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

Influenza Other Respir Viruses

Centre for Infectious Diseases and Microbiology Laboratory Services, Institute for Clinical Pathology and Medical Research, Westmead Hospital, Westmead, NSW, Australia; Westmead Clinical School, University of Sydney, Westmead Hospital, Westmead, NSW, Australia.

Published: May 2015

Background: Rapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; however, the performances of currently available assays vary widely.

Objectives: We 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(®) Influenza A+B fluorescent immunoassay (FIA) and Alere(™) BinaxNOW(®) Influenza A & B immunochromatographic (ICT) assay.

Methods: A total of 202 paired nasopharyngeal swabs collected from patients ≥ 16 years old with an influenza-like illness (ILI) were eluted in 2 ml 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.

Results: Compared to RT-PCR, Alere(™) iNAT detected 77.8% influenza A positive samples versus 71.4% and 44.4% for the Quidel Sofia(®) Influenza A+B FIA and BinaxNOW(®) Influenza A & B ICT assay, respectively. For influenza B, Alere(™) iNAT detected 75% of those positive by RT-PCR, versus 33.3% and 25.0% for Sofia(®) and BinaxNOW(®), respectively. The specificity of Alere(™) iNAT was 100% for influenza A and 99% for influenza B.

Conclusions: Alere(™) i Influenza A&B is a promising new rapid influenza diagnostic assay with potential point-of-care applications.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415699PMC
http://dx.doi.org/10.1111/irv.12303DOI Listing

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