电化学发光法检测胃泌素释放肽前体的方法学评价

Evaluation of Electrochemical Luminescence Method for Detection of Pro-Gastrin-Releasing Peptide

目的对电化学发光法检测胃泌素释放肽前体(Pro GRP)进行方法学评价及性能验证。方法对电化学发光法检测胃泌素释放肽前体的不精密度、线性分析、回收实验、相关性分析、反复冻融实验以及正常参考范围验证等方面进行评价。结果低、中、高值样本批内不精密度分别为2.08%、1.58%和2.31%,批间不精密度分别为3.72%、2.26%和2.13%;线性分析的稀释健全性良好,R2=0.9743;平均回收率为99.94%;与酶联免疫法比较,R2=0.9109,好相关性良好;反复冻融实验进行8次,CV小于5%,结果稳定性良好;结果电化学发光法检测胃泌素释放肽前体方法可靠、检测性能良好,符合临床实验室要求,可广泛开展使用。

Objective To evaluate the electrochemical luminescence method for detection of Pro-gastrinreleasing peptide（Pro GRP）.Methods The imprecision,linearity,recovery test,correlation analysis,repeated freezing-thawing test were all evaluated.Results The imprecision of within-run of high,mid and lowconcentration of Pro GRP were 2.08%,1.58% and 2.31%,respectively.The imprecision of between-run of low,mid and high concentration of Pro GRP were 3.72%,2.26% and 2.13%,respectively.The results showed a good linearity,and R2= 0.9743.Compared with enzyme linked immunosorbent assay,R2=0.9109.The average recovery rate was 99.94%.The results of eight freezing-thawing tests showed CV ≤5%,the stability is good.Conclusion The electrochemical luminescence method has a good performance in Pro GRP detection,and meets the requirements of clinical laboratory,and can be used in clinical application widely.