BOSON COVID-19 Rapid Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal swab obtained from patients with signs and symptoms of respiratory infection. The device is designed to aid in the rapid diagnosis of COVID-19 Virus infection.

Results are for the identification of SARS-CoV-2 viral nucleoprotein antigen. Antigens are generally detectable in nasal secretions 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. Laboratories are required to report all positive results to the appropriate public health authorities.

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 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.

Pursuant to section 5 of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020, the BOSON COVID-19 Rapid Antigen Test is now authorized for sale or importation in Canada. Authorization Ref Number: 323096