Roche E2010检测系统测定促甲状腺激素（TSH）分析灵敏度与功能灵敏度的验证

目的：对Roche E2010检测系统测定促甲状腺激素（TSH）项目的检测低限、功能灵敏度进行验证。方法：对空白样品进行连续10 d重复性实验,验证TSH检测低限;制备系列低浓度的TSH样品,验证其功能灵敏度。结果：RocheE2010检测系统测定TSH的最低检测限为0.007 mIU/L,与Roche厂家产品说明书声称有差异,其最低检测限为0.005 mIU/L;功能灵敏度验证值为0.010 mIU/L,与Roche厂家产品说明书声称有差异（0.014 mIU/L）。结论：实验室必须验证和建立本实验室条件的功能灵敏度,为甲状腺患者提供准确可靠的促甲状腺激素（TSH）低值结果。

Validation for Analytical Sensitivity of Thyrotropin(TSH) Detected by Roche E2010 System

Objective：To validate the analytical sensitivity lower lim it of detection（LLD） and functional sensitivity（FS） of thyroid stimulating hormore（TSH） detected by Roche E2010 system.Methods： Two different kinds of samples were prepared.One sample was a＂blank ＂that had a zero concentration of TSH.The second was a ＂spiked＂sample that had a low concentration of TSH.Both the blank and spiked samples were measured repeatedly 10days in a replication type of experiment,then the means and SDs were calculated from the values observed for the samples.Different estimates of detection limit may be calculated from the data on blank and spiked samples.The validation of the LLD was＂blank＂samples;the validation of the FS was the＂spiked＂samples.Results：The LLD of TSH detected by Roche E2010 system was 0.007 mIU/L,which was inconsistent with the value provided by specification;the FS of TSH detected by Roche E2010 system was 0.010 mIU/L,which was less than the value（0.014 mIU/L） provided by manufactrure claim.Conclusion： The laboratory should validate the fuctional sensitivity in its owner situation,to insure the values of low concentration TSH reliably.