SARS-CoV-2 Latex Flow Self-test Kit

Basis Information

The product is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal swab, saliva specimens and superficial nasal swab directly from individuals who are suspected of COVID- 19 by their healthcare provider.

Results are to identify SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens 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.

Test Procedure

Please read the instruction for use carefully before testing, and complete the test in strict accordance with the directions of the manual, otherwise reliable results cannot be guaranteed.

• Peel off aluminum foil seal from the top of the extraction tube containing the extraction buffer.
• Place the sample tube on the workbench. Place the swab into the sample tube,ensure the swab head is completely immersed. Vigorously mix the extraction buffer by rotating the swab forcefully against the side of the tube at least 10 times (while submerged)；Squeeze the tube 5 times by hand to ensure that the specimen on the swab is fully eluted into the extraction buffer, then break off the swab head from the breaking point and leave it in the tube；Cover the tube with a tube cap and make sure to be tight and does not leak.
• Install the dropper cap onto the sample tube.
• Open the aluminum foil bag, put the test cassette on a clean, horizontal bench.
• Put 3 drops of the extraction solution into the sample well and start the timer.
• Read the results within 15 minutes, and the results after 15 minutes are invalid.

Pic1Test procedure for nasopharyngeal swabs,nasal swabs samples or oropharynx swabs

Discard used test tubes and test device in suitable biohazards waste container caution: Use a clean pipette or tip for every sample to avoid cross-contamination.