title: Evaluation of the new test VERSANT CT/GC DNA 1.0 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens.
abstract: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the two most common sexually transmitted bacterial infections in developed countries. The purpose of the present study was evaluating a new system for CT/GC detection in urine specimens. A total of 700 urine specimens were obtained from patients attending the STD Outpatients Clinic of St. Orsola University Hospital, Bologna, Italy. Samples were tested by VERSANT® CT/GC DNA 1.0 Assay (Siemens Healthcare Diagnostics Inc., Tarrytown, NY), a multiplex Real-Time PCR assay, for simultaneous CT/GC detection. Results obtained by VERSANT assay were compared with those obtained by culturing genital secretions of the same patients. Moreover, urine specimens testing positive in VERSANT assay were retested by in-house PCR assays, used as confirmatory tests. VERSANT® CT/GC DNA 1.0 Assay performed with 99.4% and 99.2% of specificity for GC and CT detection, respectively, whereas sensitivity was 100% both for CT and GC. Culture methods were 100% specific, but far less sensitive than VERSANT assay. VERSANT® CT/GC DNA 1.0 Assay demonstrated to be a highly sensitive and specific technique for CT/GC detection.
authors.affiliation: Section of Microbiology, DESOS, University of Bologna, Bologna, Italy. antonella.marangoni@unibo.it
authors.forename: Antonella
authors.initials: A
authors.lastname: Marangoni
authors.forename: Claudio
authors.initials: C
authors.lastname: Foschi
authors.forename: Paola
authors.initials: P
authors.lastname: Nardini
authors.forename: Antonietta
authors.initials: A
authors.lastname: D'Antuono
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Banzola
authors.forename: Antonietta
authors.initials: A
authors.lastname: Di Francesco
authors.forename: Roberto
authors.initials: R
authors.lastname: Cevenini
mesh_terms: D000328:Adult; D001681:Biological Assay; D002690:Chlamydia Infections / Q000382:microbiology / Q000652:urine; D002692:Chlamydia trachomatis / Q000235:genetics* / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000235:genetics* / Q000652:urine*; D005260:Female; D005835:Genitalia / Q000382:microbiology; D006069:Gonorrhea / Q000382:microbiology / Q000652:urine; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics* / Q000302:isolation & purification*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*
chemical_list: D004269:DNA, Bacterial