A Microfluidics Device for the Measurement of Traumatic Brain Injury Biomarkers at the Point of Care
Abstract
The Problem: Deciding on which traumatic brain injury (TBI) patient needs evaluation with a brain computed tomography (CT) scan remains a challenge for both civilian and military medical practice. Brain CT scans take a picture of the brain to look for bleeding caused by trauma. This is important because patients with bleeding in the brain may need surgery to stop the bleeding and remove blood clots. Brain CT scans are not useful for patients who do not have bleeding in the brain and unnecessary CT scans expose patients to unnecessary medical radiation (can contribute to causing cancer) and financial cost. Furthermore, in combat zones, getting a brain CT requires evacuating a wounded Warrior from a combat zone to a facility that has a CT scan. Therefore, the decision regarding which wounded Warrior needs a brain CT scan is very important and consequential. Work funded by the Department of Defense led the U.S. Food and Drug Administration (FDA) to approve two blood tests in January 2021 to help clinicians in deciding whether a TBI patient needs a brain CT. A positive blood test means the clinician should order a brain CT, and a negative blood test means there is no need to get a CT. Unfortunately, to quantify these blood tests in a blood sample, expensive instrumentation is needed that is not available in all hospitals, and especially not in resource-poor areas such combat zones. Furthermore, laboratory results can take a long time to deliver results. The Abbott i-STAT is a portable device that can measure these blood tests; however, it is bulky and only utilizes processed blood (plasma) and not unprocessed (whole blood). The Solution: This proposal will develop a new device for measuring these blood tests. Our device will be: (i) small (credit-card sized) to make it easy for military medics to carry it in their backpacks; (ii) as accurate as current devices or better; (iii) produce results within 15 minutes; (iv) will use a special technology (a microfluidic device that uses a variable height-channel method) that makes it easy to measure other new blood tests at the same time; (v) works well in extreme temperature conditions that Service Members are often exposed to; (vi) will not need refrigeration. Most of the existing devices have reagents that need to be refrigerated. This luxury is not always available in resource poor areas; and (vii) it is simple enough to be operated by a medic who is not a trained laboratory specialist. Project Objective: The result of our project will be a new device for measuring blood tests for brain injury that can be used in both resource-rich and resource-poor areas. The device will allow a rapid determination of whether a wounded Warrior or civilian who has had injury to the head is likely to have bleeding in the brain. We already have a prototype of the device that can measure one of the two FDA-approved blood tests. If this proposal is funded, we will be able to add the ability to measure the second FDA-approved blood test to the device. In addition, we will fine-tune the device by adding the following capabilities: (i) make it smaller; (ii) use reagents that do not require refrigeration; and (iii) add modifications that will allow it to work in extremes of temperature. Furthermore, we will perform a number of rigorous tests and experiments to measure the accuracy and reliability of the device. Our ultimate goal is to commercialize this technology for use in real-world settings so Service Members and the American public can directly benefit from this technology. Focus Area: This proposal fits within the Treat sub-area of the Fiscal Year 2021 Traumatic Brain Injury and Psychological Health Research Program Translational Research Award Focus Area. We are specifically addressing the area of encouragement in 3.a to develop a technology that can be used to objectively assess and diagnose mild TBI in deployed and far-forward environments. Impact of Project: At the end of our p
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211057
Entities
People
- Frederick Korley
Organizations
- United States Army
- University of Michigan