Sysmex CA7000及CS5100全自动凝血分析仪性能评价  

Performance evaluation of Sysmex CA7000 and CS5100 automatic blood coagulation analyzer system

作　　者：苏杨[1] 冀承杰[1] 赵太强[1] 李焱鑫[1] 麦涛[1] 蒋黎[1] 

机构地区：[1]四川省医学科学院.四川省人民医院检验科,四川成都610072

出　　处：《实用医院临床杂志》2017年第5期33-36,共4页Practical Journal of Clinical Medicine

摘　　要：目的验证Sysmex CA7000和CS5100全自动凝血分析仪系统性能。方法参考美国临床和实验室标准化协会(NCCLS)相关文件,并对照全国临床检验操作规程(第4版)及卫生行业标准的有关规定,对Sysmex CA7000和CS5100不精密度、准确度、携带污染率、线性、检测限、参考区间进行系统评价。结果批内精密度、日间精密度正常样本和异常样本变异系数(CV)均在规定范围内。准确度验证各项目符合卫生部室间质评定值范围,携带污染率、线性评价、检测限、参考范围验证均符合本室质量管理要求。结论 CA7000及CS5100凝血分析仪不精密度、准确度、携带污染率、线性、检测限、参考区间验证评价通过,该系列仪器性能良好,有效保证凝血检测结果的可靠性及可比性。Objective To verify the performance of Sysmex CA7000 and CS5100 automatic blood coagulation analyzer system. Methods According to the relative references of American National Committee for Clinical Laboratory standards （NCCLS） and the national guide to clinical laboratory procedures （fourth edition） and the relevant provisions of the health occupation standards, the pre- cision ,accuracy, carrying contamination rate, linearity,detection limit and reference interval of Sysmex CA7000 and CS5100 were evalu- ated. Results Validated Intra-and inter-assay CV of normal and abnormal samples, accuracy, carrying contamination rate, linearity, de- tection limit and reference interval were consistent with the quality controls. Conclusion Sysmex CAT000 and CS5100 blood coagula- tion analyzer is with good performance which can guarantee the results of coagulation test with reliability and comparability.

关 键 词：SYSMEX CA7000 SYSMEX CS5100 全自动凝血分析仪 性能评价 

分 类 号：R446[医药卫生—诊断学]