Objective To evaluate primarily the detection of pepsinogen II (PG II )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 PG II 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 PG II were 1.70% ,1.21% ,3. 79% and 4. 32% respectively. When PG II 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 (P > 0. 05). The equation of linear regression of PG II was Y =0.975 IX -0.016 8,and the coefficient of determination(R2)= 0.998 7. Conclusions The latex-enhanced immunoturbidimetry assay for the PG II detection with good repeatability meets the clinical application requirements of EPS-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.%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、39.8 μg/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=0.9757X -0.0168,决定系数(R2) =0.9987.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.
展开▼
