Evaluation of a Novel PCR-Based Assay for Detection and Identification of Chlamydia trachomatis Serovars in Cervical Specimens

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Zeitschriftentitel:	Journal of Clinical Microbiology
Personen und Körperschaften:	Quint, Koen, Porras, Carolina, Safaeian, Mahboobeh, González, Paula, Hildesheim, Allan, Quint, Wim, van Doorn, Leen-Jan, Silva, Sandra, Melchers, Willem, Schiffman, Mark, Rodríguez, Ana Cecilia, Wacholder, Sholom, Freer, Enrique, Cortes, Bernal, Herrero, Rolando
In:	Journal of Clinical Microbiology, 45, 2007, 12, S. 3986-3991
Format:	E-Article
Sprache:	Englisch
veröffentlicht:	American Society for Microbiology
Schlagwörter:	Microbiology (medical)

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Zusammenfassung:	<jats:title>ABSTRACT</jats:title> <jats:p> The aims of this study were to compare a novel PCR-based <jats:italic>Chlamydia trachomatis</jats:italic> detection and genotyping (Ct-DT) assay with the FDA-approved, commercially available <jats:italic>C. trachomatis</jats:italic> detection Hybrid Capture 2 (HC2) assay and to investigate the <jats:italic>C. trachomatis</jats:italic> 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 <jats:italic>C. trachomatis</jats:italic> by HC2. A sample of 1,229 specimens consisting of 100% HC2 <jats:italic>C. trachomatis</jats:italic> -positive specimens ( <jats:italic>n</jats:italic> = 827) and a random sample of 8% HC2 <jats:italic>C. trachomatis</jats:italic> -negative specimens ( <jats:italic>n</jats:italic> = 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 <jats:italic>C. trachomatis</jats:italic> 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, <jats:italic>P</jats:italic> < 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 <jats:italic>C. trachomatis</jats:italic> serovars. </jats:p>
Umfang:	3986-3991
ISSN:	0095-1137 1098-660X
DOI:	10.1128/jcm.01155-07