title: The first performance report for the Bio-Rad Dx CT/NG/MG assay for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in urogenital samples.
abstract: We evaluated the clinical performance of the Bio-Rad Dx CT/NG/MG assay for the detection of Chlamydia trachomatis, Mycoplasma genitalium and Neisseria gonorrhoeae in urogenital samples in comparison with the Roche COBAS® TaqMan® CT assay for C. trachomatis and an in-house TaqMan PCR assay for M. genitalium. Swab specimens were cultured for N. gonorrhoeae. In this prospective study, urogenital samples were obtained from symptomatic and asymptomatic patients attending the sexually transmitted disease clinic of Bordeaux, France, from January to April 2010. A total of 658 clinical specimens (259 male and 180 female urines, 191 vaginal, 21 endocervical and 7 urethral swabs) from 453 patients were analyzed. The prevalence of C. trachomatis and M. genitalium infections was 8.1% (21/260) and 1.9% (5/260) in men and 10.4% (20/193) and 2.1% (4/193) in women, respectively. The Bio-Rad Dx CT/NG/MG clinical sensitivity was 100% for C. trachomatis and M. genitalium in men and women. In male urine, the clinical specificity was 99.6% for C. trachomatis and 100% for M. genitalium. In women, the specificity was 99.5% for swabs and 100% for urines for detecting C. trachomatis and M. genitalium. All seven N. gonorrhoeae PCR-positive samples were also positive by culture. Patients were co-infected in 5/57 cases (8.8%), with C. trachomatis and M. genitalium in three cases, and C. trachomatis and N. gonorrhoeae in two cases. In conclusion, the Bio-Rad Dx CT/NG/MG assay can be recommended for the simultaneous detection of C. trachomatis, M. genitalium and N. gonorrhoeae in urogenital specimens of symptomatic and asymptomatic individuals.
authors.affiliation: Univ. Bordeaux, USC mycoplasmal and chlamydial infections in humans, Bordeaux, France.
authors.forename: Chloé
authors.initials: C
authors.lastname: Le Roy
authors.forename: Isabelle
authors.initials: I
authors.lastname: Le Hen
authors.forename: Maïthé
authors.initials: M
authors.lastname: Clerc
authors.forename: Véronique
authors.initials: V
authors.lastname: Arfel
authors.forename: Françoise
authors.initials: F
authors.lastname: Normandin
authors.forename: Cécile
authors.initials: C
authors.lastname: Bébéar
authors.forename: Bertille
authors.initials: B
authors.lastname: de Barbeyrac
mesh_terms: D000293:Adolescent; D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods*; D002692:Chlamydia trachomatis / Q000302:isolation & purification*; D005260:Female; D005602:France; D005836:Genitalia, Female / Q000382:microbiology; D005837:Genitalia, Male / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D045704:Mycoplasma genitalium / Q000302:isolation & purification*; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D015231:Sexually Transmitted Diseases, Bacterial / Q000175:diagnosis*; D014556:Urine / Q000382:microbiology; D055815:Young Adult