INTENDED USE

The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARSCoV-2, influenza A and influenza B viral nucleoprotein antigens in nasopharyngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

Product information

COMPONENT

Materials Provided Test Cassette: a test cassette includes the COVID-19 Antigen Test Strip and the Influenza A+B Test Strip, which are fixed inside a plastic device

· Extraction Reagent: Ampoule containing 0.4 mL of extraction reagent

· Sterilized Swab

· Extraction Tube

· Dropper Tip

· Work Station

· Package Insert

The quantity of tests was printed on the labeling. Materials required but not provided Timer