Sexually transmitted diseases · 2025
Clinical Performance of the CTGCTV2 Assay for the BD COR System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae From Extragenital Specimens.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Van Der Pol Barbara, Ippolito Jordan, Gao Rachel, Passow Courtney, Christensen Katherine
Аннотация
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.
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.