Rapid Tets Kit Antigen Rapid Test SARS-CoV-2 Antigen Saliva Rapid Test Kit

Intend Use

The rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in hunman saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset.

Product Details

Product Feature

• Fast: Quick test speed, you can read the result within 15 minutes
• Accurate: High accuracy, specificity and sensitivity, accuracy rate more than 95%
• Protable: Easy to collect sample, you can do the test anywhere, anytime
• Simple: Easy to operate, one step testing process

Test Principle

• Immunochromatography assay.
• Gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples.
• There is virus antigen presence in the sample, the antigen binds with the corresponding colloidal gold monoclonal antibody and the coated monoclonal antibody at the detection line to form a compound and then condenses into a red band, indicating a positive result.
• There is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
• Notic: Whether the sample contains antigen or not, the gold monoclonal antibody will bind to the enveloped antibody at the quality control line, form a compound and condense into a red band.

• Main Components
• Test Cassettes
• Saliva Collectors With Collection Tubes
• Sample Extraction Buffers
• Tube stand
• Package Insert

Use Step

• Open the cap of the collection tube and istall saliva collector.
• Put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. Tje volum of saliva needs to be half of 0.5 scal mark(0.25).
• Screw the sample extraction buffer carefully.

• Add all sample extration buffer to the collection tube. Discard the saliva collector, tighten the cap onto the specimen collection tube.
• Shake the specimen collection tube at least three time vigorously to mix the saliva and the extraction buffer. Squeeze bottom of the collection tube ensure the saliva is thoroughly mixed.
• Add 3 full drops of the solution to the sample well(S). Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Result Interpretation

• POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

• NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit.

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Virus Sources

Certificate