Intended Use
The Syphilis Ab Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Syphilis in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Syphilis. Any reactive specimen with the Syphilis Ab Rapid Test must be confirmed with alternative testing methods and clinical findings.
Principle
The test strip consists of: 1) a burgundy colored conjugate pad containing recombinant Tp antigens conjugated with colloid gold (Tp conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated recombinant Tp antigens, and the C band is pre-coated with goat anti-rabbit IgG antibody.
When an adequate volume of test specimen is dispensed into the sample well of the 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 band, indicating a Tp antibody positive test result.
Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.
Composition
1. Test Card Pouch
2. Sterile Lancets
3. Disposable Droppers
4. Sample Diluent Buffer
5. Alcohol Pad
6. Instructions for Use
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