ISO15189在酶联免疫检测性能验证方法的探讨

Study on the application of ISO15189 in methods of performace verification of ELISA

目的经血传播疾病的抗原抗体检测采用酶联免疫方法,对这些方法进行性能验证,以符合ISO15189的要求。方法血液筛查检测采用的酶联免疫方法共有8个检测系统,针对这8个检测系统进行重复性、精密度、灵敏度及特异性、符合性、最低检出限、CUTOFF值的验证。结果 7个方面的性能验证数据与相应的标准进行比较,8个检测系统所有的性能验证结果都符合相应标准的要求。结论针对酶联免疫检测采用的性能验证方法能够满足ISO15189的要求,同时也符合实验室的要求,能够提高实验室对检测系统的性能指标的认识,对实验室管理水平的提高起到了重要的作用。

Objective ELISA is used to detect the antigens and antibodies of blood transmited diseases. In this study, this method is validated to meet the requirement of ISO15189. Methods Eight detection systems of ELISA were used for the blood screening test. For the eight detection systems,the performace indexes including repeatability, precision, sensitivity and specicifity,compliance,detection limit and CUTOFF value were verified. Results Through camparing the data of the seven indexes of performaee verification with the corresponding standards,it was found that all the results of the performace indexes of the eight detection systems meet the requirements of the corresponding standards. Conclusion The methods of pefformaee verification aimed at ELISA could meet both the requirements of ISO15189 and the requirements of laboratory. Meanwhile, the methods play an important role in enhancing the cognition of laboratorian on performance indexs and raising the level of management of labretatory.