Syphilis Antibody Test
- Article ID
- ulti med Products (Deutschland) GmbH
- Handling time
A rapid test for the qualitative detection of Treponema Pallidum (TP) in whole blood, serum or plasma. For professional in vitro diagnostic use only. The Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.1 Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.
Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibody response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. The Syphilis Ultra Rapid Test Device (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma.
The Syphilis Test is a qualitative membrane device based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the device. After a specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a coloured line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a coloured line will not appear in this region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.