EZER™ HPIVs Fluorescence HPIVs Antigen Rapid Test Device CE

INTENDED USE
The EZER™ HPIVs Fluorescence is a fluorescent immunochromatographic assay for direct and qualitative detection of Human parainfluenza viruses type 1, 2, 3 nucleoprotein antigens from a direct nasopharyngeal (NP) swab, throat swab and nasal aspirate samples. The test is intended to aid of rapid diagnosis of suspect Human parainfluenza viruses type 1, 2, 3 infections. A negative result does not exclude HPIVs viral infection. It is recommended that negative results be confirmed by viral culture or HPIVs molecular assay.

SPECIMEN: Nasopharyngeal Swabbing, Nasal Aspiration, Throat Swabbing

TIME TO RESULTS: The test results will be displayed on the GEI-0100 screen.

STORAGE CONDITIONS: Test devices must be stored at 2~30°C. DO NOT FREEZE.

CONTENTS
- HPIV Fluorescence test devicee
- Sterilized swab
- Extraction tube (with extraction buffer 0.5mL/tube)
- Nozzle
- Tube Stand
- ID Card
- Package Insert

APPLICABLE INSTRUMENTImmunofluorescence assay analyzer FIC-S100