Clinical Performance of the CTGCTV2 Assay for the BD COR System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae From Extragenital Specimens.

BACKGROUND

Extragenital (oropharyngeal and anorectal) Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (or gonococci [GC]) infections are underdiagnosed. Here we report sensitivity and specificity estimates that were obtained from the multiplex, polymerase chain reaction-based BD CTGCTV2 (CTGCTV2) assay, which simultaneously detects CT and GC from extragenital specimens on the high-throughput BD COR (COR) system.

METHODS

Testing on the index assay used remnant (collected during a predicate, registrational trial) oropharyngeal (n = 2318) or anorectal (n = 2292) specimens, stored in PreservCyt ThinPrep liquid-based cytology media, from sexually active individuals (≥15 years of age). A composite comparator algorithm was used to define infectious status in the predicate study, which consisted of a 2 out of 3 agreement from Food and Drug Administration-cleared CT/GC molecular assays for a reference-positive or reference-negative result. Results obtained from the CT/GC assay on the COR were compared with the predefined composite comparator algorithm.

RESULTS

Testing for CT on COR had an estimated sensitivity of 100% (95% confidence interval, 86.2%-100%) and 97.7% (93.5%-99.2%) from oropharyngeal and anorectal specimens, respectively. GC testing on COR resulted in sensitivity estimates of 92.8% (85.8%-96.5%) and 95.8% (89.7%-98.4%) from oropharyngeal and anorectal specimens, respectively. Specificity estimates for CT were 99.8% (99.5%-99.9%) and 99.4% (99.0%-99.7%), respectively. For GC, specificity estimates were 99.5% (99.1%-99.7%) and 99.8% (99.5%-99.9%) for oropharyngeal and anorectal specimens, respectively.

CONCLUSIONS

CTGCTV2 performance on COR was accurate when testing oropharyngeal and anorectal specimens.