Abbott Receives CE Mark for First Widely Available Lab-based Blood Test for Traumatic Brain Injury, Increasing Access to Concussion Evaluation

  • The test to help evaluate mild traumatic brain injury (TBI), commonly known as concussion, produces a result within 18 minutes using Abbott’s Alinity™ i laboratory instrument
  • CE Mark will expand access to concussion evaluation on Alinity i laboratory instruments across major European countries and marks the first time the TBI test will be available on a broadly adopted hospital laboratory-based system.
  • This follows recent CE Mark for Abbott’s i-STAT TBI Plasma Test, the first rapid, portable blood test for concussion

MAIDENHEAD, Berkshire, 3rd December, 2021— Abbott has received CE Mark for a laboratory traumatic brain injury (TBI) blood test, which will be the first widely available and will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott’s Alinity™ i laboratory instrument, which produces a result within 18 minutes.

Approximately 69 million people worldwide are estimated to sustain a TBI each year. TBIs are caused by a bump, blow or jostle to the head and can pose risk of both short- and long-term effects. This test measures specific proteins, known as biomarkers, present in the blood after a suspected TBI. 

The test requires a blood sample drawn from the arm, which is placed in a centrifuge to extract plasma or serum and then introduced to the instrument in the laboratory.

When someone is sent for a CT scan to assess brain injury, the vast majority of results come back negative. This blood test can be used as an aid to rule out the need for a head CT scan, potentially reducing costs for patients as well as the amount of time they spend in the emergency department. Running on Abbott’s trusted Alinity i instrument, the laboratory test will provide a more objective and definitive method of concussion evaluation while enabling more rapid triaging of patients, offering increased confidence and efficiency for healthcare professionals.

Abbott also announced CE Mark for its rapid, portable i-STAT TBI Plasma Test, furthering its vision for the future to have a fast, point-of-care test that can be used outside the traditional healthcare setting where people experience head injuries and need a quick evaluation, such as sporting events.

Expanding use of the TBI blood test to Abbott’s Alinity i instrument will increase access to concussion assessment testing, as it is already used in major trauma centers across Europe.

“We know people may brush off a hit to the head for many reasons. Some are unaware of the signs and symptoms of concussion – and others are skeptical that a trip to the doctor will be able to give them a clear answer on whether they’ve injured their brains and what to do about it,” said Beth McQuiston, M.D., medical director in Abbott’s diagnostics business. “This test is revolutionary because it provides an objective blood test result to aid in concussion assessment, so people can consult with their doctors to heal in the best way possible.” 

Immediacy, accuracy and access are needed in detecting TBI globally
People who experience a TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). 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.

These effects are worsened by misdiagnosis or lack of diagnosis, so increasing access to tools that can objectively aid in the evaluation of a TBI or concussion is key.

About Alinity i laboratory test for TBI
The Alinity i TBI test measures complementary biomarkers in blood plasma and serum - Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value.

The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

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