Sexually transmitted infections · 2026
Evaluation of three syphilis algorithms: resolving discordance to ensure diagnostic accuracy.
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Wu Sirui, Huang Yike, Luo Lan, Deng Jielun, Wang Yuanfang, Ye Fei, Li Dongdong
Аннотация
OBJECTIVES: With the increasing incidence and persistent prevalence of syphilis, it is necessary to reevaluate the clinical utility of three syphilis algorithms.
METHODS: Cases with concurrent Treponema pallidum-electrochemiluminescence immunoassay (TP-ECLIA), T. pallidum particle agglutination (TPPA) and toluidine red unheated serum test (TRUST) results from a large hospital in China were collected. The diagnostic performance of three syphilis algorithms-the traditional algorithm (start with TRUST and confirmation by TPPA), reverse algorithm 1 (start with TP-ECLIA and confirmation by TRUST with TPPA for TRUST-negative cases) and reverse algorithm 2 (start with TP-ECLIA and confirmation by TPPA with TRUST for TPPA-positive cases)-was evaluated using kappa coefficient analysis and Bayesian latent class model (BLCM), along with assessing their capabilities, discrepancies and limitations in identifying discordant results for T. pallidum antibodies.
RESULTS: High agreement was observed between the two reverse algorithms. BLCM revealed sensitivities of 49.1%, 98.9% and 98.5% and specificities of 99.6%, 99.2% and 100.0% for the traditional algorithm, reverse algorithm 1 and reverse algorithm 2. The traditional algorithm identified 11 biological false-positive cases but missed 1177 TPPA+/TRUST- syphilis diagnoses. Discordant treponemal test results (TP-ECLIA+/TPPA-/±) were common (18.2%) and associated with significantly lower TP-ECLIA cut-off index values. The reverse algorithm 1 identified 500 treponemal test-discordant cases, while the reverse algorithm 2 identified 517 cases. Besides, 17 discordant cases were identified among untested components of the algorithms.
CONCLUSIONS: The reverse algorithm 2 is recommended, as the confirmation of TP-ECLIA by TPPA reduces the underdiagnosis of previously treated syphilis compared with the traditional algorithm and compensates for the limited specificity of TP-ECLIA, thereby representing an improvement over reverse algorithm 1.
METHODS: Cases with concurrent Treponema pallidum-electrochemiluminescence immunoassay (TP-ECLIA), T. pallidum particle agglutination (TPPA) and toluidine red unheated serum test (TRUST) results from a large hospital in China were collected. The diagnostic performance of three syphilis algorithms-the traditional algorithm (start with TRUST and confirmation by TPPA), reverse algorithm 1 (start with TP-ECLIA and confirmation by TRUST with TPPA for TRUST-negative cases) and reverse algorithm 2 (start with TP-ECLIA and confirmation by TPPA with TRUST for TPPA-positive cases)-was evaluated using kappa coefficient analysis and Bayesian latent class model (BLCM), along with assessing their capabilities, discrepancies and limitations in identifying discordant results for T. pallidum antibodies.
RESULTS: High agreement was observed between the two reverse algorithms. BLCM revealed sensitivities of 49.1%, 98.9% and 98.5% and specificities of 99.6%, 99.2% and 100.0% for the traditional algorithm, reverse algorithm 1 and reverse algorithm 2. The traditional algorithm identified 11 biological false-positive cases but missed 1177 TPPA+/TRUST- syphilis diagnoses. Discordant treponemal test results (TP-ECLIA+/TPPA-/±) were common (18.2%) and associated with significantly lower TP-ECLIA cut-off index values. The reverse algorithm 1 identified 500 treponemal test-discordant cases, while the reverse algorithm 2 identified 517 cases. Besides, 17 discordant cases were identified among untested components of the algorithms.
CONCLUSIONS: The reverse algorithm 2 is recommended, as the confirmation of TP-ECLIA by TPPA reduces the underdiagnosis of previously treated syphilis compared with the traditional algorithm and compensates for the limited specificity of TP-ECLIA, thereby representing an improvement over reverse algorithm 1.