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Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
J Clin Microbiol. 2010 Sep; 48(9):3236-43.JC

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+Show Affiliations

Johns Hopkins University, 855 North Wolfe St., 530 Rangos Building, Baltimore, MD 21205, USA. cgaydos@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20668135

Citation

Gaydos, C A., et al. "Performance of the Abbott RealTime CT/NG for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae." Journal of Clinical Microbiology, vol. 48, no. 9, 2010, pp. 3236-43.
Gaydos CA, Cartwright CP, Colaninno P, et al. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2010;48(9):3236-43.
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), 3236-43. https://doi.org/10.1128/JCM.01019-10
Gaydos CA, et al. Performance of the Abbott RealTime CT/NG for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae. J Clin Microbiol. 2010;48(9):3236-43. PubMed PMID: 20668135.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. AU - Gaydos,C A, AU - Cartwright,C P, AU - Colaninno,P, AU - Welsch,J, AU - Holden,J, AU - Ho,S Y, AU - Webb,E M, AU - Anderson,C, AU - Bertuzis,R, AU - Zhang,L, AU - Miller,T, AU - Leckie,G, AU - Abravaya,K, AU - Robinson,J, Y1 - 2010/07/28/ PY - 2010/7/30/entrez PY - 2010/7/30/pubmed PY - 2010/12/14/medline SP - 3236 EP - 43 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 48 IS - 9 N2 - 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. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/20668135/Performance_of_the_Abbott_RealTime_CT/NG_for_detection_of_Chlamydia_trachomatis_and_Neisseria_gonorrhoeae_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=20668135 DB - PRIME DP - Unbound Medicine ER -