Abstract
Fifteen commercial syphilis kits were assessed against the same moderately sized specimen panel that included 114 serum and plasma specimens from syphilis cases and 249 specimens from unselected blood donors. The 114 specimens from syphilis cases comprised 40 from cases of primary syphilis, 43 from cases of secondary syphilis, 19 from cases of early latent syphilis, and 12 from cases of late latent syphilis. Of the 15 kits, ten were enzyme immunoassays, four were Treponema pallidum haemagglutination assays, and one was a T. pallidum particle agglutination assay. Thirteen of the 15 kits gave final specificities of 100%; the other two kits were repeatedly reactive with one to two specimens. Initial sensitivities ranged from 93.9 to 99.1%. Most variation between kits was observed in results for the groups with untreated primary and treated late latent disease, although the differences were not statistically significant. The comparative data on kit performance derived from this study is useful for examining syphilis testing guidelines and for making informed purchasing decisions.
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References
Luger A (1988) Serological diagnosis of syphilis: current methods. In: Young H, McMillan A (eds) Immunological diagnosis of sexually transmitted diseases. Marcel Dekker, New York, pp 249–274
Wicher K, Horowitz HW, Wicher V (1999) Laboratory methods of diagnosis of syphilis for the beginning of the third millennium. Microbes Infect 1:1035–1049
Egglestone SI, Turner AJ (2000) Serological diagnosis of syphilis. PHLS Syphilis Serology Working Group. Commun Dis Public Health 3:158–162
Hagedorn HJ, Kraminer-Hagedorn A, De Bosschere K et al (2002) Evaluation of INNO-LIA Syphilis assay as a confirmatory test for syphilis. J Clin Microbiol 40:973–978
Ebel A, Bachelart L, Alonso JM (1998) Evaluation of a new competitive immunoassay (BioElisa Syphilis) for screening for Treponema pallidum antibodies at various stages of syphilis. J Clin Microbiol 36:358–361
Rodriguez I, Alvarez EL, Fernandez C, Miranda A (2002) Comparison of a recombinant-antigen enzyme immunoassay with Treponema pallidum hemagglutination test for serological confirmation of syphilis. Mem Inst Oswaldo Cruz 97:347–349
Castro R, Prieto ES, Santo I et al (2003) Evaluation of enzyme immunoassay technique for detection of antibodies against Treponema pallidum. J Clin Microbiol 41:250–253
Gutierrez J, Vergara MJ, Soto MJ, Piedrola G, Maroto M (2000) Clinical utility of a competitive ELISA to detect antibodies against Treponema pallidum. J Clin Lab Anal 14:83–86
Nayar R, Campos JM (1993) Evaluation of the DCL Syphilis-G enzyme immunoassay test kit for the serologic diagnosis of syphilis. Am J Clin Pathol 99:282–285
Sambri V, Marangoni A, Simone MA, D’Antuono A, Negosanti M, Cevenini R (2001) Evaluation of recomWell Treponema, a novel recombinant antigen-based enzyme-linked immunosorbent assay for the diagnosis of syphilis. Clin Microbiol Infect 7:200–205
Young H, Aktas G, Moyes A (2000) Enzywell recombinant enzyme immunoassay for the serological diagnosis of syphilis. Int J STD AIDS 11:288–291
Young H, Moyes A, Seagar L, McMillan A (1998) Novel recombinant-antigen enzyme immunoassay for serological diagnosis of syphilis. J Clin Microbiol 36:913–917
Young H, Moyes A, McMillan A, Robertson DH (1989) Screening for treponemal infection by a new enzyme immunoassay. Genitourin Med 65:72–78
Hooper NE, Malloy DC, Passen S (1994) Evaluation of a Treponema pallidum enzyme immunoassay as a screening test for syphilis. Clin Diagn Lab Immunol 1:477–481
Reisner BS, Mann LM, Tholcken CA, Waite RT, Woods GL (1997) Use of the Treponema pallidum-specific captia syphilis IgG assay in conjunction with the rapid plasma reagin to test for syphilis. J Clin Microbiol 35:1141–1143
Silletti RP (1995) Comparison of CAPTIA syphilis G enzyme immunoassay with rapid plasma reagin test for detection of syphilis. J Clin Microbiol 33:1829–1831
Lefevre JC, Bertrand MA, Bauriaud R (1990) Evaluation of the Captia enzyme immunoassays for detection of immunoglobulins G and M to Treponema pallidum in syphilis. J Clin Microbiol 28:1704–1707
Young H, Moyes A, McMillan A, Patterson J (1992) Enzyme immunoassay for anti-treponemal IgG: screening or confirmatory test? J Clin Pathol 45:37–41
Halling VW, Jones MF, Bestrom JE, Wold AD, Rosenblatt JE, Smith TF, Cockerill FR III (1999) Clinical comparison of the Treponema pallidum CAPTIA syphilis-G enzyme immunoassay with the fluorescent treponemal antibody absorption immunoglobulin G assay for syphilis testing. J Clin Microbiol 37:3233–3234
Tholcken CA, Woods GL (2000) Evaluation of the Bio-Rad syphilis IgG test performed on the CODA system for serologic diagnosis of syphilis. Diagn Microbiol Infect Dis 37:157–160
Schmidt BL, Edjlalipour M, Luger A (2000) Comparative evaluation of nine different enzyme-linked immunosorbent assays for determination of antibodies against Treponema pallidum in patients with primary syphilis. J Clin Microbiol 38:1279–1282
Castro RR, Prieto ES, Santo I et al (2001) Evaluation of the passive particle agglutination test in the serodiagnosis and follow-up of syphilis. Am J Clin Pathol 116:581–585
Pope V, Fears MB, Morrill WE, Castro A, Kikkert SE (2000) Comparison of the Serodia Treponema pallidum particle agglutination, Captia Syphilis-G, and SpiroTek Reagin II tests with standard test techniques for diagnosis of syphilis. J Clin Microbiol 38:2543–2545
Aktas G, Young H, Moyes A (2005) Evaluation of the Serodia Treponema pallidum particle agglutination, the Murex Syphilis ICE and the Enzywell TP tests for serodiagnosis of syphilis. Int J STD AIDS 16:294–298
Huber TW, Storms S, Young P, Phillips LE, Rogers TE, Moore DG, Williams RP (1983) Reactivity of microhemagglutination, fluorescent treponemal antibody absorption, venereal disease research laboratory, and rapid plasma reagin tests in primary syphilis. J Clin Microbiol 17:405–409
World Health Organisation (1982) Treponemal infections. Technical report series, no. 674. WHO, Geneva
Acknowledgements
This work was funded by the Device Evaluation Service (DES) of the Medicines and Healthcare products Regulatory Agency (MHRA). The DES has since transferred to the National Health Service Purchasing and Supply Agency (NHS-PASA) and is now known as the Centre for Evidence-based Purchasing (CEP). We would like to acknowledge the assistance from the manufacturers and thank them for supplying kits. We would like to thank Brian Dow (Scottish National Blood Transfusion Service), David Wenham, Anant Patel, Ruth Bradshaw, and Colette Cullen (North London Blood Centre) for providing specimens. We thank David Gelb (HPA Statistics, Modelling and Bioinformatics Department) for his assistance with the statistical analysis, Jude Pendrey and Ingrid Hamilton (HPA Virus Reference Department) for confirmatory testing of some specimens, and Laura Dean, Rachel White, Li Fu, and Ajay Patel (HPA Evaluations and Standards Laboratory) for their assistance in the laboratory and with the preparation of this report. We would also like to thank Ian Simms (HPA HIV and STI Department), who conducted the national syphilis study from which many of the positive specimens were drawn.
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Cole, M.J., Perry, K.R. & Parry, J.V. Comparative evaluation of 15 serological assays for the detection of syphilis infection. Eur J Clin Microbiol Infect Dis 26, 705–713 (2007). https://doi.org/10.1007/s10096-007-0346-9
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DOI: https://doi.org/10.1007/s10096-007-0346-9