The Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) is used for qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum(TP)in Whole Blood,
serum or plasma to aid in the diagnosis of Syphilis.
The Syphilis Rapid Test Cassette has been compared with a leading commercial TPPA Syphilis test, demonstrating an overall accuracy greater than or equal to 99.8%.
The Syphilis Rapid Test Cassette has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of the Syphilis Rapid Test Cassette is >99.9% and the relative specificity is 99.7%.
Relative sensitivity: >99.9% (97.5%CI*: 97.2%~100.0%);
Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);
Accuracy: 99.8% (95%CI*: 98.2%~100.0%). *Confidence Intervals