The Syphilis Test1 Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma to aid in the diagnosis of syphilis.
Serum, plasma, whole blood
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. 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 that a large number of HIV-infected females exhibited reactive syphilis serological test results. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphilis. Primary syphilis infection 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 Test Device (Serum/Plasma) utilizes a double antigen combination of a syphilis antigen coated particle and syphilis antigen to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma
Principle Of The Test
The Syphilis Ultra Test Device (Serum/Plasma) is a qualitative membrane strip based immunoassay for the detection of TP antibodies (IgG and IgM) in serum or plasma. In this test procedure, recombinant syphilis antigen is immobilized in the test line region of the device. After a serum or plasma specimen is placed in the specimen well, it reacts with syphilis antigen coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized syphilis antigen. If the specimen contains TP antibodies, a colored line will appear in the test line region indicating a positive result. The double antigen test format can detect both IgM and IgG in specimens. If the specimen does not contain TP antibodies, a colored line will not appear in this region indicating a negative result.To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.