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Item Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections(Wolters Kluwer, 2021) Van Der Pol, Barbara; Torres-Chavolla, Edith; Kodsi, Salma; Cooper, Charles K.; Davis, Thomas E.; Fife, Kenneth H.; Taylor, Stephanie N.; Augenbraun, Michael H.; Gaydos, Charlotte A.; Medicine, School of MedicineBackground: Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV). Methods: Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent. Results: Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types. Conclusions: BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.Item Findings From a Scoping Review: Presumptive Treatment for Chlamydia trachomatis and Neisseria gonorrhoeae in the United States, 2006–2021(American Sexually Transmitted Diseases Association, 2023-04) Allen, Katie S.; Hinrichs, Rachel J.; Heumann, Christine L.; Titus, Melissa K.; Duszynski, Thomas J.; Valvi, Nimish R.; Wiensch, Ashley; Tao, Guoyu; Dixon, Brian E.Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the 2 most common reported sexually transmitted infections in the United States. Current recommendations are to presumptively treat CT and/or GC in persons with symptoms or known contact. This review characterizes the literature around studies with presumptive treatment, including identifying rates of presumptive treatment and overtreatment and undertreatment rates. Of the 18 articles that met our inclusion criteria, 6 pertained to outpatient settings. In the outpatient setting, presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 12% to 100%, and the percent positive of those presumptively treated ranged from 25% to 46%. Three studies also reported data on positive results in patients not presumptively treated, which ranged from 2% to 9%. Two studies reported median follow-up time for untreated, which was roughly 9 days. The remaining 12 articles pertained to the emergency setting where presumptive treatment rates, for both asymptomatic and symptomic patients, varied from 16% to 91%, the percent positive following presumptive treatment ranged from 14% to 59%. Positive results without presumptive treatment ranged from 4% to 52%. Two studies reported the percent positive without any treatment (6% and 32%, respectively) and one reported follow-up time for untreated infections (median, 4.8 days). Rates of presumptive treatment, as well as rates of overtreatment or undertreatment vary widely across studies and within care settings. Given the large variability in presumptive treatment, the focus on urban settings, and minimal focus on social determinants of health, additional studies are needed to guide treatment practices for CT and GC in outpatient and emergency settings.