Revolutionary concussion detection blood test from Abbott receives FDA approval

USA— Abbott has received clearance from the U.S. Food and Drug Administration (FDA) for the first commercially available laboratory test for traumatic brain injury (TBI), which will be widely accessible to hospitals in the United States.

The Alinity i TBI test, which takes 18 minutes, will provide clinicians with an objective way to quickly assess individuals with mild TBIs or concussions by measuring two biomarkers in the blood that are correlated with brain injury.

Previously, doctors had to rely on the Glasgow Coma Scale and CT scans, which could lead to unnecessary tests, costs, and time spent in the emergency department.

The Alinity i TBI test could reduce the need for CT scans by up to 40%, offering potential cost savings to the healthcare system and patients.

Millions of people in the United States experience a concussion each year, but over half of those affected do not get medical attention.

The test offers a solution to the lack of objective concussion assessments and provides people with the answers and treatment they need.

TBI can cause short- and long-term effects, such as memory impairment, sensory changes, emotional functioning, and personality changes, which can be worsened by misdiagnosis or lack of diagnosis.

Abbott’s medical director, Beth McQuiston, M.D., said that the availability of the test is great news for both doctors and people trying to find out if they have suffered a TBI.

Abbott has been leading the way in traumatic brain injury (TBI) testing technology for over a decade, and the recent FDA clearance of the Alinity i TBI test is a major milestone in their efforts.

This clearance complements Abbott’s i-STAT TBI Plasma test, which was already cleared by the FDA as the first rapid blood test for concussion.

The Alinity i clearance allows for TBI blood testing to be conducted on Abbott’s high throughput Alinity i laboratory instrument, which is widely used in hospitals and laboratories across the U.S.

This advancement in technology will make TBI testing more widely available to those who need it.

The Alinity i TBI test can be used for patients who present to the hospital with a suspected mild TBI (mTBI) within 12 hours of injury.

A blood sample is drawn from the arm and sent to the lab for preparation, and the test is run on the Alinity i instrument.

Results are available in as little as 18 minutes and can be shared with the treating healthcare provider for evaluation.

Broadening the availability of the TBI blood test for use on lab-based instruments is a critical component of Abbott’s strategy to ensure that their tests are available in all settings where people seek care for head injuries.

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