CL6000i全自动化学发光免疫分析仪检测甲状腺激素的性能验证

Performance verification of CL6000i automatic chemiluminescence immunoanalyzer for detecting thyroid hormone

目的对迈瑞CL6000i全自动化学发光免疫分析仪检测甲状腺激素进行性能验证和评估。方法参照美国临床和实验室标准协会相关文件的性能评估指导,对迈瑞CL6000i全自动化学发光免疫分析仪检测血清甲状腺激素8项的精密度、准确度、线性范围、生物参考区间、最低检出限等进行验证和评价,并与罗氏Cobas8000全自动生化分析仪进行方法学比对,比较两种仪器检测结果的一致性和符合率。结果甲状腺素(T4)、三碘甲状腺原氨酸(T3)、游离甲状腺素、游离三碘甲状腺原氨酸、促甲状腺激素(TSH)、甲状腺球蛋白(Tg)、甲状腺过氧化物酶抗体(TPO-Ab)、甲状腺球蛋白抗体(Tg-Ab)的低值、高值质控品和临床标本的批内精密度变异系数(CV)为0.42%~4.96%,均小于美国临床实验室改进修正法规′88(CLIA′88)认可的1/4 TEa,批间精密度CV为0.68%~5.47%,均小于CLIA′88认可的1/3 TEa;各项目准确度比对偏倚范围为-5.95%~11.34%,均小于CLIA′88认可的1/2 TEa;T3、T4、TSH、TPO-Ab、Tg的线性回归方程斜率在0.97~1.03,R 2≥0.990,表明线性良好,与厂家声明一致;95%的健康者检测结果在厂家标注的生物参考区间范围内;最低检出限小于厂家声明参数;除TPO-Ab、Tg-Ab外,两种仪器对甲状腺激素其他各项目的比对结果有较好的一致性。结论迈瑞CL6000i全自动化学发光免疫分析仪检测甲状腺激素的主要分析性能与厂家声明一致,符合CLIA′88和ISO15189实验室认可标准要求,能够满足临床需求。

Objective To verify and evaluate the performance of Mindray CL6000i automatic chemiluminescence immunoanalyzer for detecting thyroid hormone.Methods According to the evaluation protocols of American Clinical and Laboratory Standards Institute and other relevant documents,precision,accuracy,linear range,biological reference interval,minimum detection limit of Mindray CL6000i automatic chemiluminescence immunoanalyzer for detecting 8 items of serum thyroid hormone were verified and evaluated,and compared with Roche Cobas8000 automatic biochemical analyzer in methodology to compare the consistency and coincidence rate of the detection results of the two instruments.Results The intra batch precision coefficient of variation(CV)of low value and high value quality control products and clinical samples of thyroxine(T4),triiodothyronine(T3),free thyroxine,free triiodothyronine,thyrotropin(TSH),thyroglobulin(Tg),thyroid peroxidase antibody(TPO-Ab)and thyroglobulin antibody(Tg-Ab)was 0.42%-4.96%,which was less than 1/4 TEa approved by Clinical Laboratory Improvement Amendments of 1988(CLIA′88),and the inter batch precision CV was 0.68%-5.47%,which was less than 1/3 TEa approved by CLIA′88.The accuracy comparison bias range of each item was-5.95%-11.34%,which was less than 1/2 TEa approved by CLIA′88.The slope of linear regression equation of T3,T4,TSH,TPO-Ab and Tg was 0.97-1.03,R 2≥0.990,indicating good linearity,which was consistent with the manufacturer′s statement.95%of the test results of healthy people were within the biological reference range marked by the manufacturer.The minimum detection limit was less than the parameters declared by the manufacturer.In addition to TPO-Ab and Tg-Ab,the comparison results of other items of thyroid hormone by the two instruments had a good consistency.Conclusion The main analytical performance of Mindray CL6000i automatic chemiluminescence immunoanalyzer for detecting thyroid hormone is consistent with the manufacturer′s declaration,meets the requirements of CLIA′88 and ISO15189 laboratory accreditation standards,and could meet clinical needs.