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

Performance verification of NAG detected by automatic biochemical analyzer

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0.72U/L;线性范围为1.5-196.0U/L;临床可报告范围为0.72-1 960.00U/L;参考区间为0.3-12.0U/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。

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 interval 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% and9.50% 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 manufacturer,it is usable for clinical testing.