口蹄疫病毒O型抗体液相阻断ELISA试验的测量不确定度评估

Evaluation of Measurement Uncertainty in Detecting Antibodies against FMDV Type O by LPB-ELISA

为探索一种较为合理的兽医实验室ELISA试验的测量不确定度评估模式,应用液相阻断ELISA试验方法,对口蹄疫O型抗体进行检测,依据《测量不确定度评定与表示》(JJF1059.1—2012),分析试验的不确定来源并评定各分量的标准不确定度、合成标准不确定度和扩展不确定度。结果显示:最终cutoff临界值与样品判定浓度的OD_(450 mm)值的比值为1.390,U=0.221(k=2);测量不确定度的加入提升了测量结果的可信度,并有效降低了假阳性、假阴性出现的风险;分析不确定度各分量对测量结果的相对贡献,可以找出影响检测质量的主要因素,从而有利于实验室的质量控制和检测质量的提高。

In order to explore a reasonable model to evaluate the measurement uncertainty of ELISA results in veterinary laboratories,the Foot-and-mouth disease virus(FMDV)type O antibodies was detected by liquidphase blocking ELISA(LPB-ELISA).According to the Evaluation and Expression of Uncertainty in Measurement(JJF 1059.1-2012),the sources of uncertainty were analyzed,and the standard uncertainty,combined standard uncertainty and expanded uncertainty for each component were evaluated.The results showed that ratio of final cutoff value to the OD450 mm of the determined concentration of the sample was 1.390,U=0.221(k=2).Uncertainty in measurement improved the credibility of the measurement results and effectively reduced the risks of false positive and false negative results.By analyzing the relative contribution of various components,the main factors influencing detection results could be found out,so it was helpful for control quality of laboratories and improvement of detection quality.