The game changer: UCH-L1 and GFAP-based blood test as the first marketed in vitro diagnostic test for mild traumatic brain injury.

IF 3.9 3区 医学 Q1 PATHOLOGY
Firas Kobeissy, Rawad Daniel Arja, Jennifer C Munoz, Deborah A Shear, Janice Gilsdorf, Jiepei Zhu, Hamad Yadikar, William Haskins, J Adrian Tyndall, Kevin K Wang
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引用次数: 0

Abstract

Introduction: Major organ-based in vitro diagnostic (IVD) tests like ALT/AST for the liver and cardiac troponins for the heart are established, but an approved IVD blood test for the brain has been missing, highlighting a gap in medical diagnostics.

Areas covered: In response to this need, Abbott Diagnostics secured FDA clearance in 2021 for the i-STAT Alinity™, a point-of-care plasma blood test for mild traumatic brain injury (TBI). BioMerieux VIDAS, also approved in Europe, utilizes two brain-derived protein biomarkers: neuronal ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). These biomarkers, which are typically present in minimal amounts in healthy individuals, are instrumental in diagnosing mild TBI with potential brain lesions. The study explores how UCH-L1 and GFAP levels increase significantly in the bloodstream following traumatic brain injury, aiding in early and accurate diagnosis.

Expert opinion: The introduction of the i-STAT Alinity™ and the Biomerieux VIDAS TBI blood tests mark a groundbreaking development in TBI diagnosis. It paves the way for the integration of TBI biomarker tools into clinical practice and therapeutic trials, enhancing the precision medicine approach by generating valuable data. This advancement is a critical step in addressing the long-standing gap in brain-related diagnostics and promises to revolutionize the management and treatment of mild TBI.

游戏规则的改变者:基于 UCH-L1 和 GFAP 的血浆检验是首个上市的轻度脑外伤体外诊断检验。
导言:用于肝脏的ALT/AST和用于心脏的心肌肌钙蛋白等基于器官的主要体外诊断(IVD)检测方法已经确立,但一直没有获得监管机构批准的脑部IVD血液检测方法,这凸显了医疗诊断领域的重大空白:i-STAT Alinity™ 和同样在欧洲获得批准的生物梅里埃 VIAD 采用了两种脑源性蛋白生物标志物:神经元泛素 C 端水解酶-L1(UCH-L1)和神经胶质纤维酸性蛋白(GFAP)。这些生物标志物在健康人体内的含量通常极低,但在诊断轻度创伤性脑损伤和潜在脑损伤时却非常有用。该研究探讨了脑外伤后血液中 UCH-L1 和 GFAP 水平如何显著增加,从而帮助早期准确诊断:i-STAT Alinity™ 和 Biomerieux Vidas TBI 血液检验的推出标志着创伤性脑损伤诊断领域的突破性发展。它为将创伤性脑损伤生物标志物工具纳入临床实践和治疗试验铺平了道路,通过产生有价值的数据加强了精准医疗方法。这一进展是解决脑相关诊断领域长期存在的空白的关键一步,有望彻底改变轻度创伤性脑损伤的管理和治疗。
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来源期刊
CiteScore
6.60
自引率
0.00%
发文量
71
审稿时长
1 months
期刊介绍: Expert Review of Molecular Diagnostics (ISSN 1473-7159) publishes expert reviews of the latest advancements in the field of molecular diagnostics including the detection and monitoring of the molecular causes of disease that are being translated into groundbreaking diagnostic and prognostic technologies to be used in the clinical diagnostic setting. Each issue of Expert Review of Molecular Diagnostics contains leading reviews on current and emerging topics relating to molecular diagnostics, subject to a rigorous peer review process; editorials discussing contentious issues in the field; diagnostic profiles featuring independent, expert evaluations of diagnostic tests; meeting reports of recent molecular diagnostics conferences and key paper evaluations featuring assessments of significant, recently published articles from specialists in molecular diagnostic therapy. Expert Review of Molecular Diagnostics provides the forum for reporting the critical advances being made in this ever-expanding field, as well as the major challenges ahead in their clinical implementation. The journal delivers this information in concise, at-a-glance article formats: invaluable to a time-constrained community.
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