Evaluation of VERSANT® CT/GC DNA 1.0 Assay in conjunction with VERSANT® kPCR Molecular system

A total of 463 first void urine specimens were obtained from patients attending the Sexually Transmitted Diseases (STD) Outpatients Clinic of the St. Orsola University Hospital in Bologna, Italy. Samples were tested by the new test VERSANT® CT/GC DNA 1.0 Assay (Siemens Healthcare Diagnostics Inc.), a multiplex Real-Time Polymerase Chain Reaction (PCR) assay, for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).A total of two specimens were collected from each patient, respectively: one urine sample for VERSANT® CT/GC DNA 1.0 Assay testing and one urethral or endocervical swab for the detection of C. trachomatis by IDEIA™ PCE Chlamydia (Oxoid). In our population, the prevalence of CT in patients was 11.9%, when studied by VERSANT® CT/GC DNA 1.0 Assay, whereas it was only 5.0%, when samples where analyzed by IDEIA™ PCE Chlamydia. In conclusion,VERSANT® CT/GC DNA 1.0 Assay demonstrated to be a highly sensitive and specific technique for the detection of CT in patients attending a STD Clinic. Nucleic acid amplifications tests are the most sensitive assays available to date for CT and GC in clinical specimens and this new Real-Time PCR assay adds to the group of commercially available assays that are available to laboratories as choices for superior diagnostic performance.