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.
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
