免疫体外诊断试剂批间差评价方法的简析  

Discussion on Inter-batch Difference and Evaluation Method of in Vitro Diagnostic Reagents

作　　者：卢亚丽 吕利强 陈静 刘利晶 罗利红 张金蕊 LU Yali;LV Liqiang;CHEN Jing;LIU Lijing;LUO Lihong;ZHANG Jinrui(Autobio Diagnostics Co.,Ltd.,Henan Zhengzhou 450000)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450000

出　　处：《中国质量》2024年第7期119-124,共6页China Quality

摘　　要：为了提高对免疫体外诊断试剂批间差评价方法的认识,本文讨论了质控物和临床样本的基质效应、稳定性、均匀性、分析物水平四个关键因素对试剂批间差评价的影响,为客观地评价批间差提供了理论依据和研究思路。结合医药行业标准、CNAS标准、国家标准的三种批间差评价方法,本文探讨了不同评价方法的特点和适用情况:并结合CNAS标准、国家标准将其进行转化,提出了一种计算批间相对极差的不同的批间差评价方法,对免疫体外诊断试剂生产企业批间差的评价提供了一种可借鉴的方法。In order to improve the understanding of the methods for evaluating inter batch differences in immune in vitro diagnostic reagents,the four key factors of matrix effect,stability,uniformity and analytical level of quality control materials and clinical samples were discussed on the evaluation of batch difference of reagents,which provided theoretical basis and research ideas for objective evaluation of batch difference.The characteristics and application of different evaluation methods were discussed by combining the three evaluation methods of pharmaceutical industry standard,CNAS standard and national standard.Combined with the CNAs standard and national standard,a different evaluation method for calculating the relative range between batches was proposed,which provides a reference method for the evaluation of inter batch difference in immune in vitro diagnostic reagent production enterprises.

关 键 词：批间差 质控物 患者样本 评价方法 

分 类 号：R446.6[医药卫生—诊断学]