微粒子酶免疫法检测前列腺特异抗原的评价

Analytical evaluation of MEIA assay for prostate specific antigen

目的:对微粒子酶免疫法 (MEIA )检测血清总前列腺特异抗原 (T- PSA )、游离前列腺特异抗原 (F-PSA)进行方法学评价。 方法:MEIA测定血清总 PSA(T- PSA)、游离 PSA (F- PSA )的精密度、灵敏度、回收率、校正曲线的稳定性及干扰因素进行分析。 结果 :MEIA法检测 T- PSA、F- PSA均具有较高的精密度 (总 CV分别为4 .4 6 %～ 4 .83%和 3.96 %～ 4 .70 % ) ,灵敏度分别为 T- PSA0 .0 5μg/ L ,F- PSA0 .0 3μg/ L ,回收率分别为 91.7%～10 2 .8% ,92 .6 %～ 10 2 .1% ,校正曲线至少可稳定 4周 ,黄疸、脂血、溶血现象对测定结果基本无影响。结论:MEIA法操作简单 ,自动化程度高 ,检测速度快 ,有较高的精密度、灵敏度和特异性 ,结果准确可靠 ,适合各实验室的应用 。

Objective: To evaluate the analytical characters of total PSA and free PSA with Micropartical Enzyme Immunoassay(MEIA) technology. Methods: The parameters of total PSA and free PSA, such as precision, sensitivity, recovery and calibration curve stability were determined. Results: The MEIA method showed an excellent precision (total CV for total PSA and free PSA were 4.46%~4.83% and 3.96% ~4.70% respectively), and the sensitivity were 0.05 μg/L,0.03ug/L respectively,and the recovery were 91.7%~102.8% and 92.6%~102.1% respectively. The calibration curve was stable for at least four weeks. There was no interference to the results for bilirubin, triglyceride, and hemoglobin. Conclusion: The MEIA method is reliable, precise, rapid and easy to perform. The assay is very useful and suitable to determined the levels of total PSA and free PSA in clinical laboratory.