Diana-5全自动血液分析仪测定参数的临床研究

目的　对Diana 5全自动血液分析仪的测定参数及临床应用价值进行研究与评价。方法　根据国际临床实验室标准化委员会 (NCCLS)颁布的《定量临床实验室方法初步评定试行准则 (EP1 0 T2 )》的要求 ,用Diana 5血液分析仪进行全血细胞计数和白细胞五分类测定 ,MicrosoftExcel2 0 0 0及SAS软件进行统计学处理。结果　中、高值WBC、RBC、HGB的批内CV<2 % ,低值 <3% ,批间CV <3% ;MCV的批内和批间CV <2 % ;PLT的批内CV <4 .5 % ,批间CV <5 .2 %。WBC、RBC、HGB、MCV的总不精密度 <2 .5 % ,PLT <5 %。WBC、RBC、HGB、HCT、PLT的线性相关系数分别为 0 .999、0 .999、0 .999、0 .998和 0 .995。PLT的最大偏差为3% ,WBC、RBC、HGB、HCT的实测值均等于或接近于靶值。WBC的携带污染率为 1 % ,RBC、PLT <1 % ,HGB、MCV为 0。Neu、Lym、Mon、Eos、Bas与镜检结果的相关系数分别为 0 .982、0 .95 6、0 .84 2、0 .5 36和 0 .32 8。结论　Diana 5血液分析仪主要测定参数的线性好 ,精密度和准确度高 ,携带污染率低 ;白细胞五分类结果的重复性好 ,准确性较高 ,能有效发挥仪器的过筛作用

Clinical study of measurement parameters from Diana-5 fully automated blood cell analyzer

Objective To evaluate the clinical application value of measurement parameters from Diana 5 fully automated blood cell analyzer.Methods According to criterion of preliminary evaluation of quantitative clinical laboratory methods(EP10 T2) of National Committee for Clinical Laboratory Standards(NCCLS), the complete blood count (CBC) and 5 part difference were measured by Diana 5 fully automated blood cell analyzer. Then the results were statistically analyzed using Microsoft Excel 2000 and SAS software. Results The within run CV was less than 2% for WBC, RBC and HGB in samples of high and middle value.They were less than 3% in low value,and the between run CV was <3% within them.The within run and between run CV were <2% for MCV, and those of PLT were <4.5% and 5.2%.The toal CV was <2.5% for WBC, RBC, HGB and MCV, and that of PLT was <5%.The linearity correlation coefficients of WBC, RBC, HGB, HCT and PLT were 0.999 , 0.999, 0.999, 0.998 and 0.995,respectively.The bias of PLT was <3%,but the detection values of WBC, RBC, HGB and HCT were near to true value of quality control samples.The carryover of WBC was 1%, and those of RBC and PLT were <1%, and that of HGB and MCV was 0. Compared with by those microscope examination,correlation coefficients of Neu, Lym, Mon, Eos and Bas were 0.982, 0.956 , 0.842, 0.536 and 0.328, respectively.Conclusion The results of CBC by Diana 5 blood cell analyzer possess good linearity,and high preciseness and accuracy,and the carryover is lower.The results of 5 part difference are precise and accurate, suitable for screening abnormal blood cell.