Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis

Clin Vaccine Immunol. 2007 Jun;14(6):710-3. doi: 10.1128/CVI.00068-07. Epub 2007 Apr 25.


We report the results of an evaluation of the LIAISON Treponema pallidum-specific assay, a one-step sandwich chemiluminescence immunoassay (CLIA), as a screening test and as a confirmatory test for the diagnosis of syphilis. The assay was compared with the CAPTIA Syphilis-G enzyme immunoassay (EIA) and with a testing algorithm that also included the rapid plasma reagin (RPR) and T. pallidum particle agglutination (PA) assays. As a screening test, the CLIA showed levels of agreement with the EIA and with the algorithm, respectively, of 94.1 and 100% for 51 samples from patients with primary or secondary syphilis, 93.2 and 98.7% for 999 samples sent to the laboratory for routine syphilis testing, 84.5 and 94.0% for 200 samples from human immunodeficiency virus-positive patients, 98.0 and 100% for 200 samples from pregnant patients, and 94.3 and 98.3% for 992 samples from apparently healthy adults. As a confirmatory test, the CLIA showed 99% agreement with the EIA for 204 RPR-positive samples. After resolution with further T. pallidum PA testing and the discarding of one sample of insufficient quantity, there was 100% agreement for the remaining 203 samples. For the total group of 2,645 samples, the overall relative sensitivity was 95.8% and the relative specificity was 99.1%. We conclude that the LIAISON CLIA demonstrated excellent sensitivity and specificity when evaluated as a confirmatory test and as a screening test for syphilis among various patient populations, including specific populations with reportedly increased rates of false-positive nontreponemal test results.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Agglutination Tests
  • Algorithms
  • Case-Control Studies
  • False Positive Reactions
  • Female
  • HIV Seropositivity
  • Humans
  • Immunoenzyme Techniques
  • Luminescence*
  • Luminescent Measurements
  • Male
  • Pregnancy
  • Reagins / blood
  • Sensitivity and Specificity
  • Syphilis / diagnosis*
  • Syphilis / microbiology
  • Treponema pallidum / immunology
  • Treponema pallidum / isolation & purification*


  • Reagins