Abstract
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® Influenza A+B fluorescent immunoassay (FIA) and Alere™ BinaxNOW® Influenza A & B immunochromatographic (ICT) assay.MethodsA 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.ResultsCompared 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.ConclusionsAlere™ i Influenza A&B is a promising new rapid influenza diagnostic assay with potential point-of-care applications.
Highlights
Rapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; the performances of currently available assays vary widely
Forty-eight (23Á8%) samples collected from 202 adults were positive for influenza virus by reverse-transcription polymerase chain reaction (RT-PCR), 36 (17Á8%) influenza A and 12 (5Á9%) influenza B
The Alere iNAT internal control for influenza A failed in one sample, and the Sofia internal controls for influenza A and B failed in four samples
Summary
Rapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; the performances of currently available assays vary widely. Rapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making as a rapid diagnosis of influenza A or B can facilitate the prescription of antivirals, reduce unnecessary pathology testing and antibacterial therapy and allow the implementation of appropriate infection control and public health measures.[1,2] Currently, available RIDTs such as lateral flow or fluorescent immunochromatographic assays detect the presence of influenza A and B virus nucleoproteins These assays are relatively simple to perform and can provide results within 10–30 minutes, they suffer from inaccuracies with widely disparate published sensitivities and specificities.[3,4] Their performance is affected by various factors including patient age, duration of illness before sample collection, sample type and circulating influenza virus subtypes.[4,5]. The technical details of Alere iNAT have been recently described, but in brief, the assay involves real-time fluorescence-based detection of short amplicons following exponential isothermal amplification.[6,7] Unlike common nucleic acid amplification assays that require nucleic acid extraction followed by thermal cycling using specialised equipment, Alere iNAT is a partially automated process that can be completed in
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
