title: Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum.
abstract: Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified.
authors.affiliation: Laboratory of G. Enders & Colleagues, MVZ and Institute of Virology, Infectious Diseases and Epidemiology e.V., Stuttgart, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Enders
authors.affiliation: Laboratory of G. Enders & Colleagues, MVZ and Institute of Virology, Infectious Diseases and Epidemiology e.V., Stuttgart, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Hunjet
authors.affiliation: Labor Schottdorf MVZ GmbH, Augsburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Gleich
authors.affiliation: Labor Schottdorf MVZ GmbH, Augsburg, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Imdahl
authors.affiliation: Central Institute for Blood Transfusion and Immunology, Innsbruck, Austria.
authors.forename: Annelies
authors.initials: A
authors.lastname: Mühlbacher
authors.affiliation: Central Institute for Blood Transfusion and Immunology, Innsbruck, Austria.
authors.forename: Harald
authors.initials: H
authors.lastname: Schennach
authors.affiliation: National Blood Center, Thai Red Cross Society, Bangkok, Thailand.
authors.forename: Kriangsak
authors.initials: K
authors.lastname: Chaiwong
authors.affiliation: National Blood Center, Thai Red Cross Society, Bangkok, Thailand.
authors.forename: Tasanee
authors.initials: T
authors.lastname: Sakuldamrongpanich
authors.affiliation: Faculty of Medicine, Ege University, Izmir, Turkey.
authors.forename: Ajda
authors.initials: A
authors.lastname: Turhan
authors.affiliation: Faculty of Medicine, Ege University, Izmir, Turkey.
authors.forename: Rüchan
authors.initials: R
authors.lastname: Sertöz
authors.affiliation: MUC Research GmbH, Munich, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Wolf
authors.affiliation: Immumed GmbH, Munich, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Mayer
authors.affiliation: West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Chuanmin
authors.initials: C
authors.lastname: Tao
authors.affiliation: West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Lan Lan
authors.initials: LL
authors.lastname: Wang
authors.affiliation: The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Semprini
authors.affiliation: The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy vittorio.sambri@unibo.it.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Sambri
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000175:diagnosis* / Q000276:immunology; D014210:Treponema pallidum / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic