For In Vitro Diagnostic Use Only
The SARS-CoV-2 Antigen Rapid Test Cassette is a rapid, lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from nasal swabs and nasopharyngeal swabs. Intended for use in individuals with symptoms or other epidemiological reasons to suspect a SARS-CoV-2 infection, the cassette is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection collected by professionals.
The SARS-CoV-2 Antigen Rapid Test Cassette (Colloidal Gold Immunochromatography) contains 4 core elements for operation:
⚫ Test cassette: The test cassette is a plastic shell with a test strip (for single use)
⚫ SARS-CoV-2 Antigen Test Sample Treatment Solution: Bottle containing sample treatment solution (for single use)
⚫ Swabs: Sterile swab (for single use)
⚫ Sample processing tube: Used to process samples and prepare sample mixtures (for single use).
Simple to use
Convenient, no devices required
Rapid, get result in 15-20 minutes
Stable, with high accuracy
You must read the instruction manual completely before performing any test, and use the
reagents and specimens after returning to room temperature.
1. Wash and dry your hands, take out test cassette from outer package.
2. Place test cassette flat on a clean table.
3. Take out swab from stick-end, refer to standard nasal swab or nasopharyngeal swab specimen
collection to collect specimen.
4. Add 10 drops of sample treatment solution into the sample processing tube.
5. Insert the swab with sampling into the sample treatment solution and rotate about 10 times to
dissolve the specimen in the solution as much as possible.
6. Rotate the swab while squeezing the sample processing tube, gently squeeze out the liquid on
the swab head, take out the swab, and discard it properly.
7. Close the sample processing tube tightly with the provided cap, and gently mix the sample
8. Add 3 drops of the sample mixture into the sample well (S) of the test cassette.
9. Start timing and wait for the appearance of purple-red band. Test results should be read within
10. After test, dispose of used specimens, test cassettes and other waste into medical waste
container in accordance with relevant local laws and regulations.
A brief operation instruction is listed below: