title: Performance evaluation of the PelvoCheck CT/NG test kit for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
abstract: OBJECTIVE
  Assessment of the performance of the PelvoCheck CT/NG test (Greiner-Bio-One GmbH) to detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in first-void urine (FVU) of females.
  
  
  METHODS
  A cross-sectional study to compare the PelvoCheck CT/NG with COBAS TaqMan CT Test V.2.0 (Roche) for the detection of CT and with an in-house porA-based PCR for the detection of NG in FVU specimens. In addition, pools of 5 FVU specimens containing only CT-negative or 1 CT-positive and 4 CT-negative samples were tested. Abbott RealTime CT/NG was used as an additional test to resolve discordant results.
  
  
  METHODS
  Samples sent from six laboratories were tested at the University Medical Center Hamburg.
  
  
  METHODS
  Urine samples were from 1622 female patients attending gynaecological practices for chlamydia screening, another 120 urine samples were from patients pretested for NG at Synlab, Medical Service Center, Weiden GmbH. In addition, 50 urine samples spiked with various concentrations of reference material were used.
  
  
  RESULTS
  For the detection of CT and NG, the sensitivity and specificity of the PelvoCheck CT/NG test were 98.8% and 100%, and 98.3% and 98.2%, respectively. The data obtained with the PelvoCheck CT/NG for pooled urine specimens resulted in a positive agreement of 90.9% and a negative agreement of 100%.
  
  
  CONCLUSIONS
  The PelvoCheck CT/NG assay is a suitable test method for the detection of CT and NG in female FVU samples, with sensitivity and specificity comparable with other Food and Drug Administration approved CT/NG nucleic acid amplification tests. To the best of our knowledge, this is the first commercial test system validated for the analysis of pooled urine specimens. No false-positive or invalid result was observed in 55 analysed pools. Nevertheless, 5 samples were false negative due to a target concentration below the limit of detection of the PelvoCheck CT/NG test as a consequence of pooling-associated dilution.
authors.affiliation: Institute of Medical Microbiology, Virology and Hygiene University Medical Center Hamburg-Eppendorf (UKE) Hamburg, Hamburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Meyer
authors.affiliation: Synlab Weiden, Medizinisches Versorgungszentrum Weiden GmbH, Molekularbiologie, Zur Kesselschmiede 4, Weiden, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Klos
authors.affiliation: Greiner Bio-One Diagnostics GmbH, Rainbach, Austria.
authors.forename: Regina
authors.initials: R
authors.lastname: Kofler
authors.affiliation: Greiner Bio-One GmbH, Frickenhausen, Germany.
authors.forename: Annett
authors.initials: A
authors.lastname: Kilic
authors.affiliation: Greiner Bio-One GmbH, Frickenhausen, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Hänel
mesh_terms: D000293:Adolescent; D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000652:urine; D002692:Chlamydia trachomatis / Q000302:isolation & purification*; D003430:Cross-Sectional Studies; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000652:urine; D006801:Humans; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: MOLECULAR BIOLOGY; SEXUAL MEDICINE