Alere i RSV Assay Delivers 98.6% Sensitivity in Under 13 Minutes at Point of Care
A prospective nine-center US clinical trial evaluated the Alere i RSV isothermal nucleic acid amplification test in children and older adults with respiratory symptoms. The assay achieved 98.6% sensitivity and 98.0% specificity for RSV detection compared to real-time RT-PCR, with results available in 13 minutes or less. The high accuracy and minimal hands-on time make this molecular platform well-suited for rapid RSV diagnosis in emergency and point-of-care settings.
The original study
Multicenter Clinical Evaluation of the Alere i Respiratory Syncytial Virus Isothermal Nucleic Acid Amplification Assay.
- Authors
- Hassan F, Hays LM, Bonner A, Bradford BJ, Franklin R, Hendry P, et al.
- Journal
- Journal of clinical microbiology
- Type
- Comparative Study, Evaluation Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
- PMID
- 29263208
Original abstract
The Alere i respiratory syncytial virus (RSV) assay is an isothermal nucleic acid amplification test capable of detecting RSV directly from respiratory specimens, with results being available in ≤13 min after test initiation. The objective of this study was to evaluate the performance characteristics of the Alere i RSV assay in a point-of-care setting by using direct nasopharyngeal (NP) swab specimens (direct NP) and nasopharyngeal swab specimens eluted and transported in viral transport medium (VTM NP). The study was a prospective, multicenter, clinical trial conducted at 9 sites across the United States to evaluate the clinical performance of the Alere i RSV assay with respiratory specimens obtained from both children (age, <18 years) and older adults (age, >60 years). The performance of the Alere i RSV assay was compared with that of the reference method, the Prodesse ProFlu+ real-time reverse transcriptase PCR (RT-PCR) assay. All specimens with discrepant test results were tested further by a second FDA-cleared PCR assay (the Verigene respiratory virus plus nucleic acid test; Luminex Inc., TX). A total of 554 subjects with signs and symptoms of respiratory infections were enrolled, and respiratory samples were collected in this study. In comparison with the ProFlu+ real-time RT-PCR, the overall sensitivity and specificity of Alere i RSV assay for the detection of RSV were 98.6% (95% confidence interval [CI], 94.4 to 99.7%) and 98.0% (95% CI, 95.8 to 99.1%), respectively, for direct NP and 98.6% (95% CI, 94.4 to 99.7%) and 97.8% (95% CI, 95.5 to 98.9%), respectively, for VTM NP. The Alere i RSV is a highly sensitive and specific molecular assay ideal for rapid RSV detection in patients in the point-of-care setting due to its minimal hands-on time and rapid result availability.