FDA Clears First Commercially Available Blood Test to Evaluate for TBI, Concussion

Abbott has received clearance from the FDA for the first commercially available laboratory blood test for traumatic brain injury (TBI), according to a company press release.¹ The test, which will complement the company’s rapid i-STAT TBI Plasma test, which received FDA clearance in 2021,² will run on Abbott’s Alinity i laboratory instrument.

According to the press release, the test will give health care providers an objective way to quickly assess individuals with mild TBIs or concussion. The test measures 2 blood biomarkers that are “tightly correlated to brain injury.” Test results are available within 18 minutes.

The availability of this blood test removes the subjectivity in concussion diagnosis and eliminates the need for costly CT scans in patients who test negative, reducing both health care system and patient costs.

“People sometimes minimize a hit to the head, thinking its no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care. Now that this test will be widely available…medical centers will be able to offer an objective blood test that can aid in concussion assessment,” said Beth McQuiston, MD, medical director of Abbott’s diagnostic business.¹ “That’s great news for both [health care providers] and people who are trying to find out if they have suffered a traumatic brain injury.”

TBI symptoms—including impairment of memory, movement, sensation, and emotional function—can be made worse through misdiagnosis or lack of diagnosis.

“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, MD, PhD, vice chair of neurological surgery at the University of California.² “Beyond those who go to the hospital for a suspected TBI, many more never do.” Tests like those created by Abbott may lead to more people being evaluated for potential TBI.

The new test measures ubiquitin C-terminal hydrolaste L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), complementary biomarkers found in blood plasma and serum, that are—when presented in elevated concentrations—highly correlated to brain injury. Test results are provided with 96.7% sensitivity and 99.4% negative predictive value.

The test is cleared for use in the evaluation of patients aged 18 or older who present with suspected mild TBI (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining if additional CT testing is needed.

References

1. Abbott receives FDA clearance for first commercially available lab-based blood test to help evaluate concussion. News release. Abbott. March 7, 2023. Accessed March 7, 2023. https://abbott.mediaroom.com/2023-03-07-Abbott-Receives-FDA-Clearance-for-First-Commercially-Available-Lab-based-Blood-Test-to-Help-Evaluate-Concussion

2. Abbott receives FDA 510(K) clearance for the first rapid handheld blood test for concussions. News release. Abbott. January 11, 2021. Accessed March 7, 2023. https://abbott.mediaroom.com/2021-01-11-Abbott-Receives-FDA-510-k-Clearance-for-the-First-Rapid-Handheld-Blood-Test-for-Concussions