MEDSUP COVID-19 RAPID ANTIGEN TEST

MEDSUP COVID-19 RAPID ANTIGEN TEST

REF: TRA-5

For the qualitative assessment of SARS-CoV-2 virus antigen nasal swab specimens. For in vitro diagnostic use only. For OTC use at home and other non-laboratory sites. For the most up to date information on COVID-19, please visit: www.canada.ca .

INTENDED USE

MEDSUP COVID-19 RAPID ANTIGEN TEST is a lateral flow immunochromatographic assay intended for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in nasal swab specimens from individuals that are self-collected by an individual 18 or older or are collected by an adult from an individual aged 5 years of age and older. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. Results are for the identification of SARS-CoV-2 nucleocapsid protein. Antigen is generally detectable in nasal swab specimens 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. Persons who test positive should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary in accordance with local, regional, and federal requirements. Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or user 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. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. MEDSUP COVID-19 RAPID ANTIGEN TEST is intended for over-the-counter (OTC) use at home and other non-laboratory sites.