title: Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting.
abstract: The goal of the point-of-care (POC) sexually transmitted infection (STI) Diagnostics meeting was to review the state-of-the-art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, nonprofit, and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, human papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations, and future areas of development. Key points of the meeting are as follows: (i) although some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider, and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed, and new technologies can be used to improve diagnostic testing, test uptake, and treatment; (iii) efficient deployment of self-testing in supervised (ie, pharmacies, clinics, and so on) and/or unsupervised (ie, home, offices, and so on) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies; and (v) questions regarding quality management are emerging including the mechanism by which poor-performing diagnostics are removed from the market and quality assurance of self-testing is ensured.
authors.affiliation: From the *Center for Infectious Diseases Research, Social & Scientific Systems, Inc, Silver Spring, MD; †University of California San Diego School of Medicine, La Jolla, CA; ‡London School of Hygiene and Tropical Medicine, London, UK; §University of Alabama at Birmingham School of Medicine, Birmingham, AL; ¶University of California, Los Angeles, CA; ∥Florida International University, Miami, FL; **Stanford University, Stanford, CA; ††McGill University Health Centre, Montreal, QC, Canada; ‡‡Johns Hopkins University, Baltimore, MD; §§Boston University, Boston, MA; and ¶¶Public Health Research Institute of India, Mysore, India.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Cristillo
authors.forename: Claire C
authors.initials: CC
authors.lastname: Bristow
authors.forename: Rosanna
authors.initials: R
authors.lastname: Peeling
authors.forename: Barbara
authors.initials: B
authors.lastname: Van Der Pol
authors.forename: Sasha Herbst
authors.initials: SH
authors.lastname: de Cortina
authors.forename: Ivan K
authors.initials: IK
authors.lastname: Dimov
authors.forename: Nitika Pant
authors.initials: NP
authors.lastname: Pai
authors.forename: Dong
authors.initials: D
authors.lastname: Jin Shin
authors.forename: Ricky Y T
authors.initials: RY
authors.lastname: Chiu
authors.forename: Catherine
authors.initials: C
authors.lastname: Klapperich
authors.forename: Purnima
authors.initials: P
authors.lastname: Madhivanan
authors.forename: Sheldon R
authors.initials: SR
authors.lastname: Morris
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
mesh_terms: D003226:Congresses as Topic; D006801:Humans; D000067716:Point-of-Care Testing / Q000639:trends*; D011634:Public Health / Q000379:methods; D012749:Sexually Transmitted Diseases / Q000175:diagnosis*