摘要
目的对SYSMEX XT-4000i血液分析仪的性能进行验证及评价。方法使用临床常规血液、体液标本和仪器配套质控物对XT-4000i的本底计数、携带污染率、精密度(批内、日间)、线性范围、准确度,仪器间的比对等分析性能进行验证和评价。结果 XT-4000i测定的本底计数均低于厂商设计规定的要求;XT-4000i检测血液标本白细胞、红细胞、血红蛋白含量、血小板4项,其携带污染率低,精密度、线性范围、准确度均良好,其白细胞分类计数与显微镜分类具有相关性;XT-4000i检测体液标本白细胞、红细胞计数及白细胞分类与手工法检测结果具有较高的相关性。结论 XT-4000i血液分析仪性能良好,可以较好地满足临床常规血液标本及体液标本的检测要求。
Objective To test and evaluate the performance of SYSMEX XT-4000 i hematology analyzer. Methods Clinical blood samples, body fluid samples and quality control materials were used to test and evaluate the background counting, contamination rate, precision（within-run precision, within-day precision）, linear range, accuracy, and the contrast between XT-4000 i machines. Results The background counting tested by XT-4000 i was lower than the specified requirements designed by the manufacturer. Using the XT-4000 i to test the WBC, RBC, HGB and PLT has advantages of low contamination rate, and high precision, linear range and accuracy, as well as strong correlation between differential leukocyte counting and microscope classification. The results of testing the WBC, RBC and differential leukocyte manual counting by XT-4000 i are highly related. Conclusion The XT-4000 i hematology analyzer has good performance to meet the requirements of clinical routine detections of blood and body fluid samples.
出处
《中国医疗设备》
2015年第1期114-116,119,共4页
China Medical Devices
关键词
血液分析仪
性能评价
体液细胞检测
质量控制
hematology analyzer
performance assessment
body fluid detection
quality control
