title: Evaluation of two automated chemiluminescence immunoassays, the LIAISON Treponema Screen and the ARCHITECT Syphilis TP, and the Treponema pallidum particle agglutination test for laboratory diagnosis of syphilis.
abstract: BACKGROUND
  Automated Treponema pallidum-specific chemi-luminescence immunoassays (CLIA) run on random-access analyzers allow for rapid diagnosis of syphilis infection.
  
  
  METHODS
  We evaluated the LIAISON Treponema Screen (LIA) and the ARCHITECT Syphilis TP (ARCH) in comparison to the Treponema pallidum particle agglutination (TPPA) test, as a screening test for syphilis. We performed a prospective study using 577 sera submitted for diagnosis of syphilis, including 318 samples from pregnant women. In addition, 42 stored sera from 32 patients with clinically and serologically characterized syphilis infection were investigated.
  
  
  RESULTS
  In the prospective study, the sensitivity and specificity of LIA, ARCH, and TPPA were 100% (18/18), 100% (17/17), and 100% (18/18), and 100% (558/558), 99.8% (552/553), and 99.6% (556/558), respectively. In pregnant women, the specificity of LIA and ARCH was 100% (317/317) and of TPPA 99.7% (316/317). One sample from a child with assumed exposure to maternal antitreponemal antibodies was omitted from analysis. LIA, ARCH, and TPPA were also positive in all investigated sera from patients with known syphilis.
  
  
  CONCLUSIONS
  Both automated CLIA demonstrated excellent diagnostic sensitivity and specificity when evaluated as a screening test for syphilis under routine conditions of a diagnostic laboratory. Thus, these may be used independently as an alternative to the manual TPPA screen.
authors: Dr. Gaertner and Colleagues Laboratory, Ravensburg, Germany.
authors: Nele
authors: N
authors: Wellinghausen
authors: Dr. Gaertner and Colleagues Laboratory, Ravensburg, Germany.
authors: Hanna
authors: H
authors: Dietenberger