Multiple-viruses IVDs

Intended purpose

The COVID-19/RSV/ADV/Flu A&B Antigen Combo Rapid Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, Adenovirus, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARSCoV-2, respiratory syncytial, Adenovirus, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B, Adenovirus or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms).