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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. • • 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. Antigen is 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. • Do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. • • 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. • • 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. The Rapid Response® COVID-19 Antigen Rapid Test Device is for use at the Point of Care for professional use only. • • 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. • • To learn more about the product, visit our website: https://www.btnx.com • • For information on purchase orders please contact your local sales representative or contact us at [email protected] or 1-888-339-9964.
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