尿HCG质控品均匀性和稳定性的评价  

Assessment of the uniformity and stability of the quality control products for urine HCG detection

作　　者：丁玮洁 夷峥 王梓蒙 石巍 黄维纲 DING Weijie;YI Zheng;WANG Zimeng;SHI Wei;HUANG Weigang(Shanghai Center for Clinical Laboratory,Shanghai 200126,China;Shanghai Yihua Medical Science&Technology Co.Ltd.,Shanghai 201203,China)

机构地区：[1]上海市临床检验中心,上海200126 [2]上海伊华医学科技有限公司,上海201203

出　　处：《检验医学与临床》2021年第24期3568-3570,共3页Laboratory Medicine and Clinic

摘　　要：目的通过化学发光免疫分析法(CLIA)和胶体金法两种方法对尿人绒毛膜促性腺激素(HCG)质控品的均匀性和稳定性进行评价。方法采用CLIA和胶体金法检测尿HCG质控品中的HCG。结果储存4个月内,质控品的均匀性和稳定性均符合要求,两种方法评价的结果一致。质控品储存5个月时,CLIA检测显示:质控品HCG水平不在稳定性范围(92.55~103.89 mIU/mL)内,质控品不稳定;胶体金法检测显示:结果为100%阳性,质控品稳定。结论用CLIA和胶体金法相结合的评价方式可更准确地评价尿HCG质控品的均匀性和稳定性。Objective To evaluate the uniformity and stability of quality control products for urinary human chorionic gonadotropin(HCG)detection by using chemiluminescence immunoassay(CLIA)and colloidal gold technique.Methods The HCG in the quality control products were detected by using chemiluminescent and colloidal gold technique.Results Within 4 months of storage,the uniformity and stability of the quality control products all met the requirements,and the evaluation results of the two methods were consistent.When the quality control products were stored for 5 months,the results of CLIA showed that the HCG concentrations of the quality control products were not within the stability range(92.55-103.89 mIU/mL),and the quality control products were unstable;the colloidal gold test showed that the result was 100%positive,the quality control products were stable.Conclusion The evaluation method combining CLIA and colloidal gold test can evaluate the uniformity and stability of urine HCG quality control products more accurately.

关 键 词：尿人绒毛膜促性腺激素 质控品 化学发光免疫分析法 均匀性 稳定性 

分 类 号：R446.11[医药卫生—诊断学]