Comparison of the BD Viper System with XTR Technology to the Gen-Probe APTIMA COMBO 2 Assay using the TIGRIS DTS system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens

Sex Transm Dis. 2012 Jul;39(7):514-7. doi: 10.1097/OLQ.0b013e31824f2f5b.

Abstract

Background: Performances of the BD ProbeTec Chlamydia trachomatis (CT)/Neisseria Gonorrhoeae (GC) Q(x) Amplified DNA Assay reagents on a BD Viper System with XTR Technology and APTIMA COMBO 2 Assay reagents on a TIGRIS DTS platform, for detection of both CT and GC were compared.

Methods: A total of 1018 first-void urine specimens were tested for the presence of CT and GC DNA using the 2 assays.

Results: CT was detected in 143 specimens (14%). Eight specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement for CT was 99.2%, with 97.1% and 99.5% in agreement with positive and negative specimens, respectively. Cohen's Kappa was 0.967. GC was detected in 27 specimens (2.6%). Two specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement was 99.8%, with 96.2% and 99.9% in agreement for positive and negative specimens, respectively. Cohen's Kappa was 0.961.

Conclusions: There was a high level of agreement between the systems for both CT and GC detection.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Algorithms
  • Automation, Laboratory / instrumentation
  • Automation, Laboratory / methods
  • Bacterial Typing Techniques / methods
  • Chlamydia Infections / microbiology
  • Chlamydia Infections / urine*
  • Chlamydia trachomatis / genetics
  • Chlamydia trachomatis / isolation & purification*
  • Female
  • Gonorrhea / microbiology
  • Gonorrhea / urine*
  • Humans
  • Male
  • Molecular Diagnostic Techniques / methods
  • Neisseria gonorrhoeae / genetics
  • Neisseria gonorrhoeae / isolation & purification*
  • Nucleic Acid Amplification Techniques / instrumentation
  • Nucleic Acid Amplification Techniques / methods*
  • Reagent Kits, Diagnostic
  • Saskatchewan
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic