Treponema Pallidum(TP) antibody Cassette

This rapid gold Immunoassay Kit for Treponema Pallidum (TP) antibody is an in-vitro immunoassay for the qualitative detection of Anti-TP antibody present in the human serum or plasma in just one step. It is used for diagnosis of early infection and epidemic survey.

PRINCIPLE

This test kit uses a 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 conjugate to the colloidal-gold is coupled on the label pad. For performing the test, a sample should be added to the sample well of the test card. The sample then flows through to the label pad and if it contains an Antibody to Treponema Pallidum, the antibody bind to the antigen coated on the colloidal gold particles and form antibody-antigen-gold complexes. These complexes then move on the nitrocellulose membrane by the capillary action toward the test line region where it reacts with specific recombinant TP antigen to produce a pink line on the membrane. A second red line will always appear in the result window, it indicates that the test has been correctly performed and the test device is functioning properly. If an antibody to Treponema Pallidum (TP) is not present or lower than the detection level of the test, only the control line will be visible. If the control line is not developed, the test is invalid. The color intensity reflects the antibody intensity present in the sample; the test is fast and easy to operate.

MATERIALS PROVIDED

Antibody to Treponema Pallidum test card or strip

Each cassette or strip contains a test strip with TP antigen on the test region of the membrane and colored Treponema Pallidum antigen-gold conjugate pad.

SAMPLE COLLECTION AND PRESERVATION

Blood serum samples are routinely prepared from the vein and blood plasma sample are prepared with the routine amount of anticoagulants such as heparin or sodium citrate. Samples should be stored at 2 to 8^oC and used within 5 days without interfering with the assay performance. Storage for long-term of specimens requires being stored at -20^oC or colder is recommended. Repeated freezing and thawing of specimens should be avoided as it may cause erroneous results. Samples with cloud or precipitation should be centrifuged or filtered before testing. Prevent serum from bacterial contamination during the collection and storage.

TEST PROCEDURE

INTERPRETATION OF RESULTS

LIMITATION

It is used for qualitative and assistant diagnosis. Confirmation of the infection should refer to other clinical diagnosis.

PRECAUTIONS

EXPIRATION

The shelf life is of 24months and does not use the kit beyond its expiry date.