510(k) ClearedCE-IVD
Detection of Influenza A, B, and RSV from NP swabs at point of care
Technical Specifications
PlatformGeneXpert
MultiplexYes
Target Count3
Sensitivity≥95%
Specificity≥98%
Turnaround Time30 min
Storage Temperature2–28°C
Shelf Life18 months
Pathogen Targets (3)
Sample Types
Nasopharyngeal swab
Nasal swab
Detection Methods
RT-PCR