Abbott’s blood test for concussions receives FDA 510(k) clearance
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Abbott’s blood test for concussions receives FDA 510(k) clearance

12 Jan 2021 (Last Updated January 12th, 2021 15:37)

Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for its rapid handheld traumatic brain injury (TBI) blood test.

Abbott’s blood test for concussions receives FDA 510(k) clearance
The test measures biomarkers UCH-L1 and GFAP, specific proteins found in the blood after a TBI. Credit: Belova59 / Pixabay.

Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for its rapid handheld traumatic brain injury (TBI) blood test.

Developed in partnership with the US Department of Defense (DoD), the test helps clinicians to assess people with suspected mild TBIs known as concussions.

It runs on Abbott’s handheld i-STAT Alinity platform and delivers results within 15 minutes once the plasma is placed in the test cartridge.

The test measures biomarkers UCH-L1 and GFAP, specific proteins found in the blood after a TBI.

For this, the blood sample is drawn from the arm and plasma is extracted from it using a centrifuge. It is then applied to the cartridge that can be inserted into the handheld instrument.

i-STAT Alinity TBI plasma test could help alleviate the need for unnecessary CT scans of the head, a tool used to identify concussions.

Furthermore, the test provides results with a sensitivity of 95.8% and a negative predictive value of more than 99%.

Abbott diagnostics business medical director Beth McQuiston said: “Healthcare providers have been waiting for a blood test for the brain and now we have one.

“You can’t treat what you don’t know and now physicians will be equipped with critical, objective information that will help them provide the best care possible, allowing patients to take steps to recover, prevent re-injury, and get back to doing the things they care about most.”

Based on the clearance, Abbott is working on a test that uses whole blood for testing without requiring plasma separation and could be used in a healthcare setting.

In addition, the company has received FDA breakthrough designation for a TBI test that runs on Alinity i and ARCHITECT core laboratory instruments.

Last month, the FDA issued emergency use authorisation (EUA) for Abbott’s virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.