The COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A and influenza B in nasal swab specimens directly from individuals within the first seven days of symptom onset. It is intended to aid in the rapid diagnosis of SARS-CoV-2, influenza A and/or influenza B infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings.

It is used by healthcare professionals or trained operators who are proficient in performing rapid tests and trained clinical laboratory personnel specifically instructed on in vitro diagnostic procedures and proper infection control procedures or individuals similarly trained in point of care settings.