Traumatic Brain Injury Immunoassay to Eliminate Need for Head CT Scans

Traumatic brain injury (TBI) is an alteration in brain function due to an external impact and represents a significant health issue affecting 69 million people globally each year. The severity of TBI is assessed using the Glasgow Coma Scale (GCS) and is categorized as mild, moderate, or severe. A majority of TBIs—between 70 and 90%—are classified as mild but still account for a large number of emergency department (ED) visits. Although CT scans of the head are mandatory for moderate and severe TBI, they are often also used for initial evaluation in mild TBI (mTBI) cases to check for intracranial lesions (ICL). However, less than 10% of mTBI cases actually present with ICL, making many of these scans unnecessary. These extra scans not only lengthen patient processing time in the ED but also expose them to radiation and consume valuable resources. Now, a blood test based on a unique combination of brain biomarkers can support clinicians in assessing patients with mTBI.

The VIDAS TBI (GFAP, UCH-L1) from bioMérieux (Marcy-l’Étoile, France) offers a new approach to patient screening by safely excluding the possibility of ICL and providing objective information to help decide if a CT scan is needed for adults. This test measures the levels of two brain biomarkers, GFAP and UCH-L1, that are released into the bloodstream shortly after a brain injury occurs. The test is easy to interpret and can be conducted within a broad 12-hour window post-injury, encompassing a large adult mTBI demographic and potentially reducing the total time patients spend in the ED.

This accurate and objective test has the potential to cut down on unnecessary head CT scans for mTBI patients and reduce ED congestion by reliably ruling out acute ICLs after head trauma. VIDAS TBI (GFAP, UCH-L1) has received CE-marking and is available on VIDAS 3 and VIDAS KUBE immunoanalyzers, allowing for 24/7 on-demand automated testing. The test is set to be commercially launched in select European, North African, and South American markets in late 2023, with plans for global expansion in 2024 and 2025.

“ED doctors must make decisions fast for the benefit of patients, and for efficient patient management in EDs. A significant number of CT-scans could be avoided in the case of mTBI because 90% show no abnormalities,” said Mark Miller, Executive Vice President, Chief Medical Officer. “VIDAS TBI (GFAP, UCH-L1), in combination with a clinical evaluation, provides an objective and accurate blood test result for optimal mTBI management to help clinicians perform fast and efficient ED patient screening with confidence, optimizing CT-scan usage and improving the standard of patient care.”

“At bioMérieux, we have demonstrated for over 20 years our ability to leverage innovative biomarkers to impact patient management and outcomes in EDs,” added Jennifer Zinn, Executive Vice President, Clinical Operations. “We believe that VIDAS TBI (GFAP, UCH-L1) could be a real game changer for ED physicians assessing mTBI cases daily. It’s an important innovation that further strengthens the VIDAS test range for emergency and critical care.”

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