Accuracy of the novel automated VIDAS TBI (GFAP, UCH-L1) assay for ruling out acute intracranial traumatic lesions in patients under 65 years of age with mild traumatic brain injury in an Emergency Department: An exploratory study.

IF 1.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2026-10-01 DOI:10.1177/00045632261497264

Eva Pérez Fernández, Esther Montoro Jorquera, Leandro Noblia, Alberto Fernández Reina, Joaquín Valle Alonso, Francisco Manuel Gómez Morales, Juan Manuel Sánchez Gil, Mercedes González Morales, Luis García de Guadiana-Romualdo

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引用次数: 0

Abstract

BackgroundCombination of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) is useful to exclude intracranial injury after mild traumatic brain injury (mTBI). We evaluated the diagnostic performance of the novel regulatory-approved VIDAS^® TBI assay for this purpose.MethodPatients under 65 years of age presenting to the Emergency Department with TBI, Glasgow Coma score 13-15, completed head computed tomography (CT) scan and blood collected within 12 hours of injury were included. UCH-L1/GFAP levels were analysed using prespecified cutoffs and combined into a single result and evaluated against CT findings.Results78 enrolled participants were analysed. Intracranial injury was detected in 4 patients. VIDAS^® TBI test achieved a sensitivity and negative predictive value of 100%.ConclusionThe VIDAS TBI assay showed potential as a rule-out test in this exploratory cohort; however, estimates were based on only four CT-positive cases and require confirmation in larger prospective studies.

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新型自动VIDAS TBI （GFAP, ch - l1）检测在急诊科排除65岁以下轻度外伤性脑损伤患者急性颅内外伤性病变的准确性：一项探索性研究。

背景：神经胶质纤维酸性蛋白（GFAP）联合泛素c端水解酶- l1 （UCH-L1）可用于轻度创伤性脑损伤（mTBI）后颅内损伤的排除。为此目的，我们评估了经监管部门批准的新型VIDAS®TBI检测的诊断性能。方法：纳入就诊于急诊科的65岁以下TBI患者，格拉斯哥昏迷评分13-15分，完成头部计算机断层扫描（CT）扫描并在损伤后12小时内采血。使用预先设定的截止值分析UCH-L1/GFAP水平，并将其合并为单一结果，并根据CT表现进行评估。结果：78名入组参与者被分析。颅内损伤4例。VIDAS®TBI检测的灵敏度和阴性预测值均为100%。结论：VIDAS TBI试验在该探索性队列中具有排除试验的潜力；然而，估计仅基于4例ct阳性病例，需要在更大规模的前瞻性研究中得到证实。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).