The PANBIO™ COVID-19 Ag Rapid Nasal Test Device is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal secretion samples.
In just 15 minutes, individuals can determine a positive or negative result. If positive, individuals should adhere to their local public health guidelines and verify results with a PCR test.
Antigens are generally detectable in nasal secretions during the acute phase of infection. Positive results indicate the presence of viral antigens, but other diagnostic information is necessary to determine infection status.
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.
Accessible, large-scale testing helps contain the virus spread. It is the perfect screening tool for organizations that want to protect their workplace from the risk of COVID-19 transmission.
Recommended use by Healthcare Practitioners, within the scope of their respective Provincial and Professional Standards.
Health Canada Authorized Testing Device. You can verify this by searching the Device ID on the Health Canada List of Authorized Testing Devices Link Here.
** All Rapid Tests are FINAL SALE – we cannot offer cancellations or refunds after your order has shipped. **
COVID-19 screening provides rapid results, 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
- 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
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 judgement to perform the test.
Rapid antigen testing devices should only be used for screening purposes. Nucleic acid-based testing, also called molecular testing or PCR, is the gold standard to diagnose active COVID-19 infection in patients with symptoms. For more information about self-testing and antigen testing devices, please visit the Health Canada website here.
Information, regulations, and guidance around the use of rapid antigen testing devices in Canada is frequently changing. While The Safe Direct website is updated often, we recommend referring to the Health Canada website for the most up to date information on: