Health Canada Approved Screening Test. Device ID: 41FK10.
You can verify this by searching the Device ID on the Health Canada List of Authorized Testing Devices Link Here.
Identifies potentially contagious patients within 15 minutes.
For use by Healthcare Practitioners only, within the scope of their respective Provincial and Professional Standards.
High-performance rapid test allows for screening as an additional measure to minimize transmission.
Nasopharyngeal sample collection types.
Accessible, large-scale testing helps contain the virus spread.
Product not available in all countries. Not approved for sale in the USA.
The use of this screening test does in no way replace or alter the need for adherence to applicable Federal, Provincial or Municipal Regulations and Public Guidance.
COVID-19 screening providing rapid results to qualified healthcare practitioners, enabling fast decision making as a pre-emptive measure
Easily Deployed at a large scale
Can be used in a wide variety of non-laboratory settings
No special/additional instruments required
Self-contained tube with "break off" swab minimizes staff exposure
Extraction tube is fully enclosed for disposal
Consult with your Healthcare Professional Board/College and your Respective Provincial Health Authority before collecting samples from members of the public. Additional regulations may apply depending on provincial jurisdiction.
- Test time: 15 minutes
- Nasal swab vs Nasal PCR:
- Sensitivity 98.1% (99.0% for samples with Ct values ≤ 33) / Specificity 99.8%.
- Nasal swab vs Nasopharyngeal PCR:
- Sensitivity 91.1% / Specificity 99.7%
- Nasopharyngeal swab vs Nasopharyngeal PCR:
- Sensitivity 91.4% (94.1% for samples with Ct values ≤ 33) / Specificity 99.8%
- Storage: 2°C–30°C
- CE MARK
- WHO EUL
- Sample type: Nasal or Nasopharyngeal swab
- Quantity: 25 tests/kit
For use only by appropriately licensed Healthcare Practitioners on compliant premises within the scope of a practitioner-patient relationship. Customers are responsible for determining their suitability to provide testing services within the regulatory parameters of their respective Province. Consult with your local Health Authority and Professional College to understand if you qualify before purchasing. Safe Direct Medical Supplies is in no way responsible for the misuse or application of products sold.