This product is used for in vitro qualitative detection of novel coronavirus (SARS CoV 2) antigen in human oropharyngeal swabs nasal swabs and nasopharyngeal swabs.
ASSAY KIT COMPONENTS
1. Test device: one plate per bag
a. Sealed in an aluminum foil bag.
b. Contains immobilized SARS-CoV-2 spike antigen protein and mouse IgG labeled with colloidal gold,
c. Goat anti-mouse IgG antibodies as a control.
2. Specimen diluent buffer: 1 vial (4.5mL per vial for 40 tests)
a. Contains 1.0% NaCl, 0.1% Na2HPO4 and 0.5% Casein.
• Store in a dry place at 2-30 ℃, protected from light.
• The kit shall should be used within 30 minutes after the aluminum foil bag is opened.
• Testing should not be performed when the ambient temperature is higher than 30 ℃ or the relative humidity is
higher than 70%.
• The date for the manufacturing and the expiration date are printed on the outside of the package.
1. For fresh samples, begin with Step 2. For frozen samples, bring the specimens and test components to room
temperature, and mix the specimen well once thawed.
2. When ready to test, open the pouch and remove the test device. Place the test device on a clean, flat, dry surface.
3. Label the device with specimen ID number.
4. Add specimens:
• Serum/Plasma: Take 10 μL of serum or plasma with a pipette into sample well (S), and then add
vertically 2 drops (about 100 μL) of specimen diluent.
5. Set timer for 10 minutes.
6. Read the results at 10 minutes but no longer than 15 minutes.