Mild traumatic brain injury (mTBI), commonly known as concussion, is the most prevalent form of brain injury, with over three million suspected cases admitted to hospitals each year in Europe. Ordinarily, admitted patients undergo an expensive and time-consuming CT scan, exposing the brain to potentially harmful radiation just to detect the presence or absence of trauma. Around 90% of such cases are diagnosed as negative for brain injury.
Decoding biomarkers:
Researchers at the University of Geneva (UNIGE), along with their collaborators at hospitals in Barcelona, Madrid, and Seville, may have found a more efficient, quicker and cheaper alternative to detecting mTBI brain lesions. This discovery, described in PLoS One, is a point-of-care test (POCT) that uses a device called the TBIcheck to detect the level of a particular protein called H-FABP in blood to confirm the presence of brain injury.
“Our idea was to find a way to do a quick examination that would allow, during a boxing or American football match for example, to determine whether the athlete can return to the field or if his condition requires hospitalization. The opposite of the CT Scan, an exam that lasts a long time and cannot be done anywhere,” explains Jean-Charles Sanchez, a professor at the Department of Internal Medicine of Specialties and the Biomarkers Center of the Faculty of Medicine of the UNIGE.
Researchers used proteomic analysis, which simultaneously quantifies thousands of proteins and their levels in the blood, to demonstrate that four molecules—H-FABP, interleukin-100, S100B, and GFAP—were detected at varying levels in patients with brain injury. In addition, the scientists also noticed that the H-FABP level alone made it possible to confirm that there was no risk of injury in one-third of the patients admitted after a shock.
Inspired by pregnancy test:
This diagnostic blood test, inspired by the principle of pregnancy testing, analyzes a single drop of blood within 10 minutes to detect whether H-FABP level is higher than 2.5 nanograms per milliliter of blood.
“If a lane appears, the injured person must go to a hospital for a CT scan, if there is nothing, he can go home safely!” Jean-Charles Sanchez says.
A second device called the Cube Reader can be installed on the TBIcheck, which is meant to simplify the response by eliminating any ambiguous results. This device will read either “positive” or “negative” and transmit the information to the caregiver’s or patient’s Bluetooth-paired smartphone.
What’s next?
Commercialization of this patented technology is planned for early 2019 by ABCDx, a start-up founded by Jean-Charles Sanchez and Joan Montaner, co-authors on the study. Earlier this year, the U.S. Food and Drug Administration approved marketing of a similar blood test called the Banyan Brain Trauma Indicator that traces two protein biomarkers to effectively correlate with patients that have intracranial lesions. However, this test takes about 2 hours to complete, whereas the TBIcheck is done in 10 minutes. The researchers at UNIGE are currently working on combining H-FABP and GFAP levels in a panel that provides even more accurate results along with greater sensitivity, thus, leading to a more effective TBIcheck. The Geneva researchers concluded that ABCDx’s ultimate goal is to decode and bring to market biomarkers capable of diagnosing brain trauma, stroke, and aneurysms.
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