Field Performance and usability of a novel molecular point-of-care assay for Chlamydia trachomatis and Neisseria gonorrhoeae detection.

BackgroundFew studies have evaluated the field performance of novel point-of-care molecular assays for Chlamydia trachomatis and Neisseria gonorrhoeae. We aimed to assess the performance, feasibility and acceptability of the prototype OraSure CT/NG assay (InteliQuick, OraSure Technologies Inc., USA) among clinics in Peru.MethodsBetween May and June 2025, we recruited men and women from three clinics in Lima. Participants self-collected rectal and vaginal or penile meatal swabs and provided urine samples, while clinic staff collected pharyngeal swabs. We compared results of the prototype OraSure CT/NG assay with reference testing using the Xpert CT/NG assay (Cepheid, USA) on rectal, pharyngeal, and vaginal swabs as well as male urine, and the Aptima Combo 2 CT/NG assay (Hologic, USA) on penile meatal swabs and male urine. We applied an intention-to-diagnose framework, calculating explanatory scientific accuracy, which permits repeat testing on invalid specimens, and pragmatic application accuracy which classifies invalid results as false positives or negatives. We calculated the positive (PPA) and negative percent agreement (NPA) for each anatomic site and used closed-ended surveys to assess acceptability and feasibility among laboratory personnel.ResultsWe enrolled 157 participants. Of 470 specimens tested by the OraSure CT/NG assay, 92.3% yielded a valid result on the first attempt (99.1% after repeated testing). Among symptomatic participants, PPA for N. gonorrhoeae was 100.0% (penile meatal), 72.7% (pharyngeal), and 69.2% (rectal), while for C. trachomatis the PPA was 50.0% (penile meatal), 33.3% (pharyngeal), and 85.7% (rectal). NPA remained >90% across all sites. Seven of eight clinic laboratory personnel rated the assay as easy to use and compatible with existing clinic workflows.ConclusionsThe OraSure CT/NG assay showed consistently high NPA and was acceptable to users, while the PPA varied by pathogen and specimen type.