[Product Name]

COV19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method)

[Packing Specifications]

1 Test/box;2 Test/box;5 Test/box;25 Test/box

[Intended Use]

the kit is an in vitro immunochromatographic assay for the qualitative detection of Cov19, F A+B antigens in human nasopharyngeal, oropharyngeal swab, and salvia samples.

[Detection Principle]

the kit is an immunochromatographic assay,based on double antibody sandwich method to detect Cov19 and F A/B antigens. this method does not require expensive medical instruments and consumables. after adding the extracted specimen to the sample well on the test cassette, Cov19, F A/B antigens in the sample will interact with the colloidal gold-labeled anti-SARS-CoV-2 and F A/B antibodies on the conjugate pads. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward.

as the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COV19 antigen, it will bind to the colloidal goldanti-SARS-CoV-2 Np monoclonal antibody, diffuse forward, and then react with the anti-SARS-CoV-2 Np monoclonal antibody immobilized on the NC membrane detection line (COV19 Test line). Similarly, if the specimen contains F A/F B antigens, the antigens will react with antibody-coated particles, the conjugate migrate laterally forward, and cause a colored lines (A, B linesrespectively).

on the contrary, if there is no Cov19, F A/B antigen in the sample or the concentration of the antigens is below the minimum detection limit, there is no colored lines in the test area and the result is considered to be negative.

as a procedure control, there is a quality control line (C line), this line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred, otherwise the test result is invalid.