The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs from individuals suspected by their healthcare provider of being infected with COVID-19. The results are used to identify the SARS CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasopharyngeal swabs and oropharyngeal swabs during the acute phase of infection. Positive results indicate the presence of viral antigen. Clinical relevance to the patient's medical history and other diagnostic information are required to determine the infection status. Positive results do not exclude the possibility of bacterial infection or co-infection with other viruses. The pathogen detected may not be the clear cause of the disease. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered on the basis of a patient's recent exposure history, medical history and the presence of clinical signs and symptoms in accordance with COVID-19 and, where appropriate, confirmed by a molecular assay for patient management. The COVID-19 rapid antigen detection kit is intended for use by trained clinical laboratory personnel who have been specifically instructed and trained in the in vitro diagnostic procedure.

Materials provided:

    25 test cassettes: Each test cassette is packed in a foil pouch with desiccant.
    25 extraction reagents: Ampoule bottles with 0.3 ml extraction reagent.
    25 Sterilised swabs: Disposable swabs for sample collection.
    25 Extraction Tubes
    25 drip tips
    1 workstation
    1 package insert

Additional materials required: Timer