We often are subjected to the impetus from social media to keep up with the latest trends in an increasingly competitive society. So, when a new device becomes commercially available claiming it’s a quick way to diagnose a TBI, we need to ask—is it too good to be true? Could our health potentially suffer at the expense of skipping an integral step, in favor of cutting cost and saying we used x device?
In the last ten years, we have all heard about traumatic brain injuries thanks to the NFL, sports injuries, relatives who have had them due to motor vehicle collisions, and soldiers injured in war zones. We know that when brain injuries occur, they are often not diagnosed right away and can lead to terrible consequences when they are missed.
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Introducing…New Tech
As a result, for many years, there has been a push to develop a test that can quickly diagnose a concussion or brain injury to help doctors decide if more serious treatment is necessary.
Recently Abbott Core Laboratory deployed what they billed as the rapid blood test for brain injury. Named the Alinity i test, this blood test received an FDA clearance for commercial use in hospitals in 2023 as the first rapid blood test for concussion. Sounds exciting, right?
However, currently it is only available in very few hospitals and not commonly used, which begs the question- why has the medical community has not fully embraced this new device. Are they exercising some healthy skepticism?
Criteria
Let’s dive deeper into the process. Basically, if the following criteria are met with a person who has had a head injury:
- 18 years of age or older
- suspected of having a mild traumatic brain injury,
- a Glasgow Coma Scale test score of 13-15 (A screening tool for acute brain injury) and
- time of injury being within 12 hrs.
Then the use of the device is approved on such a patient.
Ease of Use
It is important to point out that these tests are billed to rule out giving a more expensive CT scan that can detect a dangerous brain bleed, in favor of this less expensive blood test. Hold that thought for a moment…
If the blood test is given within 12 hours of the head injury, a small amount of blood is drawn from the patient’s arm, it is sent to the lab, run on the Alinity I device, and resulted in less than 20 minutes it allows the provider to diagnose TBI. How? The device measures two biomarkers in the blood that are directly correlated to brain injury – Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), in elevated concentrations. Testing for these two biomarkers immediately following an injury can allegedly help providers develop a patient care plan based on the results.
Potential Issues
However, as cool as this sounds, there are big questions about the use of this new technology.
As tempting as it might be to use blood biomarkers to diagnose TBI, note that this blood test, like most of the FDA-approval seeking clinical trials and commercially available devices, target severe to moderate TBI. Yet, greater than 80% of all TBI patients fall in the mild category.
Thus, proving its worth becomes a challenge. The researchers found that the biomarkers were strongest in those with a moderate to severe TBI—thus excluding a significant percentage of the population.
Next, a portion of the Alinity data used to get FDA approval showed that there can be false negative results-in other words, the blood test did not accurately show there was no concussion. This can be an issue if the ER physician decides not to do a CT scan and misses a brain bleed that can have serious consequences. (perhaps this is why hospitals seem reluctant to use them as a substitute for a good clinical exam and a CT scan).
What about mTBI?
Furthermore, with regard to “mild” TBIs, if you don’t make it to an emergency room or hospital that uses these tests within 12 hours of the concussion, they are useless. But let’s say you do get to the ER room in time, and one of these tests is given, and it claims you do have a concussion. Then in theory the ER doctor should order a CT scan to rule out more serious pathology.
But if it says you do not have a concussion, then you should still be vigilant about whether you do have a head injury.
Recall that this test is only good for the first 12 hours. The CDC makes clear that head injuries can evolve in the days and weeks following a head injury, and that symptoms do not always appear immediately. This is because the biochemistry occurring in the brain following a brain injury does not stop at 12 hours-it continues on with multiple other biomarkers unrelated to the two that the Alinity test isolates.
Core Demographic Excluded
Furthermore, who immediately pops into your head when you think of who succumbs to concussions and TBI most often? Children, athletes, military, etc which is a problematic demographic due to their proximity to hospitals and time constraints they may face getting to a facility for testing.
The device has incredible potential however the kinks need to be worked out, especially when used to diagnose TBI. In the meantime, I invite you to consider the impact long-term as it could mean the difference between a full life and one rife with complications before you turn down a CT in favor of a quick blood test.
For more information, contact us or visit Brain Injury Law of Seattle, we are here to help!
