Performance of the Abbott RealTime CT/NG for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

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 femal...

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Bibliographic Details
Published in:Journal of Clinical Microbiology 2010-09, Vol.48 (9), p.3236-3243
Main Authors: Gaydos, C.A, Cartwright, C.P, Colaninno, P, Welsch, J, Holden, J, Ho, S.Y, Webb, E.M, Anderson, C, Bertuzis, R, Zhang, L, Miller, T, Leckie, G, Abravaya, K, Robinson, J
Format: Article
Language:English
Subjects:
Adolescent
Adult
Automation - methods
Bacteriological Techniques - methods
Bacteriology
Biological and medical sciences
Cervix Uteri - microbiology
Chlamydia Infections - diagnosis
Chlamydia Infections - epidemiology
Chlamydia trachomatis
Chlamydia trachomatis - isolation & purification
Chlamydiology and Rickettsiology
Female
Fundamental and applied biological sciences. Psychology
Gonorrhea - diagnosis
Gonorrhea - epidemiology
Humans
Male
Microbiology
Middle Aged
Miscellaneous
Neisseria gonorrhoeae
Neisseria gonorrhoeae - isolation & purification
Polymerase Chain Reaction - methods
Prevalence
Sensitivity and Specificity
Urethra - microbiology
Urine - microbiology
Vagina - microbiology
Young Adult
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Summary: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.
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.01019-10