The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
- Sensitivity 97.1% (95% CI= 93.1% ~ 98.9%)
- Specificity 99.5% (95% CI= 98.2% ~ 99.9%)
- Total Coincidence Rate 98.8% (95% CI= 97.6% ~ 99.5%)
- Contents: 5 Test Cassettes, 5 Extraction Buffer Tubes, 5 Disposable Nasal Swabs, 1 Packaging Insert
- Time for result: 15 to 30 minutes
- Conservation: Keep at 2℃ - 30℃, keep dry
- Expiry date: 24 months after manufacturing
- Assembled and Distributed by MedSup Medical, Montréal, QC
The SARS-CoV-2 Antigen Rapid Test can also test specimens from individuals without symptoms or other 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. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples 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.
Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results 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.
The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.