【摘要】 目的 对Coulter LH750血细胞分析仪的本底计数、精密度、携带污染率、线性、准确度给予评估,核实仪器性能是否符合要求。方法 以Coulter LH750血细胞分析仪为实验仪器,执行本底测试,查看本底计数详细结果;使用EDTA-K₂抗凝新鲜全血进行批内精密度测试;使用两个水平的血液学质控物进行日间精密度测试;测试仪器检测结果的携带污染率,评价仪器的自清洗效率;选取一份接近预期上限的高值全血样本,按比例进行梯度稀释并测定,进行线性验证;通过参加卫生部临床检验中心组织的室间质评评估全血细胞计数结果的测量准确度,采用五分类分析仪白细胞分类准确性试验评估白细胞分类准确度。结果 各参数本底测试、批内精密度和日间精密度均满足仪器要求。携带污染率为WBC0.22%,RBC 0.14%,HGB 0.15%和PLT 0.54%,满足仪器要求。线性验证WBC:Y=1.006 1X=1.609 5,r=0.999 9;RBC:Y=1.000 3X—0.115 5,r=0.999 2;HGB:Y=1.000 9X-2.605,r=0.999 6;PLT:Y=0.988 7X-3.135,r=0.9992,均满足a值在1±0.05范围内、相关系数r≥0.975的要求;各浓度样本实测值与理论值偏差（%）均满足仪器设定要求。准确度:WBC 2.74%,RBC 1.73%,HGB 1.55%,HCT 4.37%,MCV 2.09%,MCH 1.61%,MCHC 3.88%和PLT3.29%;中性粒细胞、淋巴细胞、单核细胞和嗜酸性粒细胞合格率100%,嗜碱性粒细胞合格率90%,满足白细胞分类准确度的要求。结论 Coulter LH750血细胞分析仪的使用性能经评估符合要求。更多还原

【Abstract】 Objective To evaluate background value,precision,carryover rate,linearity,accuracy of Coulter LH 750,review the result and check that performance evaluation of Coulter LH750 hematology analyzer meet the machine requirement.Methods Coulter LH750 hematology analyzer was used to executive the test of background value,review the background counts.Inter batch precision was through the test of fresh whole blood anticoagulated by EDTA-K₂.Inter day precision was through the review of two different level of hematology quality control.The auto cleaning efficiency of machine was through the test of carryover rate.The linear verification was through the test of sequence samples which were from the sample was close to up limit and then was diluted in gradient.The count accuracy of whole blood was through participation in the external quality assessment organized by National Center for Clinical Laboratories.Accuracy of white blood classification was through the test the five classification of white blood cell differential count.Results Background value inter batch precision and inter day precision all meet the requirement.Carryover rate in WBC was 0.22%,RBC 0.14%,HGB 0.15%and PLT0.54%.The result met the machine requirement.Linear verification in WBC:Y= 1.006 1X-1.609 5,r=0.999 9;RBC:Y= 1.000 3X-0.115 5,r=0.999 2;HGB:Y= 1.000 9X-2.605,r=0.999 6;PLT:Y=0.988 7X-3.135,r=0.999 2,all met the requirement a value between 1 ± 0.05,correlation coefficient r≥0.975,the deviation of sample measure and theoretical value met the set requirement.Accuracy in WBC was 2.74%,RBC 1.73%,HGB 1.55%,HCT 4.37%,MCV 2.09%,MCH 1.61%,MCHC 3.88%and PLT 3.29%.Qualification rate in neutrophils,lymphocyte,monocyte and eosnophil was100%.basophil 90%,the result met the requirement of white blood classification accuracy.Conclusion The preferment evaluation indicated Coulter LH 750 hematology analyzer meet the machine requirement.更多还原