【摘要】 目的验证化学发光法检测第3代促甲状腺素(TSH-3)的性能。方法参照美国临床和实验室标准化协会(CLSI)的评价方法和国内文献,结合实际工作条件,设计验证方案,对西门子Centaur XP化学发光免疫检测系统测定血清TSH-3的精密度、准确度、分析灵敏度、分析测量范围、临床可报告范围以及生物参考区间等6个性能指标进行验证评价,并将检测结果与厂家提供的分析性能进行比较。结果 TSH-3检测的批内和批间精密度分别为2.17%和2.14%,高、中、低三个浓度水平的日间精密度分别为7.98%、6.81%、6.69%;检测偏差在-3.45%～-1.55%;检测低限为0.005 4μIU/ml,生物检测限在(0.010 2～0.015 3)μIU/ml,功能灵敏度约为0.017 0μIU/ml;分析测量范围在(0.005 4～140.613 0)μIU/ml;临床可报告范围为(0.015 3～703.065)μIU/ml;37份健康体检儿童中除2份标本结果在厂家提供的参考区间外,其余35份全部在参考范围内。结论化学发光法检测TSH-3在本室的分析性能与厂家提供的性能基本吻合,符合临床需求。更多还原

【Abstract】 Objective To verify the method performance of TSH-3 chemiluminescence immunoassay.Methods Referring to CLSI evaluation protocols and pertinent literature,combining our actual works,we designed verification procedure and experimental methods.The precision,accuracy,analytical sensitivity,analytical measurement range,clinical reportable range and biotic interval of TSH-3 were verified on the Centaur XP chemiluminescence immunoassay system.Results would be compared with the declaration of the manufacturer.Results The results showed the within,without and between-day inaccuracy were 2.17%,2.14% and 7.98%,6.81%,6.69% respectively.The relative bias were from-3.45% to-1.55%.LLD was 0.005 4 μIU/ml,BLD was between 0.010 2 μIU/ml and 0.015 3 μIU/ml,FS was about 0.017 0 μIU/ml.AMR was(0.005 4～140.613 0) μIU/ml.CRR was(0.015 3～703.065) μIU/ml.Except for 2 specimen′s TSH-3 results were beyond manufacturer′s claimed,35 results were within.Conclusion The performances of the detection system are according with the declaration of the manufacturer and meet the requests of the physicians.更多还原