干化学淀粉酶、脂肪酶的临床可报告范围研究

目的建立干化学淀粉酶（Amylase,AMYL）、脂肪酶（Lipase,LIPA）的临床可报告范围,以指导实验室处理高值AMYL及LIPA的标本。方法参考美国临床实验室标准化协会（Clinical and Laboratory Standards Institute,CLSI）EP6-A文件和相关文献,进行干化学AMYL和LIPA的分析测量范围（analytical measurement range,AMR）验证实验及最大允许稀释度测定实验,建立其临床可报告范围（clinical reportable range,CRR）。结果血清AMYL和LIPA的AMR与厂商一致;用生理盐水稀释血清AMYL,最大允许稀释倍数是8倍,CRR是30～9600U/L;血清LIPA不能用生理盐水稀释,可用7%BAS稀释,最大允许稀释倍数是9倍,CRR是10～16000U/L。结论对于高值有特别意义的检测项目,测定其最大稀释倍数并建立其临床可报告范围意义重大。

Determining the clinical report range AMYL and LIPA in dry chemistry

Objective To establish the clinical reportable range of dry chemical of Amylase （AMYL） and Lipase （ LIPA ）. Methods Referring to CLSI EP6-A evaluation protocols, we performed the validate experiments of analytical measurement rang （AMR）and max dilution limit. Combining functional sensitivity, the clinical reportable range was established. Results Serum AMYL and LIPA＇s AMR is consistent with the manufacturer＇s data.The max dilution limit of serum AMYL was 8 time with saline,the clinical reportable range was 30-9 600 U/L. Serum LIPA can not be diluted by saline.With 7% BAS dilution by instruction,the max dilution limit was 9 times ,the clinical reportable range of serum LIPA was 10-16 000 U/L. Conclusion It is important to determines the biggest dilution muhiple and establish clinical reportable range for the analytics with high-value in clinical specimen.