TBI innovation: Brain injury diagnosed with a single drop of blood

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One drop of blood is enough for TBIcheck to diagnose a possible mild brain trauma. If a line appears below the control line, the injured person will have to go to the hospital for a CT scan.
One drop of blood is enough for TBIcheck to diagnose a possible mild brain trauma. If a line appears below the control line, the injured person will have to go to the hospital for a CT scan. © UNIGE

Researchers in Europe have developed a test using a single drop of blood that can diagnose the possibility of a mild traumatic brain injury.

Researchers from the University of Geneva (UNIGE), in collaboration with the hospitals of Barcelona, Madrid and Seville, developed a small device – a Point-of-Care Test – that analyses the level of proteins in the blood.

The discovery, described in PLOS One, will not only relieve emergency departments, free patients from often long waits, but also save on costly medical examinations.

Every year in Europe, three million people are admitted into hospitals for concussion or suspected mild traumatic brain injury (mTBI) cases. Today, the only reliable diagnosis is the CT Scan, which is available only in some hospitals and, in addition to being expensive, exposes patients to radiation.

Falling whilst playing sport, tumbling down the stairs or getting hit on the head can cause symptoms such as blurred vision, vomiting, loss of consciousness or memory for about 30 minutes. There is then a risk of mild cerebral trauma, which represents more than 90% of brain injuries admitted to hospitals. But is there really a brain lesion? Or are these symptoms merely the consequence of the violence of the shock, of which will ultimately only leave a bump behind?

Professor Jean-Charles Sanchez
Professor Jean-Charles Sanchez

Professor Jean-Charles Sanchez said the idea was to find a way to do a quick examination that would determine whether the athlete can return to play or if the condition requires further treatment. He described it as “the opposite of the CT Scan, an exam that lasts a long time and cannot be done anywhere”.

During a shock on the head, some brain cells are damaged and release the proteins they contain, increasing their level in the blood. Scientists then compared the blood of patients admitted for mild traumatic brain injury but diagnosed as negative with that of patients actually suffering from a brain lesion. Using proteomic analyses, which can quantify thousands of proteins simultaneously and observe variations in their levels in the blood, they gradually isolated four molecules indicating the presence of a brain injury: H-FABP, Interleukin-10, S100B and GFAP.

“We have noticed that the H-FABP level alone makes it possible to confirm that there is no risk of trauma in one-third of patients admitted after a shock,” Sanchez said. The rest of the patients will have to undergo a CT scan to confirm the diagnosis.

The team developed a rapid diagnostic test called TBIcheck, inspired by the principle of pregnancy testing: by placing a single drop of blood on the well of a small 5cm plastic case, the patient knows within 10 minutes whether there is a risk of mild trauma, namely whether or not his H-FABP level is higher than 2.5 nanograms per millilitre of blood.

“If a line appears, the injured person must go to a hospital for a CT scan, if there is nothing, he can go home safely,” Sanchez says. In case of doubt when reading the result, a small reader, the Cube Reader, can be installed on TBIcheck. It will display the word “positive” or “negative” and send the result to the patient’s or caregiver’s smartphone via Bluetooth.

The test, which will be marketed from 2019 by ABCDx. It has been patented by UNIGE and was awarded the Prix de l’Innovation Academy in December 2017.

“We are currently preparing an even more effective TBIcheck, which will allow 50% of patients to be sent home, but which requires an increase in the sensitivity of the test that receives the blood.”

ABCDx’s ultimate goal is to bring to market biomarkers capable of diagnosing brain trauma, stroke and aneurysms.

“Biomarkers are a mine of information on patients’ state of health, it is up to us to decode them,” Sanchez said.

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