WS/T406-2012标准在Sysmex CS-2000i血凝仪分析性能验证中的应用

目的 评价Sysmex CS-2000i全自动血凝仪的分析性能.方法 根据中华人民共和国卫生行业标准WS/T406-2012文件及相关文献,对Sysmex CS-2000i全自动血凝仪检测PT、APTT和Fib的批内精密度、日间精密度、线性、正确度和准确度进行验证,确保分析性能满足临床需要.结果 PT、APTT、Fib的批内精密度1.44％～3.58％,日间精密度2.28％～4.88％;Fib的标本浓度在0.39～7.79 g/L范围内呈一次线性;正确度和准确度均符合WS/T406-2012标准要求.结论 Sysmex CS-2000i全自动血凝仪分析性能满足临床需要,WS/T406-2012行业标准具有较好的操作性和实用性,易于常规实验室使用和推广.

Application of 406-2012 WS/T standard in performance verification of Sysmex CS-2000i blood coagulation analyzer

Objective To evaluate the analytical performance of Sysmex CS-2000i automatic blood coagulation analyzer.Methods PT,APTT,and Fib were detected by Sysmex CS-2000i automatic blood coagulation analyzer.The corresponding within-run precision,inter-day precision,linearity,trueness,and accuracy were analyzed.The WS/T 406-2012 document-a health industry standard of the People's Republic of Chinawas used to evaluated the aforementioned analytical performances.Results For PT,APTT,and Fib,the withinrun precision and the inter-day precision were 1.44％-3.58％ and 2.28％-4.88％,respectively.Fib had a good linearity within 0.32-7.79 g/L.Both the trueness and the accuracy could meet the requirement of WS/T 406-2012 standard.Conclusions The analytical performance of Sysmex CS-2000i automatic blood coagulation analyzer is able to meet the clinical requirement.The WS/T 406-2012 standard has good operability and practicability,and it is suitable to be applied and popularized in routine laboratory.