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Use of high-sensitivity digital ELISA improves the diagnostic performance of circulating brain-specific proteins for detection of traumatic brain injury during triage.
Neurological Research ( IF 1.9 ) Pub Date : 2020-02-12 , DOI: 10.1080/01616412.2020.1726588
Grant C O'Connell 1 , Megan L Alder 1 , Christine G Smothers 1 , Carolyn H Still 1 , Allison R Webel 1 , Shirley M Moore 1
Affiliation  

Background: Historically, limited sensitivity associated with traditional immunoassay methods has prevented the use of brain-specific proteins as blood biomarkers of traumatic brain injury (TBI) during triage, as these proteins exhibit low circulating concentrations. Digital ELISA is a newly-developed technique that is up to 1000 times more sensitive than conventional ELISA methods. The purpose of this study was to determine whether the use of digital ELISA over conventional ELISA improves the performance of brain-specific proteins as blood biomarkers of TBI during triage.Methods: Blood was sampled from TBI patients (n = 13) at emergency department admission, as well as from neurologically normal controls (n = 72). Serum levels of two brain-specific proteins, neurofilament light chain (NfL) and Tau, were measured via digital ELISA. Estimated conventional ELISA measures were generated by adjusting values according to the lower limits of detection achievable with commercially available conventional ELISA assays, and receiver operating characteristic (ROC) analysis was used to compare the diagnostic performance of digital ELISA measures to estimated conventional ELISA measures in terms of their ability to discriminate between TBI patients and controls.Results: Used in combination, digital ELISA measures of NfL and Tau could discriminate between groups with 100% sensitivity and 91.7% specificity. Estimated conventional ELISA measures could only discriminate between groups with 7.7% sensitivity and 94.4% specificity. This difference in diagnostic performance was statistically significant when comparing areas under ROC curves.Conclusions: The use of digital ELISA over conventional ELISA methods improves the diagnostic performance of circulating brain-specific proteins for detection of TBI during triage.

中文翻译:

使用高灵敏度数字 ELISA 提高了循环脑特异性蛋白的诊断性能,用于在分诊过程中检测创伤性脑损伤。

背景:从历史上看,与传统免疫测定方法相关的有限灵敏度阻碍了在分诊过程中使用脑特异性蛋白质作为创伤性脑损伤(TBI)的血液生物标志物,因为这些蛋白质表现出较低的循环浓度。数字 ELISA 是一种新开发的技术,其灵敏度比传统 ELISA 方法高出 1000 倍。本研究的目的是确定在分诊期间使用数字 ELISA 相对于传统 ELISA 是否可以提高脑特异性蛋白作为 TBI 血液生物标志物的性能。方法:在急诊科入院时从 TBI 患者 (n = 13) 中采集血液样本,以及神经系统正常对照 (n = 72)。通过数字 ELISA 测量两种脑特异性蛋白、神经丝轻链 (NfL) 和 Tau 的血清水平。通过根据市售常规 ELISA 测定可实现的检测下限调整值来生成估计的常规 ELISA 测量值,并使用接受者操作特征 (ROC) 分析来比较数字 ELISA 测量值与估计的传统 ELISA 测量值的诊断性能结果:结合使用 NfL 和 Tau 的数字 ELISA 测量,可以以 100% 的敏感性和 91.7% 的特异性区分各组。估计传统 ELISA 方法只能以 7.7% 的敏感性和 94.4% 的特异性区分各组。当比较 ROC 曲线下的面积时,诊断性能的差异具有统计学意义。结论:与传统 ELISA 方法相比,使用数字 ELISA 提高了分诊期间检测 TBI 时循环脑特异性蛋白的诊断性能。
更新日期:2020-02-12
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