In a significant step forward, a whole blood test for mild traumatic brain injuries (mTBI) – commonly referred to as concussions – is now available in the UK. The test enables healthcare providers to assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes.
Previously, the tests to help with the assessment of TBI were only authorised for use with blood plasma or serum, requiring samples to be sent to a lab for processing and testing. Access to this new whole blood test will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments where they are able to perform moderate complexity tests.
There are 900,000 accident and emergency attendances with a head injury annually in the UK, and 160,000 people with suspected head injuries are admitted to hospital each year.1 The vast majority of people with head injuries are not admitted to hospital, and most people with head injuries do not seek hospital care. Knowing they could have access to information from an objective blood result could encourage people to get a suspected concussion checked.
For decades, standard TBI assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions.
In conjunction with other clinical information, test results from Abbott’s i-STAT TBI cartridge can help rule out the need for a CT scan of the head, which is found to be normal in approximately 90 percent of patients with mTBI, and assist in determining the best next steps for patient care. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas.
Use in emergency settings
East Anglian Air Ambulance provides advanced critical care by air and by road to the most seriously ill and injured people in East Anglia. The charity is using Abbott’s i-STAT TBI test with patients at risk of traumatic brain injury, alongside existing protocols within a healthcare setting, as part of a 12-month study.
Dr. James Price, Consultant Emergency Physician at East Anglian Air Ambulance, said: “Trauma is a disease of time. When a person suffers a traumatic brain injury, the measurement of brain biomarkers at the scene of an accident may support our specialist teams by informing critical diagnostic decisions in real-time, ensuring that the patient is transferred to the hospital most suited to their needs, rather than only considering the nearest hospital.
“While our initial study will assess the feasibility of measuring blood biomarkers in the hyper-acute phase of care, we hope if successful, this test will be used to improve the pre-hospital care for patients who have suffered traumatic brain injury.”
Abbott has been researching and investing in this innovative testing technology for more than a decade with academia, the U.S. Department of Defense, and other key partners.
“Clinicians have needed an objective way to assess patients with concussions,” said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. “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. 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. We know this test has the potential to forever change how concussion and mTBI evaluations are conducted moving forward.”
How the test works
The i-STAT TBI cartridge works with the handheld i-STAT Alinity System and requires a small, venous whole blood sample, which is applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two brain-specific biomarkers that are released into the bloodstream following a traumatic brain injury. Testing for these two biomarkers – ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) – within 24 hours of injury can provide clinicians with information about a patient's condition and can help healthcare providers decide an appropriate diagnostic workup.
The ability to use whole blood to help assess mTBI is an important step in the vision to make this kind of testing available in all settings where people seek care for head injuries. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used in non-healthcare settings and with a broader population including teens and paediatrics.
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