The world’s first rapid handheld blood test for mild traumatic brain injury (TBI) has been given clearance by US regulators, it has been revealed.
The device, developed by Abbott, will help detect injuries including concussions, and will help clinicians determine if further assessments, including a CT scan, are necessary.
A blood sample will be taken from the patient, with plasma drawn and applied to the test’s cartridge, with results being delivered a short time later.
Millions of people worldwide sustain mild brain injuries each year, with Abbott estimating five million in the US alone are affected, and to which its new test could be relevant.
Its approval by the FDA marks a significant step forward in its implementation in the US, and potentially on a global scale thereafter.
“TBIs, including concussions, are an alteration in brain function caused by an external force,” Abbott said in a statement.
“This test measures specific proteins present in the blood after a TBI.
“A negative result on this test can be used to rule out the need for a head CT scan, a common tool used to diagnose concussion.
“For those who test positive, this test result complements CT scans to help clinicians evaluate whether someone has a TBI.”
The blood test will mark a significant step forward for those working in frontline healthcare, says Dr. Beth McQuiston, medical director for Abbott’s diagnostics business.
“You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent re-injury and get back to doing the things they care about most,” she says.
Abbott added that its vision is to have a 15-minute portable test for the future, which it is in the process of developing.
This could potentially be used outside of medical environments, such as at sporting events.
“Survivors of TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms),” Abbott continued.
“Effects of TBI can last anywhere from a few days post-injury or may be permanent.
“People who sustain a TBI are more likely to have another one — similarly to how a sprained ankle or torn ligament is more susceptible to future injury.”
