西门子Altellica IM1600全自动化学发光分析仪检测甲状腺激素5项的性能及检出限验证

Performance and Detection Limit Verification of Siemens Altellica IM1600 Fully Automatic Chemiluminescence Analyzer for Detecting Five Thyroid Hormones

目的探讨应用西门子Altellica IM1600全自动化学发光分析仪检测三碘甲状腺原氨酸(T_(3))、甲状腺素(T_(4))、游离三碘甲状腺原氨酸(FT_(3))、游离甲状腺素(FT_(4))及促甲状腺素(TSH)水平的性能。方法参照行标及CNAS性能验证相关文件,对西门子Altellica IM1600全自动化学发光分析仪检测甲状腺激素5项的精密度、准确度、线性范围、最低检出限等进行验证和评价。结果甲状腺激素5项批内精密度为1.60%~4.04%,均小于1/4 Tea(6.25%),批间精密度为1.90%~8.01%,均小于1/3 Tea(8.33%);甲功5项的偏倚范围为-3.93%~3.70%,<1/2 Tea(12.5%),在允许偏差范围之内,准确度验证合格;线性验证斜率为0.973~1.007,R^(2)≥0.99,线性验证良好;检出限验证中空白检出限(LoB)与定量检出限(LoD)均符合厂家说明书要求,且在临床可接受范围内。结论西门子Altellica IM1600全自动化学发光分析仪检测甲状腺激素5项性能符合要求,能够满足临床诊断需求。

Objective To evaluate the performance of using Siemens Altellica IM1600 fully automatic chemiluminescence analyzer to detect triiodothyronine(T_(3)),thyroxine(T_(4)),free triiodothyronine(FT_(3)),free thyroxine(FT_(4)),and thyrotropin(TSH)items.Methods Referring to the industry standards and CNAS performance verification documents,the precision,accuracy,linear range,and minimum detection limit of the Siemens Altellica IM1600 fully automatic chemiluminescence analyzer for detecting thyroid hormones were verified and evaluated.Results The intra batch precision of thyroid hormones was within 1.60%to 4.04%,which was less than 1/4Tea(6.25%),and the inter batch precision was within 1.90%to 8.01%,which was less than 1/3Tea(8.33%);The bias range of the five items of Jia Gong was-3.93%to 3.70%,<1/2Tea(12.5%),which was within the allowable deviation range,and the accuracy verification was qualified;The slope of linear validation was 0.973-1.007,R^(2)≥0.99,indicating a good linear validation;The detection limit verification of hollow white detection limit(LoB)and quantitative detection limit(LoD)both met the requirements of the manufacturer’s instructions and were within the clinically acceptable range.Conclusion Siemens Altellica IM1600 fully automatic chemiluminescence analyzer can meet the requirements for detecting thyroid hormones in five aspects and is qualified for clinical diagnostic needs.