荧光标记CD3/CD4/CD8单克隆抗体的质量控制

Quality Control on Fluorescein-labeled Monoclonal Antibodies against CD3/CD4/CD8

目的对荧光素标记的CD3、CD4和CD8单克隆抗体进行质量控制。方法采用多参数的流式细胞分析技术,对单色、多色荧光标记抗体的偶联率及偶联效果进行分析与评价,并进行稳定性试验。结果荧光标记的单克隆抗体特异性保持完好;单色标记的抗体荧光强度均比进口对照低一个数量级;FITC-CD3/PE-CD4平均荧光强度与进口对照相差较大,FITC-CD3/PE-CD8和FITC-CD4/PE-CD8平均荧光强度与进口对照相差较小;FITC标记产物的F/P值控制在1～2之间;标记抗体于2～8℃放置18个月,稳定性良好。结论应用FITC、PE标记的CD3、CD4和CD8单克隆抗体可以采用流式细胞仪进行检测。

Objective To control the qualities of fluorescein-labeled monoclonal antibodies （McAbs） against CD3/CD4/ CD8. Methods Analyze and evaluate the coupling rate and effect of monochromatic and polychromatic fluorescein-labeled McAbs by mulit-parameter flowcytometry （FCM）. Observe the stability of fluorescein-labeled McAb after storage at 2-8℃ for various months. Re- sults The fluorescein-labeled McAbs showed good specificity. Compared with that of imported product of the same kind, the fluores- cence intensity of monochromatic fluorescein-labeled McAb decreased by one order of magnitude. FITC-CD3/PE-CD4 showed signifi- cant difference, while FITC-CD3/PE-CD8 and FITC-CD4/PE-CD8 showed no significant difference with the imported product of the same kind in mean fluorescence intensity. The F/P value of FITC-labeled McAb was 1-2. The fluorescein-labeled McAb showed good stability after storage at 2 - 8℃ for 18 months. Conclusion The qualities of FITC- and PE-labeled monoclonal antibodies（McAbs） a- gainst CD3/CD4/CD8 may be controlled by FCM.