LH750自动血细胞分析仪的性能初步评价  

Performance Evaluation of LH 750 Automatic Hematology Analyzer

作　　者：乐家新[1] 兰亚婷[1] 徐菡[1] 炼鑫[1] 王红霞[1] 朱红[1] 

机构地区：[1]解放军总医院临床检验科

出　　处：《医疗卫生装备》2011年第10期86-88,共3页Chinese Medical Equipment Journal

摘　　要：目的：评价LH 750自动血细胞分析仪全血细胞计数（CBC）和白细胞分类（DC）的性能。方法：按照有关文件规定对该仪器CBC的性能指标进行评价,并与人工分类进行比较。结果：该仪器CBC的精密度、携带污染率和总重复性均符合要求;用LIN-C线性质控物进行测定,结果均在期待值范围;与对照仪器的结果比较,相关性好（r^2〉0.963 0）,偏倚%小（-2.094-1.284）。DC：中性粒细胞（Neut）、淋巴细胞（Lym）、单核细胞（Mon）、嗜酸性粒细胞（Eos）和嗜碱性粒细胞（Baso）的重复性好;WBC形态正常的样本,仪器与人工DC的结果比较,Neut、Lym和Eos相关性较好（r^2=0.946 9-0.966 1）;Mon次之（r^2=0.801 3）,Baso的相关性欠佳（r^2=0.518 0）。白细胞分类报警的假阳性为15.93%,假阴性为4.35%,准确度为86.78%,特异度为84.07%,敏感度为95.65%。结论：该仪器检测的结果准确、可靠,主要性能指标符合实验要求;对怀疑WBC分类异常的标本,仪器DC结果必须经显微镜复核后才能报告。Objective To evaluate the performance of LH 750 hematology analyzer.Methods The indexes including precision,total reproducibility,carry-over,linearity and comparability were examined according to published evaluation standard.At the same time,the indexes of differential count（DC） were compared between those produced by the analyzer and manual methods.Results Precision,carry-over and total reproducibility in counting of leucocytes,erythrocytes,platelets and examination of hemoglobin on the analyzer were showed in the prescriptive range.The determined results for linearity-control were expected ranges.The results correlated well（r^2〉0.963） and bias were little（-2.094%-1.284%） with those obtained on the comparative instrument.DC：reproducibility was good for neutrophils,lymphocytes,monocytes,eosinophils and basophils.Comparison of the results by instrument with manual for normal samples in morphology,the correlation was better for neutrophils,lymphocytes and eosinophils（r^2=0.946 9-0.966 1）;good for monocytes（r^2=0.801 3）,not good for basophils（r^2=0.518 0）.Comparison of instrument flags with manual DC for 296 samples,false positive ratio,false negative ratio,accuracy,specificity and sensitivity were 15.93%,4.35%,86.78%,84.07% and 95.65% separately.Conclusion The analyzer can be used to test blood cell parameters accurately and reliably.Its main performance indices accords with the experimental requirements;the results are credible.It is necessary to check with microscopy for DC before reported when it is doubted.

关 键 词：血细胞分析仪 精密度 重复性 携带污染率 线性 

分 类 号：R446.113[医药卫生—诊断学] R318.6[医药卫生—临床医学]