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 laboratory 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 laboratory 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 (mTBI), commonly labelled '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 laboratory, which helps to accelerate the evaluation of head trauma.
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.
Standard TBI assessment has remained the same for some years, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions.
"Emergency departments can be a busy place. It's important to be able to triage patients quickly," said Geoffrey Manley MD PhD, Chief of Neurosurgery at Zuckerberg San Francisco General Hospital, Professor of Neurosurgery at the University of California San Francisco and contact principal investigator for the TRACK-TBI Network. "Historically, that process for suspected concussions was largely subjective. With the help of this whole blood test, we can quickly and objectively determine whether or not a patient needs a CT scan or additional evaluation, right at the point of care. It's an incredibly helpful tool that advances the treatment of traumatic brain injury."
The i-STAT TBI cartridge with the i-STAT Alinity System (pictured above) requires a small venous blood sample, which is applied to the test cartridge. 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 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 paediatrics.