CAJ | 학술논문

目的探讨UniCel DxH 800全自动血细胞分析仪检测全血细胞计数(CBC)的相关性能,并与LH 750和ADVIA 2120全自动血细胞分析仪及显微镜白细胞分类计数比较.方法使用新鲜血标本和仪器配套质控品评价UniCel DxH 800测定CBC的精密度、携带污染率和线性范围；以显微镜法为“金标准”,评价其白细胞分类计数和网织红细胞计数的准确性；计算UniCel DxH 800与LH750和ADVIA 2120血细胞分析仪测定结果的偏差和相关性,并比较3种仪器对异常细胞报警的有效性.结果 UniCel DxH 800测定RBC、Hb和MCV的批内精密度(CV)＜0.5％,WBC和PLT的批内CV＜1.5％.上述5项参数的批间CV均＜2.5％,携带污染率均＜0.51％.在临床样本所覆盖的浓度范围内,WBC、RBC、Hb、PLT测定值与理论值呈线性相关(r＞0.999,P＜0.01).UniCel DxH 800与LH 750、ADVIA 2120血液分析仪对WBC、RBC、Hb、MCV和PLT的测定结果有良好的相关性(r ＞0.973,P＜0.01).UniCel DxH 800血细胞分析仪计数网织红细胞与显微镜法计数的相关性较好(r =0.920,P＜0.01).UniCei DxH 800血液分析仪与显微镜法分类计数白细胞比较,中性粒细胞、淋巴细胞和嗜酸粒细胞的相关性较好(r值分别为0.914、0.900和0.725,P＜0.01),其次为单核细胞(r =0.612,P＜0.01),优于类似检测原理的LH 750.UniCel DxH 800对异常细胞报警的敏感度为96.6％,假阴性率为2.5％；对中性粒细胞核左移的敏感度为90.5％,假阴性率为5.0％.结论 UniCel DxH 800全自动血液分析仪用于全血细胞计数具有高精密度、低携带污染率和宽线性范围的优点,与LH 750和ADVIA 2120全自动血液分析仪的检测结果具有良好的相关性.
목적 탐토UniCel DxH 800전자동혈세포분석의검측전혈세포계수(CBC)적상관성능,병여LH 750화ADVIA 2120전자동혈세포분석의급현미경백세포분류계수비교.방법 사용신선혈표본화의기배투질공품평개UniCel DxH 800측정CBC적정밀도、휴대오염솔화선성범위；이현미경법위“금표준”,평개기백세포분류계수화망직홍세포계수적준학성；계산UniCel DxH 800여LH750화ADVIA 2120혈세포분석의측정결과적편차화상관성,병비교3충의기대이상세포보경적유효성.결과 UniCel DxH 800측정RBC、Hb화MCV적비내정밀도(CV)＜0.5％,WBC화PLT적비내CV＜1.5％.상술5항삼수적비간CV균＜2.5％,휴대오염솔균＜0.51％.재림상양본소복개적농도범위내,WBC、RBC、Hb、PLT측정치여이론치정선성상관(r＞0.999,P＜0.01).UniCel DxH 800여LH 750、ADVIA 2120혈액분석의대WBC、RBC、Hb、MCV화PLT적측정결과유량호적상관성(r ＞0.973,P＜0.01).UniCel DxH 800혈세포분석의계수망직홍세포여현미경법계수적상관성교호(r =0.920,P＜0.01).UniCei DxH 800혈액분석의여현미경법분류계수백세포비교,중성립세포、림파세포화기산립세포적상관성교호(r치분별위0.914、0.900화0.725,P＜0.01),기차위단핵세포(r =0.612,P＜0.01),우우유사검측원리적LH 750.UniCel DxH 800대이상세포보경적민감도위96.6％,가음성솔위2.5％；대중성립세포핵좌이적민감도위90.5％,가음성솔위5.0％.결론 UniCel DxH 800전자동혈액분석의용우전혈세포계수구유고정밀도、저휴대오염솔화관선성범위적우점,여LH 750화ADVIA 2120전자동혈액분석의적검측결과구유량호적상관성.
Objective To evaluate the improvement on test performance of UniCel DxH 800 automated hematology analyzer for complete blood count (CBC) by detecting its performance indicators and comparing the differences of the results with LH 750 hematology analyzer and ADVIA 2120 hematology analyzer.Methods The precision,carryover and linearity of UniCel DxH 800 in measurement of CBC were evaluated by using fresh blood samples and instrument quality control of products.To evaluate the accuracy of leukocyte differential count and reticulocyte count with the microscopic method as the “gold standard”.To calculate the bias and correlation between the results measured by LH 750,ADVIA 2120 and UniCel DxH 800 hematology analyzers and compare these three instruments on the validity of the alarm in abnormal cells.Results Intra-precision:The coefficient of variation (CV) of the results of RBC,Hb and MCV were less than 0.5％,the CV of WBC and PLT results were less than 1.5％.Inter-precision:the CV of the parameters above were less than 2.5％.The carryover rate of WBC,RBC,Hb,MCV and PLT were less than 0.51％.In the concentration range covered by clinical samples,the correlation coefficients between the measured values and theoretical value in testing WBC,RBC,Hb and PLT were greater than 0.999 ( P ＜0.01 ).The measurement results of WBC,RBC,Hb,MCV and PLT hy UniCel DxH 800,ADV1A 2120 and LH 750 hematology analyzers have good correlation (r ＞ 0.973,P ＜ 0.01 ).Correlation of reticulocyte count between the UniCel DxH 800 hematology analyzer and microscolpic method was significant (r =0.920,P ＜0.01 ).Correlation of leukocyte differential count about the grauulocytes, lymphocytes and eosinophils between the UniCel DxH 800 hematology analyzer and microscopic method was good (r =0.914,0.900 and 0.725,P ＜0.01 ),followed by monocytes ( r =0.612,P ＜0.01 ),which were better than the LH 750 with similar detection principle.The UniCel DxH 800 hematology analyzer demonstrated higher sensitivity (96.6％ ) for the alarm of abnormal cells and achieved a lower false-negative rate (2.5％ ).Meanwhile,the sensitivity of the neutrophil nuclei left shift was higher (90.5％ ) and the false-negative rate (5.0％) was lower.Conclusions The UniCel DxH 800 hematology analyzer for complete blood count shows advantages of high precision,low carryover rate and wide linear range.The results detected by the UniCel DxH 800 hematology analyzer have good correlation with the LH 750 and ADVIA 2120.