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目的:进行重组人CD22单抗(SM03)临床药动学研究,建立血药浓度测定的酶联免疫分析(ELISA)方法。方法:构建并表达SM03抗独特型抗体(LRID03)和CD22抗原,分别建立夹心ELISA(S-ELISA)和竞争ELISA(C-ELISA)分析法,并对2种方法测定血药浓度的适用性进行比较和验证。结果:S-ELISA和C-ELISA都具有良好特异性、准确度和精密度。结论:S-ELISA方法的灵敏度更高并且干扰因素少,因而更适于临床药动学研究。
OBJECTIVE: To study the clinical pharmacokinetics of recombinant human CD22 monoclonal antibody (SM03) and establish an enzyme-linked immunoassay (ELISA) method for the determination of plasma concentration. Methods: SM03 anti-idiotypic antibody (LRID03) and CD22 antigen were constructed and expressed. The sandwich ELISA and C-ELISA assays were established respectively. The applicability of the two methods in determining plasma concentration Compare and verify. Results: Both S-ELISA and C-ELISA have good specificity, accuracy and precision. Conclusion: The S-ELISA method is more sensitive and less interfering and therefore more suitable for clinical pharmacokinetic studies.