Evaluation of ELISA and CLIA for Treponema pallidum specific antibody detection in China: A multicenter study

Background: Considering the rapid increase of syphilis infections in several countries including China, searching for a screening test with sufficient sensitivity and specificity is extremely urgent. The current study mainly researched the performance for Treponema pallidum (TP) detection by electro-chemiluminescence immunoassays (ECLIA), chemiluminescence immunoassays (CLIA) and four commercially available ELISA assays commonly used in China. Methods: 1372 plasma samples collected from blood centers/banks were tested with 6 assays in 8 laboratories with the Western blot (WB) or TP particle agglutination assay (TPPA) as confirmatory tests. Results: With the WB or TPPA as confirmatory test, the ECLIA demonstrated the highest specificity (95.2%) and Kappa coefficient (0.915), but lowest sensitivity (97.2%) compared with the other 5 assays. While the Wantai-ELISA showed the highest sensitivity (99.6%) among the 6 assays. Sensitivities were found to be significantly increased when any two of the six assays were combined for TP detection. Our study demonstrated that the Wantai-ELISA combined with the ECLIA or the KHB-ELISA or the InTec-ELISA would increase the sensitivities up to 100%. Further analysis showed that the specificities and positive predictive values were both 100.0% when cut-off of S/CO values were served as 15.42 for the ECLIA and 7.14 for the CLIA, indicating that samples under these conditions can be directly considered as positive without confirmation. Conclusions: The CLIA and the ECLIA are more specific than ELISA to detect TP antibodies. However, ELISA is a sensitive method, especially in combination with the CLIA or the ECLIA or another types of ELISA, suitable for the routine screening of blood donations in China.