title: Performance of cobas® 4800 and m2000 real-time™ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen.
abstract: A prospective, multicenter trial was designed to compare the performance characteristics of the cobas® 4800 (Roche Diagnostics, Indianapolis, IN, USA) and m2000 real-time™ (Abbott Molecular Inc., Des Plaines, IL, USA) assays for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in rectal and self-collected vaginal swabs. Rectal (n = 234) or self-collected vaginal swabs (n = 687) were obtained from consenting individuals visiting their general practitioners, dermatologists, gynecologists, sexually transmitted disease clinics, or family planning centers from May 2010 to February 2011. High concordance rates (≥96%) were observed between the cobas® 4800 and m2000 real-time™ assays for CT/NG detection in both rectal and self-collected vaginal swabs. The performance profiles confirm the usefulness of both kinds of swab types for CT and NG detection using described nucleic acid amplification tests assays. Based on this study, rectal and self-collected vaginal swabs offer a noninvasive alternative, which may improve screening for CT and NG infections.
authors.affiliation: Department of Medical Microbiology, University Medical Center Maastricht, The Netherlands.
authors.forename: Tanja H
authors.initials: TH
authors.lastname: Geelen
authors.forename: John W
authors.initials: JW
authors.lastname: Rossen
authors.forename: Antoine M
authors.initials: AM
authors.lastname: Beerens
authors.forename: Linda
authors.initials: L
authors.lastname: Poort
authors.forename: Servaas A
authors.initials: SA
authors.lastname: Morré
authors.forename: Wilma S
authors.initials: WS
authors.lastname: Ritmeester
authors.forename: Harry E
authors.initials: HE
authors.lastname: van Kruchten
authors.forename: Masja M
authors.initials: MM
authors.lastname: van de Pas
authors.forename: Paul H M
authors.initials: PH
authors.lastname: Savelkoul
mesh_terms: D015373:Bacterial Typing Techniques / Q000379:methods*; D002690:Chlamydia Infections / Q000175:diagnosis / Q000382:microbiology*; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000302:isolation & purification; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis / Q000382:microbiology*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D012007:Rectum / Q000382:microbiology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D014621:Vagina / Q000382:microbiology*
chemical_list: D004269:DNA, Bacterial
keywords: Chlamydia trachomatis; Diagnostic screening; Neisseria gonorrhoeae; PCR; Rectal swabs; Self-collected vaginal swabs; Sexually transmitted infections