U.S. Army officials, in partnership with Abbott, announced today that the company’s i-STAT® TBI (Traumatic Brain Injury) cartridge has received clearance from the U.S. Food and Drug Administration to be used with whole blood.
The newly cleared device can run whole blood testing at the patient’s bedside, allowing clinicians to obtain lab quality results for patients suspected of concussion in 15 minutes, according to company officials. Previous tests to help with the assessment of concussion were only cleared for use with plasma or serum, requiring samples to be sent to a laboratory for processing and results. In addition, patients can be evaluated up to 24 hours after injury, a significant improvement from previously available tests.
About the Test
A small venous blood sample is applied to the i-STAT TBI test cartridge, which is then inserted into the portable i-STAT Alinity® instrument. The test measures the presence of two biomarkers that may be released into the bloodstream, indicating a possible brain injury. Testing for these two biomarkers—ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP)—in the aftermath of an injury can provide clinicians with essential information about a patient’s condition and can help healthcare providers decide on an appropriate treatment plan.
