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目的为保证检测系统间的稳定可比,对申报市药监局待评审的血流变测试仪A与已通过评审并临床应用很稳定的血流变测试仪B进行比对偏倚分析,验证待审仪器A申报资料中的重复性、精密度。方法根据审核标准对两台仪器进行重复性以及精密度评价,参照美国国家临床实验室标准化协会(NCCLS)的EP9-A2文件对两台仪器进行方法验证。结果待评审的血流变测试仪A重复性误差大于仪器说明书的范围。仪器A与仪器B比对,全血1切、5切、30切、200切黏度和血浆黏度的偏倚为14.08%,30.95%,22.82%,13.07%,20.92%。结论仪器A重复性误差与其说明书数据不一致;仪器A与仪器B相比,全血黏度1切、5切、30切、200切、血浆黏度性能不相当。
Objective To ensure the stability of the detection system comparable to the City Drug Administration to be reviewed by the rheological tester A and has been through the review and clinical application is very stable hemorheology tester B bias analysis to verify pending Instrument A to declare the repeatability of data, precision. Methods The repeatability and precision of the two instruments were evaluated according to the audit criteria, and the two instruments were validated by reference to the EP9-A2 file from the National Institute of Clinical Laboratory Standards (NCCLS). Results The blood rheology tester to be reviewed A repeatability error is greater than the scope of the instrument manual. Instrument A and instrument B were compared. The biases of 1, 5, 30, 200 shear viscosity and plasma viscosity in whole blood were 14.08%, 30.95%, 22.82%, 13.07% and 20.92% respectively. Conclusion The repeatability error of instrument A is inconsistent with the data of its instruction manual. Compared with instrument B, the whole blood viscosity of instrument A is 1, 5, 30, 200, and the viscosity of plasma is not equivalent.