Sysmex Ca1500全自动血凝仪检测D二聚体临床可报告范围的建立  

The clinical reportable range of D-dimer on the automatic hemagglutinin apparatus Sysmex Ca1500

作　　者：李广华[1] 范小斌[1] 梁玲[1] 谢红东[1] 黄锦维[1] 叶联珍[1] 葛艳芬[1] 王景健[1] 

机构地区：[1]广东省人民医院(广东省医学科学院)检验科,广东广州510080

出　　处：《中国现代医学杂志》2013年第1期94-97,共4页China Journal of Modern Medicine

摘　　要：目的建立免疫比浊法检测D二聚体的临床可报告范围。方法参考美国临床检验标准化委员会（NCCLS）EP6-P2文件和相关文献，在SysmexCa1500全自动血凝仪上进行D二聚体分析测量范围验证实验、最大允许稀释度验证实验，并结合功能灵敏度建立其临床可报告范围。结果D二聚体的分析测量范围为29～1980ng／mL，最大允许稀释度为1：8；其临床可报告范围为54．7-15840ng／mL。结论临床可报告范围的建立，对于高值有特别意义的检测项目至关重要。[ Objective ] To establish the clinical reportable range of D-dimer by immunoturbidimetry method. [Methods] The analytical measurement range （AMR） and the maximum allowable dilution rate were validated on Automatic Sysmex Cal500, according to NCCLS EP6-P2 evaluation protocols and relevant literature. Combined with functional sensitivity, the clinical reportable range was established. [Results] The AMR of D-dimer was during 29-1 980 ng/mL, and the maximum allowable dilution was 1 ： 8, which was consistent with the manufacturer＇s data. The clinical reportable range was 54.7-15 840 ng/mL. [ Conclusions] The clinical reportable range was established, which was significant for clinical diagnosis with the high test value.

关 键 词：临床可报告范围 免疫比浊法检验 D二聚体 分析测量范围 

分 类 号：R446.11[医药卫生—诊断学]