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Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases

PI: Charlotte Gaydos, M.P.H., Ph.D.
PI Institution: Johns Hopkins University
Grant Number: 1-U54-EB007958-01
NIH Program Officer (PO): Brenda Korte, Ph.D.
NIH Lead Science Officer (LSO): Christine Kelley, Ph.D.
NIH Associate Science Officer (ASO): Todd Merchak
Center Website: http://www.hopkinsmedicine.org/medicine/std

The need to develop acceptable, available Point-of-Care Tests (POCT) for identifying Sexually Transmitted Diseases (STDs) in at-risk populations is significant. In the U.S., five of the top ten reportable diseases are STDs and, per year, there are greater than 18 million new STDs that cost more than $2 billion. Stigma, privacy, and confidentiality issues make STDs optimal for POCT at healthcare facilities and for over-the-counter (OTC) assays performed at home. The Center will conduct in-house clinical testing of POC devices, collaborate with scientists and engineers on exploratory technology development projects, complete a clinical needs assessment among STD healthcare professionals, provide training to technology developers on clinical issues pertaining to STD POCT, and provide an administrative structure to ensure that the Center achieves its goals.

The Center will implement five Cores that complement each other and work with other Centers in the POCTRN to facilitate transitions form prototype development through in-house pilot testing, by ensuring that such assays' specifications and qualifications have scientific merit that is sufficient for future clinical trials and FDA submission.

Core 1 will provide expert testing laboratory facilities for testing newly-developed POCT assys. It will also test unique methods of home-delivering OTC assys to end users via the Internet, as well as novel approaches for measuring acceptability and accuracy of OTC-type assys in primary care settings.

Core 2 will provide grants to scientists to develop new assys, as well as utilize the molecular and basic scientific expertise of the Center's investigators in selecting appropriate applications.

Cores 3 and 4 will work in an integrated fashion to provide the needs assessment, the results of which will reach scientists in the technology community and aid them in developing assays that will be meaningful, with regard to sensitivity and specificity, and positively influence public health.

Core 5 will provide an effective management structure for a complex Center, the integration of all Core activities, responsiveness to members of the research community wishing to access the Center, and provide administrative services to the POCT Center.

Funding Announcement - Developing Point-of-Care Tests for Chlamydia and Other STDs

The Johns Hopkins Center for STD Point-of-Care Tests (JHU C STD POCT) is seeking the development of novel detection technologies for Point of Care Tests. Successful applications will describe the development of tests which minimally:

• Can detect less than 5,000 elementary bodies of chlamydia/ml
• Are rapid (time from sample to result under 4 hours)
• Have low-labor burden for sample preparation and assay, and
• Will be low cost (under $30/test)

The Pre-Application, including Quad Chart and White Paper is due October 27, 2008 11:59 pm EST. PDF files may be uploaded and sent by email to POCT-STD@jhuapl.edu no earlier than 2 weeks prior to deadline listed above for Quad Chart/White Paper and for full expedited proposal if requested.

Solicitation and additional information available at http://www.hopkinsmedicine.org/Medicine/std/funding_announcements/.