全自动生化分析仪检测尿 N-乙酰-β-D-氨基葡萄糖苷酶性能验证

摘要

Objective To verify the analytical performance of NAG detected by Olympus AU2700 automatic biochemical analyzer .Methods The precision ,functional sensitivity ,linearity ,clinical reportable range ,reference in‐terval were validated ,according to Clinical and Laboratory Standards Institute(CLSI) documents(EP5‐A2 ,EP6‐A and C28‐A2) .Results The total coefficients of variation of high and low NAG concentration samples were 6 .05% and 9 .50% respectively ,functional sensitivity was 0 .72 U /L ,linearity was 1 .5 - 196 .0 U /L ,clinical reportable range was 0 .72 - 1 960 .00 U /L ,and reference interval was 0 .3 - 12 .0 U /L .Conclusion The analytical performance of NAG detected by Olympus AU2700 automatic biochemical analyzer is consistent with the statement offered by manu‐facturer ,it is usable for clinical testing .%目的：对奥林巴斯 AU2700全自动生化分析仪检测尿 N‐乙酰‐β‐D‐氨基葡萄糖苷酶（NAG）进行性能验证。方法参照 CLSI EP5‐A2、EP6‐A 、C28‐A2文件和相关文献要求，对奥林巴斯 AU2700全自动生化分析仪检测 NAG 进行精密度、功能灵敏度、线性范围、临床可报告范围和参考区间的验证试验。结果 NAG 的高、低浓度标本总变异系数分别为6．05％和9．50％；功能灵敏度为0．72 U ／L ；线性范围为1．5～196．0 U ／L ；临床可报告范围为0．72～1960．00 U ／L ；参考区间为0．3～12．0 U ／L 。结论奥林巴斯 AU2700全自动生化分析仪检测 NAG 的各项分析性能与厂家的声明基本一致，可用于临床检测。