Sysmex CA7000及CS5100全自动凝血分析仪性能评价

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 precision,accuracy,carrying contamination rate,linearity,detection limit and reference interval of Sysmex CA7000 and CS5100 were evaluated.Results Validated Intra-and inter-assay CV of normal and abnormal samples,accuracy,carrying contamination rate,linearity,detection limit and reference interval were consistent with the quality controls.Conclusion Sysmex CA7000 and CS5100 blood coagulation analyzer is with good performance which can guarantee the results of coagulation test with reliability and comparability.