摘要
目的验证迈瑞CL-6000I化学发光分析仪检测系统的性能。方法参照国家临床实验室标准化委员会(NCCLS)等相关文件对迈瑞CL-6000I化学发光免疫分析仪检测系统检测甲状腺激素:三碘甲状腺原氨酸(T3)、四碘甲状腺原氨酸(T4)、游离三碘甲状腺原氨酸(FT3)、游离四碘甲状腺原氨酸(FT4)、促甲状腺素(TSH)5个项目的精密度、准确度、线性范围、生物参考区间进行验证。结果检测的5个项目批内精密度变异系数CV%在1.837%~4.07%,批间精密度变异系数CV%在2.634%~7.49%,准确度比对偏倚范围为6.289%~9.62%,线性范围斜率在0.9812~1.013,r2在0.9517~0.9992,均满足相关文件的要求;参与生物参考区间验证的样本检测结果均在厂家标注的范围内。结论迈瑞CL-6000I化学发光分析仪检测系统精密度、准确度、线性范围、生物参考区间验证通过。满足临床诊断与预后监测的需要。
Objective To verify the performance of Mindray CL-6000I chemiluminescence analyzer detection system.Methods According to the National Clinical Laboratory Standardization Committee(NCCLS)and other relevant documents,the Mindray CL-6000I chemiluminescence immunoassay detection system was used to detect thyroid hormones:triiodothyronine(T3),tetraiodothyronine(T4),Free triiodothyronine(FT3),free tetraiodothyronine(FT4),and thyroid stimulating hormone(TSH)were tested for precision,accuracy,linear range,and biological reference interval.Results The precision variation coefficient CV%of the five items tested was 1.837%-4.07%,the precision variation coefficient CV%between batches was 2.634%-7.49%,the accuracy comparison bias range was 6.289%-9.62%,and the linear range slope was 0.9812-1.013,r2 of 0.9517-0.9992,all met the requirements of relevant documents;the test results of the samples participating in the biological reference interval verification were within the range marked by the manufacturer.Conclusion Mindray CL-6000I chemiluminescence analyzer detection system precision,accuracy,linear range and biological reference interval have been verified,which meets the needs of clinical diagnosis and prognosis monitoring.
作者
谢菊红
何沛
郭炫
XIE Ju-hong;HE Pei;GUO Xuan(Department of Laboratory,Chang'an District Hospital,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an,Shanxi Province,710100 China)
出处
《中国卫生产业》
2020年第7期1-3,共3页
China Health Industry
关键词
化学发光
性能验证
甲状腺激素
Chemiluminescence
Performance verification
Thyroid hormone
