FDA Approves First Rapid Handheld Blood Test for Concussions

March 2021

In January 2021, the US Food and Drug Administration (FDA) approved Abbott’s rapid handheld traumatic brain injury (TBI) handheld blood test. The test will run on Abbott’s i-STAT Alinity platform and produce results within 15 minutes that can help clinicians assess patients with suspected mild TBIs, including concussions.

The test measures specific proteins found in the blood following a TBI. A negative test result could help rule out the need for a head computed tomography (CT) scan. A positive test result could help supplement CT findings and assist clinicians in determining whether the patient has suffered a TBI. To administer the test, clinicians must draw a small blood sample from the patient and extract plasma from it via centrifuge. The blood plasma is then applied to a test cartridge and inserted into the handheld device.

According to Abbott, the i-STAT Alinity TBI blood test measures the biomarkers’ glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 in blood plasma, “complementary biomarkers that, in elevated concentrations, are tightly correlated to brain injury.” The test has a 95.8% sensitivity and >99% negative predictive value.

TBI is associated with short-term, long-term, and even permanent impaired memory, movement, vision and hearing, and emotional functioning. Misdiagnosis or delayed diagnosis can increase the severity of these effects. Sustaining a TBI also increases a patient’s risk of subsequent TBIs. The news release announcing the FDA approval of the blood test noted that the availability of this tool “could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%.”

Beth McQuiston, MD, Medical Director for Abbott’s diagnostics business, said, “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.”

Abbott is also developing a whole blood test that does not require plasma to be separated from a blood sample and could be incorporated into a portable system for use outside of the healthcare setting. As a complement to the handheld TBI blood test, Abbott has also received approval for a TBI test that runs on its proprietary laboratory instruments.

Research suggests that only about half of patients who go to the hospital with a suspected TBI are properly evaluated and diagnosed. “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,” said Geoffrey Manley, MD, PhD, Vice Chair of Neurological Surgery at the University of California, San Francisco.


Abbott. Abbott receives FDA 510(k) clearance for the first rapid handheld blood test for concussions. Published January 11, 2021. www.prnewswire.com/news-releases/abbott-receives-fda-510k-clearance-for-the-first-rapid-handheld-blood-test-for-concussions-301205058.html. Accessed March 1, 2021.

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