학술논문
Clinical Integration of a Highly Accurate Polymerase Chain Reaction Point-of-Care Test Can Inform Immediate Treatment Decisions for Chlamydia, Gonorrhea, and Trichomonas.
Document Type
Academic Journal
Author
Dawkins M; From the Premier Health Urgent Care, Baton Rouge, LA.; Bishop L; From the Premier Health Urgent Care, Baton Rouge, LA.; Walker P; Visby Medical, Inc., San Jose, CA.; Otmaskin D; Visby Medical, Inc., San Jose, CA.; Ying J; Visby Medical, Inc., San Jose, CA.; Schmidt R; Visby Medical, Inc., San Jose, CA.; Harnett G; No Resistance Consulting Group, LLC, Birmingham, AL.; Abraham T; Visby Medical, Inc., San Jose, CA.; Gaydos CA; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.; Schoolnik G; Visby Medical, Inc., San Jose, CA.; DiBenedetto K; From the Premier Health Urgent Care, Baton Rouge, LA.
Source
Publisher: J B Lippincott Country of Publication: United States NLM ID: 7705941 Publication Model: Print Cited Medium: Internet ISSN: 1537-4521 (Electronic) Linking ISSN: 01485717 NLM ISO Abbreviation: Sex Transm Dis Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Accurate same-day sexually transmitted infection (STI) diagnostic testing is generally unavailable, leading to syndromic management with high rates of overtreatment and undertreatment. 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 to 56 years, women self-collected vaginal swab samples that were analyzed using the Visby STI Panel for Chlamydia trachomatis, Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Results were compared with standard-of-care clinic results from send-out laboratory polymerase chain reaction 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 the impact on clinical workflow, and syndromic treatment decisions were compared with 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 overtreatment and undertreatment of STIs. If integrated efficiently into the clinical workflow, the test would have minimal impact on staff time and visit duration for patients.
Competing Interests: Conflict of Interest and Sources of Funding: MD, LB, KD, GH, and CAG received research funding from Visby Medical, Inc. All other authors declared no potential conflicts of interest.
(Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
Methods: In a cross-sectional single-visit study of 55 women aged 18 to 56 years, women self-collected vaginal swab samples that were analyzed using the Visby STI Panel for Chlamydia trachomatis, Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Results were compared with standard-of-care clinic results from send-out laboratory polymerase chain reaction 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 the impact on clinical workflow, and syndromic treatment decisions were compared with 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 overtreatment and undertreatment of STIs. If integrated efficiently into the clinical workflow, the test would have minimal impact on staff time and visit duration for patients.
Competing Interests: Conflict of Interest and Sources of Funding: MD, LB, KD, GH, and CAG received research funding from Visby Medical, Inc. All other authors declared no potential conflicts of interest.
(Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)