用于测定血清中胶质纤维酸性蛋白（GFAP）的快速免疫测定法。

Rapid immunoassay for the determination of glial fibrillary acidic protein (GFAP) in serum.

作者信息

Vissers Joost L M, Mersch Marsha E C, Rosmalen Chris F, van Heumen Marijke J M T, van Geel Wieneke J A, Lamers Karel J B, Rosmalen Frans M A, Swinkels Leon M J W, Thomsen Jens, Herrmann Manfred

机构信息

Future Diagnostics, Nieuweweg 172, 6603 BT Wijchen, The Netherlands.

出版信息

Clin Chim Acta. 2006 Apr;366(1-2):336-40. doi: 10.1016/j.cca.2005.11.017. Epub 2006 Jan 10.

DOI:10.1016/j.cca.2005.11.017

PMID:16405937

Abstract

BACKGROUND

This study was aimed to develop a sensitive and rapid assay for the determination of glial fibrillary acidic protein (GFAP) in serum and to evaluate the clinical applicability in serum samples from patients with acute stroke.

METHODS

The two-site chemiluminometric immunoassay, intended to use in a near-patient setting with a single incubation step (20 min), was used to measure serum samples from healthy blood donors and from patients with brain injury and correlated to serum S100B levels.

RESULTS

The GFAP assay covered a concentration range up to 18 microg/L with an analytical sensitivity of 0.014 microg/L. The intra-assay precision was 3.5% at 1.55 microg/L (n=20) and 4.1% at 0.39 microg/L (n=20). The inter-assay precision was 3.8% at 9.1 microg/L (n=10) and 10.3 % at 0.21 microg/L (n=9). Normal controls (n=46) showed non-detectable GFAP with a 99% upper limit of <0.04 microg/L. GFAP values were associated with progression and severity of the illness in acute stroke patients.

CONCLUSIONS

We have developed an improved assay for the measurement of GFAP levels in serum. Serum GFAP is a potential marker for prognosis and outcome in patients with central nervous system disorders.

摘要

背景

本研究旨在开发一种灵敏快速的检测血清中胶质纤维酸性蛋白（GFAP）的方法，并评估其在急性中风患者血清样本中的临床适用性。

方法

采用双位点化学发光免疫分析法，该方法旨在用于近患者检测且只需一步温育（20分钟），用于检测健康献血者以及脑损伤患者的血清样本，并与血清S100B水平进行相关性分析。

结果

GFAP检测方法的浓度范围高达18μg/L，分析灵敏度为0.014μg/L。批内精密度在1.55μg/L时为3.5%（n = 20），在0.39μg/L时为4.1%（n = 20）。批间精密度在浓度为9.1μg/L时为3.8%（n = 10），在0.21μg/L时为10.3%（n = 9）。46例正常对照者的GFAP检测结果为不可测，99%上限<0.04μg/L。急性中风患者的GFAP值与疾病进展和严重程度相关。