The mission of the JHU Center for Point-of-Care Testing 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 OTC-type assays in primary care settings with comparisons between trained and untrained users.
The need to develop acceptable, available point-of-care tests (POCT) 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. There are over 15 million new STDs per year. Costs to the U.S. for STDs are over $2 billion per year. Stigma, privacy, and confidentiality issues make STDs optimal areas for point-of-care tests at healthcare facilities and for over-the-counter (OTC) assays performed at home. Our Center has implemented five Cores that complement each other and work in an integrated fashion:
- Core 1: conducts in-house clinical testing of prototype POC devices
- Core 2: collaborates with scientists and engineers on exploratory technology development projects
- Core 3: completes clinical needs assessments of STD healthcare professionals
- Core 4: provides training to technology developers on clinical issues related to the development of POCT devices for STDs
- Core 5: provides an administrative structure to ensure the Center achieves its goals
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 POCT 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 are in the initial stages of the study, performing the needs assessment, whose results will reach and instruct scientists in the biotechnology community toward the development of assays that are meaningful with regard to sensitivity and specificity and can positively influence public health. Our Center works with the other Centers of the NIH NIBIB Point-of-Care Technologies Research Network, 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.
