Maidenhead, December 3, 2021 — Abbott has achieved CE Mark for the i-STAT TBI Plasma test, the first rapid handheld traumatic brain injury (TBI) blood plasma test, which permits marketing in the European Union and will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott’s handheld i-STAT™ Alinity™ platform. Test results are available in approximately 15 minutes after plasma is placed in the test cartridge.
TBIs, including concussions, are an alteration in brain function caused by an external force. This test measures specific proteins present in the blood after a mild TBI. A negative result on this test can be used to help rule out the need for a head CT scan, an imaging tool commonly used to diagnose concussion. For those who test positive, this test result complements CT scans to help clinicians in the further assessment of those patients who may have a mild TBI.
“Having this blood plasma test available could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%,” said Beth McQuiston, M.D., medical director for Abbott’s diagnostics business. “Hopefully this encourages more people to get tested after a head injury, allowing patients to take the appropriate steps to recover.”
The test requires a small blood sample drawn from the arm, from which plasma is extracted with a centrifuge and applied to the test’s cartridge. The cartridge is then inserted into the handheld instrument.
Abbott is also working on a whole blood test, which would eliminate the need for separation of plasma and could be used at the patient’s side in a healthcare setting. Abbott’s vision for the future is to have a portable test that can be used outside the traditional healthcare setting where people experience head injuries and need a quick evaluation, like sporting events.
Immediacy and accuracy in diagnosing TBIs are needed globally
Approximately 69 million people worldwide are estimated to sustain a TBI each year.
Survivors of 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 to years of life changing symptoms. 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. Abbott’s blood plasma test will give healthcare professionals an objective tool to help evaluate people suspected of having an injury to the brain.
About the i-STAT TBI Plasma test
The i-STAT TBI Plasma test simultaneously measures glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma, two complementary biomarkers that have been shown to be elevated after brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value.
The i-STAT TBI Plasma test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command’s (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott’s i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood biomarker test can be used for the benefit of TBI patients in clinical care.
About Abbott
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