title: Evaluation of the Versant CT/GC DNA 1.0 assay (kPCR) for the detection of extra-genital Chlamydia trachomatis and Neisseria gonorrhoeae infections.
abstract: Screening for extra-genital Chlamydia trachomatis and Neisseria gonorrhoeae infections is a crucial component for sexually transmitted diseases management, even if at present days no commercial methods have been approved for use on pharyngeal and rectal specimens by the US FDA or have received the conformity CE marking. Here we report the analytical sensitivities of the Versant CT/GC 1.0 assay (Siemens Healthcare Diagnostics, Tarrytown, NY, USA) on rectal and pharyngeal swabs, and an evaluation about the suitability for this assay with two widely used swab collection devices (E-Swab and eNAT, Copan, Brescia, Italy). The limits of detection for rectal and pharyngeal specimens with the Versant assay were 10 copies/ml and 1.0 copies/ml, for C. trachomatis and N. gonorrhoeae, respectively. False positive results due to the presence of non-gonococcal Neisseria species were excluded when clinical rectal and pharyngeal samples containing organisms identified as N. meningitidis, N. sicca, N. flavescens and N. subflava were tested. Due to its sensitivity and specificity, the Versant assay represents a good choice for the diagnosis of chlamydial and/or gonococcal infections not only in genito-urinary samples, but also on rectal and pharyngeal swabs.
authors: Microbiology, Experimental Diagnostic and Specialty Department (DIMES), University of Bologna, Bologna, Italy.
authors: Antonella
authors: A
authors: Marangoni
authors: Microbiology, Experimental Diagnostic and Specialty Department (DIMES), University of Bologna, Bologna, Italy.
authors: Claudio
authors: C
authors: Foschi
authors: Microbiology, Experimental Diagnostic and Specialty Department (DIMES), University of Bologna, Bologna, Italy.
authors: Paola
authors: P
authors: Nardini
authors: Microbiology, Experimental Diagnostic and Specialty Department (DIMES), University of Bologna, Bologna, Italy.
authors: Monica
authors: M
authors: Compri
authors: Microbiology, Experimental Diagnostic and Specialty Department (DIMES), University of Bologna, Bologna, Italy.
authors: Roberto
authors: R
authors: Cevenini
mesh_terms: D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000235:genetics*; D006069:Gonorrhea / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D009344:Neisseria gonorrhoeae / Q000235:genetics*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods* / Q000592:standards; D016133:Polymerase Chain Reaction / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic