title: Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA.
abstract: OBJECTIVE
  In this study we aimed to evaluate the performance effects of chemiluminescence assay (CLIA) for Treponema pallidum specific antibodies detection, and to compare T. pallidum specific antibodies detection accuracy between CLIA and ELISA with TPPA (T. pallidum particle agglutination assay) as a confirmatory test.
  
  
  METHODS
  A total of 865 samples from suspected syphilis patients and preoperative patients were included, in which T. pallidum specific antibodies were simultaneously detected by CLIA and ELISA. Among them, 457 samples were determined by TPPA.
  
  
  RESULTS
  All coefficients of variation (CVs) of ELISA in high-, median-, and low-level samples were more than 5% and the maximum CV was 54.39% in the low-level sample. CVs of CLIA in different-level samples were all below 5%. Among the three assays the Spearman correlation and Kappa coefficients were 0.771 (P ≤ 0.001) and 0.854 (P ≤ 0.001, CLIA vs. ELISA), 0.806 (P ≤ 0.001) and 0.897 (P ≤ 0.001, ELISA vs. TPPA), 0.937 (P ≤ 0.001) and 0.967 (P ≤ 0.001, CLIA vs. TPPA), respectively. The area under the receiver operating characteristic curve (AUC) of CLIA was higher than that of ELISA (0.994 vs. 0.989) with TPPA as the confirmatory test. In 18 discrepant samples the consistency rate between CLIA and TPPA was elevated compared with that between ELISA and TPPA (72.22% vs. 27.78%, P = 0.008). In gray zone, the consistency rate of CLIA with TPPA was higher than that of ELISA with TPPA (90.91% vs. 41.67%, P = 0.027).
  
  
  CONCLUSIONS
  Compared with ELISA, CLIA is more reliable, sensitive and accurate to detect serum T. pallidum specific antibodies. In the future it may be an alternative test with higher sensitivity to ELISA.
authors.affiliation: Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Lixin
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Bei
authors.initials: B
authors.lastname: Cai
authors.affiliation: Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Chuanmin
authors.initials: C
authors.lastname: Tao
authors.affiliation: Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Lanlan
authors.initials: L
authors.lastname: Wang
mesh_terms: D000371:Agglutination; D000907:Antibodies, Bacterial / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D015203:Reproducibility of Results; D013045:Species Specificity; D014210:Treponema pallidum / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial
keywords: Treponema pallidum particle agglutination assay (TPPA); Treponema pallidum specific antibodies; chemiluminescence assay (CLIA); enzyme immunoassay (EIA); syphilis