COVID-19 Point-of-Need Diagnostic Device COVID-19 Point-of-Need Diagnostic Device The COVID-19 pandemic has exacted a devastating toll in countries across the globe and revealed critical gaps in diagnostic testing technologies. Nucleic acid tests that detect the genetic signature of the SARS-CoV-2 virus, the causative agent of COVID-19, are highly specific and sensitive; however, they require expensive instrumentation and are usually run in centralized facilities. As a result, most test results take one to three days to be returned to patients and have been beset with even larger delays as testing demands surge during rapidly expanding outbreaks. Lateral flow immunoassays, on the other hand, are fast and do not require sophisticated instrumentation. However, they are not as sensitive or specific as nucleic acid tests, and they return a positive result only after a patient has mounted an immune response to the infection. Thus, there exists an urgent need for rapid, specific, and distributed nucleic acid testing capacity to identify those in the acute phases of the infection and capable of passing the illness to others. This capacity is critical for curbing the spread of the illness, implementing effective contact tracing, and enabling the state economy to reopen safely. An interdisciplinary team of investigators at Arizona State University has developed a suite of transformative technologies with the potential to provide rapid low-cost point-of-need (PON) testing for SARS-CoV-2: Dr. Alex Green has extensive expertise in the development of rapid, inexpensive, and portable nucleic acid tests for virus detection. In field tests for detection of the Zika virus, these technologies have demonstrated equal sensitivity to gold-standard CDC assays and provide an accuracy of 98.5%. Dr. Mark Hayes is an internationally respected expert in bioanalysis, micro/nanofluidics, technical diagnostics, complex sample analysis and sample preparation. Dr. Hayes will (1) support the development of current virus detection by filtering the saliva sample to remove background species, increase the concentration of the virus, and sense the unlabeled virions, and (2) design, fabricate and test the fully integrated PON device which will need the ability to separate, isolate and concentrate only the virus particles and deliver that sample to an optimized micro/nanoscale sensing element based on the mechanisms developed by the team. Dr. Jennifer Blain Christen has over 20 years of experience integrating biosensors and bioelectronics from custom integrated circuits to embedded systems at the interface between silicon and biofluids/tissue. Dr. Blain Christen will lead the hardware team in designing the point of care reader to enable the assay and perform a quantitative fluorescence-based detection with results transmitted via wired and wireless communication. The proposed project will provide a much-needed new diagnostic technology to combat the COVID-19 pandemic in Arizona and will prove valuable in fighting new pathogens as they emerge in the future.
|Effective start/end date||9/1/20 → 2/28/22|
- Arizona Department of Health Services: $6,002,329.00
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