Methicillin-resistant Staphylococcus aureus (MRSA) is the most common multidrug-resistant pathogen in healthcare settings worldwide. The use of active detection and isolation (ADI) is a proven method to prevent MRSA infections that requires the detection of the MRSA-colonized patient through active surveillance testing (AST). Our long-term goal is to develop accurate tests with rapid turn-around times (<15 minutes) that could increase the efficacy of ADI and AST for MRSA prevention and control programs and molecular diagnosis across all healthcare settings. Our hypothesis is that droplet PCR will provide accurate test results with reduced analysis time, complexity and cost thereby making nucleic acid amplification tests viable near point-of- care. We propose to develop two in vitro point-of-care nucleic acid amplification tests for detecting MRSA in patient specimens. In addition to supporting development, this project would enable a mechanism and provide support for partnership between technology developers in private industry at QuantaLife Inc. and healthcare professionals at the University of Mississippi Medical Center (UMMC). QuantaLife scientists and engineers have decades of experience developing and fielding diagnostics for biological pathogens, and will be responsible for designing and building the prototype droplet PCR instrumentation and accompanying assays. UMMC has the requisite clinical expertise, specifically in the area of healthcare acquired infections, to guide test design and requirements and critically evaluate droplet PCR performance and potential impact in real- world clinical settings. These partnerships could accelerate the translation of droplet PCR technology from the laboratory into an instrument for near-point-of-care testing thereby impacting healthcare sooner.

Public Health Relevance

We propose to develop rapid tests for detecting the DNA of antibiotic resistant bacteria from patient samples. If implemented near the point of patient care these tests could quickly identify people who carry these bacteria and prevent subsequent infections within hospitals and clinics. This technology makes billions of copies of DNA in tiny droplets that accurately fingerprints the bacteria.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Research Project (R01)
Project #
1R01EB010106-01A1
Application #
7900825
Study Section
Special Emphasis Panel (ZRG1-BST-N (03))
Program Officer
Korte, Brenda
Project Start
2010-08-15
Project End
2015-07-31
Budget Start
2010-08-15
Budget End
2011-07-31
Support Year
1
Fiscal Year
2010
Total Cost
$820,894
Indirect Cost
Name
Quantalife, Inc.
Department
Type
DUNS #
867094380
City
Pleasanton
State
CA
Country
United States
Zip Code
94566
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Belgrader, Phillip; Tanner, Stephanie C; Regan, John F et al. (2013) Droplet digital PCR measurement of HER2 copy number alteration in formalin-fixed paraffin-embedded breast carcinoma tissue. Clin Chem 59:991-4
Kelley, Kashonda; Cosman, Angela; Belgrader, Phillip et al. (2013) Detection of methicillin-resistant Staphylococcus aureus by a duplex droplet digital PCR assay. J Clin Microbiol 51:2033-9
Pinheiro, Leonardo B; Coleman, Victoria A; Hindson, Christopher M et al. (2012) Evaluation of a droplet digital polymerase chain reaction format for DNA copy number quantification. Anal Chem 84:1003-11
Hindson, Benjamin J; Ness, Kevin D; Masquelier, Donald A et al. (2011) High-throughput droplet digital PCR system for absolute quantitation of DNA copy number. Anal Chem 83:8604-10