预设框架质控法在ELISA中的应用探讨

目的 探讨预设框架质控法在ELISA中应用的可行性.方法 查阅同一质控批号ELISA检测的连续20批室内质控测定值,应用即刻法、预设框架质控法和Levery-Jennings (L-J)法分别进行分析,观察其在控、告警与失控情况.结果 案例一:在即刻法中,20次质控测定值中的第6点为告警,其余测定值均为在控;在预设框架质控法中,20次质控测定值中的第6点为失控,第7点为失控,其余测定值均为在控;在L-J法中,20次质控测定值中的第6点为失控,第7点为告警,其余测定值均为在控.案例二:在即刻法中,20次质控测定值全在控;在预设框架质控法中,20次质控测定值中的第22点告警,其余测定结果在控;在L-J法中,20次质控测定值中的第22点为告警,其余测定值为在控.结论 预设框架质控法可以作为ELISA检测的室内质控方法.

Discussion on Application of the Preset Frame Quality Control Method in ELISA

Objective To discuss the feasibility of the preset frame quality control method in ELISA.Methods We evaluated consecutively 20 batches of internal quality control data at the same quality control batch number in ELISA.The data were analyzed by the Grubbs method,the preset frame quality control method and the Levery-Jennings method.We observed its situations in the control,alarm and out of control cases.Results Case one:In the Grubbs method,the 6th point of the 20 batches internal quality control data is the alarm and the rest of the data are in the control.In the preset frame quality control method,the 6th and the 7th point is out of control and the rest of the data are in the control cases.In the Levery-Jennings method,the 6th point is out of control case,the 7th point is alarm and the rest of the data are in the control cases.Case two:In the Grubbs method,all of the 20 batches are in the control cases.In the preset frame quality control method,the 22th point is alarm case and the rest of the data are in the control cases.In the Levery-Jennings method,the 22th point is alarm case and the rest of the data are in the control cases.Conclusion The preset frame quality control method can be used as an internal quality control method in ELISA.