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

C. A. Gaydos, C. P. Cartwright, P. Colaninno, J. Welsch, J. Holden, S. Y. Ho, E. M. Webb, C. Anderson, R. Bertuzis, L. Zhang, T. Miller, G. Leckie, K. Abravaya, J. Robinson

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)3236-3243
Number of pages8
JournalJournal of clinical microbiology
Volume48
Issue number9
DOIs
StatePublished - Sep 2010

ASJC Scopus subject areas

  • Microbiology (medical)

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    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. (2010). Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Journal of clinical microbiology, 48(9), 3236-3243. https://doi.org/10.1128/JCM.01019-10