title: Evaluation of LIAISON Treponema Screen, a novel recombinant antigen-based chemiluminescence immunoassay for laboratory diagnosis of syphilis.
abstract: The purpose of this study was to evaluate the diagnostic performance of LIAISON Treponema Screen (DiaSorin, Saluggia, Italy), a new automated chemiluminescence immunoassay (CLIA), in comparison with that of rapid plasma reagin (RPR) and the following currently used treponemal tests: hemagglutination test (TPHA), immunoenzymatic assay (EIA), and Western blot (WB). First, a retrospective study was performed with a panel of 2,494 blood donor sera, a panel of 131 clinical and serologically characterized syphilitic sera, and 96 samples obtained from subjects with potentially interfering diseases or conditions. A prospective study was also performed by testing 1,800 unselected samples submitted to the Microbiology Laboratory of the St. Orsola Hospital in Bologna, Italy, for routine screening for syphilis. As expected, RPR was the least specific method, especially when potentially cross-reacting sera were tested. On the contrary, all of the treponemal tests proved to be very specific (99.9%) and they performed with the following sensitivities: 100% (WB), 99.2% (CLIA), 95.4% (EIA), and 94.7% (TPHA).
authors.affiliation: Microbiology Section, DMCSS, University of Bologna, Bologna, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Marangoni
authors.forename: Vittorio
authors.initials: V
authors.lastname: Sambri
authors.forename: Silvia
authors.initials: S
authors.lastname: Accardo
authors.forename: Francesca
authors.initials: F
authors.lastname: Cavrini
authors.forename: Antonietta
authors.initials: A
authors.lastname: D'Antuono
authors.forename: Alessandra
authors.initials: A
authors.lastname: Moroni
authors.forename: Elisa
authors.initials: E
authors.lastname: Storni
authors.forename: Roberto
authors.initials: R
authors.lastname: Cevenini
mesh_terms: D000942:Antigens, Bacterial; D003429:Cross Reactions / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D008163:Luminescent Measurements; D011994:Recombinant Proteins; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis*; D013588:Syphilis Serodiagnosis / Q000379:methods* / Q000592:standards; D014208:Treponema / Q000276:immunology / Q000302:isolation & purification*
chemical_list: D000942:Antigens, Bacterial; D011994:Recombinant Proteins