CAJ | 학술논문

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。
목적：대오림파사 AU2700전자동생화분석의검측뇨 N‐을선‐β‐D‐안기포도당감매（NAG）진행성능험증。방법삼조 CLSI EP5‐A2、EP6‐A 、C28‐A2문건화상관문헌요구，대오림파사 AU2700전자동생화분석의검측 NAG 진행정밀도、공능령민도、선성범위、림상가보고범위화삼고구간적험증시험。결과 NAG 적고、저농도표본총변이계수분별위6．05％화9．50％；공능령민도위0．72 U ／L ；선성범위위1．5～196．0 U ／L ；림상가보고범위위0．72～1960．00 U ／L ；삼고구간위0．3～12．0 U ／L 。결론오림파사 AU2700전자동생화분석의검측 NAG 적각항분석성능여엄가적성명기본일치，가용우림상검측。
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 .