摘要
目的加强艾滋病筛查实验室的监督管理,提高艾滋病检测实验室的检测和校准能力,以及实验室室内的比对能力,从而更好地完成实验室检测能力验证。方法对实验室收集的无肉眼可见溶血、黄疸、乳糜颗粒的原料血浆或血清进行病毒灭活,经离心、防细菌污染、稳定蛋白等方法处理后,依照标准程序对艾滋病病毒(HIV)实验室室内质控品的均一性和稳定性进行质量评价。结果HIV能力验证质控品均一性和稳定性试验中,高浓度、低浓度室内质控品的标准差(SD)均小于0.1,变异系数(CV)均小于10%;在2℃~8℃、室温及37℃存放不同时间后,两种不同浓度室内质控品抗-HIV的S/CO值的CV均小于15%。结论HIV抗体实验室质控品具有良好的均一性与稳定性,能够在能力验证工作中稳定有效地发挥出检测能力评价的作用。
Objective To strengthen the supervision and management of HIV/AIDS screening laboratories,improve the testing,calibration and internal comparison capacity of HIV/AIDS testing laboratories,so as to better complete the laboratory testing ability verification.Methods Raw plasma or serum without visible hemolysis,jaundice and chylous granules collected in the lab were processed by virus inactivation,centrifugation,anti-bacterial contamination,protein stabilization and so on.The homogeneity and stability of the quality-control products were valuated according to standard procedures.Results During the quality-control homogeneity and stability evaluation test on HIV ability verification,standard deviations(SD)for high and low concentration of internal quality-control products were all less than 0.1,and the coefficients of variation(CV)were all less than 10%.After storing at 2℃-8℃,room temperature and 37℃for different time,the S/CO values of high and low concentration internal quality control products were all less than 15%.Conclusion The HIV antibody internal quality-control products have good homogeneity and stability,which can play a stable and effective role in the HIV test capability evaluation during the ability verification work.
作者
崔海燕
李颖
邢苏培
CUI Haiyan;LI Ying;XING Supei(Zhumadian Center for Disease Control and Prevention,Zhumadian,Henan 463000,China)
出处
《河南预防医学杂志》
2021年第7期500-502,548,共4页
Henan Journal of Preventive Medicine
关键词
艾滋病病毒
实验室
质控品
质量评价
HIV/AIDS
Laboratory
Quality-control products
Quality evaluation
