定量检测猕猴血清中重组人源化抗狂犬病毒单克隆抗体间接ELISA法的建立

目的：建立定量检测血清中重组人源化抗狂犬病毒单克隆抗体（HuMabs）NM57的间接ELISA法，为药代动力学研究提供一种简单快速的方法。方法：采用狂犬病毒糖蛋白包被酶标板、HRP标记的IgG-Fc段为标记抗体，建立定量检测HuMabsNM57的间接ELISA法，并对其特异性、灵敏度、精密度及准确度进行检测。结果：间接ELISA法检测HuMabsNM57的灵敏度为5ng／mL，组内及组间精密度分别为2．6％-6．0％、8．5％-11．3％。结论：建立了灵敏度高、特异性强的检测HuMabs NM57的间接ELISA法，精密度及准确度均符合药代动力学要求，可用于猕猴及人血清中HuMabsNM57的检测。

Establishment of Indirect ELISA for Quantitative Measurement of Recombinant Human Rabies Monoclonal Antibody in Rhesus Serum

Objective： To establish indirect ELISA for quantitative measurement of recombinant human rabies monoclonal antibody（HuMabs）NM57 and provide a new convenient method for the investigation of pharmacokinetics. Methods： The microplate was coated with glycoprotein of rabies. HRP labeled IgG-Fc was used as labelled antibody. The established ELISA would be evaluated by the specificity, sensitivity, precision and accuracy. Results： The lower limit of sensitivity of the assay was 5 ng/mL. Intra-assay and inter-assay variability were 2.6%-6.0% and 8.5%-1.3%, respectively. Conclusion： The results showed that the established indirect ELISA was a sensitive and specific method and could be used for quantitative measurement of HuMabs NM57 in rhesus serum samples.