Mindray BC-5200全自动血细胞分析仪主要性能评价

目的对巩留县人民医院的Mindray BC-5200全自动血细胞分析仪的主要性能进行评价。方法按照国际血液学标准化委员会(ICSH)的有关规定和仪器说明书要求对Mindray BC-5200全自动血细胞分析仪进行精密度、携带污染率、线性范围、总重复性等指标进行检测,同时与Sysmex XE-2100和瑞士奥菲Mytic 22全自动血细胞分析仪进行可比性试验。白细胞分类计数与显微镜目测进行比较分析。结果 (1)各主要指标的精密度和总重复性满足1/4美国临床检验修正法规(CLIA′88)要求。(2)携带污染率皆符合ICSH小于1.00%的要求,且线性良好(r≥0.98)。(3)与Sysmex XE-2100和瑞士奥菲Mytic 22全自动血细胞分析仪进行对比分析,各主要指标相关性良好。白细胞分类计数与手工镜检存在差异。结论 Mindray BC-5200检测各项指标均符合CLIA′88相应标准范围要求,测定白细胞、红细胞、血小板等指标的总数可信度较高,能满足临床需要,白细胞分类计数不能完全代替手工镜检。

Performance evaluation of Mindray BC-5200 automatic hematology analyzer

Objective To analyze performance evaluation of Mindray BC-5200 automatic hematology analyzer.Methods According to international hematology standardization commission（ICSH） concerned regulation and instrument specifications of Mindray BC-5200 automatic hematology analyzer,precision,carry the rate of pollution,the linear range,total repeatability index were tested,at the same time and Sysmex XE-2100 and Switzerland dare Mytic 22 automatic hematology analyzer were comparable experiments.White blood cells classification and the microscope visual were analyzed.ResultsThe main indices of precision and total repeatability met a quarter of the American clinical inspection fixed regulations（CLIA′88） requirements.Carry the rate of pollution was less than 1.00% of ICSH the requirements and with good linear（r≥0.98）.Sysmex XE-2100 and Switzerland dare Mytic 22 automatic hematology analyzer contrast analysis,the main indices had good correlation.White blood cells classification had difference comparing to the manual microscopic.Conclusion All the indices of Mindray BC-5200 can accord with CLIA ′88 corresponding standard specifications.Determinations of white blood cells,the red blood cells,the platelet have high reliability,which can satisfy the clinical needs.White blood cells cannot completely replace manual classification count microscopic.