The COVID-19 Antigen Rapid Test Device is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal secretions from individuals suspected of COVID-19 within 6 days of symptom onset.
This test is authorized for use at the Point of Care i.e., in patient care setting.
Antigen is generally detectable in nasopharyngeal and nasal secretions during the acute phase of infection.
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 Rapid Response COVID-19 Antigen Rapid Test Device is now authorized for sale or importation in Canada.
*Upload test results to your database using RapidReader App.
POINTS TO REMEMBER
- 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
- 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