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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.