Multicenter evaluation of the Alere™ i influenza A&B assay using respiratory specimens collected in viral transport media.
Rapid and accurate detection of influenza virus is critical for proper patient management. The Alere™ 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™ 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™ 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 98.3% (95% CI 97.4-98.0) for influenza B. The Alere™ 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.
Diagnostic microbiology and infectious disease
Humans; Influenza A virus; Influenza B virus; Influenza, Human; Molecular Typing; Point-of-Care Testing; Reagent Kits, Diagnostic; Real-Time Polymerase Chain Reaction; Sensitivity and Specificity
Alere i Influenza A&B assay; Clinical trial; Influenza virus; Molecular method; Point-of-care testing; Turn-around time
Hassan, Ferdaus; Crawford, Jordan; Bonner, Aleta B.; Ledeboer, Nathan A.; and Selvarangan, Rangaraj, "Multicenter evaluation of the Alere™ i influenza A&B assay using respiratory specimens collected in viral transport media." (2018). Manuscripts, Articles, Book Chapters and Other Papers. 1348.