Clinical Integration of a Highly Accurate PCR Point-of-care Test Can Inform Immediate Treatment Decisions for Chlamydia, Gonorrhea and Trichomonas.

BACKGROUND Accurate same-day STI diagnostic testing is generally unavailable, leading to syndromic management with high rates of over- and under-treatment. We analyzed the ease of integration of the Visby STI Panel into clinical practice, studied acceptance by patients and clinic personnel, and assessed the potential to inform accurate treatment decisions. METHODS In a cross-sectional single visit study of 55 women, aged 18-56 years, women self-collected vaginal swab samples which were analyzed using the Visby STI panel for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Results were compared to standard-of-care clinic results from send-out laboratory PCR tests. Surveys assessed patient and device operator experiences with the Visby STI panel and clinicians' perceived need for and acceptance of the device. Time parameters were measured to evaluate impact on clinical workflow, and syndromic treatment decisions were compared to anticipated treatment based on the Visby STI panel results. RESULTS Patients strongly agreed that sample self-collection was easy, and operators reported the device easy to use. Clinicians valued the rapid return of results, and patients were comfortable waiting up to 30-minutes to receive them. In 13 of 15 cases, the Visby STI Panel correctly identified undertreated patients as infected, and correctly identified all 33 incidences of overtreatment. CONCLUSIONS Clinical adoption of the Visby STI Panel into primary care clinics and doctors' offices could reduce over- and under-treatment of STIs. If integrated efficiently into the clinical workflow, the test would have minimal impact on staff time and visit duration for patients.