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Coretests, Inc.
Product Name: Anti-Syphilis Test
Intended Use:
One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.
Introduction:
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 a large number of HIV-infected females exhibited reactive Syphilis serological test results. Multiple clinical stages and long periods of latent asymptomatic infection are characteristics of Syphilis.
Primary Syphilis is defined by the presence of a chance at the site of inoculation. The antibody's 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.
Test Principle:
One Step Syphilis Test is a qualitative membrane strip based on immunoassay for the detection of TP antibodies in WB/serum/plasma. In this test procedure, recombinant syphilis antigen is immobilized in the test line region of the device. After the specimen is dropped into the sample well, it reacts with antigen-coated gold particles that have been applied to the conjugate pad. This mixture migrates chromatographically along the length of the test device and interacts with the immobilized syphilis antigen. If the specimen contains TP antibodies, a colored line will appear in the test region indicating a positive result. If the specimen does not contain TP antibodies, the colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control region indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Product Name: Anti-Syphilis Test
Intended Use:
One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.
Introduction:
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 a large number of HIV-infected females exhibited reactive Syphilis serological test results. Multiple clinical stages and long periods of latent asymptomatic infection are characteristics of Syphilis.
Primary Syphilis is defined by the presence of a chance at the site of inoculation. The antibody's 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.
Test Principle:
One Step Syphilis Test is a qualitative membrane strip based on immunoassay for the detection of TP antibodies in WB/serum/plasma. In this test procedure, recombinant syphilis antigen is immobilized in the test line region of the device. After the specimen is dropped into the sample well, it reacts with antigen-coated gold particles that have been applied to the conjugate pad. This mixture migrates chromatographically along the length of the test device and interacts with the immobilized syphilis antigen. If the specimen contains TP antibodies, a colored line will appear in the test region indicating a positive result. If the specimen does not contain TP antibodies, the colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control region indicating that the proper volume of specimen has been added and membrane wicking has occurred.