血清粗纤维调节素ELISA的建立及初步应用

Establishment of a competition enzyme linked immunosorbent assay for serum undulin and its preliminary clinical application

以提纯的人胎盘粗纤维调节素 (Un)及兔抗人Un IgG ,建立血清Un的竞争抑制ELISA标准曲线 ,并检测了 6 0名正常人和 12 4例肝病患者。结果采用棋盘试验确定包被Un及其抗体的浓度 ,表明该法灵敏度为 5 μg/L ,回收率为 96 6 %～10 8 3% ,批内 CV为 7 5 % ,批间CV 为 7 9%。 6 0名正常成人血清Un含量为 71 14± 2 9 6 0 μg/L ,参考值范围为 11～ 130μg/L,慢性肝病患者Un含量显著高于正常人。提示此法稳定、可靠、特异 ,基本符合临床使用要求 ,可用于慢性肝病的诊断。

A competition enzyme linked immunosorbent assay(c ELISA)was developed for the measurement of serum undulin(Un)to apply clinical study.First to establish the standard curve of c ELISA base on determining the optimum concentration of coating Un and its specific antibody using chessboard test.Then to test its precision,sensitivity,recovery and specificity.Finally to measure the levels of serum Un in 60 normal controls and 124 patients with various liver diseases using this method.This assay offer a sensitive of 5 μg/L and a rate of recovery of 96 6%～108 6%.The coefficient of variation for within and between assays was 7 5% and 7 9%,respectively.The mean level of normal controls was 71 14±29 6 μg/L(x±s)and the reference range for serum Un was 11～130 μg/L.Serum Un levels in patients with various liver diseases show significantly increased compared with that in normal controls.c ELISA for serum Un is stable,reliable and precise .it can be used for the diagnosis of liver diseases.