Whitehouse Daniel P, Needham Edward J, Bernstock Joshua D, Gaude Edoardo, Barrett Liam, Ebrahimi Soraya, Menon David K, Newcombe Virginia F J
Department of Medicine: Perioperative, Acute, Critical Care and Emergency Medicine (PACE) Section, University of Cambridge, Cambridge, UK.
Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
Cell Mol Neurobiol. 2025 Jul 12;45(1):69. doi: 10.1007/s10571-025-01594-6.
Glial fibrillary acidic protein (GFAP) is an emerging biomarker for the detection of acute intracranial pathology following acute brain injuries such as traumatic brain injury (TBI), stroke, and hypoxic-ischaemic encephalopathy. We undertake a proof-of-concept technical assessment of a commercial lateral flow test (LFT) for the detection of GFAP [the Upfront DX LVOne GFAP lateral flow assay (LFA)], against GFAP concentrations measured using a gold-standard assay [Single Molecule Arrays (Simoa®)-based Human Neurology 4-Plex B assay] in a TBI population. The ability of the LVOne GFAP LFA for identification of samples with GFAP concentrations above the manufacturer's reported lower limit of detection (≥ 0.2 ng/ml) was assessed, with further assessment of the association between the LVOne and a gold-standard assay made using Spearman's rank correlation coefficient and linear-mixed-effects modelling. Of the 50 samples, 39 had serum GFAP concentrations exceeding the reported lower limit of detection, with the LVOne GFAP LFA having a 95% (95% CI: 83%, 99%) sensitivity and a 64% (95% CI: 31%, 89%) specificity for detecting a serum GFAP concentrations over this lower limit. There was a significant positive correlation (Rho = 0.94, p < 0.001) between the Quanterix Simoa® GFAP level and the LVOne semiquantitative score, with a significant positive association seen using a linear-mixed-effects model (p < 0.001). In conclusion, the Upfront DX LVOne GFAP LFA is sensitive for the detection of elevated serum GFAP levels, and as such, may be a useful adjunct to the care of patients with acute brain injuries in the pre-hospital setting.
胶质纤维酸性蛋白（GFAP）是一种新兴的生物标志物，用于检测急性脑损伤（如创伤性脑损伤（TBI）、中风和缺氧缺血性脑病）后的急性颅内病变。我们针对TBI人群中使用金标准检测法[基于单分子阵列（Simoa®）的人类神经学4联检B检测法]测得的GFAP浓度，对一种用于检测GFAP的商用侧向流动检测（LFT）[Upfront DX LVOne GFAP侧向流动分析（LFA）]进行了概念验证技术评估。评估了LVOne GFAP LFA识别GFAP浓度高于制造商报告的检测下限（≥0.2 ng/ml）的样本的能力，并使用Spearman等级相关系数和线性混合效应模型进一步评估了LVOne与金标准检测法之间的相关性。在50个样本中，39个样本的血清GFAP浓度超过报告的检测下限，LVOne GFAP LFA检测血清GFAP浓度超过此下限的灵敏度为95%（95%CI：83%，99%），特异性为64%（95%CI：31%，89%）。Quanterix Simoa® GFAP水平与LVOne半定量评分之间存在显著正相关（Rho = 0.94，p < 0.001），使用线性混合效应模型也观察到显著正相关（p < 0.001）。总之，Upfront DX LVOne GFAP LFA对检测血清GFAP水平升高很敏感，因此，在院前环境中可能是急性脑损伤患者护理的有用辅助手段。
