The National Institutes of Health has awarded researchers affiliated with the Geneva Foundation and the University of Maryland $4.8 million to develop an integrated protein microarray and microfluidics device for diagnosing viral infections.
The project, called "Integrated polymer microfluidic device for multiplex diagnosis of viral infection," is budgeted through July 31, 2016. The grant was made through Partnerships for Next Generation Biodefense Diagnostics, a sponsored program of the National Institute of Allergy and Infectious Diseases.
The first-year budget for the project is $1.1 million and the principal investigator is Robert Ulrich, who holds joint appointments with the Geneva Foundation, a Tacoma, Wash.-based nonprofit that promotes the advancement of military medicine, and the US Army Medical Research Institute of Infectious Diseases in Frederick, Md.
Ulrich told BioArray News this week that he is working with Don DeVoe, a professor of mechanical engineering at the university's College Park campus, to develop a "low-cost platform for the rapid diagnosis of infections caused by several viruses that are important to public health."
Ulrich, who is based at USAMRIID's facility in Frederick, said that the chip is being developed for health practitioners with "very little experience in laboratory methods." To this end, the researchers seek to integrate most of the complex tasks required for antibody-based diagnosis into a small device intended for single use.
The compartmentalized laboratory tasks will include processing and dilution of microliters of blood samples, storage and reconstitution of reagents isolated by burst valves, movement of samples across detection zones, measurements of antibody biomarkers, and transmission of assay results back to the operator, Ulrich said. He added that the multiplexed antibody detection zones will consist of protein probes assembled into microarrays connected by microfluidic channels to other components of the device.
"Our ultimate goal is to develop a versatile system that can incorporate new diagnostic assays as these become available, leading to a high-content platform for extensive coverage of infectious diseases," Ulrich said.
The project pairs Ulrich's background in protein microarrays with DeVoe's lab-on-chip expertise. USAMRIID's Biosensor and Protein Microarray Laboratory and the MicroElectroMechanical Systems and Microfluidics Laboratory at UMD are taking part in the effort.
"My laboratory uses protein microarrays and other proteomic tools combined with biosensors and molecular biology to improve methods for diagnosing and treating infectious diseases," Ulrich said. "A major goal of Dr. DeVoe's research is to improve diagnostic methods by lab-on-a-chip platforms that integrate nanostructured surfaces and components within microfluidic systems," he said.
According to the grant abstract, the rapid and accurate diagnosis of infection is "critical" for managing potential exposures to highly virulent pathogens. The researchers maintained in the abstract that commonly practiced methods for measuring antibody responses in the clinic are encumbered by a focus on single pathogens, "time-consuming" performance steps, "slow turn-around time" for data acquisition, issues of specificity and sensitivity, and variable results.
They claim that their device will integrate tasks required for antibody-based diagnosis, from processing of finger-prick blood samples to identifying exposure to specific infectious agents.
The project will focus on point-of-care diagnosis of infections caused by two pathogen groups: arboviruses, such as Japanese encephalitis, Chikungunya, dengue, yellow fever and others; and filoviruses such as Ebola and Marburg.
Additionally, the researchers envision that the microarray format of the microfluidic device can be expanded to include tests for an extensive number of other biological agents.
"Recently emerged and future infectious threats will continue to expand the list of medically significant human viruses, requiring diagnostic methods that also keep pace," said Ulrich this week.
To develop and evaluate the device, the researchers will rely on sera from clinical and veterinary cases of infection. "Our approach will require only nanoliter quantities of serum for analysis," Ulrich claimed. He said that the device could eventually be used to detect pre-symptomatic, symptomatic, or convalescent biomarkers of infectious diseases.
The recent grant is just one of many the NIH has made in recent years to support chip-based infectious disease testing. The University of California, San Francisco, received funding in 2010 to develop a rapid, pan-viral microarray diagnostic for category A-C biodefense pathogens (BAN 9/7/2010). The UCSF researchers are working with Frederick, Md.-based Akonni Biosystems to develop and validate the array.
In June, NIH awarded $2.5 million to researchers at Lawrence Livermore National Laboratory in Livermore, Calif., to move their pathogen detection tests to NanoString Technologies' nCounter system (BAN 6/7/2011).
And researchers at the University of Hawaii at Manoa in September received more than $400,000 to develop a chip for tropical infectious disease detection and prevention (BAN 12/13/2010).
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