FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury

Introduction

On Jan. 11st, 2021, the Food and Drug Administration (FDA) granted 510(k) clearance for i-STAT Alinity TBI plasma test, a rapid and the first handheld blood test to evaluate individuals with suspected mild traumatic brain injuries (TBIs), commonly known as concussions.

 

After a small blood sample is drawn from the arm, the plasma is extracted with a centrifuge, which can separate the red blood cells, platelets, and plasma. The plasma is then applied to the test’s cartridge and then inserted into the handheld instrument, Abbott's i-STAT™ Alinity™ handheld device. The test results are available within 15 minutes after the plasma is placed in the test cartridge. According to the company, the test has demonstrated 95.8% sensitivity and greater than 99% negative predictive value.

 

Brain injuries are complex and can be easily misdiagnosed, which can lead to worsening effects. "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, M.D., Ph.D., vice chair of neurological surgery at the University of California, San Francisco. For those who receive positive test results, this result complements CT scans to help clinicians evaluate whether someone has a TBI.

 

Benefits of having a blood test:

  • Having a blood test available could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%

  • The test simultaneously measures two protein biomarkers ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) found at elevated concentrations in the blood after a brain injury. 

  • The company is also working on a test that would use whole blood on i-STAT at the point of care, and developing a test for its Alinity™ i and ARCHITECT® core laboratory instruments under FDA breakthrough designation.

 

 

References:

Abbott. “Abbott Receives FDA 510(k) Clearance for the First Rapid Handheld Blood Test for Concussions.” Cision PR Newswire, 11 Jan. 2021, www.prnewswire.com/news-releases/abbott-receives-fda-510k-clearance-for-the-first-rapid-handheld-blood-test-for-concussions-301205058.html.

Park, Brian PharmD. “FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury.” Neurology Advisor, 13 Jan. 2021, www.neurologyadvisor.com/topics/traumatic-brain-injury/suspected-mild-traumatic-brain-injuries-diagnostics-i-stat-alinity-plasma-test.

Resources by Judy Zhu