Tags

Type your tag names separated by a space and hit enter

First report of performance of the Versant CT/GC DNA 1.0 assay (kPCR) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
J Clin Microbiol. 2011 Apr; 49(4):1347-53.JC

Abstract

We evaluated the analytical, work flow, and clinical performance of the Versant CT/GC DNA 1.0 assay (Versant CT/GC assay, where "CT" represents Chlamydia trachomatis and "GC" represents Neisseria gonorrhoeae). The assay simultaneously detects Chlamydia trachomatis and Neisseria gonorrhoeae in swab and first-catch urine (FCU) specimens. The limit of detection (LoD) was determined to be 342 copies/ml for C. trachomatis and 137 copies/ml for GC. The Versant CT/GC assay detected 15 C. trachomatis serovars and 46 GC strains. The Versant CT/GC assay demonstrated no cross-reactivity with 136 potentially cross-reacting organisms. Clinical concordance of the Versant CT/GC assay to the Aptima Combo 2 (AC2) assay from Gen-Probe was demonstrated using 1,129 patient specimens, including 589 urine and 540 swab specimens. Discrepant specimens were subjected to DNA sequencing to identify the presence of amplified targets and to identify false-positive and false-negative results. Overall percent agreement was greater than 98%. Positive and negative percent agreements for detection of C. trachomatis were 94.4% and 99.1%, respectively, in urine specimens and 95.8% and 99.8%, respectively, in swab specimens. Positive percent agreement for the detection of N. gonorrhoeae was 100% in both urine and swab specimens, and negative percent agreements were 99.6% and 99% in urine and swab specimens, respectively. In conclusion, the performance of the Versant CT/GC assay was comparable to that of the AC2 assay. The Versant CT/GC assay can be recommended for the detection of C. trachomatis and N. gonorrhoeae in swab and urine specimens of symptomatic and asymptomatic individuals.

Authors+Show Affiliations

Los Angeles County Department of Public Health, Los Angeles, California, USA.No 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)

Journal Article

Language

eng

PubMed ID

21307209

Citation

Kerndt, P R., et al. "First Report of Performance of the Versant CT/GC DNA 1.0 Assay (kPCR) for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae." Journal of Clinical Microbiology, vol. 49, no. 4, 2011, pp. 1347-53.
Kerndt PR, Ferrero DV, Aynalem G, et al. First report of performance of the Versant CT/GC DNA 1.0 assay (kPCR) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2011;49(4):1347-53.
Kerndt, P. R., Ferrero, D. V., Aynalem, G., Monga, D., Wang, S., Zhang, N., Wong, C., Liggins, M., & Meng, Q. (2011). First report of performance of the Versant CT/GC DNA 1.0 assay (kPCR) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Journal of Clinical Microbiology, 49(4), 1347-53. https://doi.org/10.1128/JCM.01634-10
Kerndt PR, et al. First Report of Performance of the Versant CT/GC DNA 1.0 Assay (kPCR) for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae. J Clin Microbiol. 2011;49(4):1347-53. PubMed PMID: 21307209.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - First report of performance of the Versant CT/GC DNA 1.0 assay (kPCR) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. AU - Kerndt,P R, AU - Ferrero,D V, AU - Aynalem,G, AU - Monga,D, AU - Wang,S, AU - Zhang,N, AU - Wong,C, AU - Liggins,M, AU - Meng,Q, Y1 - 2011/02/09/ PY - 2011/2/11/entrez PY - 2011/2/11/pubmed PY - 2011/7/19/medline SP - 1347 EP - 53 JF - Journal of clinical microbiology JO - J. Clin. Microbiol. VL - 49 IS - 4 N2 - We evaluated the analytical, work flow, and clinical performance of the Versant CT/GC DNA 1.0 assay (Versant CT/GC assay, where "CT" represents Chlamydia trachomatis and "GC" represents Neisseria gonorrhoeae). The assay simultaneously detects Chlamydia trachomatis and Neisseria gonorrhoeae in swab and first-catch urine (FCU) specimens. The limit of detection (LoD) was determined to be 342 copies/ml for C. trachomatis and 137 copies/ml for GC. The Versant CT/GC assay detected 15 C. trachomatis serovars and 46 GC strains. The Versant CT/GC assay demonstrated no cross-reactivity with 136 potentially cross-reacting organisms. Clinical concordance of the Versant CT/GC assay to the Aptima Combo 2 (AC2) assay from Gen-Probe was demonstrated using 1,129 patient specimens, including 589 urine and 540 swab specimens. Discrepant specimens were subjected to DNA sequencing to identify the presence of amplified targets and to identify false-positive and false-negative results. Overall percent agreement was greater than 98%. Positive and negative percent agreements for detection of C. trachomatis were 94.4% and 99.1%, respectively, in urine specimens and 95.8% and 99.8%, respectively, in swab specimens. Positive percent agreement for the detection of N. gonorrhoeae was 100% in both urine and swab specimens, and negative percent agreements were 99.6% and 99% in urine and swab specimens, respectively. In conclusion, the performance of the Versant CT/GC assay was comparable to that of the AC2 assay. The Versant CT/GC assay can be recommended for the detection of C. trachomatis and N. gonorrhoeae in swab and urine specimens of symptomatic and asymptomatic individuals. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/21307209/First_report_of_performance_of_the_Versant_CT/GC_DNA_1_0_assay__kPCR__for_detection_of_Chlamydia_trachomatis_and_Neisseria_gonorrhoeae_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=21307209 DB - PRIME DP - Unbound Medicine ER -