【摘要】 目的用雅培Architect c16000全自动生化分析系统对肌酸激酶(CK)的分析测量范围(analytical measurement range,AMR)进行验证,并建立其临床可报告范围(clinical reportable range,CRR)。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,在雅培Architect c16000全自动生化分析仪上进行CK的最大稀释度实验、功能灵敏度实验及分析测量范围实验,并由此建立其临床可报告范围。结果 CK的最大允许稀释度为1:16;功能灵敏度为2.0U/L;分析测量范围(6.0～2500U/L)内呈线性(r=0.9994),与厂商声明基本一致,故其临床可报告范围为2.0～40000U/L。结论雅培Architect c16000全自动生化分析系统检测CK在厂家声明的分析测量范围内线性良好,所建立的临床可报告范围可以满足临床需要。更多还原

【Abstract】 Objective To investigate the analytical measurement range( AMR) and establish the clinical range( CRR) of Architect c16000 biochemical measurement system in the detection of creatine kinase( CK) . Methods Referring to clinical and laboratory standards institute( CLSI) EP6-A evaluation protocols and pertinent literature,performed the CK validate experiments of max dilution limit,functional sensitivity and analytical measurement range( AMR) ,and establish clinical report range( CRR) by Architect c16000 automatic analyzer. Results All experimental dates accord the setting requires,the max dilution limit was 1: 16,functional sensitivity was 2. 0U / L,and CK showed good linearity( r = 0. 9994) in AMR ( 6. 0 ～ 2500U / L) ,according with the declaration of the manufacture; so the CRR was 2. 0U / L ～ 40000U / L. Conclusion There can be fine linearity within the AMRclaimed by manufacture of Architect c16000 biochemical measurement system in the detection of CK and CRR established in this research can meet the needs of clinical laboratory.更多还原