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ELISA法检测血清HIV抗原抗体的测量不确定度评定 被引量:1

Evaluation of measurement uncertainty in detecting serum HIV antigen-antibody by ELISA
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摘要 目的:本文依据JJF1059-1999《测量不确定度评定与表示》,希望能探索一种较为合理的ELISA法检测结果不确定度的评定模式。方法:用ELISA法检测含弱阳性HIV1型抗体和弱阳性HIV抗原的混合血清,分析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:混合血清的样品吸光度值与cutoff值的比值为4.335,U=1.2(k=2);Urel=0.27。结论:ELISA法检测血清HIV抗原抗体的结果判定应考虑样品吸光度值与cutoff值的比值(B)测量不确定度对结果的影响,可有效降低假阴性出现的风险。分析不确定度各分量对测量结果的相对贡献,可以看出影响检测质量的主要因素,有利于实验室的质量控制和提高检测质量。 Objective: To explore a more reasonable assessment model of the uncertainty of the test result with ELISA according to Evaluation and expression of uncertainty in measurement (JJF 1059-1999). Methods: Mixed serum of weak positive HIV antibody and weak positive HIV antigen were detected by ELISA in which sources of uncertainty was analysed and standard uncertainty of each component, combined standard uncertainty and expanded uncertainty were evaluated. Results: Absorbance value and cutoff value of the ratio in pooled serum samples was 4.335, U=1.2 (k=2), Urel=0.27. Conclusion: Result determination should consider the effect of uncertainty of the test resuh in absorbance value and cutoff value of the ratio which can reduce validly risk of appearing false negative by ELISA.Analysing relative contribution of various components of uncertainty on measurement results can find main factors of effecting test quality which is help to quality control and improving test quality of laboratory.
出处 《甘肃医药》 2012年第1期24-28,共5页 Gansu Medical Journal
关键词 ELISA法 HIV抗原抗体 测量不确定度 ELISA HIV 1 antibody HIV antigen measurement uncertainty
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参考文献4

  • 1BIPM,IEC,IFCC,ISO,IUPAC,IUPAP,OIML. Guide to the expression of uncertainty in measurement(GUM)[$].lST edition, the lnternation',d Organization for standardization, Geneva, 1995.
  • 2国家质量技术监督局.JJFl059—1999,测量不确定度评定与表示[M].北京:中国计量出版社,1999.
  • 3BIO-RAD公司.人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法)说明书,2009.
  • 4国家质量技术监督局计量司.测量不确定度评定与表示指南[M].北京:中国计量出版社,2000.29-44.

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