Abbott achieves CE mark for first head injury laboratory test

by time news

Abbott awarded CE mark for a laboratory blood test for traumatic brain injury (TBI), the first to be available on a large scale and that it will help clinicians in evaluating people with suspected mild head injury, such as concussions. The test can be performed on the laboratory solution Alinity i by Abbott and will produce a result within 18 minutes.

It is estimated that around 69 million people around the world suffer a head injury every year. Traumatic brain injuries, such as concussions, are due to head trauma caused by an external force and can have both short and long-term consequences. This test measures specific proteins, known as biomarkers, found in the blood after a suspected head injury.

The test requires sampling from the arm of a small blood sample, from which plasma or serum is extracted by centrifugation and is then inserted into the laboratory diagnostic system.

Alinity and TBI Test will help healthcare professionals in the objective assessment of patients who may have suffered mild head injury. Most computed tomography (CT) scan results required by clinicians to evaluate a suspected brain injury are negative. This blood test can be used to help rule out the need for a CT scan, reducing ER wait times and reducing costs.

Abbott recently received the CE mark for i-STAT TBI Plasma Test, the first portable rapid plasma test for traumatic brain injury, in line with its future vision to develop a portable test that can also be used outside the traditional care setting, i.e. in places where people suffer head injuries and need quick evaluation, such as during sporting events.

The extension of the use of the TBI blood test to the diagnostic system Alinity i by Abbott will broaden access to the assessment of mild brain injury, as it is a system widely deployed in the laboratories of major trauma centers across Europe.

“We are aware that often people who suffer a TBI tend to underestimate the accident or are unaware of the signs and symptoms of concussion.”, dichiara Beth McQuiston, M.D., medical director in Abbott’s diagnostics business. “This test is revolutionary because it provides an objective laboratory result that can help doctors evaluate people with suspected brain injury so that they can take appropriate care.”.

Immediacy, accuracy and access to the diagnosis of traumatic brain injury are needed globally

People who have suffered a head injury may experience impaired memory, coordination, senses (e.g. sight and hearing), and emotional function (e.g. personality changes, psychological symptoms). The effects of traumatic brain injuries can last a few days after the injury or be permanent. People who experience a head injury are more likely to have another – similar to how a sprained ankle or torn ligament are more susceptible to future injury.

These effects are aggravated by misdiagnosis or lack of diagnosis, so it is imperative to improve access to objective tools that can aid in the assessment of a head injury or concussion.

Alinity and TBI Test

Alinity and TBI Test measures two complementary biomarkers in blood plasma and serum: L1 carboxyl-terminal ubiquitin hydrolase (UCHL1) and glia acid fibrillar protein (GFAP), which, at high concentrations, are closely related to brain damage. The test results provide a sensitivity of 96.7% and a negative predictive value of 99.4%.

The test is used 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 help determine the need for more in-depth instrumental investigations of the skull (computed tomography, CT).


Abbott is a global healthcare leader and is committed to helping people live their best at every stage of life. The supply of breakthrough technologies encompasses the health sector as a whole, with innovative solutions and products in the fields of diagnostics, medical devices, nutrition and branded generic drugs. Abbott is present in over 160 countries with approximately 109,000 employees.

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