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The mission of the JHU Center for Point-of-Care Tests for Sexually Transmitted Diseases is to create and test unique methods for the diagnosis of sexually transmitted diseases, including the home delivery of over-the-counter (OTC) tests to end-users via the Internet. Additionally, our Center will develop novel approaches for measuring acceptability and accuracy of point-of-care and OTC-type assays in primary care settings with comparisons between trained and untrained users.
The need to develop acceptable, accurate, and available point-of-care (POC) tests for diagnosing sexually transmitted diseases (STDs) for all at-risk populations is significant. Five of the top ten reportable diseases in the United States are STDs. New CDC estimates (February 2013) show that there are about 20 million new sexually transmitted infections (STIs) in the United States each year, costing the American healthcare system nearly $16 billion in direct medical costs alone. CDC's new data suggest that there are more than 110 million total (both new and existing) STIs among women and men across the nation. Young people (ages 15-24) are particularly affected, accounting for half (50%) of all new STIs. Some of these STIs have the potential to cause serious health problems, especially if not diagnosed and treated early. Stigma, privacy, and confidentiality issues make STDs/STIs optimal areas for point-of-care tests at healthcare facilities and for over-the-counter assays performed at home.
The long-term goals of the Center include addressing the epidemics of STDs and HIV in the United States and in resource-poor settings by development and better use of POC tests, to address health inequity, and improve the sexual health of individuals. The Center will:
- conduct integrated clinical needs assessments and health impact assessments with clinicians, end-users, and other appropriate stakeholders, to advance the field of POC testing
- inform the design, development, and utilization of POC devices by disseminating clinical needs information to the technology development community
- collaborate with physical and biochemical scientists, computational scientists, and systems engineers on the development of exploratory technologies
- test mature POC assays and devices for utilization in settings such as emergency departments, in the home, and in resource-poor countries, to improve health especially for those experiencing health disparities and inequities
- provide training to technology developers on clinical needs and health care delivery processes. This will include training for scientists in resource-poor settings and education of relevant stakeholders on the development and potential impact of POC technologies.
We are utilizing the molecular and scientific expertise of the basic scientists in our Center, and will provide expert laboratory facilities for testing newly-developed POC assays. Unique methods of home delivery of OTC assays to end-users via the use of the Internet are being explored, as well as novel approaches for measuring acceptability and accuracy of OTC-type testing in primary care settings. We have performed needs assessment,s whose results have reached and instructed scientists in the biotechnology community toward the development of assays that are meaningful with regard to sensitivity and specificity and that can positively influence public health. Our Center works with the other Centers of the NIH NIBIB Point-of-Care Technologies Research Network (POCTRN), to execute and facilitate transitions from prototype assay development through in-house pilot testing. Our goal is to ensure that assays which prove to be "worthy" of pilot testing have specifications and qualifications to be of sufficient scientific merit to be acceptable for future clinical trials and FDA submission.