摘要
目的探讨在胃蛋白酶原(PG)定量检测方法中,化学发光微粒子免疫分析法(CMIA)试剂和乳胶颗粒增强免疫比浊法(PETIA)试剂对标本检测结果的一致性,为证实采用PETIA试剂检测PG的可靠性提供实验依据。方法参考美国临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,以PETIA为待评方法,CMIA为参比方法,挑选出已经通过胃镜确诊的不同胃萎缩状态下的患者标本96份,分别用CMIA和PETIA试剂盒双向检测,并记录胃蛋白酶原Ⅰ(PGⅠ)、PGⅠ与胃蛋白酶原Ⅱ(PGⅡ)比值(PGⅠ/PGⅡ)的检测结果,对两组结果进行方法比对和偏倚估计。结果 CMIA和PETIA试剂检测PGⅠ与PGⅠ/PGⅡ的预期相对偏倚在方法的线性范围内可以被接受。结论应用PETIA试剂检测标本PGⅠ、PGⅡ的结果可以被接受。
Objective To explore the consistency of chemiluminescence microparticle immunoassay（CMIA）reagent and particle‐enhanced turbidimetric immunoassay（PETIA） reagent for detecting pepsinogen（PG） ,so as to provide laboratory references for en‐suring the reliability of PETIA reagent in detecting PG .Methods According to the requirement of EP9‐A2 file made by the Nation‐al Committee for Clinical Laboratory Standards（NCCLS） ,taking PETIA as evaluating method and CMIA as reference method ,a to‐tal of 92 specimens collected from patients with various degrees of gastric atrophy were selected ,PETIA and CMIA reagents were utilized for bidirectional detection of PG .Then recorded test results of pepsinogenⅠ（PGⅠ） ,and PGⅠ /pepsinogenⅡ（PG Ⅱ） rati‐o ,and carried out method comparison and bias evaluation for the two kinds of reagents .Results The expected relative bias of detec‐tion results of PGⅠ and PGⅠ /PG Ⅱ ratio by using PETIA and CMIA reagents were acceptable within linear range of methods . Conclusion The results of PGⅠ and PG Ⅱ detected by using PETIA reagent could be accepted .
出处
《国际检验医学杂志》
CAS
2015年第18期2706-2707,2710,共3页
International Journal of Laboratory Medicine
