Texansphan
Football connoisseur
Good stuff.This a seemingly very exciting breakthrough. However, as you dig more deeply into the the data, the excitement must be approached with caution. As I have reviewed FDA submissions for decades, this is what I would offer.
This test has never been test in sports. The test demonstrates 95.6% sensitivity. But no specificity data is offered. Keep in mind that in general, the higher the sensitivity, the lower the specificity, and vice versa.
A highly sensitive test means that there are few false negative results, and thus fewer cases of disease are missed. The specificity of a test is its ability to designate an individual who does not have a condition as negative. A highly specific test means that there are few false positive results.
Beyond the above limitations of the test, in the NFL there is an additional very important limitation............a concussion must be suspected AND acted upon before any test is ordered. We have commonly seen players demonstrate gross signs of concussion that are either missed or ignored.
Another potential problem is that players have historically been against having blood tests taken from them. They seldom have a problem with taking an MRI or CT scan........but they do have a problem with blood testing outside of routine physical exams unless they are mandated.
The trials mostly included Emergency Room cases such as auto accidents and other usually severe trauma (including those with crushed skulls). A clinical trial will have to be performed if validity of the test in that arena is to ve validated.
There is also a question as to if the detected "markers" for concussion are affected by previous concussion history.
The authors of the trials themselves acknowledge that they cannot prove the validity of the test when applied now to those with an immature brain...........ages <25 years old.............which make up such a large percentage of the NFL player population.
So in essence we have a concussion blood test now with as many questions as potentials. Only time will answer the critical questions for its value in the NFL.
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Rapid concussion blood test gets FDA approval, could be used on sidelines in future
By Josh Alper
Published April 18, 2024 08:13 AM
A blood test designed to aid in the rapid diagnosis of concussions has gained FDA approval.
The i-STAT Alinity test can detect two proteins released into the blood when someone suffers a concussion and, per statistics from its developer Abbott, has a 95.6 percent rate of ruling out concussions if the test is conducted within 24 hours of the injury. The test is faster than the existing i-STAT TBI test, which requires blood serum and the use of a centrifuge to process results.
Dr. David Okonkwo, a University of Pittsburgh professor and the Steelers’ team neurologist, helped lead the development team of the test and said it could be used during NFL games and other sporting events after further research.
“The nature of the studies performed to gain FDA clearance for these tests were done in patients brought to level one trauma centers,” Dr. Okonkwo said, via Abby Mackey of the Pittsburgh Post-Gazette. “We have every reason to believe there is significant overlap with the injuries to athletes who sustain a concussion, but we need to do studies specifically in that patient population to confirm that use.”
Abbott expects the test to be available in emergency rooms and urgent care centers this summer.
A blood test will remove all doubt and take the matter out of teams hands.
More protection for the players = a win.