Over the last several years the Institute of Fluorescence (IoF) at the University of Maryland Baltimore County has developed a fundamental technology which has the potential to profoundly change Point-of-Care testing and subsequently specific Human Health diseases. Our studies of the Microwave-Accelerated Metal-Enhanced Fluorescence technology (MAMEF), when applied to RNA- target assay sensing platforms, Salmonella Serovar targets, Bioagent targets such as Bacillus Anthraces and sexually transmitted Infections (STI's), is providing for the equivalent of PCR-level sensitivity, but without any thermal cyclic amplification steps, detecting as low as 1cfu/ml of bacterial target within 20 seconds. Not only does the MAMEF technology look set to seriously compete with PCR amplification approaches, but the combined speed, sensitivity and upfront sample preparation steps which we have developed to date, are allowing the technology to be seriously considered in Point-of-Care (POC) settings, where both sample preparation and target detection can be remarkably achieved within 1 minute. To the best of our knowledge, there is no other published technology which offers both the combined speed, sensitivity, low cost and the ability to be readily applied to numerous clinical targets. During the last 5 years, the Institute of Fluorescence was invited to participate in a trial study of our rapid and sensitive MAMEF technology, with the NIH's (NIBIB) POCTRN group. NIBIB created the national Point-of-Care Technologies Research Network (POCTRN) to drive the development of selected technologies through collaborations that merge scientific and technological capabilities with clinical need. The network was comprised of 4 world renowned centers, which span the USA, each with an individual research and health care delivery theme. Based on a highly successful evaluation phase of the MAMEF technology, NIBIB has continued to fund the MAMEF technology for the detection of STI's (Sexually Transmitted Infections) through one of these centers; a subaward from a Johns Hopkins University U54 STI Center grant, U54 EB007958, headed by Dr Charlotte Gaydos, a world renown STI researcher. While the U54 center grant has funded the development of the actual technology itself, with a limited testing phase, the funds are not available for a large scale prospective study and clinical validation. Subsequently, this R03 proposal is specifically focused at blindly clinically validating the MAMEF CT and GC assays developed under the U54 center grant, with 1800 female patients, over a 2 year period. The significance of a successful validation of the MAMEF technology in a clinical setting cannot be over stated. The MAMEF technology has the potential to directly impact STI testing and health care.
Accurate point-of-care Sexually Transmitted Infection diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections are urgently needed for the rapid and low cost treatment of patients. This proposal aims to blindly clinically test and validate an already developed very rapid low cost test for both CT and GC, which has been developed for women, using 1800 swabs from female patients, from 2 clinical sites in the US, namely Baltimore and Cincinnati.
| 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 |
| Melendez, Johan H; Santaus, Tonya M; Brinsley, Gregory et al. (2016) Microwave-accelerated method for ultra-rapid extraction of Neisseria gonorrhoeae DNA for downstream detection. Anal Biochem 510:33-40 |
| Patterson-Rose, Sherine; Mullins, Tanya L Kowalczyk; Hesse, Elizabeth A et al. (2015) Syphilis among adolescents and young adults in Cincinnati, Ohio: testing, infection and characteristics of youth with syphilis infection. Sex Health 12:179-80 |
