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目的测定恒河猴经静脉重复给予重组人角质细胞生长因子(rhKGF)后血清中特异性抗体的水平及抗体中和性质。方法采用间接ELISA法检测猴血清中的抗体水平,同时采用32D-KGFR细胞检测抗体的中和活性。结果确定了抗原包被浓度为10μg·mL-1,抗体从1.6×103开始稀释,二抗稀释倍数为1∶5×103的间接ELISA法实验体系;14～56 d均可检测到抗体的存在;生物学活性测定的结果显示其为非中和性抗体。结论重复给予恒河猴rhKGF的毒性试验中,部分猴的血清中检测到抗体,但不是中和抗体。
Objective To determine the levels of serum specific antibodies and the antibody neutralization properties of recombinant human keratinocyte growth factor (rhKGF) administered intravenously in rhesus monkeys. Methods The serum level of antibody in monkey serum was detected by indirect ELISA, and the neutralizing activity of the antibody was detected by 32D-KGFR cells. The results showed that the antibody concentration was 10μg · mL-1, the antibody was diluted from 1.6 × 103, and the dilution of secondary antibody was 1: 5 × 103 by indirect ELISA. The antibody could be detected from 14 to 56 days ; The result of the biological activity assay shows that it is a non-neutralizing antibody. Conclusions In the toxicity test of rhKGF given to rhesus monkeys, antibodies were detected in the sera of some monkeys, but not neutralizing antibodies.