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, PCR-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 utilized remnant (collected during a predicate, registrational trial) oropharyngeal (n = 2,318) or anorectal (n = 2,292) specimens, stored in PreservCyt ThinPrep liquid-based cytology media, from sexually active individuals (≥15 years of age). A composite comparator algorithm (CCA) was utilized to define infectious status in the predicate study, which consisted of a two out of three agreement from FDA-cleared CT/GC molecular assays for a reference-positive or -negative result. Results obtained from the CT/GC assay on the COR were compared to the predefined CCA. Results Testing for CT on COR had an estimated sensitivity of 100% [95% CI: 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.