[NOTE: the “15-minute” TBI test described below will not be performed on the field. The machinery to make it possible involves centrifuges and sizeable support only provided in a health care facility/hospital. Als, this “blood test for the brain” will not (yet) measure blood-O2 levels. We’ll follow all that.]
By DR. MISHAL REJA and DR. LEAH CROLL, ABC News
(NEW YORK) — In a world first, a newly authorized handheld device will allow doctors to detect traumatic brain injuries (TBIs) in under 15 minutes, potentially saving lives by dramatically shortening the time it takes to properly diagnose the issue.
The device is made by Abbott, a medical device company based in the United States.
“This is a huge milestone that has never been done before — a blood test for the brain,” said Dr. Beth McQuiston, medical director for Abbott’s diagnostic businesses. “Until now, health care providers have needed to rely on subjective measurements for TBIs, but we finally have a more objective tool to help evaluate patients.”
Independent experts interviewed by ABC News agreed that this test for the brain may chart a new era in medical care for patients with TBI.
“I think this is groundbreaking. The first time we are able to assess brain health using a blood test,” said Dr. Frederick Korley, an associate professor of emergency medicine at the University of Michigan Medical School and a Michigan Concussion Center faculty member.
TBI is a disruption in normal brain function caused by a blow or jolt to the head. A concussion is the mildest form of TBI, but patients may suffer a constellation of physical, cognitive, emotional and sleep symptoms. Some of the most common signs include confusion, headaches, blurry or double vision, dizziness, fatigue, memory loss, difficulties with concentration and insomnia.
TBI is a major cause of death and disability in the U.S. There were 2.87 million TBI-related emergency department visits, hospitalizations and deaths in 2014, according to the Centers for Disease Control and Prevention. Athletes and older people are the most at-risk of TBIs.
Unfortunately, many patients with mild TBI struggle to get an accurate and timely diagnosis, even as they grapple with ongoing symptoms. This ultimately results in delayed treatment.
Doctors often use a series of screening questionnaires, physical examinations and CT scans to take pictures of the brain in order to evaluate TBI. However, experts agree these techniques aren’t perfect and there is no objective way to reliably evaluate TBI.
“One of the most challenging aspects of diagnosing concussion today is there are no objective tests,” said Dr. Farng-Yang Foo, a neurologist at NYU Langone Health’s Concussion Center. “Currently, much of the diagnosis is by self-report of the patient, what the patient tells us. This makes it hard to make a diagnosis.”
Abbott’s new blood test may serve as an objective tool to help doctors triage TBI patients, because it relies on molecular signatures in the blood rather than on murkier clues, such as patient interviews.
The test requires a small blood sample drawn from the arm, from which plasma is extracted and inserted into the handheld instrument.
“The real value is in helping to guide emergency room and urgent care medical providers. The test will help them decide who needs to get a CT or MRI and who does not,” said Dr. Steven Flanagan, chair of rehabilitation medicine and co-director of the Concussion Center at NYU Langone Health.
The test was developed in collaboration with the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team and the U.S. Department of Defense. Dr. Geoffrey Manley, chief of neurosurgery at San Francisco General Hospital and principal investigator of TRACK-TBI, told ABC News this new test will improve patient flow in busy emergency rooms.
“I’m hoping there will be widespread adoption of this tool because it will facilitate getting people through the system quicker, getting people out of the emergency department that don’t need to sit there for 3 hours waiting for a head CT,” he said.
Preventing people from undergoing unnecessary CT scans can have far-reaching implications. Aside from reducing health care costs, it can save people from unnecessary radiation that has been shown to increase the risk of cancer.
“So many times people have to wait for these scans, causing longer lengths of stay in the ER, which is especially problematic in the COVID era,” Korley, the University of Michigan Medical School professor, said.
Despite the benefits, experts agree that physicians cannot rely entirely on this diagnostic test, stating it will only serve to supplement clinical judgment.
“You have to ultimately rely on clinical judgment. There’s always false negatives. You have to be cautious with that. The levels of GFAP and ubiquitin will never trump the judgment of an emergency room physician that someone really needs a CT scan,” Flanagan pointed out.
But the benefits of this test could reach beyond the emergency room. For example, it could be used on the sidelines of sporting events.
“It would enable us to be able to quickly diagnose a concussion and to make quick clinical decisions such as pull an athlete out of a game or send them for imaging,” Foo added.
According to the CDC, 50% of concussions go unreported or undetected.
“We were missing 50% of people that had TBI in the emergency department,” Manley said. “The game-changing innovation of having a tool like this is that, as it becomes more widely used, I believe we will identify more people with TBI that’s more subtle, that could be life-altering.”
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ABBOTT RECEIVES FDA 510(K) CLEARANCE FOR THE FIRST RAPID HANDHELD BLOOD TEST FOR CONCUSSIONS
ABBOTT PARK, Ill., Jan. 11, 2021 /PRNewswire/ — Abbott (NYSE: ABT) has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions. The test will run on Abbott’s handheld i-STAT™ Alinity™ platform. Tests results are available within 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 TBI. A negative result on this test can be used to rule out the need for a head CT scan, a common tool used to diagnose concussion. For those who test positive, this test result complements CT scans to help clinicians evaluate whether someone has a TBI.
“Healthcare providers have been waiting for a blood test for the brain and now we have one,” said Beth McQuiston, M.D., medical director for Abbott’s diagnostics business. “You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent reinjury and get back to doing the things they care about most.”
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. Our vision for the future is that we’d have a 15-minute, portable test that can be used outside the traditional healthcare setting where people experience head injuries and need a quick evaluation, like sporting events.
Abbott has also received FDA breakthrough designation – which speeds assessment of tests through increased FDA interaction – for a TBI test that would run on its Alinity™ i and ARCHITECT® core laboratory instruments. This is part of Abbott’s strategy to ensure that its tests are available both in the lab and in other settings where people need immediate answers and care.
The need for immediacy and accuracy in diagnosing TBI
Nearly 5 million people go to the emergency room for a TBI in the U.S. each year.
“Evaluating brain injuries is complex – and research shows that we only catch about half of those who show up to the hospital with a suspected TBI,” said Geoffrey Manley, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. “And beyond those who go to the hospital for a suspected TBI, many more never do. A test like this could encourage more people to get tested after a head trauma, which is important, because not receiving a diagnosis can be dangerous and may prevent people from taking the necessary steps to recover safely.”
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 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. Abbott’s blood test will give healthcare professionals an objective tool for evaluating people suspected of having an injury to the brain.
About the i-STAT Alinity TBI plasma test
The i-STAT Alinity TBI plasma test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma, two complementary biomarkers that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value.
The TBI blood 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
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For further information: Abbott Media: Kim Modory, (224) 668-4696, Ellen Wichman, (847) 393-5238, Darcy Ross, (224) 667-3655, Abbott Financial: Laura Dauer, (224) 667-2299