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The Determine Syphilis TP is an In Vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, which is the bacteria that causes syphilis infection, in human serum, plasma or whole blood. The test is intended as an aid to detect antibodies to Treponema pallidum from infected individuals.
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SUMMARY AND EXPLANATION OF THE TEST Syphilis is caused by infection with the bacterium Treponema pallidum which can be transmitted congenitally or by sexual contact. The disease can evolve into a latent phase in which syphilis is clinically inapparent.
Serologic tests (nontreponemal specific and treponemal specific) are currently the primary method for syphilis diagnosis and management. Nontreponemal tests (VDRL, RPR, ect.) are generally used for screening, and treponemal test (TPHA, FTA-ABS, ect.)are used as confirmatory tests.
BIOLOGICAL PRINCIPLES OF THE PROCEDURE Determine Syphilis TP is an immunochromatographic test for the qualitative detection of antibodies to Treponema pallidum antigens.
Sample is added to the sample pad. As the sample migrates through the conjugate pad. It reconstitutes and mixes with the Treponema pallidum antigen-selenium colloid conjugate. This mixture continues to migrate through the solid phase to the immobilized Treponema pallidum antigens at the patient window site.
If antibodies to Treponema pallidum are present in the sample, the antibodies bind to the Treponema pallidum antigen-selenium colloid and to the Treponema pallidum antigen at the patient window, forming a red line at the patient window site.
If antibodies to Treponema pallidum are absent, the Treponema pallidum antigen-selenium colloid flows past the patient window and no red line is formed at the patient window site.
To insure assay validity, a procedural control bar is incorporated in the assay device. |
| Cat No. |
Description |
Packing |
| 7D24-13 |
Determine Syphilis TP Serum/plasma/Whole Blood Assay |
100 Tests |
| 7D22-11 |
Chase Buffer |
1 Bottle (2.5ml) |
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