title: Evaluation of the cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.
abstract: OBJECTIVE
  To investigate the performance of the fully automated cobas 4800 CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
  
  
  METHODS
  The study was conducted using 900 clinical specimens (496 urine and 404 swab specimens) for C trachomatis testing, of which 498 specimens (318 urine and 180 swab specimens) were also tested for N gonorrhoeae. The results of the cobas 4800 CT/NG test were compared with those obtained from the Roche COBAS AMPLICOR CT/NG and COBAS TaqMan CT assays. N gonorrhoeae-positive specimens were further tested using in-house, real-time PCR assays. A panel of 223 Neisseria isolates was used to further investigate the performance of the cobas 4800 N gonorrhoeae assay.
  
  
  RESULTS
  For urine specimens, the sensitivity, specificity and negative and positive predictive values of the cobas 4800 CT/NG test were 94.5%, 99.5%, 98.8% and 97.7%, respectively, for C trachomatis, and 92.9%, 100%, 99.7% and 100%, respectively, for N gonorrhoeae. For swab specimens, the sensitivity, specificity and negative and positive predictive values were 92.0%, 100%, 99.5% and 100%, respectively, for C trachomatis, and 100%, 99.4%, 100% and 90.0%, respectively, for N gonorrhoeae. All N gonorrhoeae isolates were positive and all non-gonococcal Neisseria strains were negative by the cobas 4800&emsp14;N gonorrhoeae assay.
  
  
  CONCLUSIONS
  The cobas 4800 CT/NG test is suitable for high through-put identification of C trachomatis and N gonorrhoeae infections.
authors: Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Queensland Children's Medical Research Institute, Children's Health Service District, Queensland, Australia.
authors: Rebecca
authors: R
authors: Rockett
authors: Namraj
authors: N
authors: Goire
authors: Athena
authors: A
authors: Limnios
authors: Mark
authors: M
authors: Turra
authors: Geoffrey
authors: G
authors: Higgens
authors: Stephen B
authors: SB
authors: Lambert
authors: Cheryl
authors: C
authors: Bletchly
authors: Michael D
authors: MD
authors: Nissen
authors: Theo P
authors: TP
authors: Sloots
authors: David M
authors: DM
authors: Whiley
mesh_terms: D001331:Automation; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000235:genetics*; D004269:DNA, Bacterial / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics*; D021141:Nucleic Acid Amplification Techniques / Q000592:standards; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests
chemical_list: D004269:DNA, Bacterial