免疫层析试验影响因素的可控性研究  

Controllability of Influencing Factors in Immunochromatographic Test

作　　者：肖辉 贾蜀光[2] 唐莹 XIAO Hui;JIA Shuguang;TANG Ying(Youxian District Center for Disease Control and Prevention, Mianyang 621000, Sichuan Province, China;Mianyang Center for Disease Control and Prevention, Mianyang 621000, Sichuan Province, China.)

机构地区：[1]绵阳市游仙区疾病预防控制中心,四川绵阳621000 [2]绵阳市疾病预防控制中心,四川绵阳621000

出　　处：《预防医学情报杂志》2018年第6期754-758,共5页Journal of Preventive Medicine Information

摘　　要：目的探讨免疫层析检测板对免疫层析试验影响因素的可控性。方法选用辖区内艾滋病检测点常用的3种艾滋病病毒(HIV)抗体快速筛查试剂,以高、中、低3种浓度单位(NCU)的阳性标准品作为样品,测试其在不同的环境温度、样品温度、结果判读时间、加样量等检测影响因素下的阳性检出率,使用免疫层析检测板控制上述检测影响因素,以说明书规定的试验条件为对照组,其他为试验组,比较两组的阳性检出率,同时对2012-2016年游仙辖区艾滋病检测点室间质控考核样品结果进行分析。结果除杭州艾博2 NCU样品外,实验环境温度、结果判断时间、样品温度、试剂温度和加样量对低浓度样品的阳性检出率有明显影响,对高浓度样品影响不明显,但在一定条件下,高浓度样品仍会出现漏检,当温度<10℃,3种试剂对高、中、低3种浓度单位对照组样品的阳性检出率均高于各试验组的同浓度单位样品;当增加观察时间和加样量时,会导致低浓度样品的阳性检出率升高,但可能出现假阳性结果。结论在免疫层析试验中,使用"免疫层析检测板"可有效控制温度、加样量、结果判读时间等实验条件对免疫层析试验结果的影响,提高免疫层析试验的阳性检出率。Objective To investigate the effecting factors to controllability of detecting plate on immunochromatographic test. Methods Selected three kinds of HIV antibody rapid screening reagents in the area of AIDS detection points,and used high,medium and low concentration unit（ NCU） of positive standards as samples,the positive detection rate was measured under different ambient temperature,sample temperature,results observation time,sample loading and other factors, the influencing factors of the above tests were controlled by immunochromatographic test plate,and the test condition which prescribed by the instruction manual was used as the control group,and the other were the test group,and the positive rate of the two groups was compared. Analyzed the results between laboratory quality control of the AIDS detection points in Youxian district during 2012-2016. Results Except Hang Zhou AIBO 2 NCU sample,the experimental environment temperature, observation time, sample temperature,reagent temperature and sample loading had significant effects on the positive detection rate of low concentration samples,and high concentration samples was not effected obvious. But under certain conditions,high concentration samples were still be missed. When the temperature below10 ℃,Three kinds of reagents of high,medium and low concentration unit positive detection rate of control group samples were higher than experimental group with the same concentration samples. When increasing the observation time and the amount of sample,would increase the positive detection rate of low concentration samples,but that may be the false positive results. Conclusion In the immunochromatographic test,the use of＂immunochromatographic detection plate＂can effectively control the temperature,the amount of sample,the results of interpretation time and other experimental conditions on the impact of immunochromatographic test results,improve the positive detection rate of immunochromatographic test.

关 键 词：免疫层析试验 影响因素 可控性 研究 

分 类 号：R446.6[医药卫生—诊断学]