National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health, is throwing $8.5 million of our (and your) hard-earned money to establish the UC Davis-Lawrence Livermore National Laboratory Center for Point-Of-Care Technologies to speed the detection of bloodstream infections.
Here’s what the partnership is planning to accomplish:
The grant… will fund the development of two prototype instruments that simultaneously detect five bacterial and fungal pathogens. The grant also funds evaluations of other exploratory diagnostic technologies intended to prepare the nation for future disasters.
“The goal of our center is to improve the accessibility, portability and field robustness of POC instruments for critical-emergency-disaster care in community hospitals, rural areas and disaster response sites,” said Gerald Kost, professor of Pathology and Laboratory Medicine and director of the POCT-CTR at UC Davis Health System.
Events during Hurricane Katrina demonstrated the basic feasibility of POCT, but follow-up laboratory experiments showed that current equipment is not adequate for field use, said Kost, the grant’s principal investigator.
“We need rapid diagnostics and rugged instruments for use in disasters,” Kost said. “Rescues were slowed during Katrina because hospitals were out of commission. Doctors didn’t have adequate tools needed to make fast diagnoses; treatment was delayed. Instruments could not stand the environmental stresses.”
“Research is needed to develop field-worthy, battery-operated devices robust enough to withstand extreme ranges of humidity, temperature and altitude encountered during rescue operations,” Kost said. “Reagents, test strips and quality-control materials must withstand the same harsh conditions, because it is difficult or impractical to transport materials in environmentally controlled containers that are either refrigerated or heated.”
The diagnostic instruments to be developed will be easy to use with minimal training and rugged, so they can be deployed in challenging environments, said LLNL chemist Ben Hindson, who with chemical engineer John Dzenitis, is directing the grant work at the Laboratory…
Under the grant, the LLNL-UC Davis research team will develop two prototype detection instruments — one for hospital settings and one that is field portable…
The LLNL Pathogen Informatics Group, with assistance from UC Davis researchers, will use its capabilities to design unique DNA signatures or assays for use with the new instruments. The five pathogens for which unique identification signatures will be developed under the grant are:
Methicillin-resistant Staphylococcus aureus (MRSA)… Pseudomonas aeruginosa … Escherichia coli … Streptococcus pneumoniae … Candida …
As envisioned, blood samples would be loaded into the LLNL-UC Davis instruments, which would automatically handle all of the processing steps.
Instead of relying on the polymerase chain reaction (PCR) technique, the instruments will use a new DNA amplification method called loop mediated amplification (LAMP).
The LAMP method uses a portion of the Bacillus stearothermophilus DNA polymerase protein, an enzyme that splits the double strand of DNA and allows it to be copied at a single temperature (63 degrees Celsius or 145 degrees Fahrenheit), rather than using multiple cycles of heating and cooling, as PCR requires.
Initially, using a blood sample from one person, the instruments will run a simultaneous test for all five pathogens within one hour. Eventually, the team hopes to outfit the instruments with the capability to run tests for all five pathogens within an hour for several people at the same time, Hindson said.
Several LLNL-developed biodetection technologies, such as the Autonomous Pathogen Detection System, that are designed to protect against bioterrorism, will provide some of the foundational technologies for these new POC instruments.
Or put more simply, the government is now in the business of developing medical devices. By the way, did you notice any lack of innovation from the private sector? We certainly did not.
Press release: NIH establishes UC Davis-LLNL Center for Point-Of-Care Technologies to speed detection of bloodstream infections …