Sam Brusco, Associate Editor04.02.24
Abbott’s iSTAT TBI cartridge has earned clearance from the U.S. Food and Drug Administration (FDA) for use with whole blood. This lets doctors assess patients with suspected concussion at the bedside and get lab-quality results in 15 minutes, according to the company.
In the past, TBI tests were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing. Abbott’s FDA nod enables testing to be expanded to urgent care clinics with a certificate to perform moderate complexity tests.
The whole blood test is performed on a portable instrument on adult patients who present with mild traumatic brain injury (mTBI), known as concussion. The results can help rule out need for a head CT and help determine the next steps for care.
The i-STAT TBI test can evaluate patients up to 24 hours after injury. The test measures biomarkers from the brain 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.
The newly cleared test expands Abbott's TBI test offerings, which includes the i-STAT TBI Plasma test and the ARCHITECT and Alinity i lab test (serum and plasma), which were all cleared previously.
"Clinicians have needed an objective way to assess patients with concussions," said Beth McQuiston, M.D., 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."
In the past, TBI tests were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing. Abbott’s FDA nod enables testing to be expanded to urgent care clinics with a certificate to perform moderate complexity tests.
The whole blood test is performed on a portable instrument on adult patients who present with mild traumatic brain injury (mTBI), known as concussion. The results can help rule out need for a head CT and help determine the next steps for care.
The i-STAT TBI test can evaluate patients up to 24 hours after injury. The test measures biomarkers from the brain 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.
The newly cleared test expands Abbott's TBI test offerings, which includes the i-STAT TBI Plasma test and the ARCHITECT and Alinity i lab test (serum and plasma), which were all cleared previously.
"Clinicians have needed an objective way to assess patients with concussions," said Beth McQuiston, M.D., 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."