The US Food and Drug Administration has formally approved Abbott’s i-STAT TBI cartridge, which can now be used alongside whole blood to help assess patients with suspected concussion at their bedside and generate lab-quality results in no more than 15 minutes. To understand the significance of such a development, we must take into account how, so far, the tests to help with the assessment of TBI were only cleared for use with plasma or serum. This, in turn, would require samples to be sent to a lab for processing and testing. Fortunately enough, Abbott’s latest brainchild ensures one can do the stated testing across healthcare settings that go beyond hospital emergency departments, accommodating instead facilities like urgent care clinics certified to perform moderate complexity tests. Talk about how the whole development works on a more actionable note, Abbott’s i-STAT TBI requires a small venous blood sample, which is applied to the test cartridge. This cartridge is then inserted into the portable i-STAT Alinity instrument. All in all, the test measures two biomarkers from the brain that may be released into the bloodstream, indicating a possible brain injury. These biomarkers include ubiquitin C-terminal hydrolase L1 (UCH-L1), and glial fibrillary acidic protein (GFAP), each one capable of providing clinicians with essential information regarding a patient’s condition and helping them decide an appropriate treatment plan.
Among other details, we must mention how Abbott’s whole blood test on a portable instrument helps clinicians evaluate patients aged 18 years and older, who are suspected to have mild traumatic brain injury or mTBI.
“Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” said Geoffrey Manley, M.D., 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.”
The development in question provides an interesting follow up to one report, which revealed that even though more than 5 million people go to the emergency department for a TBI in the U.S. each year, nearly half of people who suspect they have a concussion never even get it checked.
Coming back to the development in question, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, marking an important advancement because those affected by the condition often have to wait for long before receiving the care they need. It also, of course, expands upon Abbott’s TBI test offerings that include the i-STAT TBI Plasma test, the ARCHITECT®, and Alinity i lab test (serum and plasma).
“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.”
