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New rapid blood test for concussions gets FDA approval

The device from Abbott Laboratories can reportedly detect if a patient has mild traumatic brain injury in just 15 minutes.
New rapid blood test for concussions gets FDA approval
Posted at 1:04 PM, Apr 19, 2024

A new rapid blood test that can reportedly detect brain injuries like concussions in just minutes has cleared a major hurdle toward becoming widely available for use in the U.S.

Health care company Abbott Laboratories announced that its i-STAT TBI cartridge has been granted approval by the Food and Drug Administration and can now be used by clinicians to evaluate patients with suspected mild traumatic brain injury. Abbott says the test requires a small sample of a patient's blood to be inserted into the cartridge, and then it produces lab-quality results in just 15 minutes.

According to the National Institutes of Health, approximately 5 million people visit urgent care centers each year with traumatic brain-related injuries. And for decades, the process of detecting head trauma in patients has primarily been based on subjective doctor assessments or required blood samples to be sent off to a lab for processing and testing. 

However, Abbott claims its new rapid blood test is an important step forward in providing patients with quick results right at their bedside, and eventually at places like sporting events where head injuries are more common.

SEE MORE: How the NFL is working to prevent concussions and protect players

"With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care," said Dr. Geoffrey Manley, chief of neurosurgery at the University of California San Francisco. "It's an incredibly helpful tool that advances the treatment of traumatic brain injury." 

For now, the test is only approved for use on patients 18 years or older in places like hospitals and emergency departments. But Abbott hopes to eventually make the tests widely available to people of all ages anywhere they are seeking care for head trauma.

"When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what's happening," said Dr. Beth McQuiston, medical director in Abbott's diagnostics business. "Now, we have a whole blood test that can help assess the brain right at the patient's bedside — expanding access to more health providers and therefore patients."

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