Regulatory FDA approves Abbott’s latest lab blood test for concussion

FDA approves Abbott’s latest lab blood test for concussion


The Food and Drug Administration (FDA) has cleared Abbott’s laboratory blood test for evaluating concussions, also known as traumatic brain injuries (TBI), in patients aged 18 and over, 12 hours after the injury is sustained. This test will be the first commercially available laboratory blood test for concussions.

The test will function as a triage for computed tomography (CT) scans, which doctors previously relied on a patient’s visual, verbal, and motor responses before authorizing a scan. According to Abbott, making the blood test the first step in diagnosing a concussion will reduce unnecessary CT scans by up to 40%. This, in turn, will reduce the amount of time patients spend in hospital emergency rooms.

Since the test is compatible with Abbott’s Alinity i laboratory instrument, which is already a commonly used system across hospitals and labs in the US, this approval will significantly increase the availability of the test. The system can generate results in just 18 minutes with a negative predictive value of over 99% and sensitivity of around 97%. Despite only being recently approved in the US, the test has been cleared for use in the European Union for the past 2 years.

The test works by analyzing a blood sample from the arm for two biomarkers in the blood that are correlated to brain injury when found in higher concentrations. The test measures levels of Glial Fibrillary Acidic Protein and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) biomarkers in the blood plasma and serum to determine whether a patient is suffering from a concussion or not.

Mild traumatic brain injury can also be detected by the Alinity i TBI test, Abbott’s i-STAT TBI plasma test and was approved by the FDA in 2021. The test generates results in just 15 minutes with the help of a smartphone-sized, handheld device. This version of the concussion-detecting blood test runs on the i-STAT Alinity platform, where plasma is first separated from the blood sample and then a biomarker analysis is conducted on it.

According to the Centre for Disease Prevention and Control, there were over 223,000 hospitalizations due to TBI-related injuries in 2019 alone, and the number of deaths related to the disease crossed 64,000 in 2020. Older people over the age of 75 are at the greatest risk of TBI-related hospitalizations and deaths. Beth McQuiston, M.D., medical director of Abbott’s diagnostics business, said, “Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test that can aid in concussion assessment. This is great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”

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