Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

ALiA SARS-CoV-2 Antigen FIA Test is a fluorescent immunoassay intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swab from individuals who are suspected of COVID-19 infection by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasopharyngeal swab during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as a sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The ALiA SARS-CoV-2 Antigent FIA Test is intended for use with ALiA FIA Analyser by medical professionals, trained operators, and clinical laboratory technicians. The COVID-19 Test Kit also includes an External Control Pack. ALiA SARS-CoV-2 Antigen FIA Test External Control Pack contains 1 vial of Positive Control (SARS-CoV-2 recombinant nucleocapsid in stabliser) and 1 vial Negative control (stabliser). Each control pack contains 0.5mL of ALiA SARS-CoV-2 Positive and Negative Control. These controls are to be used with the ALiA FIA Analyser and ALiA SARS-CoV-2 Antigen FIA Test only and are intended to verify that the test kits are working and that the test is performed correctly. The test is intended for us by medical professionals, trained operators, and clinical laboratory technicians.