Biological and biomedical measurements are often made in specialized laboratories, remote from the site of sample collection. Assays that can be done quickly in the field, without delays from transport of samples to central labs, provide timely information when a rapid response is crucial. Development of point-of-care diagnostics requires advanced technology to translate sensitive biological measurements to formats that are rapid, portable, and robust. SRI teams apply expertise in biology, chemistry and engineering to develop devices that are accurate, field-ready and easy to use.
Point of care diagnostic solutions
Although ionizing radiation has many uses in medicine, research and other areas, it presents a health hazard if used improperly. Radiation exposure causes damage to living tissue and can result in sickness, cancer or death. In a nuclear or radiological incident, first responders must quickly measure exposure, because treatments are radiation dose-dependent and time-sensitive.
SRI is developing a low-cost, field-portable triage device that can rapidly assess a person’s exposure to ionizing radiation to determine the need for additional testing and treatment by healthcare professionals. The SRI biodosimeter performs this assessment by quantifying protein biomarkers—biological substances that are found in bodily fluids (such as blood) and reflect the physiological status of the body. SRI scientists have identified a panel of time and dose-dependent biomarkers for radiation exposure and are developing the biodosimeter’s rapid and sensitive detection capabilities. Sophisticated classification software uses the measured protein biomarker concentrations to determine if recent exposure warrants further medical attention
Researchers at the institute are performing clinical testing to assess the biodosimeter’s ability to measure the amount of radiation exposure and provide test results within 30 minutes.
Anthrax is an acute disease caused by Bacillus anthracis bacteria, and if untreated, it can be deadly. The inhaled form can cause death in a matter of days. Anthrax diagnostic tests available today require sending samples to a laboratory for analysis with a delay of days before results are available. Initially, anthrax symptoms mimic the common flu, so early detection is critical.
SRI is developing a qualitative test for anthrax infection that uses blood samples on small cartridges. The cartridge is placed in a reader, and results are displayed in 30 minutes. This compact system can be used in locations close to the patient, such as hospital emergency rooms, local health clinics and potentially at the patient’s bedside or by first responders. Having the results immediately available will help doctors make fast decisions about the appropriate care and treatment for patients who may have been exposed to anthrax, such as after an anthrax bioterrorism attack.
Sentinel portable DNA analysis system
A portable biological analysis system that can identify pathogens and conduct routine health status monitoring and environmental monitoring in minutes will enable rapid intervention at the point of care. SRI has developed the Sentinel Nucleic Acid Analysis System, a portable, integrated, rapidly reconfigurable, automated biodetection hardware system that performs “sample-in to answer-out” field analyses, based on DNA or RNA dection, such as:
- Bacterial agent detection
- RNA virus detection
- mRNA/microRNA detection
The system can be further applied to diagnosis of health conditions such as flu, dengue fever, HIV and more. Sentinel’s consumable microfluidic cartridge has been transitioned to a contract manufacturer for production in an ISO 13485-compliant quality management system.
Development of a biodosimeter for radiation triage using novel blood protein biomarker panels in humans and non-human primates
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The referenced work has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, contract nos. HHSO100201600007C and HHSO1002017000030C and the Defense Advanced Research Projects Agency, contract no. HR0011-14-C-0082.