Skip to main content
Journal of Clinical Laboratory Analysis logoLink to Journal of Clinical Laboratory Analysis
. 2009 Jan 12;23(1):1–6. doi: 10.1002/jcla.20268

Laboratory diagnosis of syphilis with automated immunoassays

Antonella Marangoni 1,, Alessandra Moroni 1, Silvia Accardo 1, Roberto Cevenini 1
PMCID: PMC6649049  PMID: 19140205

Abstract

The serological detection of specific antibodies to Treponema pallidum is of particular importance in the diagnosis of syphilis. The purpose of this study was to evaluate diagnostic performances of automated immunoassays in comparison with T. pallidum hemagglutination test (TPHA) and Western Blot (WB). The retrospective study was performed with different panels of sera: 244 clinical and serological characterized syphilitic sera and 203 potentially interfering samples. All the sera were tested by Enzygnost Syphilis, ARCHITECT Syphilis TP, TPHA, and homemade WB. The diagnostic performances of the two assays were very similar: both Enzygnost Syphilis and ARCHITECT Syphilis TP performed with a sensitivity of 99.2%, whereas the specificity was 98.5 and 98.4%, respectively. Considering the suitability for automation, both immunoassays may represent a good choice as a screening test. However, the use of a confirmatory test, such as TPHA or WB, remains a must in order to avoid false‐positive results. J. Clin. Lab. Anal. 23:1–6, 2009. © 2009 Wiley‐Liss, Inc.

Keywords: syphilis serology, Treponema pallidum, automated immunoassays, TPHA, Western Blot

REFERENCES

  • 1. Peeling RW, Mabey DCW. Syphilis. Nat Med 2004;2:448–449. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2. Tikhonova L, Salakhov E, Southwick K, Shakarishvili A, Ryan C, Hillis S for the Congenital Syphilis Investigation Team . Congenital syphilis in the Russian Federation: Magnitude, determinants, and consequences. Sex Transm Infect 2003;79:106–110. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3. Watson‐Jones D, Changalucha J, Gumodoka B, et al. Syphilis in pregnancy in Tanzania. I. Impact of maternal syphilis on outcome of pregnancy. J Infect Dis 2002;186:940–947. [DOI] [PubMed] [Google Scholar]
  • 4. Greenblatt RM, Lukehart SA, Plummer FA, et al. Genital ulceration as a risk factor for human immunodeficiency virus infection. AIDS 1988;2:47–50. [DOI] [PubMed] [Google Scholar]
  • 5. Stamm WE, Handsfield H, Rompalo AM, Ashley RL, Roberts PL, Corey L. The association between genital ulcer disease and acquisition of HIV infection in homosexual men. J Am Med Assoc 1988;260:1429–1433. [PubMed] [Google Scholar]
  • 6. Ashton M, Sopwith W, Clark P, McKelvey D, Lighton L, Mandal D. An outbreak no longer: Factors contributing to the return of syphilis in Greater Manchester. Sex Transm Infect 2003;79:291–293. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 7. Hopkins S, Lyons F, Coleman C, Courtney G, Bergin C, Mulcahy F. Resurgence in infectious syphilis in Ireland: An epidemiological study. Sex Transm Dis 2004;31:317–321. [DOI] [PubMed] [Google Scholar]
  • 8. Hourihan M, Wheeler H, Houghton R, Goh BT. Lessons from the syphilis outbreak in homosexual men in east London. Sex Transm Infect 2004;80:509–511. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9. Chen SY, Gibson S, Katz MH, et al. Continuing increases in sexual risk behavior and sexually transmitted diseases among men who have sex with men: San Francisco, Calif., 1999–2001, USA. Am J Public Health 2002;92:1387–1388. [PMC free article] [PubMed] [Google Scholar]
  • 10. Larsen SA, Steiner BM, Rudolph AH. Laboratory diagnosis and interpretation of tests for syphilis. Clin Microbiol Rev 1995;8:1–21. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11. Singh AE, Romanovsky B. Syphilis: Review with emphasis on clinical, epidemiological and some biologic features. Clin Microbiol Rev 1999;12:187–209. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12. Farshy CE, Hunter EF, Helsel LO, Larsen SA. Four‐step enzyme linked immunosorbent assay for the detection of Treponema pallidum antibody. J Clin Microbiol 1985;21:387–389. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13. Halling VW, Jones MF, Bestrom JE, et al. Clinical comparison of the Treponema pallidum CAPTIA‐syphilis IgG enzyme immunoassay with the fluorescent treponemal absorption immunoglobulin G assay for syphilis testing. J Clin Microbiol 1999;37:3233–3234. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14. Schmidt BL, Edalalipur M, Luger A. Comparative evaluation of nine different enzyme‐linked immunosorbent assays for determination of antibodies against Treponema pallidum in patients with primary syphilis. J Clin Microbiol 2000;38:1279–1282. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15. Woznicová V, Valisová Z. Performance of CAPTIA SelectSyph‐G enzyme‐linked immunosorbent assay in syphilis testing of a high‐risk population: Analysis of discordant results. J Clin Microbiol 2007;45:1794–1797. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16. Castro R, Prieto ES, Santo I, Azevedo J, Exposto FdL. Evaluation of an enzyme immunoassay technique for detection of antibodies against Treponema pallidum . J Clin Microbiol 2003;41:250–253. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 17. Young H, Moyes A, McMillan A, Robertson DHH. Screening for treponemal infection by a new enzyme immunoassay. Genitourin Med 1989;65:72–78. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18. Sambri V, Marangoni A, Simone MA, D'Antuono A, Negosanti M, Cevenini R. Evaluation of recomWell Treponema, a novel recombinant antigen‐based enzyme‐linked immunosorbent assay for the diagnosis of syphilis. Clin Microbiol Infect 2001;7:200–205. [DOI] [PubMed] [Google Scholar]
  • 19. Sambri V, Marangoni A, Eyer C, et al. Western immunoblotting with five Treponema pallidum recombinant antigens for serological diagnosis of syphilis. Clin Diagn Lab Immunol 2001;8:534–539. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20. Zrein M, Maure I, Boursier F, Soufflet L. Recombinant antigen‐based enzyme immunoassay for screening of Treponema pallidum antibodies in blood bank routine. J Clin Microbiol 1995;33:525–527. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 21. Marangoni A, Sambri V, Accardo S, et al. Evaluation of LIAISON® Treponema Screen, a novel recombinant antigen‐based chemiluminescence immunoassay for the laboratory diagnosis of syphilis. Clin Diagn Lab Immunol 2005;12:1231–1234. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 22. Knight CS, Crum MA, Hardy RW. Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis. Clin Vaccine Immunol 2007;14:710–713. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 23. Norris SJ, Larsen SA. 1995. Treponema and host‐associated spirochetes In: Murray PR, Baron EJ, Pfaller MA, Tenover FC, Volken RH, editors. Manual of Clinical Microbiology, sixth edition Washington, DC: American Society for Microbiology; p 636–651. [Google Scholar]
  • 24. Marangoni A, Sambri V, Olmo A, D'Antuono A, Negosanti M, Cevenini R. IgG Western blot as confirmatory test in early syphilis. Zentralbl Bakteriol 1999;289:125–133. [DOI] [PubMed] [Google Scholar]
  • 25. Laemmli UK. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature (London) 1970;227:680–685. [DOI] [PubMed] [Google Scholar]
  • 26. Towbin H, Staehlin T, Gordon J. Electrophoretic transfer of proteins from polyacrylamide gels to nitrocellulose sheets: Procedure and some applications. Proc Natl Acad Sci USA 1979;76:4350–4354. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 27. Giacani L, Sambri V, Marangoni A, et al. Immunological evaluation and cellular location analysis of the TprI antigen of T. pallidum subsp. pallidum . Infect. Immun. 2005;73:3817–3822. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 28. Peeling RW, Mabey D, Herring A, Hook EW III. Why do we need quality‐assured diagnostic tests for sexually transmitted infections? Nat Rev Microbiol 2006;9:909–921. [DOI] [PubMed] [Google Scholar]
  • 29. Hook EW III, Peeling RW. Syphilis control—A continuing challenge. N Engl J Med 2004;351:122–124. [DOI] [PubMed] [Google Scholar]
  • 30. Tridapalli E, Capretti MG, Sambri V, et al. Prenatal syphilis infection is a possible cause of preterm delivery among immigrant women from Eastern Europe. Sex Transm Infect 2007;83:102–105. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from Journal of Clinical Laboratory Analysis are provided here courtesy of Wiley

RESOURCES