酶标法检测丙型肝炎病毒抗体结果不确定度评定

The Evaluation of the uncertain result of the hepatitis Cvirus antibody determination by ELLSA

目的:对用酶标法测定丙型肝炎病毒抗体结果的不确定度进行评定,确保检测结果的准确可靠。方法:使用北京万泰生物药业股份有限公司的丙型肝炎病毒抗体诊断试剂盒,采用酶标法,同一实验室工作人员、同一时间、同一环境对未知标本进行10次重复测试,获得未知样本OD值,建立数学模型,分析酶标法测定丙型肝炎病毒抗体的不确定度来源,对分量不确定度进行评估来评定酶标法测定丙型肝炎病毒抗体的不确定度。结果:样品中丙型肝炎病毒抗体的扩展不确定度U=0.178,K=2。结论:在检测结果中带入测量不确定度结果,可以降低出现假阴性结果的可能性,还可以通过对各分量不确定度的评定,了解实验过程中各分量对实验结果的影响情况,以制订更科学、更完善的检测操作规程,使检测结果更准确可靠。

Objective：To evaluate the uncertainty of hepatitis Cvirus antibodies detected by ELISA were to ensure accurate and reliable test results.Methods： One unkown sample was measured repeatedly 10 times by one laboratory technician at the same time in the same working condition with hepatitis Cvirus antibody diagnostic reagent kit by Beijing Wantai Biological Pharmacy.The OD values were collected to build a mathematical model to analyse the indeterminacy origin of the measurement.The indeterminacy was assessed by evaluating the component indeterminacy.Results： The extended uncertainty of hepatitis C virus antibody level in sample was 0.178（k=2）.Conclusion： The probability of false negative result could be reduced by adding the measurement indeterminacy results.It is also helpful to establish a more scientific and more thorough operating procedure to make the detection results accurately by evaluating the indeterminacy of component and realizing its effect for detection results.