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使用两种自动免疫测定法(i-STAT和Alinity)检测胶质纤维酸性蛋白(GFAP)和泛素羧基末端水解酶L1(UCH-L1)以管理轻度创伤性脑损伤患者的比较:来自法国单中心研究的初步结果

Comparison of GFAP and UCH-L1 Measurements Using Two Automated Immunoassays (i-STAT and Alinity) for the Management of Patients with Mild Traumatic Brain Injury: Preliminary Results from a French Single-Center Approach.

作者信息

Oris Charlotte, Khatib-Chahidi Clara, Pereira Bruno, Bailly Defrance Valentin, Bouvier Damien, Sapin Vincent

机构信息

Biochemistry and Molecular Genetics Department, University Hospital, 63000 Clermont-Ferrand, France.

Clinical Research and Innovation Department, University Hospital, 63000 Clermont-Ferrand, France.

出版信息

Int J Mol Sci. 2024 Apr 21;25(8):4539. doi: 10.3390/ijms25084539.

Abstract

The measurement of blood glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) may assist in the management of mild traumatic brain injury (mTBI). This study aims to compare GFAP and UCH-L1 values measured using a handheld device with those measured using a core laboratory platform. We enrolled 230 mTBI patients at intermediate risk of complications. Following French guidelines, a negative S100B value permits the patient to be discharged without a computed tomography scan. Plasma GFAP and UCH-L1 levels were retrospectively measured using i-STAT and Alinity i analyzers in patients managed within 12 h post-trauma. Our analysis indicates a strong correlation of biomarker measurements between the two analyzers. Cohen's kappa coefficients and Lin's concordance coefficients were both ≥0.7, while Spearman's correlation coefficient was 0.94 for GFAP and 0.90 for UCH-L1. Additionally, the diagnostic performance in identifying an intracranial lesion was not significantly different between the two analyzers, with a sensitivity of 100% and specificity of approximately 30%. GFAP and UCH-L1 levels measured using Abbott's i-STAT and Alinity i platform assays are highly correlated both analytically and clinically in a cohort of 230 patients managed for mTBI according to French guidelines.

摘要

血液中胶质纤维酸性蛋白(GFAP)和泛素羧基末端水解酶L1(UCH-L1)的检测可能有助于轻度创伤性脑损伤(mTBI)的管理。本研究旨在比较使用手持设备测量的GFAP和UCH-L1值与使用核心实验室平台测量的值。我们纳入了230例有中度并发症风险的mTBI患者。根据法国指南,S100B值为阴性时允许患者在不进行计算机断层扫描的情况下出院。对创伤后12小时内接受治疗的患者,使用i-STAT和Alinity i分析仪回顾性测量血浆GFAP和UCH-L1水平。我们的分析表明两种分析仪之间生物标志物测量结果具有很强的相关性。科恩kappa系数和林氏一致性系数均≥0.7,而GFAP的斯皮尔曼相关系数为0.94,UCH-L1的为0.90。此外,两种分析仪在识别颅内病变方面的诊断性能没有显著差异,敏感性为100%,特异性约为30%。在根据法国指南治疗的230例mTBI患者队列中,使用雅培i-STAT和Alinity i平台检测法测量的GFAP和UCH-L1水平在分析和临床方面都高度相关。

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