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 United States, 5 of the top 10 reportable diseases are STDs and, per year, there are >18 million new STDs that cost >$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. We will develop a """"""""Center for Developing and Testing of Point of Care Tests (POCT) for STDs"""""""" with Cores that 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 our Center achieves its goals. For Core 1, we will provide expert testing laboratory facilities for testing newly developed POCT assays. We have extensive experience validating new assays. We will also test unique methods of home-delivering OTC assays to end users, via the Internet, as well as novel approaches for measuring acceptability and accuracy of OTC-type assays in primary care settings. For Core 2, we will provide grants to scientists to develop new assays, as well as utilize the molecular and basic scientific expertise of our Center's investigators in selecting appropriate applications. We will insure that Cores 3 and 4 work in an integrated fashion to provide the'needs assessment, results of which will reach scientists in the technology community and instruct them toward developing assays that will be meaningful, with regard to sensitivity and specificity, and positively influence public health. For Core 5, we 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. We will implement five Cores that complement each other and work with other Centers in the NIBIB POCT Research Network to facilitate transitions from 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54EB007958-05
Application #
8288714
Study Section
Special Emphasis Panel (ZEB1)
Project Start
Project End
2012-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
5
Fiscal Year
2011
Total Cost
$414,132
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
(2018) Let's Take A ""Selfie"": Self-Collected Samples for STIs. Sex Transm Dis :
Dize, Laura; Martin, Diana; Gwyn, Sarah et al. (2018) Comparison of three serological assays to measure antibody response to Chlamydia antigen Pgp3 in adolescent and young adults with pelvic inflammatory disease. Int J STD AIDS 29:1324-1329
Horst, Audrey L; Rosenbohm, Justin M; Kolluri, Nikunja et al. (2018) A paperfluidic platform to detect Neisseria gonorrhoeae in clinical samples. Biomed Microdevices 20:35
Dize, Laura; Silver, Barbara; Gaydos, Charlotte (2018) Comparison of the Cepheid GeneXpert CT/NG assay to the Hologic Aptima Combo2 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in self-collected rectal swabs. Diagn Microbiol Infect Dis 90:83-84
Trent, Maria; Coleman, Jenell S; Hardick, Justin et al. (2018) Clinical and sexual risk correlates of Mycoplasma genitalium in urban pregnant and non-pregnant young women: cross-sectional outcomes using the baseline data from the Women's BioHealth Study. Sex Transm Infect 94:411-413
Crowell, Trevor A; Hardick, Justin; Lombardi, Kara et al. (2018) Asymptomatic lymphogranuloma venereum among Nigerian men who have sex with men. Sex Transm Infect 94:578-581
Pittman, Ellen; Purcell, Hillary; Dize, Laura et al. (2018) Acceptability and feasibility of self-sampling for the screening of sexually transmitted infections in cabana privacy shelters. Int J STD AIDS 29:461-465
Gaydos, Charlotte A (2018) Let's Take A ""Selfie"": Self-Collected Samples for Sexually Transmitted Infections. Sex Transm Dis 45:278-279
Ronda, Jocelyn; Gaydos, Charlotte A; Perin, Jamie et al. (2018) Does the Sex Risk Quiz Predict Mycoplasma genitalium Infection in Urban Adolescents and Young Adult Women? Sex Transm Dis 45:728-734
Melendez, Johan H; Hardick, Justin; Barnes, Mathilda et al. (2018) Molecular Characterization of Markers Associated With Antimicrobial Resistance in Neisseria gonorrhoeae Identified From Residual Clinical Samples. Sex Transm Dis 45:312-315

Showing the most recent 10 out of 111 publications