• sensitivity
• specificity

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.

• 出版日期2015-5