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Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection—Clinical Trial Group Programmatic Meeting

Cristillo, Anthony D. PhD, MS; Bristow, Claire C. PhD, MPH, MSc; Peeling, Rosanna PhD; Van Der Pol, Barbara PhD, MPH; de Cortina, Sasha Herbst BA; Dimov, Ivan K. PhD; Pai, Nitika Pant MD, MPH, PhD; Jin Shin, Dong BSE; Chiu, Ricky Y.T. PhD; Klapperich, Catherine PhD; Madhivanan, Purnima MD, MPH, PhD; Morris, Sheldon R. MD, MPH; Klausner, Jeffrey D. MD, MPH

Sexually Transmitted Diseases: April 2017 - Volume 44 - Issue 4 - p 211–218
doi: 10.1097/OLQ.0000000000000572
Original Studies

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.

The STAR STI-CTG programmatic meeting reviewed point-of-care sexually transmitted infection diagnostics including current and emerging technologies, clinical and public health benefits, international applications, regulatory considerations, and future developments.

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

Acknowledgments: The STAR STI CTG 2016 Programmatic Meeting for POC STI Diagnostics was held on April 20, 2016 at Social & Scientific Systems, Inc (SSS) (8757 Georgia Avenue, 12th Floor, Silver Spring, MD, 20910). The authors would like to acknowledge attendees of the STAR STI CTG 2016 Programmatic Meeting for POC STI Diagnostics: Lynn Barclay, American Sexual Health Association; Claire C. Bristow, University of California, San Diego; Jose Castro, University of Miami; Ricky Chiu, Phase Diagnostics; Anthony Cristillo, Social & Scientific Systems, Inc; Carolyn Deal, National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID)/Division of Microbiology and Infectious Diseases (DMID); Yvette Delph, SSS; Ivan Dimov, Stanford University; David Ecker, Abbott; Yetunde Fakile, Centers for Disease Control and Prevention; Rick Galli, bioLytical Laboratories; Charlotte Gaydos, Johns Hopkins University; Jonathan Glock, NIH/NIAID/DMID; Thomas Hall, Abbott, Sasha Herbst de Cortina, University of California, Los Angeles; Catherine Klapperich, Boston University; Jeffrey Klausner, University of California, Los Angeles; Carol Langley, Office of the US Global AIDS Coordinator; Jill Long, NIH/NIAID/DMID; Gwendolyn Maddox, SSS; Purnima Madhivanan, Florida International University; Sean McCarthy, SSS; Sheldon Morris, University of California, San Diego; Philipp Mueller, Hologic; Sara McCurdy Murphy, SSS; Nitika Pant Pai, McGill University; Rosanna Peeling, London School of Hygiene & Tropical Medicine; Lee Pyne-Mercier, Bill & Melinda Gates Foundation; Gary Richwald, LA/Orange County HSV/HPV/HELP; Renee Ridzon, Office of the US Global AIDS Coordinator; Greg Scott, Beckman Coulter; DJ Shin, Johns Hopkins University; Joanna Sickler, Roche Molecular Systems, Inc; William Smith, National Coalition of STD Directors; Bradley Stoner, Washington University in St. Louis; Delmyra Turpin, NIH/NIAID/DMID; Barbara Van Der Pol, University of Alabama at Birmingham; Toni Waymer, SSS; Peter Wolff, NIH/NIAID/DMID; and John Waldeisen, Diassess Inc. The STAR STI CTG programmatic meeting was supported by the NIAID contract HHSN2722013000141.

Conflict of interest: None declared.

Correspondence: Anthony D. Cristillo, PhD, MS, Social and Scientific Systems, Inc, Silver Spring, MA. E-mail:

Received for publication October 10, 2016, and accepted November 21, 2016.

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