新型电化学发光仪甲状腺激素项目性能验证  

Performance Verification of Thyroid Hormone Project of New Electro Chemiluminescence Instrument

作　　者：汪津[1] 唐妮娜[1] WANG Jin;TANG Ni’na(Clinical Laboratory,Taizhou Hospital of Traditional Chinese Medicine,Taizhou Jiangsu 225300,China)

机构地区：[1]泰州市中医院检验科,江苏泰州225300

出　　处：《中国卫生标准管理》2023年第5期124-129,共6页China Health Standard Management

摘　　要：目的评价罗氏e 801电化学发光分析仪对三碘甲状腺原氨酸(triiodothyronine,T3)、甲状腺素(thyroxine,T4)、游离三碘甲状腺原氨酸(free triiodothyronine,FT3)、促甲状腺激素(thyroid-stimulating hormone,TSH)、游离甲状腺素(free thyroxine,FT4)精密度、线性范围、正确度、参考区间、分析灵敏度,以验证检测系统性能符合质量目标。方法收集泰州市中医院2022年8—10月门诊,住院,体检中心标本,排除脂血、溶血、黄疸血清样品,根据ISO15189医学实验室能力和质量认可准则制订方案,对检测系统进行性能验证。结果罗氏e 801电化学发光分析仪分析得到的精密度、正确度、线性范围、参考区间、分析灵敏度性能指标均满足临床检测要求。结论罗氏e 801电化学发光分析仪检测性能符合要求,能提供准确可靠的检测结果满足临床需求。Objective To evaluate the effect of Roche e 801 electrochemical luminescence analyzer on the determination of triiodothyronine(T3),thyroxine(T4),free triiodothyronine(FT3),thyroid-stimulating hormone(TSH),free thyroxine(FT4),linear range,accuracy,reference interval,and analytical sensitivity to verify that the performance of the detection system met the quality objectives.Methods Samples were collected from outpatient,inpatient and physical examination centers of Taizhou Hospital from August to October 2022.Serum samples of lipid,hemolysis and jaundice were excluded.According to ISO15189 medical laboratory ability and quality accreditation criteria to make a scheme,the performance of the detection system was verified.Results The precision,accuracy,linear range,reference interval and analytical sensitivity of Roche e 801 electro chemiluminescence analyzer all met the requirements of clinical detection.Conclusion The precision,accuracy,linear range,reference range,and analytical sensitivity performance indexes of the Roche e 801 electro chemiluminescence analyzer analysis all meet clinical testing requirements.

关 键 词：电化学发光仪 甲状腺激素 性能验证 精密度 正确度 分析灵敏度 

分 类 号：R446[医药卫生—诊断学]