罗氏Modular全自动生化分析仪酶指标精密度验证

摘要

目的：判定罗氏Modular全自动生化分析仪检测酶学指标丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）的分析性能。方法依照美国临床实验室标准化委员会的标准文件CLSI EP5-A2以及其他有关文献的研究方式，验证罗氏Modular全自动生化分析仪对丙氨酸基转移酶以及天门冬氨酸氨基转移酶的精密程度。结果验证的性能指标与罗氏声明的性能能力相吻合。结论罗氏Modular生化分析在检测丙氨酸氨基转移酶以及天门冬氨酸氨基转移酶时，性能与质量目标相符合。%Objective judgment of Roche Modular automatic biochemical analyzer enzymes alanine amino transferase assay (ALT) and aspartate aminotransferase (AST) analysis of its performance. Methods according to the standard file America Commit ee for clinical laboratory standards CLSI EP5-A2 and other relevant literature research methods, verification of Roche Modular automatic biochemical analyzer of alanine aminotransferase and the degree of precision aspartate aminotransferase. The Results of performance and verification of Roche's statement consistent. Conclusion the Roche Modular biochemical analysis in the detection of metastatic alanine aminotransferase and aspartate aminotransferase, performance and quality objectives consistent with.