罗氏Cobas8000 e602检测促甲状腺激素的性能验证

Performance Verification of Cobas 8000 e602 in the Detection of Thyroid Stimulating Hormone

目的对Cobas8000 e502电化学发光免疫分析仪模块检测促甲状腺激素(TSH)的性能进行验证和评估。方法参考美国临床和实验室标准协会(CLSI)的有关文件和相关文献,对Cobas8000免疫检测系统测定TSH的精密度、准确性、线性范围、参考区间及不同模块间检测结果的相关性进行验证分析。结果 TSH低值、高值批内精密度的结果分别为1.9%、1.3%,均≤1/4 CLIA′88 TEa,批间精密度为2.2%、1.5%,≤1/3 CLIA′88 TEa;能力验证实验成绩80%,准确度合格;线性范围为0.446~89.76μIU/mL,与试剂盒线性范围相符;参考区间符合实验室要求;模块间结果比对R^2≥0.95符合要求。结论 Cobas8000检测系统的主要性能均达到相关标准的要求,能够满足临床需求。

Objective To verify and evaluate the performance of thyroid stimulating hormone （TSH） by e602 Cobas8000 electrochemical luminescence immunoassay analyzer module. Methods According to the guideline from Clinical and Laboratory Standards Institute （CLSI）, precision, accuracy, linear range, reference interval and the test results were verified between different CobasS000 modules in the detection of TSH. Results The Intra-batch precision of the TSH were 1.9% and 1.3%, which were both less than 1/4 TEa （ CLIA＇88 ）. Interbatch precision were 2.2 % and 1.5 %, which were both less than 1/3 TEa （ CLIA＇88 ）. The result of proficiency testing was 80%, and the accuracy was qualified. The linear range was 0.446 89.76 μIU/mL, and the result were in accordance with the kit. In addition, the reference range is in line with the laboratory requirements, and the detection results were consistent between the two modules. Conclusion The main performance of the Cobas8000 detection system meets the requirements of the relevant standards, which can satisfy the clinical requirements.