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目的 了解百日咳疫苗血清学效力试验(PSPT)与小鼠保护力试验(MPT)结果的相关性,为该法替代MPT积累资料。方法 用不同剂量的DTP疫苗免疫小鼠,4w后采血,用ELISA测定小鼠血清中抗百日咳菌表面 抗原的总抗体滴度。用平行线法计算疫苗的效力,与MPT测定结果进行相关性分析。结果15批疫苗分别用 PSPT和MPT法测定的效力单位相关性显著(r= 0.9358,p<0.001),二者差异无显著意义(P>0.05)。与 MPT法相 比,PSFF法有更高的重复性,而且95%可信限较小。结论PSPT法有望取代MPT。
Objective To understand the correlation between the pertussis vaccine serological test (PSPT) and the mouse protective test (MPT), and to accumulate MPT data for this method. Methods Mice were immunized with different dosages of DTP vaccine and blood was collected 4 weeks later. The total antibody titer of anti-pertussis surface antigens was determined by ELISA. The efficacy of the vaccine was calculated using the parallel line method and the correlation with the MPT assay results. Results The efficacy units of 15 batches of vaccine were significantly correlated with PSPT and MPT (r = 0.9358, p <0.001), respectively. There was no significant difference between the two groups (P> 0.05). Compared with the MPT method, the PSFF method has higher repeatability and a 95% lower confidence limit. Conclusion PSPT method is expected to replace MPT.