微量动态显色法与动态显色法的等效性评价  

Study on equivalence between micro kinetic chromogenic assay and kinetic chromogenic assay

作　　者：裴宇盛[1] 陈晨[1] 耿颖[1] 高华[1] 蔡彤[1] PEI Yu-sheng;CHEN Chen;Geng Ying;GAO Hua;CAI Tong(National Institutes for Food and Drug Control, Beijing 102629, China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药理学通报》2022年第7期1107-1110,共4页Chinese Pharmacological Bulletin

基　　金：国家科技重大专项(No 2018ZX09101001);国家药监局重点实验室项目(No 2020:1-4)。

摘　　要：目的评价微量动态显色法与动态显色法的等效性,为替代方法的使用提供数据支持。方法检测条件:采用微量动态显色法和动态显色法鲎试剂,每孔样品和鲎试剂加样量25μL(动态显色法100μL),检测波长405 nm,预设OD值0.03,使用半孔酶标板检测(动态显色法使用普通酶标板)。在国内的4个实验室协作研究,以等效性检验等多种统计方法,评价两种方法的等效性。结果单因素方差分析、配对t检验和等效性检验的结果较为一致,均显示出不同厂家的现有动态显色法之间存在一定差异,而每个厂家的试剂采用微量或常规的量之间并不存在显著性差异。结论微量动态显色法在准确度回收率方面是与现有试剂等效的。Aim To evaluate the equivalence between micro kinetic chromogenic assay and kinetic chromogenic assay in order to provide data support for the use of alternative methods.Methods Detection conditions:micro kinetic chromogenic assay and kinetic chromogenic assay limulus reagent were used,sample amount of each well and limulus reagent was 25μL(kinetic chromogenic assay was 100μL),detection wavelength was 405 nm,ONSET OD value was 0.03,and half-well elisa plate was used for detection(kinetic chromogenic assay was ordinary ELISA plate).The equivalence of the two methods was evaluated by various statistical methods,such as equivalence test,in collaboration with four laboratories in China.Results The results of one-way an OVA,paired T test and equivalence test were consistent,indicating that there were some differences between the existing kinetic chromogenic assay of different manufacturers,while there was no significant difference between the trace or conventional amount of reagent used by each manufacturer.Conclusions Micro kinetic chromogenic assay is equivalent to existing reagents in terms of accuracy and recovery.

关 键 词：细菌内毒素检查法 动态显色法 鲎试剂 替代方法 生物检定 热原 

分 类 号：R378[医药卫生—病原生物学] R392.11[医药卫生—基础医学] R446R927.12R996