Evaluation of a fully automated treponemal test and comparison with conventional VDRL and FTA-ABS tests

Am J Clin Pathol. 2011 Nov;136(5):705-10. doi: 10.1309/AJCP0WOK0QDYGDCM.


We evaluated analytic performances of an automated treponemal test and compared this test with the Venereal Disease Research Laboratory test (VDRL) and fluorescent treponemal antibody absorption test (FTA-ABS). Precision performance of the Architect Syphilis TP assay (TP; Abbott Japan, Tokyo, Japan) was assessed, and 150 serum samples were assayed with the TP before and after heat inactivation to estimate the effect of heat inactivation. A total of 616 specimens were tested with the FTA-ABS and TP, and 400 were examined with the VDRL. The TP showed good precision performance with total imprecision of less than a 10% coefficient of variation. An excellent linear relationship between results before and after heat inactivation was observed (R(2) = 0.9961). The FTA-ABS and TP agreed well with a κ coefficient of 0.981. The concordance rate between the FTA-ABS and TP was the highest (99.0%), followed by the rates between FTA-ABS and VDRL (85.0%) and between TP and VDRL (83.8%). The automated TP assay may be adequate for screening for syphilis in a large volume of samples and can be an alternative to FTA-ABS.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Female
  • Fluorescent Treponemal Antibody-Absorption Test / methods
  • Humans
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Syphilis / diagnosis*
  • Syphilis Serodiagnosis / methods*
  • Treponema Immobilization Test / methods
  • Treponema pallidum / isolation & purification*