FDA Clears Rapid Whole Blood Test for Mild TBI Assessment at the Point of Care

The Food and Drug Administration (FDA) has cleared the i-STAT^® TBI cartridge for use with whole blood to aid in the evaluation of patients 18 years of age and older with suspected mild traumatic brain injury (TBI), in conjunction with other clinical information, to assist in determining the need for radiologic head imaging. 

The i-STAT TBI cartridge runs on Abbott’s portable i-STAT^® Alinity^® instrument and provides results in 15 minutes. Abbott previously received clearance for use of plasma samples with the i-STAT TBI test cartridge. The use of whole blood at the point of care eliminates the need for plasma extraction. 

The test works by applying a small amount of blood to the i-STAT cartridge that is then inserted into the portable i-STAT Alinity instrument. The test measures 2 biomarkers, ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein, which are released into the bloodstream following a brain injury. It can be used to evaluate patients up to 24 hours after injury.

“Clinicians have needed an objective way to assess patients with concussions,” said Beth McQuiston, MD, medical director in Abbott’s diagnostics business. “When you look at all the other diseases, or other organs in the body, they all have blood tests to help assess what’s happening. Now, we have a whole blood test that can help assess the brain right at the patient’s bedside, expanding access to more health providers and therefore patients.”