Wolf J
Gilead Sciences, Inc., Boulder, CO 80301, USA.
Dev Biol (Basel). 2002;107:63-7.
The IL-1ra bioassay was overhauled in 1993 at Synergen, Inc. The team included bioassay specialists and two pre-clinical statisticians. We began by focusing on the technical aspects, optimizing the number of cells per well, altering the staining procedure, and checking incubation times. We then proceeded to revise the layout of the dose-response curves on the 96-well plates and included an internal control as well as a standard. Finally, we reconfigured the statistical modelling procedure to model each plate as a whole using a 9-parameter logistic curve. When the work was concluded, the precision (%CV) had improved from 44% to 10%, while the retest rate was reduced from 20-30% to less than 5%.
1993年，Synergen公司对白细胞介素-1受体拮抗剂（IL-1ra）生物测定法进行了全面改革。团队成员包括生物测定专家和两名临床前统计学家。我们首先关注技术方面，优化每孔细胞数量，改变染色程序，并检查孵育时间。然后，我们着手修改96孔板上剂量反应曲线的布局，并纳入内部对照和标准品。最后，我们重新配置了统计建模程序，使用9参数逻辑曲线将每个平板作为一个整体进行建模。工作完成后，精密度（%CV）从44%提高到了10%，而复测率从20 - 30%降低到了5%以下。
