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

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

作　　者：黄景春[1] 尚陈宇 陈林[1] 刘持翔[1] 卢燕君[1] 罗福东[1] 潘婉仪[1] 马骥[1] 徐建华[1] 

机构地区：[1]广东省中医院检验科,广州510105

出　　处：《国际医药卫生导报》2016年第18期2854-2856,2859,共4页International Medicine and Health Guidance News

摘　　要：目的评价SysmexCS-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SysmexCS-2000i全自动血凝仪检测Prr、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0．39-7．79g／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SysmexCS-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。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 China--was used to evaluated the aforementioned analytical performances. Results For PT, APTT, and Fib, the within- run 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.

关 键 词：全自动血凝仪 分析性能 WS/T 406—2012 

分 类 号：R446.111[医药卫生—诊断学]