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Health Canada (MDEL Licences) - Medical devices establishment license listing Request access to a medical device (Overview)Īpplication Form for Custom-Made Devices and Medical Devices for Special Access Guidance for Health Care Professionals on Special Access Instructions for Use - Boson Rapid SARS-CoV-2 Antigen TestĢ0 Rapid SARS-CoV-2 Antigen Test Cards (Individually packaged)Ģ0 Sterilized nasopharyngeal swabs (Individually packaged)Ģ0 Extraction tubes (Individually packaged)īoson Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the comparative detection of nucleocapsid protein from SARS-CoV-2 in nasopharyngeal swab specimens. Product Brochure - Boson Rapid SARS-CoV-2 Antigen Testģ. Instructional Video (above) - Boson Rapid SARS-CoV-2 Antigen TestĢ. 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.ġ. Before Rapid Testing kits can be purchased, the following training materials and documents must be reviewed: In Ontario, Alberta, and British Columbia, the current guidance is that properly trained individuals may perform self-swabbing. Please contact for case, pallet or truckload pricing: Bulk PricingĭISCLAIMER - PLEASE READ PRIOR TO CHECKOUT AND SELF-TESTING The data from this study were analyzed using the minimum recommended number of low positives demonstrating that the test correctly identified 82.7% of positive samples and correctly identified 99.1% of negative samples.*Final Sale - No Refunds, Returns, Exchanges or Cancellation on all PPE orders
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The performance of the Rapid SARS-CoV-2 Antigen Test Card was established in a prospective clinical study of symptomatic individuals using an EUA molecular test as a comparator method.
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Patient comfort: Straight forward nasopharyngeal swab collection with clinically proven high accuracy results.Easy to transport with no special storage requirements, a test kit is all you need Easy to use: Testing can be easily administered in almost any environment without additional special equipment.Rapid results: Compare to standard RT-PCR tests which could take multiple days for patients to receive their results, Boson Antigen testers will show results within 15-20 minutes.The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older when tested twice over three days with at least 24 hours between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or without symptoms or other epidemiological reasons to suspect COVID-19. This test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The Rapid COVID Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.