Evaluation of the new test VERSANT CT/GC DNA 1.0 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens

J Clin Lab Anal. 2012 Feb;26(2):70-2. doi: 10.1002/jcla.21485.

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.

Publication types

  • Evaluation Study

MeSH terms

  • Adult
  • Biological Assay
  • Chlamydia Infections / microbiology
  • Chlamydia Infections / urine
  • Chlamydia trachomatis / genetics*
  • Chlamydia trachomatis / isolation & purification*
  • DNA, Bacterial / genetics*
  • DNA, Bacterial / urine*
  • Female
  • Genitalia / microbiology
  • Gonorrhea / microbiology
  • Gonorrhea / urine
  • Humans
  • Male
  • Neisseria gonorrhoeae / genetics*
  • Neisseria gonorrhoeae / isolation & purification*
  • Real-Time Polymerase Chain Reaction / methods*

Substances

  • DNA, Bacterial