title: Evaluation of a novel Chlamydia trachomatis microsphere suspension assay for detection and genotyping of the different serovars in clinical samples.
abstract: A novel Chlamydia trachomatis (Ct) microsphere suspension (MS) assay was evaluated for identification of the different serovars, using the same PCR primer set established for the Ct Detection and genoTyping assay. Both assays can detect and identify all 14 major serovars (A, B/Ba, C, D/Da, E, F, G/Ga, H, I/Ia, J, K, L1, L2/L2a, and L3) and one genovariant of serovar J. The probe specificity for the Ct-MS assay was determined using 14 Ct reference strains and 1 clinical isolate from a genovariant of serovar J. Also, the Ct-MS assay and the Ct detection and genoTyping assay were compared in 712 Ct-positive clinical samples. The Ct-MS assay showed a highly specific reaction for all probes with the amplicons of the reference strains, giving a very low background median fluorescence intensity signal (median fluorescence intensity ≤ 10). An excellent overall agreement in the Ct detection (kappa = 0.947, 95% confidence interval, 0.89 to 0.999; McNemar's test, P = 1.000) and the Ct genotyping (kappa = 0.993, 95% confidence interval, 0.977 to 1.000; McNemar's test, P = 0.053) was observed between the Ct detection and genoTyping (DT) assay and the Ct-MS assay. In conclusion, the novel Ct-MS assay permits simultaneous detection and genotyping of Ct serovars, making the Ct-MS assay an excellent high throughput method.
authors.affiliation: DDL Diagnostic Laboratory, Voorburg, The Netherlands. k.d.quint@gmail.com
authors.forename: Koen D
authors.initials: KD
authors.lastname: Quint
authors.forename: Daan T
authors.initials: DT
authors.lastname: Geraets
authors.forename: Henk A M
authors.initials: HA
authors.lastname: van den Munckhof
authors.forename: Maurits N C
authors.initials: MN
authors.lastname: de Koning
authors.forename: Vitaly
authors.initials: V
authors.lastname: Smelov
authors.forename: Willem J G
authors.initials: WJ
authors.lastname: Melchers
authors.forename: Henry J C
authors.initials: HJ
authors.lastname: de Vries
authors.forename: Servaas A
authors.initials: SA
authors.lastname: Morré
authors.forename: Chris J M
authors.initials: CJ
authors.lastname: Meijer
authors.forename: Dirk C J G
authors.initials: DC
authors.lastname: van Alewijk
authors.forename: Leen-Jan
authors.initials: LJ
authors.lastname: van Doorn
authors.forename: Wim G V
authors.initials: WG
authors.lastname: Quint
mesh_terms: D015373:Bacterial Typing Techniques / Q000379:methods*; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000235:genetics / Q000382:microbiology*; D002692:Chlamydia trachomatis / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000032:analysis; D005838:Genotype; D006801:Humans; D008863:Microspheres; D016133:Polymerase Chain Reaction / Q000379:methods
chemical_list: D004269:DNA, Bacterial