i-STAT TBI cartridge: New rapid blood test for concussions gets FDA approval

i-STAT TBI cartridge: New rapid blood test for concussions gets FDA approval

A new quick blood test that may detect brain ailments such as concussions in minutes has cleared a crucial obstacle on its way to widespread adoption in the United States.

Abbott Laboratories, a healthcare company, said that the Food and Drug Administration (FDA) has approved its i-STAT TBI cartridge, which can now be used by doctors to examine patients with suspected mild traumatic brain injuries.

The test requires a small sample of a patient’s blood to be placed into the cartridge

According to Abbott, the test requires a small sample of a patient’s blood to be placed into the cartridge, after which it gives lab-quality findings in 15 minutes.

According to the National Institutes of Health, approximately 5 million people visit urgent care clinics each year for traumatic brain injuries. For decades, the method of diagnosing head trauma in patients has relied either on subjective medical assessments or the submission of blood samples to a lab for processing and testing.

The blood test is only licensed for use on patients aged 18 or older in settings such as hospitals

However, Abbott argues that its new rapid blood test is an essential step forward in giving patients speedy results immediately at their bedside, and eventually at sites where head injuries are more common, such as sporting events.

“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,” said Dr. Geoffrey Manley, chief of neurosurgery at the University of California, San Francisco. “It’s an incredibly helpful tool that advances the treatment of traumatic brain injury.” 

For the time being, the test is only licensed for use on patients aged 18 or older in settings such as hospitals and emergency departments. However, Abbott believes that the tests will someday be widely available to people of all ages seeking treatment for brain injuries.

“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,” said Dr. Beth McQuiston, medical director of Abbott’s diagnostics business. “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.”

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