title: Novel recombinant-antigen enzyme immunoassay for serological diagnosis of syphilis.
abstract: Enzyme immunoassay (EIA) is an ideal method for screening large numbers of patients for syphilis. We evaluated a novel immune-capture EIA (ICE Syphilis; Murex Diagnostics) that uses three recombinant Treponema pallidum antigens (TpN15, TpN17, and TpN47) and compared the results with those obtained by the native T. pallidum antigen EIA (Captia SelectSyph-G; Centocor) that we currently use for the serodiagnosis of syphilis. Specificity was evaluated by screening 1,184 unselected serum specimens in parallel by the ICE Syphilis and SelectSyph-G assays, while sensitivity was tested with a panel of 101 serum specimens containing antitreponemal antibodies (treated and untreated) from patients with various stages of infection. The specificity of the ICE Syphilis EIA (99.8%) on screening was significantly higher (P < 0.02) than that of the SelectSyph-G EIA (99.2%). The sensitivity of the ICE Syphilis EIA was significantly higher (P < 0.01) than that of the SelectSyph-G EIA on both initial (99 versus 91.4%) and repeat (100 versus 92.4%) testing. The ICE Syphilis EIA was also significantly more sensitive (P < 0.01) than the fluorescent treponemal antibody-abs (92.4%) but not the T. pallidum hemagglutination assay (97.1%). Sera containing antitreponemal antibodies gave a much higher antibody index (absorbance of test serum/kit cutoff) by the ICE Syphilis EIA than by the SelectSyph-G EIA. This combined with the overall high sensitivity makes the ICE Syphilis EIA an ideal test for excluding or detecting treponemal infection in human immunodeficiency virus (HIV)-infected patients. The ICE Syphilis EIA was positive with sera from all 15 HIV-infected patients in the study, whereas sera from 3 HIV-infected patients were negative by the SelectSyph-G EIA. We conclude that the high sensitivity and specificity of the ICE Syphilis EIA and its suitability for automation make it an ideal screening test.
authors.affiliation: Department of Medical Microbiology, Edinburgh University Medical School, Scotland, United Kingdom. hugh.young@ed.ac.uk
authors.forename: H
authors.initials: H
authors.lastname: Young
authors.forename: A
authors.initials: A
authors.lastname: Moyes
authors.forename: L
authors.initials: L
authors.lastname: Seagar
authors.forename: A
authors.initials: A
authors.lastname: McMillan
mesh_terms: D000942:Antigens, Bacterial / Q000276:immunology*; D015658:HIV Infections / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques; D011994:Recombinant Proteins / Q000276:immunology; D012680:Sensitivity and Specificity; D013588:Syphilis Serodiagnosis; D014210:Treponema pallidum / Q000276:immunology*
chemical_list: D000942:Antigens, Bacterial; D011994:Recombinant Proteins