酶标法测定人血清中HIV抗体的不确定度分析  

Uncertainty Analysis of HIV Antibody in Human Serum by Enzyme-Labeling Method

作　　者：石冬月 SHI Dong-yue(Center for Disease Control and Prevention,Wanghua District,Fushun City,Liaoning Province,Liaoning Fushun 113001)

机构地区：[1]辽宁省抚顺市望花区疾病预防控制中心,辽宁抚顺113001

出　　处：《中国医疗器械信息》2021年第18期54-55,共2页China Medical Device Information

摘　　要：目的:探究分析酶标法测定人血清中HIV抗体的不确定度。方法:2019年8月~2019年12月根据JJF1059-1999《测量不确定度评定与表示》,采用酶标法测定人血清中HIV抗体,通过HIV抗体检查结果,明确其不确定度,并进行详细分析。结果:资料显示,阴性B=0.28,阴性吸光度值=0.078,cutoff值=0.278。通过cutoff值可将说明书中的批内精密性原始值重新还原成吸光度值。结合微量加样器校准证书可得出,75μ1的相对误差是0.15%,可知不确定度=0.234μ1;结合75μ1微量加样器在试验期间核查的相关数据,可知不确定度=0.341μ1;结合检验规程的规定,每批次检验过程中样品的加样时间均小于30min,可知不确定度=8.66min;结合酶标仪鉴定证书,可知不确定度=0.01。最终可得,样品的吸光度值和cutoff值比值B=4.332,不确定度U=1.2,k=2。结论:通过酶标法测定人血清中HIV抗体的不确定度,可减少假阴性出现几率,可辨别检测质量的影响因素,有利于实验室检测质量的提高。Objective:Exploring and analyzing the uncertainty of the determination of HIV antibody in human serum by enzyme-labeled method.Methods:From August 2019 to December 2019,according to JJF1059-1999"Evaluation and Expression of Uncertainty in Measurement",the enzyme-labeled method was used to determine the HIV antibody in human serum,and the result of HIV antibody test was used to clarify the uncertainty and carry out Detailed analysis.Results:The data showed that negative B=0.28,negative absorbance value=0.078,cutoff value=0.278.The cutoff value can restore the original value of the intra-batch precision in the manual to the absorbance value.Combining with the micro-sampler calibration certificate,it can be concluded that the relative error of 75μ1 is 0.15%,and the uncertainty is 0.234μ1;combined with the relevant data checked by the 75μ1 micro-sampler during the test,the uncertainty=0.341μ1;in accordance with the inspection regulations,the sample addition time for each batch of samples during the inspection process is less than 30 minutes,and the uncertainty=8.66 minutes;combined with the identification certificate of the microplate reader,the uncertainty=0.01.Finally,it can be obtained that the ratio of the absorbance value and the cutoff value of the sample is B=4.332,the uncertainty U=1.2,and k=2.Conclusion:The determination of the uncertainty of HIV antibodies in human serum by the enzyme-labeled method can reduce the probability of false negatives and identify the factors affecting the quality of the test,which is beneficial to the improvement of the quality of laboratory tests.

关 键 词：酶标法 HIV抗体 不确定度 

分 类 号：R446.11[医药卫生—诊断学]