title: Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
abstract: A multicenter clinical study was conducted to evaluate the performance characteristics of the Abbott RealTime CT/NG assay, a multiplex real-time PCR assay, for simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae. The specimens were collected from a total of 3,832 male and female subjects at 16 geographically diverse sites. Specimens included male and female urine samples, male urethral swabs, female endocervical swabs, and self-collected and clinician-collected vaginal swabs. Specimens were tested with the automated Abbott RealTime CT/NG assay, Aptima Combo 2 assay (Gen-Probe), ProbeTec ET CT/GC assay (Becton Dickinson), and culture for N. gonorrhoeae. The Aptima Combo 2 assay, the ProbeTec assay, and the N. gonorrhoeae culture were used as the reference assays. For each subject, a patient infected status (PIS) was determined based on the combined results from the reference assays. The overall prevalence in female subjects was 8.9% for C. trachomatis and 3.8% for N. gonorrhoeae. The overall male prevalence was 18.2% for C. trachomatis and 16.7% for N. gonorrhoeae. The overall sensitivity and specificity of the Abbott RealTime CT/NG assay were 92.4% and 99.2% for C. trachomatis and 96.9% and 99.7% for N. gonorrhoeae, respectively. In comparison, the sensitivity and specificity, respectively, for the Aptima Combo 2 assay were 94.5% and 99.0% for C. trachomatis and 96.1% and 99.5% for N. gonorrhoeae, and those for the ProbeTec ET assay were 90.3% and 99.5% for C. trachomatis and 92.0% and 97.3% for N. gonorrhoeae in this study. The Abbott RealTime CT/NG assay offers C. trachomatis and N. gonorrhoeae dual detection with high sensitivity and specificity. The automated assay provides a useful alternative nucleic acid amplification assay for clinical laboratories and clinicians.
authors.affiliation: Johns Hopkins University, 855 North Wolfe St., 530 Rangos Building, Baltimore, MD 21205, USA. cgaydos@jhmi.edu
authors.forename: C A
authors.initials: CA
authors.lastname: Gaydos
authors.forename: C P
authors.initials: CP
authors.lastname: Cartwright
authors.forename: P
authors.initials: P
authors.lastname: Colaninno
authors.forename: J
authors.initials: J
authors.lastname: Welsch
authors.forename: J
authors.initials: J
authors.lastname: Holden
authors.forename: S Y
authors.initials: SY
authors.lastname: Ho
authors.forename: E M
authors.initials: EM
authors.lastname: Webb
authors.forename: C
authors.initials: C
authors.lastname: Anderson
authors.forename: R
authors.initials: R
authors.lastname: Bertuzis
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.forename: T
authors.initials: T
authors.lastname: Miller
authors.forename: G
authors.initials: G
authors.lastname: Leckie
authors.forename: K
authors.initials: K
authors.lastname: Abravaya
authors.forename: J
authors.initials: J
authors.lastname: Robinson
mesh_terms: D000293:Adolescent; D000328:Adult; D001331:Automation / Q000379:methods; D001431:Bacteriological Techniques / Q000379:methods*; D002584:Cervix Uteri / Q000382:microbiology; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000453:epidemiology; D002692:Chlamydia trachomatis / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods*; D015995:Prevalence; D012680:Sensitivity and Specificity; D014521:Urethra / Q000382:microbiology; D014556:Urine / Q000382:microbiology; D014621:Vagina / Q000382:microbiology; D055815:Young Adult