Abbott receives FDA approval for rapid concussion test
Clinicians can now get results at the patient's bedside, making the test accessible at urgent care clinics and other healthcare settings
4 Apr 2024
Abbott's i-STAT TBI cartridge has received clearance from the US Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of traumatic brain injury (TBI) were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.
This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.
The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion. Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas.
With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care.
Nearly 5 million people go to the emergency department for a TBI in the US each year, but more than half of people who suspect they have a concussion never get it checked. For decades, standard TBI assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions.
How the test works
The i-STAT TBI cartridge with the i-STAT Alinity System requires a small venous blood sample, which is applied to the test cartridge. The cartridge is then inserted into the portable i-STAT Alinity instrument. The test measures two 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 and can help healthcare providers decide an appropriate treatment plan.
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.
The ability to use whole blood to help assess TBI is an important step in Abbott's vision to make its tests available in all settings where people seek care for head injuries. Abbott is engaged in ongoing research and planning that may, in the future, allow the test to be used in non-healthcare settings and with a broader population including teens and pediatrics.