PENTRA MS60血液分析仪应用性能评价

摘要

Objective To evaluate the performance of PENTRA MS60 hematology analyzer (PMS60 ) for the determination of complete blood count (CBC ) and white blood cell (WBC ) differential count. Methods The background count,carryover rate (CR),precisions [within-run and inter-day coefficients of variation (CV)],linear range and accuracy of PMS60 were evaluated by fresh blood samples and instrument quality control materials.The bias and correlation of PMS60 and SYSMEX XS800i hematology analyzer(XS800i)were calculated.The microscopy was as a″gold standard″of WBC differential count,and the accuracy of WBC differential count was calculated according to the″gold standard″.Results The background counts of WBC,red blood cell(RBC),hemoglobin(Hb)and platelet(PLT) were all 0.The CR of WBC,RBC,Hb and PLT were 0.09%,0.33%,0.54% and 0.10%.The within-run CV of RBC,Hb,hematocrit(HCT),erythrocyte mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH)and mean corpuscular hemoglobin concentration(MCHC)(normal sample and medical decision level sample)were <1 .5%, the within-run CV of WBC were 0.81% and 3.47%,and the within-run CV of PLT were 3.74% and 7.44%.The inter-day CV of RBC,Hb,HCT,MCV,MCH and MCHC(low,middle and high levels)were <2%,the inter-day CV of WBC were 3.47%,2.99% and 2.49%,and the inter-day CV of PLT were 5.28%,4.00% and 3.20%.Within the concentration range of clinical samples,the correlation coefficients(r)between the measured values and theoretical values of WBC,RBC,Hb and PLT were >0.998(P<0.01).The slope of linear regression equation was in the range of 1.00 ±0.05.The relative biases of Hb,HCT,MCV,MCH and MCHC were <3%,and the relative deviation of WBC,RBC and PLT were <6.5%,<3.5%and <9.5%,respectively.The coincidence rate of the relative deviation for CBC was >85%(r>0.8,P<0.01).Compare to microscopy,the accuracy rates of WBC differential count about lymphocytes,monocytes, granulocytes, eosinophils and basophils were 95%, 95%, 85%, 80% and 75%, respectively.Conclusions The PMS60 has a good performance.It has the advantages of low carryover rate,high precision,wide linear range and reliable accuracy of the results.%目的：对PENTRA MS60全自动微量血液分析仪（简称PMS60）测定全血细胞计数（CBC）及白细胞（WBC）分类的性能进行评价。方法使用新鲜血样本和仪器配套质控物评价PMS60，验证CBC的本底计数、携带污染率（CR）、精密度[批内、日间变异系数（CV）]、线性范围、准确度，计算PMS60与SYSMEX XS800i血液分析仪（简称XS800i）测定结果的偏差和相关性；以显微镜法为“金标准”，评价PMS60 WBC分类的准确性。结果PMS60测定WBC、红细胞（RBC）、血红蛋白（Hb）和血小板（PLT）的本底计数结果均为“0”。PMS60测定WBC、RBC、Hb 和 PLT 的 CR 分别为0．09％、0．33％、0．54％和0．10％。PMS60测定 RBC、Hb、红细胞压积（HCT）、红细胞平均体积（MCV）、平均红细胞血红蛋白含量（MCH）和平均红细胞血红蛋白浓度（MCHC）的批内CV（正常样本、医学决定水平样本）均＜1．5％，WBC的批内CV分别为0．81％和3．47％，PLT的批内CV分别为3．74％和7．44％；PMS60测定RBC、Hb、HCT、MCV、MCH和MCHC的日间CV（低、中、高水平）均＜2％，WBC的日间CV分别为3．47％、2．99％和2．49％，PLT的日间CV分别为5．28％、4．00％和3．20％。在临床样本所覆盖的浓度范围内，WBC、RBC、Hb和PLT测定值与理论值呈线性相关[相关系数（r）均＞0．998，P均＜0．01]，线性回归方程的斜率均在1．00±0．05范围内。PMS60对5份质控物测定Hb、HCT、MCV、MCH和MCHC的相对偏差均＜3％，WBC＜6．5％、RBC＜3．5％、PLT＜9．5％。PMS60与XS800i对CBC各项目的测定结果偏倚符合率均＞85％（r均＞0．8，P均＜0．01）。PMS60与显微镜法WBC分类计数比较，正常样本的淋巴细胞、单核细胞、中性粒细胞、嗜酸性粒细胞和嗜碱性粒细胞的准确率分别为95％、95％、85％、80％和75％。结论 PMS60性能良好，具有低携带污染率、精密度高、宽线性范围和结果准确可靠的优点，适用于临床常规分析。