- The study concludes that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information for determining appropriate care
- Researchers used Abbott’s i-STAT™ TBI Plasma Test—the only FDA-cleared portable concussion analyzer rapid test—and Abbott’s ARCHITECT core laboratory instrument to measure two blood plasma biomarkers associated with brain injury
ABBOTT PARKI will., August 11, 2022 /PRNewswire/ — A new study published in Lancet Neurology demonstrated the ability of two blood-based biomarkers to predict how someone will recover from a traumatic brain injury (TBI). Testing for these two biomarkers immediately after injury can help healthcare providers determine the best way to treat and care for patients.
This research shows that when a clinician runs a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery, and the long-term consequences of TBI. Markers were measured using Abbott’s i-STAT™ TBI Plasma test as well as the company’s ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery.
The researchers measured the levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) present in blood plasma within 24 hours of injury. After testing the biomarker levels on the day of injury, the researchers assessed the patients six months later, tracking how the individuals were doing and how the biomarker levels corresponded to their recovery.
“Brain injury biomarkers will one day be the standard of care for evaluating and treating patients,” said Dr. Fred Corleyassociate professor of emergency medicine in University of Michigan and first author of the study. “Objective biomarker data can be very useful in determining a patient’s prognosis, helping to gauge how severe the brain damage is, and ultimately can inform how best to counsel family members about caring for their loved one with brain damage.’
In the study, researchers examined day-of-injury blood tests of 1,696 TBI patients and compared them to patients’ six-month assessment using the Extended Glasgow Outcome Scale, which assesses outcomes and quantifies levels of disability after TBI. The researchers found that high values of the biomarkers, GFAP and UCH-L1, correlated with death and severe injury. Blood tests on the day of injury had a high probability of predicting death at six months, 87% for GFAP and 89% for UCH-L1; and a high probability of predicting severe disability at the same time point, 86% for both GFAP and UCH-L1.
GFAP and UCH-L1 are proteins found in glial cells and neurons and are released into the bloodstream after brain injury. These can be measured with diagnostic tests. Abbott’s i-STAT TBI Plasma test is the first portable analyzer rapid test to receive FDA 510(k) clearance and can help determine the need for a computed tomography (CT) scan. Test results are available approximately 15 minutes after placing a plasma sample in the i-STAT test cartridge.
Abbott is pursuing FDA approval under Breakthrough Design for the TBI test on its core laboratory instruments Alinity i and ARCHITECT, which will expand access and ensure the tests are available both in the laboratory and in other settings where people need immediate answers and care. Abbott’s Alinity i TBI test is CE marked and available outside the US
The research topics came from the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) trial. TRACK-TBI collected and analyzed detailed clinical data from people enrolled across the spectrum of injuries at 18 Level I trauma centers in the US from February 2014 through August 2018. The TRACK-TBI research team was among the first to demonstrate how this rapid TBI blood test could be used to benefit TBI patients in clinical care.
Abbott’s TBI Blood Test was developed in collaboration with the US Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and assessment of TBI for over a decade. The Department of Defense, through the US Army Medical Research and Development Command (USAMRDC) US Army Medical Materiel Development Activity (USAMMDA), played a critical role in the development of Abbott’s i-STAT TBI platform test.
regarding i-STAT™ TBI Plasma
i-STAT™ The TBI Plasma test measures the level of biomarkers associated with brain injury in the bloodstream to help determine the need for a CT scan of the head. The i-STAT TBI Plasma Test is used to assist in the evaluation of mild TBI and is only available for i-STAT use™ Alinity™ tool. The test should be used with plasma prepared from EDTA anticoagulated samples in a clinical laboratory setting by a healthcare professional. The i-STAT™ TBI plasma the test is not intended to be used in on-site establishments. More information is available at www.globalpointofcare.abbott/en/product-details/apoc/istat-tbi-plasma.html
regarding i-STAT™ Alinity™
The i-STAT™ Alinity is an easy-to-use, portable blood analyzer that provides real-time, laboratory-quality diagnostic test results. Medical professionals simply apply a few drops of blood to a cartridge, insert the cartridge into the analyzer, and can see results within minutes. The results can then be transmitted wirelessly. More information is available at www.globalpointofcare.abbott/en/product-details/apoc/istat-alinity.html
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