罗氏cobas 8000检测系统性能评价

Performance Evaluation of Roche Cobas 8000 Detection System

目的应用美国临床检验标准化研究所(CLSI)评价方案对罗氏cobas 8000检测系统的8个检验项目进行方法学性能验证与评价。方法根据CLSI系列文件(EP15-A、EP6-A、EP9-A2、C28-A2)和其它相关文献的实验方案对罗氏cobas8000检测系统中共8个项目的精密度、准确度、线性范围和参考区间进行分析和验证,其结果与厂商声明的性能或公认的质量目标进行比较。结果罗氏cobas 8000检测系统的精密度、准确度、线性范围和参考区间均符合要求。结论罗氏cobas 8000检测系统的8个检测项目的主要性能基本符合质量目标要求,能够满足临床需要。

Objective To validate and evaluate the main performance of 8 biochemical indexes tested by Roche cobas 8000 detection system. Methods Clinical and Laboratory Standards Institute（CLSI） protocols （EP15-A, EP6-A, EPg-A2, C28-A2） and other pertinent literature were used to evaluate the precision, accuracy, linearity and reference interval with the Hitachi 7180 detection system. Results were compared with the claims or acceptable standards of the manufacturer. Results The precision, accuracy, linearity and reference interval were in line with the standards or acceptable standards of the manufacturer. Conclusions The main analytic characteristics of 8 biochemical indexes tested by Roche cobas 8000 detection system are consistent with acceptable quality standards.