Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing SitesLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Influenza, Human
- Respiratory Syncytial Virus Infections
- Not Applicable
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: A performance evaluation study.Masking: None (Open Label)Primary Purpose: Diagnostic
- Younger than 125 years
- Both males and females
The LumiraDx Influenza A/B + RSV Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of Influenza type A, Influenza type B and respiratory syncytial virus (RSV) viral antigens. The test is not intended to detect...
The LumiraDx Influenza A/B + RSV Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of Influenza type A, Influenza type B and respiratory syncytial virus (RSV) viral antigens. The test is not intended to detect influenza C antigens. The LumiraDx Influenza A/B + RSV assay uses nasal swabs or nasopharyngeal swab specimens, collected from symptomatic patients. Approximately 2000 subjects will be enrolled in this study. 120 influenza A positive, 120 influenza B positive and 120 RSV positive samples are required, in addition to at least 120 samples negative for influenza and 120 negative RSV samples, representing four (4) age groups: ? 5 years, 6 to 21 years, 22 to 59 years, and ? 60 years. Depending on the prevalence of influenza A, influenza B or RSV, it will be necessary to collect a significantly higher number of total samples to obtain the required number of positives. Banked specimens may be used to supplement the data set. The objectives of this clinical study are twofold: Evaluate the performance of the LumiraDx Influenza A/B + RSV Test in detecting and differentiating influenza A, influenza B and RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of influenza and or RSV-like illness, as compared with an FDA-cleared comparative method. Evaluate LumiraDx Influenza A/B + RSV Test performance when the test is run by non-laboratory users in point-of-care (POC) locations representative of sites who perform testing under a CLIA certificate of waiver.
- NCT #
- Not Provided
- Principal Investigator: Christina Ulen Advanced Pediatrics Principal Investigator: Robert Rosen Ardmore Family Practice Principal Investigator: Ramin Farsad Access Medical Center Principal Investigator: Matthew Morgan Centura Health Physician Group Principal Investigator: Jeffrey Stewart Family Medical Associates Principal Investigator: Andre Gvozden Gvozden Pediatrics Principal Investigator: Isaac Melamed ImmunoE Health Center Principal Investigator: Nader Nakhleh Jersey Shore UMC Principal Investigator: Lisa Connery Lisa Connery MD Principal Investigator: Aftab Naz Madera Family Medical Group Principal Investigator: Salma Elfaki Nona Pediatric Center Principal Investigator: Adam Kaplan North Texas Family Practice Principal Investigator: Paul Wisman Pediatric Research of Charlottesville Principal Investigator: William Simon New Medical Healthcare Principal Investigator: Joshua Fuller Pediatric Care Principal Investigator: David King Southwest Care Principal Investigator: Song Yu MedHelp Urgent Care Principal Investigator: Michael Bell Accel-West Volusia Pediatrics