孕酮质控血清研制  

Preparation of the Progesterone Quality Control Sera for Immunoassay

作　　者：孙有香[1] 徐立根[1] 焦岩[1] 沈洪征[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《标记免疫分析与临床》2000年第4期195-198,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：为制备供免疫分析用的孕酮质控血清并确定其参考值与参考范围 ,用 0 .4L混合正常人血清和 0 .6L去甾体激素血清 ,配制低值质控血清 ;1L混合正常人血清 ,作为中值质控血清 ;在 1L混合正常人血清中加 150 0 μL孕酮乙醇溶液 (浓度为 10 μg/mL) ,配制高值质控血清。三种孕酮质控血清充分搅拌混匀后 ,按每瓶 0 .5mL分装、冻干。用天津德普公司和法国CIS公司孕酮RIA药盒测定本批和 930 60 1批号甾体激素质控血清孕酮含量。结果表明 :采用德普公司药盒数据定值 ,低、中高值三种质控血清孕酮参考值各为 1.2 3、2 .95和 15.9μg/L ,相应的参考范围分别是 0 .98- 1.4 8、2 .36-3.54和 12 .7- 19.1μg/L。本批质控血清可以作为实验室用RIA药盒检验孕酮时使用。The quality control sera(QC sera) of progesterone for immunoassay were prepared and their referrency values and fitting ranges were determinated. We mixed thoroughly 0.4 L mixed normal human sera and 0.6 L steroid hormone-free sera to prepare low value QC sera, used 1 L mixed normal human sera as middle value QC sera, and added 1500μL ethyl alcohol solution of progesterone (conc.10μg/mL)to 1 L mixed normal human sera to make high value QC sera. These three serum pools in an aliquot of 0.5mL per vial were distributed and 1yophilized. The progeterone concentrantions in the present QC sera and QC sera for steroid hormones, coded as 930601,were determined by RIA kits purchased from Tianjin Depu (DPC) Co. and CIS bio international, France. The data were obtained from Tianjin Depu(DPC) RIA kit to determin the progeterone referrency values and their ranges for low, middle and high value QC sera. Referrency value are 1.23,2.95and 15.9μg/L in given order, with appropriate ranges being 0.98-1.48,2.36-3.54 and 12.7-19.1μg/L, respectively. Present QC sera may be used for progesterone immunoassay in the laboratories.

关 键 词：孕酮 质控血清 放射免疫分析 

分 类 号：R446.112[医药卫生—诊断学] R446.6[医药卫生—临床医学]