ELISA法检测家禽活疫苗中禽白血病病毒污染的测量不确定度评估
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Evaluation on the Measurement Uncertainty of ELISA Assay for Detection of Poultry Live Vaccines Contaminated with Avian Leukosis Virus
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    摘要:

    为分析不确定度的来源并对其量化,从而提高检测结果的准确性,对酶联免疫吸附(ELISA)法检测家禽活疫苗中禽白血病病毒污染的测量不确定度进行评估。用禽白血病病毒ELISA检测试剂盒,对4批家禽活疫苗进行禽白血病病毒检测,依据《兽医检测实验室ELISA试验测量不确定度评估指南》(CNAS-GL043),分析试验的不确定度来源,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,每批家禽活疫苗连续3代细胞培养物的禽白血病病毒OD650 nm值不确定度范围的上限值均小于0.300,判定为阴性,即所检测4批活疫苗中没有禽白血病病毒污染。ELISA法检测中引入不确定度概念,不仅可以提高检测结果的准确性和可靠性,而且还可以分析不确定度各分量对测量结果的相对贡献,找出影响检测质量的主要因素,从而有利于实验室质量控制和检测质量的提高。

    Abstract:

    In order to analyze the source of measurement uncertainty and quantify it,so as to improve the accuracy of testing results,the measurement uncertainty of enzyme-linked immune-sorbent assay(ELISA)for detection of poultry live vaccines contaminated with avian leukosis virus(ALV)was evaluated. Four batches of poultry live vaccines were detected for ALV by ELISA kit,the source of uncertainty was analyzed,and the uncertainty of standard,combined standard and expansion of each component were evaluated according to the Guidelines to the Evaluation on the Measurement Uncertainty of ELISA Assay of Veterinary Laboratories(CNAS-GL043). The results showed that the upper limit of the uncertainty range of ALV OD650 nm value in three successive generations of cell culture of each batch of live vaccines was less than 0.300,which could be considered as negative,that was,no ALV contamination was detected in the four batches of live vaccines. The concept of uncertainty was introduced into ELISA assay,by which,not only the accuracy and reliability of test results were improved,but also relative contribution of each component of the uncertainty to measurement results were analyzed to identify major factors that could affect testing quality,so as to improve the quality of laboratory control and testing.

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李雪莲,党启峰,单峰,刘雪慧,徐太辉,刘相娥. ELISA法检测家禽活疫苗中禽白血病病毒污染的测量不确定度评估[J].《中国动物检疫》编辑部,2020,37(9):89-95.

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  • 在线发布日期: 2020-09-02
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