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作 者:孔莉[1] 王建平[1] 童兰庭 陈炜钢[1] 裴银桃 时宇绯 高能姣
机构地区:[1]南京医科大学第二附属医院检验医学中心,南京210011
出 处:《医疗卫生装备》2017年第5期95-98,共4页Chinese Medical Equipment Journal
基 金:南京医科大学科技发展基金面上项目(06NMUM026)
摘 要:目的:评价Sysmex XS-800i(仪器1)、Sysmex XS-1000i(仪器2)、Sysmex XE-2100D(仪器3)3种不同型号血细胞分析仪检测红细胞(RBC)计数及相关参数——血红蛋白(HGB)、红细胞比容(HCT)、平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)的比较。方法:先对仪器3进行校准前的性能评价后再校准,再通过仪器厂家配套的3个水平的全血质控品对3台血细胞分析仪的日间精密度进行测定。然后收集50例新鲜全血标本分别在3台血细胞分析仪上测定,对RBC计数及相关参数测定结果进行相关统计学分析和临床可接受性能评价。结果:仪器3的性能评价符合临床要求;3台血细胞分析仪检测全血质控品各参数具有较高的精密度;3台血细胞分析仪检测50例全血RBC及相关参数间的相关系数r^2均大于0.95;在医学决定水平处,除RBC=5.9×10^(12)/L、HCT=35%和50%处仪器1性能评价不可接受外,其他评价仪器1和仪器2都可接受。结论 :仪器1、2、3检测红细胞计数及相关参数具有较高的精密度,相关性良好,需要定期对其进行比对试验,以保证对同一份标本的同一项目检测结果具有可比性。Objective To evaluate Sysmex XS-800i, XS-1000i and XE-2100D hematology analyzers when used to detect RBC count, hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Methods XE-2100D hematology analyzer was calibrated after performance evaluation, and the three analyzers had the intra-day precisions measured with three levels of whole-blood quality control materials. Totally 50 whole-blood specimens were detected with the three analyzers respectively, and statistical analyses and clinically acceptable performance evaluation were carried out on RBC count and the obtained results. Results XE-2100D hematology analyzer met the clinical requirements, and the three analyzers all gained high precisions when used to measure the parameters of the whole-blood quality control materials. The correlation coefficients (r2) respectively between the three analyzers were all higher than 0.95 when used to test the 50 specimens. At all medical decision levels XS-800i and XS-1000i hematology analyzers both gained acceptable detection results except XS-800i hematology analyzer in case of 5.9x10^2/L RBC count as well as 35% or 50% HCT. Conclusion Sysmex XS-800i, XS-1000i and XE- 2100D hematology analyzers have high precisions and correlations when used to detect RBC count, HGB, HCT and MCV, and contrast test is suggested to be executed periodically to ensure the comparability of the result. [Chinese Medical Equipment Journal, 2017,38 (5) : 95-98]
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