摘要
目的为实验室内部验证全自动血液分析仪性能及选择确定实验室内部的基准仪器提供参考。方法卫生部临床检验中心发放的15支定值新鲜血用于正确度评价;3个浓度全血质控品用于日内和日间精密度评价;5个浓度梯度样本用于线性验证;根据性能验证统计数据给每个仪器评分,选择基准仪器。结果 3台仪器测定白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞压积(HCT)和血小板(PLT)与参考定值的相关系数R值为0.953～0.998,平均红细胞体积(MCV)的R值为0.751～0.821。除XE-2100的PLT外,其他仪器和参数的线性相关斜率的95%的置信区间包括1,截距的95%的置信区间包括0。除BC-5800 PLT的日间精密度外,其他仪器和参数的日内和日间精密度都在说明书要求范围内。LH750和BC-5800的WBC和PLT的检测范围宽于XE-2100。性能验证综合扣分排序由低到高依次为LH750、BC-5800、XE-2100。结论 XE-2100、LH750和BC-5800基本满足产品规定性能水平,但综合考虑认为LH750更适合作为本实验室的基准仪器。
Objective To verify the performance of automated hematology analyzers in clinical laboratories, and provide the reference for choosing the referred analyzer of a clinical laboratory. Methods A total of 15 fresh whole blood specimens assigned values and being provided by the National Center for Clinical Laboratory were used to evaluate trueness, 3 levels of quality control materials were used to evaluate intra-day and inter-day precisions, 5 dilutions were assayed to verify linearity, and the score of each analyzer was adopted to determine the referred analyzer. Results Correalation coefficient R values of white blood cell （ WBC ） , red blood cell （ RBC ） , hemoglobin （Hb） , hematocrit （HCT） and platelet（PLT） of each analyzer were 0. 953 -0.998. However,R values of RBC mean corpuscular volume （MCV） of each analyzer were 0. 751 -0. 821. Except PLT of XE-2100, the other parameters of each analyzer showed that the 95% confidence intervals of slope included the value 1, and the 95% confidence intervals of Y-intercepts included the value 0. Except PLT inter-day precision of BC-5800, the intra-day and inter-day precisions of the other analyzers were complied with the specification of each analyzer. Analytical measuring intervals of WBC and PLT of LH750 and BC-5800 were wider than those of XE-2100. Sorted from high to low,the rates of general performance of each analyzer were LH750, BC-5800 and XE-2100 in sequence. Conclusions The performance verification of XE-2100, LH750 and BC-5800 shows roughly satisfactory results. Meanwhile, LH750 is the most qualified as the referred hematology analyzer in the clinical laboratory.
出处
《检验医学》
CAS
2013年第10期917-920,924,共5页
Laboratory Medicine
基金
"十二五"国家科技支撑计划课题(SQ2012BAJY3779)
关键词
性能验证
血液分析仪
正确度
精密度
线性
Performance verification
Hematology analyzer
Trueness
Precision
Linearity
