FDA Clears Lab-Based Blood Test to Aid in Concussion Assessment

The Food and Drug Administration (FDA) has cleared Abbott’s Alinity^® i TBI lab test to aid in the evaluation of adults with suspected mild traumatic brain injury (mTBI; Glasgow Coma Scale score 13-15).

The Alinity i TBI test is a laboratory-based test that measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein, 2 biomarkers in the blood correlated to brain injury when present in elevated concentrations. The test provides results with 96.7% sensitivity and 99.4% negative predictive value.

The new test can be used when a patient presents to the hospital with a suspected mTBI within 12 hours of injury. After a blood sample is drawn from the patient’s arm, the test is run on Abbott’s Alinity^® i laboratory instrument, a high throughput instrument widely used in US hospitals and laboratories. Results are available in 18 minutes. Negative results rule out the need for a computed tomography (CT) scan.

The availability of a blood test provides clinicians with an objective method to quickly evaluate patients with mTBIs while eliminating the need for a head CT scan. According to the Company, the test could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing health care costs and minimizing wait times in the emergency department.

“People sometimes minimize a hit to the head, thinking it’s no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care,” said Beth McQuiston, MD, medical director in Abbott’s diagnostics business. “Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That’s great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”

The Alinity i TBI blood test will run on the Alinity^® i laboratory instrument, making TBI testing more widely available across the country. It is the first commercially available lab-based blood test for TBI and complements Abbott’s previously cleared i-STAT TBI Plasma test, the first rapid handheld blood test for TBI.

Reference

Abbott receives FDA clearance for first commercially available lab-based blood test to help evaluate concussion. News release. Abbott. Accessed March 7, 2023. https://prnmedia.prnewswire.com/news-releases/abbott-receives-fda-clearance-for-first-commercially-available-lab-based-blood-test-to-help-evaluate-concussion-301764488.html.