摘要
目的:对用酶联免疫法(ELISA)测人血浆或血清中丙型肝炎病毒抗体的测量结果进行不确定度评定。方法:依据北京万泰生物药业股份有限公司试剂盒说明书列出数学模式,参照JJF1059-1999,用两种方法对ELISA法检测丙型肝炎病毒抗体中的不确定度进行评定。第一方法是对同一份样本重复测量10次作不确定度评定,第二种方法是对一份样本测量一次作不确定度评定。结果:第一种方法测量结果的扩展不确定度为U=0.40,k=2.26;第二方法测量结果的扩展不确定度为U=0.34,k=2。结论:考虑测量不确定度可以减少出现假阴性结果。第一种方法较费时费力,第二种方法较简便易行。
Objective：To evaluate the uncertainty of measurement of antibody to hepatitis c virus in human plasma or serum detected by ELISA. Methods： The mathematical model was listed on the basis of diagnostic kit for antibody to hepatitis e virus which were manufactured by Beijing Wantai Biological Pharmacy, the uncertainty of measurement of antibody to hepatitis c virus was evaluated according to JJF1059 - 1999 by two methods. The uncertainty evaluation was carried out on the same sample for 10 times by the first method, while the second method was based on a sample for once evalution. Results： The expanded uncertainty of the first method was U = 0.40, k = 2.26, and that of the second method was U = 0.34, k = 2. Condusion： The probability of flase negative results was reduced due to the evaluation of uncertainty of measurement. The first method is time - consuming and laborious, the second method is simple and feasible.
出处
《中国卫生检验杂志》
北大核心
2013年第3期682-684,共3页
Chinese Journal of Health Laboratory Technology
