On Monday this week, Abbott Laboratories announced it had gotten clearance from the US Food and Drug Association (FDA) regarding tis i-STAT blood test and i-STAT Alinity platform. This portable test uses whole blood to detect concussions more accurately than ever before.

Developed in collaboration with the US Department of Defense US Army Medical Research and Development Command’s (USAMRDC) US Army Medical Material Development Activity (USAMMDA), the USAMRDC was critical to the iSTAT Alinity platform.

Unlike traditional tests that utilize plasma or serum, the i-STAT device can use whole blood samples to obtain lab-quality results in less than 20 minutes, without sending the samples out to a lab. This is being used to help detect mild traumatic brain injuries (mTBI) or concussions.

This is a big deal as many patients who suffer head injuries don’t take themselves in for concussion testing. This new clearance allows for these types of tests to occur outside of a hospital setting and can reduce the need for CT scans when ruling out concussions.

According to Abbott’s press release, Geoffrey Manley, M.D., P.H.D., 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 said:

“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. It’s an incredibly helpful tool, that advances the treatment of traumatic brain injury.”

While FDA clearance is a great step in the right direction, we’re still a long way from seeing this test leave a hospital setting. But Abbott is dedicated to ensuring that testing such as this becomes more widely available, even to assist teens and pediatrics in the future.