摘要
目的对胶乳增强免疫比浊法测定胃蛋白酶原Ⅱ(PGⅡ)进行初步方法学评价,为临床应用提供依据。方法依据美国临床实验室标准化委员会(NCCLS)EP5-A及EP10-A2文件提供的方法,对胶乳增强免疫比浊法测定PGⅡ进行初步的评价。结果 PGⅡ的低值样本批内变异系数(CV)为2.05%、批间CV为1.60%、日间CV为3.92%、总CV为4.70%;高值样本批内CV为1.70%、批间CV为1.21%、日间CV为3.79%、总CV为4.32%。当PGⅡ浓度分别为9.6、24.7、39.8μg/L时,相对偏倚分别为-0.18、-0.47、-0.39μg/L,总不精密度分别为4.98%、2.39%、2.71%。测试间的携带污染差异无统计学意义(P>0.05)。线性回归方程为Y=0.975 7X-0.016 8,决定系数(R2)=0.998 7。结论胶乳增强免疫比浊法测定PGⅡ的精密度符合EP5-A文件标准,具有良好的重复性。线性、偏倚、总不精密度及抗交叉污染能力均达到EP10-A2文件标准,符合临床应用要求,适用于实验室常规测定。
Objective To evaluate primarily the detection of pepsinogen Ⅱ（PGⅡ） by latex-enhanced immunoturbidimetry assay,and provide the reference for clinical application.Methods According to the National Committee for Clinical Laboratory Standards（NCCLS） EP5-A and EP10-A2 documents,the detection of PGⅡ by latex-enhanced immunoturbidimetry assay was evaluated primarily.Results The within-run,between-run,between-day and total coefficients of variation（CV） of samples with low concentration of PGⅡ were 2.05%,1.60%,3.92% and 4.70% respectively.The within-run,between-run,between-day and total CV of samples with high concentration of PGⅡ were 1.70%,1.21%,3.79% and 4.32% respectively.When PGⅡ concentrations were 9.6,24.7 and 39.8 μg/L,the relative biases were-0.18,-0.47 and-0.39 μg/L respectively.The total imprecisions were 4.98%,2.39% and 2.71% respectively.There was no statistical significance in total carry-over（P0.05）.The equation of linear regression of PGⅡ was Y =0.975 7X-0.016 8,and the coefficient of determination（R2）= 0.998 7.Conclusions The latex-enhanced immunoturbidimetry assay for the PGⅡ detection with good repeatability meets the clinical application requirements of EP5-A document for precision and the requirements of EP10-A2 document for the linearity,bias,total imprecision and carry-over.It is suitable for the clinical application.
出处
《检验医学》
CAS
2012年第2期122-125,共4页
Laboratory Medicine
