[INTENDED USE]

The COVID-19/Influenza A+B RSV Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARSCoV-2, influenza A influenza B RSV 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 RSV Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

[COMPOSITION]

Materials Provided Test Cassette: a test cassette includes the COVID-19 Antigen Test Strip , the Influenza A+B Test Strip, the RSV 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

[STORAGE AND STABILITY]

· Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.

· Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration. The LOT and the expiration date were printed on the labeling.