First rapid concussion blood test approved by FDA

Medical Watch

A new discovery may change the way young athletes and accident victims are treated when it comes to concussions.

WGN Medical Watch first covered the technology back in 2014 – a portable, rapid blood test to detect concussion. Now, nearly seven years later, the test has been approved by the Food and Drug Administration, finally addressing the growing problem of traumatic brain injuries.

Dr. Beth McQuiston is a medical director and neurologist with Abbott.

“There’s nothing out there,” McQuiston said. “This is the first of its kind. This is an absolute game changer. We’ve had blood tests for the heart, kidney, pancreas – We’ve never had one for the brain until now.”

It took 130 scientists and nearly seven years to develop. It is a way to look inside the veins for evidence of a brain wound.

“Looking at this test, what it does for patients and clinicians, it helps make the invisible visible,” McQuiston said.

There are markers in the blood to indicate damage, specific proteins released from the brain after an injury. A few drops of blood on a cartridge and 15 minutes later there are results.

“If you hit your head, we take your blood. We measure the blood,” McQuiston said. “If these brain proteins are at a certain level, that means that these proteins have been released from the brain and that some sort of damage has occurred.”

The idea is to help clinicians rule out a possible concussion without the need for a head CT.

“If the brain proteins are not present that means the person does not need a head CT and they can go home and have that sense of peace,” she said.

But higher levels of the proteins indicate a more severe injury. The Abbott Test then complements a CT scan. It has been cleared to detect the markers in the blood up to 12 hours after an injury.

“This is a ‘rule out test’ and it has 99.3 percent negative predictive value,” McQuiston said. “That means that we’d only miss one out of every 145 head CTs that would be positive. That’s really good.”

Right now, the test is for use in hospitals and clinical centers but Abbott hopes to distribute the rapid screening tool to minute clinics, urgent care centers and school sports teams.

Abbott scientists partnered with the Department of Defense to develop the test.

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