Dive Brief:

• Abbott has received clearance for a whole blood concussion test that can be performed at the patient's bedside, the company said Monday.
• The clearance is the first time the Food and Drug Administration has authorized a test that uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (TBI), also known as a concussion. 
• Eliminating the need to separate plasma from whole blood for testing could cut time to diagnosis by enabling healthcare professionals to generate results in 15 minutes at the patient's bedside, allowing for the test to be used in health facilities outside of a hospital emergency room, Abbott said. 

Dive Insight:

Abbott has received a series of clearances for concussion tests in recent years. The FDA cleared Abbott’s rapid handheld I-Stat TBI plasma test in 2021. That diagnostic generates results 15 minutes after the user inserts the test cartridge but only works with plasma samples. Abbott received clearance of a laboratory blood test, which analyzes samples of plasma and serum, in 2023. 

The latest clearance covers an I-Stat cartridge that analyzes whole blood, eliminating the time it takes to remove cells from plasma and sending samples to and from the laboratory.

“It's important to be able to triage patients quickly," Geoffrey Manley, chief of neurosurgery at Zuckerberg San Francisco General Hospital, said in a statement. “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.”

An Abbott-commissioned survey of 3,000 people in the U.S. found roughly half of people who suspect they have a concussion never get it checked. The new cartridge could remove barriers to testing by enabling urgent care clinics with certificates to perform moderate complexity tests to assess patients for TBI.

Abbott’s longer-term goal is to develop a test suitable for use in non-healthcare settings, such as on the sidelines of sporting events. The i-STAT TBI blood test was developed with the U.S. Army Medical Materiel Development Activity, a subordinate element of the U.S. Army Medical Research and Development Command.