Evaluation of the Determine Syphilis TP assay for the detection of antibodies against Treponema pallidum for the serodiagnosis of syphilis.

Currently, infectious syphilis has been resurgent in China and has become a significant public health problem. The rapid expansion of syphilis screening programs is urgently required. In the present study, the performance of the Determine Syphilis TP assay (Determine TP assay) for the detection of antibodies against Treponema pallidum (T. pallidum) for syphilis serodiagnosis was evaluated. In total, 300 serum samples were tested for the presence of treponemal-specific antibodies using the Treponema pallidum particle agglutination (TPPA) assay, the Determine TP assay, and the InTec immunochromatography assay (InTec assay). The Determine TP assay detected 99, 11, and 5 positive results, whereas the InTec assay detected 97, 3, and 3 positive samples from group I (100 TPPA-positive sera), group II (13 TPPA 1:80 +/- sera), and group III (187 TPPA-negative sera), respectively. The sensitivity, specificity, and the rate concordant with TPPA for the Determine TP assay were 97.35, 98.91, and 97.33%, respectively. In comparison to the TPPA, the Determine TP assay is simple to perform and time-saving, making it a favorable alternative for the detection of T. pallidum-specific antibodies where other T. pallidum-specific confirmatory tests are not available. In addition, this rapid treponemal test promotes prompt treatment for syphilis by providing early laboratory diagnosis.