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  NAME AND INTENDED USE

Rapid Gold Immuno-assay Kit for Antibody to Treponema Pallidum (TP) is an in vitro immunoassay for the qualitative determination of Anti-TpP antibody in human serum or plasma in one step. It is for diagnosis of early infection and epidemic survey.

  PRINCIPLE

The kit uses one step method to detect anti-TP antibodies in serum or plasma. The purified specific recombinant TP antigen is immobilized on the nitrocellulose membrane at the test line region and another specific TP Ag conjugated to the colloidal gold is coupled on the label pad. To perform the test, a sample is added to the sample well of the test card. The sample flows through to the label pad. If the sample contains Antibody to Treponema Pallidum, the antibody will bind to the antigen coated on the colloidal gold particles to form antibody-antigen-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region, and react with specific recombinant TP antigen to produce a pink color on the membrane. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If Antibody to Treponema Pallidum (TP) is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid. The pink color intensity will reflect the antibody intensity in the sample. The test is fast and easy to operate.