胃蛋白酶原I乳胶增强免疫比浊分析方法学评价

Preliminary evaluation of latex immunoassay for pepsinogen I

目的:对胃蛋白酶原I检测试剂盒进行方法学初步评价。方法:依据临床和实验室标准协会(CLSI)颁布的《定量临床检验方法的初步评价,批准指南第二版(EP10-A2)》提供的方法,按特定的顺序连续测定低、中、高浓度的质控血清5d,从而对该试剂盒检测方法进行初步评价。结果:当胃蛋白酶原I低、中、高浓度的质控血清的靶值分别为28.2、48.8、68.3ng/mL时,PGI测定的线性回归方程为y=1.0748x-3.1913,相关系数为0.9998;绝对偏倚分别是-0.8、0.1、2.1ng/mL;总不精密度(CV%)分别为1.32%、1.98%、2.19%。结论:胃蛋白酶原I检测试剂盒检测方法的线性、偏倚、总不精密度和抗交叉污染能力均达到EP10-A2文件的标准,符合临床应用要求。

Objective To evaluate primarily the pepsinogen I （PGI） test kit on methodology, which was produced by Beijing Jiuqiang Company. Methods According to the CLSI Document EP10-A2,i.c.Preliminary Evaluation of Quantitative Clinical Laboratory Methods, Approved Guideline-Second Edition, the low, middle and high control materials were performed with the specific sequence for five days, and in this way to made a preliminary evalution about the acceptability of the pepsinogen I test kit. Results When the PG I labeled value of the low, middle and high control materials were 28.2 ng/mL, 48.8 ng/mL, 68.3 ng/mL, the multiple regression equation of PGI was y = 1.074 8x-3.191 3,r2 = 0.999 8; Absolute bias were -0.8 ng/mL,0.1 ng/mL,2.1 ng/mL;Imprecision （CV%）were 1.32%,1.98%,2.19% respectively. Conclusions Nonlinearity, bias, imprecision and sample carryover of the pepsinogen I test kit arc accepted by EP10-A2, it is suitable for clinical laboratory.