FDA Approves Abbott's Bedside Rapid Test for Concussion Assessment

Abbott's i-STAT TBI cartridge has received a license from the US Food and Drug Administration (FDA), making it possible to be used with whole blood, during which doctors are allowed to evaluate a more precise patient with suspected concussion at the patient's bedside and confirm the results in 15 minutes or less.

In the past, the tests that were used for TBI assessment were cleared to use with plasma or serum, which made transporting samples to a laboratory necessary for analysis and testing.

Such new authorization will lead to testing in a wide range of other healthcare settings, including beyond hospital emergency departments like urgent care clinics that have a certificate to conduct moderate complexity probability tests. This is a significant step that one day will allow testing without patients visiting hospitals or occupying healthcare settings like the side-lines sporting events.

A whole blood restoration using a portable instrument for showing clinicians with youth populations 18 years of age and older who come up with suspected mild traumatic brain injury or mTBI, or what we commonly call concussion. 

The CT scan of the head might be eliminated or even not required. The workup of head trauma can be further specified through test results. The complete blood take capacity enables testing even away from the lab at medically fit healthcare servers. This speeds up the head trauma evaluation.

The i-STAT TBI test will be cleared with this. Then, the test will be used to help evaluate the patient within 24 hours after an injury. This is an important improvement as many of those injured wait before they decide to seek medical attention.

The emergency department receives over 4.9 million concussions a year in the US, but half of the people who mistrust themselves don’t even seek medical attention that a concussion might be.