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

Charlotte 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

Fingerprint

Neisseria gonorrhoeae
Chlamydia trachomatis
Sensitivity and Specificity
Multiplex Polymerase Chain Reaction
Nucleic Acids
Multicenter Studies
Real-Time Polymerase Chain Reaction
Urine

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. / Gaydos, Charlotte 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.

In: Journal of Clinical Microbiology, Vol. 48, No. 9, 09.2010, p. 3236-3243.

Research output: Contribution to journalArticle

Gaydos, CA, Cartwright, CP, Colaninno, P, Welsch, J, Holden, J, Ho, SY, Webb, EM, 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, vol. 48, no. 9, pp. 3236-3243. https://doi.org/10.1128/JCM.01019-10
Gaydos, Charlotte 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. / Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. In: Journal of Clinical Microbiology. 2010 ; Vol. 48, No. 9. pp. 3236-3243.
@article{011c0d69668e4dac8bf58e7de7e5d854,
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.",
author = "Gaydos, {Charlotte A} and Cartwright, {C. P.} and P. Colaninno and J. Welsch and J. Holden and Ho, {S. Y.} and Webb, {E. M.} and C. Anderson and R. Bertuzis and L. Zhang and T. Miller and G. Leckie and K. Abravaya and J. Robinson",
year = "2010",
month = "9",
doi = "10.1128/JCM.01019-10",
language = "English (US)",
volume = "48",
pages = "3236--3243",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "9",

}

TY - JOUR

T1 - Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae

AU - Gaydos, Charlotte 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.

PY - 2010/9

Y1 - 2010/9

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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=77956823601&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77956823601&partnerID=8YFLogxK

U2 - 10.1128/JCM.01019-10

DO - 10.1128/JCM.01019-10

M3 - Article

C2 - 20668135

AN - SCOPUS:77956823601

VL - 48

SP - 3236

EP - 3243

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 9

ER -