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Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay.
J Clin Microbiol 2011; 49(4):1294-300JC

Abstract

Several commercial methods exist for the molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae in clinical samples. Here we evaluated the performance characteristics of the newly FDA-cleared Abbott RealTime CT/NG assay (where "CT" stands for Chlamydia trachomatis and "NG" stands for Neisseria gonorrhoeae) that uses the automated m2000 molecular platform. Results were compared to those of the Roche Cobas Amplicor CT/NG assay. A total of 926 cervical swab, 45 female urine, 6 male urethral swab, and 407 male urine specimens from 1,384 patients were examined. After resolving all Roche N. gonorrhoeae-positive results with two additional real-time PCR assays, we found that the agreement between the assays was excellent. For urine samples, there was 99.6% positive agreement and 97.7% negative agreement for C. trachomatis, and for male urine samples, there was 100% positive agreement and 99.7% negative agreement for N. gonorrhoeae. For cervical swab samples, there was 98.8% positive agreement and 98.5% negative agreement for C. trachomatis, and there was 96.6% positive agreement and 99.8% negative agreement for N. gonorrhoeae. In limiting dilution analyses, we found that the Abbot assay was more sensitive than the Roche assay for both C. trachomatis and N. gonorrhoeae. In addition, there appeared to be an enhanced ability of the Abbott assay to detect dual infections, especially in the presence of large amounts of N. gonorrhoeae and small amounts of C. trachomatis organisms. In summary, we conclude that the Abbott RealTime CT/NG assay is an accurate and automated new addition to the available testing options for C. trachomatis and N. gonorrhoeae.

Authors+Show Affiliations

Department of Pathology, Beth Israel Deaconess Medical Center, 330 Brookline Ave., YA309, Boston, MA 02215, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21325546

Citation

Cheng, Annie, et al. "Evaluation of the Abbott RealTime CT/NG Assay in Comparison to the Roche Cobas Amplicor CT/NG Assay." Journal of Clinical Microbiology, vol. 49, no. 4, 2011, pp. 1294-300.
Cheng A, Qian Q, Kirby JE. Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay. J Clin Microbiol. 2011;49(4):1294-300.
Cheng, A., Qian, Q., & Kirby, J. E. (2011). Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay. Journal of Clinical Microbiology, 49(4), pp. 1294-300. doi:10.1128/JCM.02595-10.
Cheng A, Qian Q, Kirby JE. Evaluation of the Abbott RealTime CT/NG Assay in Comparison to the Roche Cobas Amplicor CT/NG Assay. J Clin Microbiol. 2011;49(4):1294-300. PubMed PMID: 21325546.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay. AU - Cheng,Annie, AU - Qian,Qinfang, AU - Kirby,James E, Y1 - 2011/02/16/ PY - 2011/2/18/entrez PY - 2011/2/18/pubmed PY - 2011/7/19/medline SP - 1294 EP - 300 JF - Journal of clinical microbiology JO - J. Clin. Microbiol. VL - 49 IS - 4 N2 - Several commercial methods exist for the molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae in clinical samples. Here we evaluated the performance characteristics of the newly FDA-cleared Abbott RealTime CT/NG assay (where "CT" stands for Chlamydia trachomatis and "NG" stands for Neisseria gonorrhoeae) that uses the automated m2000 molecular platform. Results were compared to those of the Roche Cobas Amplicor CT/NG assay. A total of 926 cervical swab, 45 female urine, 6 male urethral swab, and 407 male urine specimens from 1,384 patients were examined. After resolving all Roche N. gonorrhoeae-positive results with two additional real-time PCR assays, we found that the agreement between the assays was excellent. For urine samples, there was 99.6% positive agreement and 97.7% negative agreement for C. trachomatis, and for male urine samples, there was 100% positive agreement and 99.7% negative agreement for N. gonorrhoeae. For cervical swab samples, there was 98.8% positive agreement and 98.5% negative agreement for C. trachomatis, and there was 96.6% positive agreement and 99.8% negative agreement for N. gonorrhoeae. In limiting dilution analyses, we found that the Abbot assay was more sensitive than the Roche assay for both C. trachomatis and N. gonorrhoeae. In addition, there appeared to be an enhanced ability of the Abbott assay to detect dual infections, especially in the presence of large amounts of N. gonorrhoeae and small amounts of C. trachomatis organisms. In summary, we conclude that the Abbott RealTime CT/NG assay is an accurate and automated new addition to the available testing options for C. trachomatis and N. gonorrhoeae. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/21325546/Evaluation_of_the_Abbott_RealTime_CT/NG_assay_in_comparison_to_the_Roche_Cobas_Amplicor_CT/NG_assay_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=21325546 DB - PRIME DP - Unbound Medicine ER -