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Journal of Clinical Microbiology, December 2007, p. 3986-3991, Vol. 45, No. 12
0095-1137/07/$08.00+0 doi:10.1128/JCM.01155-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.
Evaluation of a Novel PCR-Based Assay for Detection and Identification of Chlamydia trachomatis Serovars in Cervical Specimens
Koen Quint,1
Carolina Porras,2
Mahboobeh Safaeian,3*
Paula González,2
Allan Hildesheim,3
Wim Quint,1
Leen-Jan van Doorn,1
Sandra Silva,2
Willem Melchers,5
Mark Schiffman,3
Ana Cecilia Rodríguez,2,3
Sholom Wacholder,3
Enrique Freer,4
Bernal Cortes,2
Rolando Herrero,2 for the Costa Rican Vaccine Trial Group
DDL Diagnostic Laboratory, Voorburg, The Netherlands,1 Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica,2 Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland,3 Centro de Investigación Estructuras Microscópicas, Universidad de Costa Rica, San José, Costa Rica,4 Department of Medical Microbiology, Medical Centre, Radboud University Nijmegen, Nijmegen, The Netherlands5
Received 8 June 2007/ Returned for modification 20 August 2007/ Accepted 13 October 2007
The aims of this study were to compare a novel PCR-based Chlamydia trachomatis detection and genotyping (Ct-DT) assay with the FDA-approved, commercially available C. trachomatis detection Hybrid Capture 2 (HC2) assay and to investigate the C. trachomatis serovar distribution among young women in a rural Costa Rican study population. A total of 5,828 sexually active women participating in a community-based trial in Costa Rica were tested for C. trachomatis by HC2. A sample of 1,229 specimens consisting of 100% HC2 C. trachomatis-positive specimens (n = 827) and a random sample of 8% HC2 C. trachomatis-negative specimens (n = 402) were tested with the Ct-DT assay. Agreement between the two assays was determined by the unweighted kappa statistic. Discrepant specimens were tested with a second commercially available test (COBAS TaqMan). The Ct-DT-positive specimens were further analyzed with the Ct-DT genotyping step to investigate the distribution of 14 different C. trachomatis serovars (A, B/Ba, C, D/Da, E, F, G/Ga, H, I/Ia, J, K, L1, L2/L2a, and L3). After accounting for the sampling fraction selected for Ct-DT testing, crude agreement with the HC2 assay was 98% and the kappa was 0.92 (95% confidence interval [CI], 0.89 to 0.97). The 33 discordant samples that were further analyzed with the COBAS TaqMan test showed better agreement with the Ct-DT assay (31/33, P < 0.001). Among the 806 Ct-DT-positive samples, serovar E was the most common serovar (31%), followed by serovars F and D (both 21%) and serovar I (15%). In conclusion, the novel Ct-DT assay permits reliable detection and identification of C. trachomatis serovars.
* Corresponding author. Mailing address: Division of Cancer Epidemiology and Genetics, Hormonal and Reproductive Epidemiology Branch, National Cancer Institute, 6120 Executive Boulevard, Suite 550, Rockville, MD 20852. Phone: (301) 594-2934. Fax: (301) 402-0916. E-mail: safaeianm{at}mail.nih.gov
Published ahead of print on 24 October 2007.
Journal of Clinical Microbiology, December 2007, p. 3986-3991, Vol. 45, No. 12
0095-1137/07/$08.00+0 doi:10.1128/JCM.01155-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.
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