DISCLAIMER - PLEASE READ PRIOR TO CHECKOUT AND SELF-TESTING
In Ontario, Alberta, and British Columbia, the current guidance is that properly trained individuals may perform self-swabbing. Before Rapid Testing kits can be purchased, the following training materials and documents must be reviewed:
It is your responsibility to ensure that you have the appropriate knowledge, skills, and judgment to perform the COVID-19 self-test, prior to purchase and usage.
Product Code: COV-19C25 Sample: Nasal / Nasopharyngeal secretions Format: Cassette Quantity: 25 Tests/Kit Time to result: 15 minutes Storage Condition: 2-30°C/36-86°F Test Principle: Immunochromatographic Assay Health Canada Authorization: IO 321669
Individually packed test devices Extraction Buffer Extraction tube Nozzle with filter Tube stand Individually packed swabs Package Insert
The Rapid Response™ 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 and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. This test is authorized for use at the Point of Care i.e., in patient care setting.
Results are for the identification of SARS-CoV-2 viral nucleoprotein antigen. Antigens are generally detectable in nasopharyngeal and 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.
The Rapid Response™ COVID-19 Antigen Rapid Test Device is intended for use by trained laboratory personnel or health care professionals.
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. Interim Authorization Number: 321669
All medically classified products listed on this website meet Health Canada regulatory requirements and are subject to regular inspection to ensure they comply with the Food and Drugs Act and the Medical Devices Regulations
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