title: Performance Evaluation of a Novel Chemiluminescence Assay Detecting Treponema Pallidum Antibody as a Syphilis Screening Method.
abstract: BACKGROUND
  Syphilis is a major concern to global public health with increasing incidence. So its screening test should have sufficient sensitivity and specificity. We evaluated the performance of the Lumipulse G TP-N assay detection for syphilis screening and compared it with the InTec ELISA test kit for TP, which is widely used.
  
  
  METHODS
  Samples of several patient groups including 133 clinical and serologically characterized syphilitic sera, 175 samples containing potentially interfering agents, and 2290 unselected samples submitted for routine screening were detected by both the Lumipulse G TP-N assay and the InTec ELISA test kit for TP. Inconsistent samples were confirmed by RecomLine Treponema IgG, IgM immunoblot.
  
  
  RESULTS
  Coefficient of variations of the Lumipulseo G TP-N assay at both levels were below 5% and of the InTec ELISA test kit for TP both over 5%. The sensitivity of the Lumipulse G TP-N assay and the InTec ELISA test kit for TP were 100% for all stages of syphilis. The two methods had consistent analytical specificity of 100% (95% CI: 97.21 - 100.00), while the clinical specificity was 100% (95% CI: 99.79 - 100.00) and 99.82% (95% CI: 99.51 - 99.94), respectively. Between them, Spearman's correlation coefficient was 0.455 and kappa value was 0.986. The overall sensitivity and specificity of the Lumipulse G TP-N assay was higher than the InTec ELISA test kit for TP (sensitivity: 100.0 versus 99.5, specificity: 100.0 versus 99.8).
  
  
  CONCLUSIONS
  The automated Lumipulse G TP-N assay demonstrated excellent diagnostic sensitivity and specificity when evaluated as a screening test for syphilis. Thus, it can be an alternative to the treponemal screening test.
authors.forename: Qixia
authors.initials: Q
authors.lastname: Chen
authors.forename: Jingna
authors.initials: J
authors.lastname: An
authors.forename: Chenli
authors.initials: C
authors.lastname: Rao
authors.forename: Tingting
authors.initials: T
authors.lastname: Wang
authors.forename: Dongdong
authors.initials: D
authors.lastname: Li
authors.forename: Shu
authors.initials: S
authors.lastname: Feng
authors.forename: Chuanmin
authors.initials: C
authors.lastname: Tao
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008163:Luminescent Measurements; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis*; D014210:Treponema pallidum / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic