title: Evaluation of a novel PCR-based assay for detection and identification of Chlamydia trachomatis serovars in cervical specimens.
abstract: 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.
authors.affiliation: DDL Diagnostic Laboratory, Voorburg, The Netherlands.
authors.forename: Koen
authors.initials: K
authors.lastname: Quint
authors.forename: Carolina
authors.initials: C
authors.lastname: Porras
authors.forename: Mahboobeh
authors.initials: M
authors.lastname: Safaeian
authors.forename: Paula
authors.initials: P
authors.lastname: González
authors.forename: Allan
authors.initials: A
authors.lastname: Hildesheim
authors.forename: Wim
authors.initials: W
authors.lastname: Quint
authors.forename: Leen-Jan
authors.initials: LJ
authors.lastname: van Doorn
authors.forename: Sandra
authors.initials: S
authors.lastname: Silva
authors.forename: Willem
authors.initials: W
authors.lastname: Melchers
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.forename: Ana Cecilia
authors.initials: AC
authors.lastname: Rodríguez
authors.forename: Sholom
authors.initials: S
authors.lastname: Wacholder
authors.forename: Enrique
authors.initials: E
authors.lastname: Freer
authors.forename: Bernal
authors.initials: B
authors.lastname: Cortes
authors.forename: Rolando
authors.initials: R
authors.lastname: Herrero
mesh_terms: D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology*; D002692:Chlamydia trachomatis / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D003364:Costa Rica; D005260:Female; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*; D012424:Rural Population; D002577:Uterine Cervical Diseases / Q000382:microbiology*