Treponema pallidum Antibody Assay Kit (Colloidal Gold)

【PRODUCT SPECIFICATION】

1 Test/Kit, 20 Tests/Kit, 25 Tests/Kit, 40 Tests/Kit

【INTENDED USE】

The Treponema pallidum Antibody Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema pallidum (Tp) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Tp. Any reactive specimen with the Treponema pallidum Antibody Assay Kit (Colloidal Gold) must be confirmed with alternative testing method(s) and clinical findings.

【PRINCIPLE OF THE PROCEDURE】

The Treponema pallidum Antibody Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay.

The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant Tp antigens conjugated with colloidal gold (Tp conjugates) and a control antibody conjugated with colloidal gold, and 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with non-conjugated recombinant Tp antigens, and the C line is pre-coated with a control line antibody.

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Anti-Tp antibody, if present in the specimen, will bind to the Tp conjugates. The immunocomplex is then captured on the membrane by the pre-coated Tp antigen forming a burgundy colored T line, indicating a Tp antibody positive test result. Absence of the T line suggests a negative result.

The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies regardless of color development on the T line. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.

【MAIN COMPONETS】

1. Individually sealed foil pouches containing:
2. One cassette device
3. One desiccant
4. Plastic droppers
5. One package insert (instruction for use)

【STORAGE CONDITIONS AND EXPIRY DATE】

All reagents are ready to use as supplied. Store unused test devices unopened at 2℃-30℃. The positive and negative controls should be kept at 2 If stored at 2℃-8℃, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit to temperatures over 30℃.