HIV抗体快速诊断室内质控品的制备及应用  

The preparation and application of the internal quality control sample in Human Immunodeficiency Virus Rapid test

作　　者：陈兵[1] 王美玉[1] 裴丽健[1] 吕铭洋[1] 沈蕊[1] 兰智辉 邢文革[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心,北京102206

出　　处：《中国艾滋病性病》2015年第7期608-610,622,共4页Chinese Journal of Aids & STD

摘　　要：目的研制艾滋病病毒(HIV)抗体快速诊断的室内质控品。通过室内质控品的使用,保证HIV抗体快速诊断的检测质量。方法用HIV抗体阴性血浆倍比稀释HIV抗体阳性血浆,寻找弱阳性的稀释倍数,制备室内质控品,评价质控品的稳定性、均一性。在检测过程中加入自制的HIV抗体快速诊断室内质控品,并建立LeveyJennings(L-J)质控图进行分析。结果 HIV抗体阳性样本按照1∶256的稀释度制备本实验室室内质控品,其均一性、稳定性均符合要求。建立质控图均值的GOD值为2.06,标准差为0.39。样本加样量、检测温度、检测时间及更换试剂盒等发生变化时,在质控图中均发生告警或失控状态,能及时发现实验室存在的误差并对失控进行处理。结论自制的HIV抗体弱阳性室内质控品,用于本实验室HIV抗体快速诊断的质量控制是经济可行的,可以满足实验室常规检测的需求。Objective The study was to develop a kind of the internal quality control sample in HIV antibody rapid test.Through the use of the internal quality control sample,the quality of HIV antibody rapid test would be guaranteed.Methods The gradient dilution method was used to dilute the HIV antibody-positive plasma with HIV antibody-negative plasma to the extent that a weakly positive test result was achieved.The corresponding diluting ratio was determined to develop the internal quality control sample.The stability and homogeneity of the internal quality control sample were tested.The internal quality control sample was then used in the process of HIV antibody rapid test,during which a Levey-Jennings（L-J）quality control chart was used for analysis.Results A diluting ratio of 1：256was determined for our HIV antibody-positive plasma.The standards for stability and homogeneity were met.The L-J quality control chart was produced with the internal quality control sample.The GOD（Gold Optical Density）mean value of the internal quality control sample was 2.06,and the standard deviation was 0.39.Warning and loss of control were manifested in the quality control chart when any of sample volume,test temperature,test time and kit were changed such that the error was found and handling of loss of control was processed.ConclusionsThe HIV antibody-weakly-positive quality control sample was commercially available for the need of routine tests in our lab.

关 键 词：艾滋病病毒抗体 快速诊断 室内质控品 

分 类 号：R446.6[医药卫生—诊断学] R373.9[医药卫生—临床医学]