Each kit contains 25 individually packaged, ready-to-use tests.
The SARS-CoV-2 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleoprotein antigen in nasopharyngeal (NP) swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of symptoms.
The SARS-CoV-2 Rapid Antigen Test is intended for use by trained laboratory personnel and healthcare professionals for laboratory use or point of care testing. Negative results do not preclude SARS-CoV-2 infection and should not be
used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
This assay is not intended to be used for diagnostics. This assay is not intended for home testing (or self-testing).
Kit components
- Test device (individually in a foil pouch with desiccant)
- Extraction buffer tube
- Nozzle cap
- Sterile swab
- Instructions for Use & Quick Reference Guide
Sensitivity:
86.2-90.0%
Specificity:
97.9-99.3% (Patients with onset of clinical symptoms within 5 days)
| Test type |
Qualitative |
| Sample type |
Nasopharyngeal swab |
|
Target antigen
|
Nucleocapsid (N) |
|
Time to result
|
15 minutes (Readout window 15 – 30 minutes)
|
|
Storage temperature
|
2 – 30°C / 36 – 86°F |
|
Stability (test, opened pouch)
|
1 hour once the test has been opened |
|
Control
|
Positive and negative controls are optional components and can be ordered separately |
Download the SARS-CoV-2 Rapid Antigen Test Fact Sheet
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