Sysmex XS-800i血液分析仪性能评估

Performance Evaluation of Sysmex XS-800i Hematology Analyzer

目的评估Sysmex XS-800i血液分析仪的空白值、精密度、携带污染率、线性、准确度,核实仪器性能是否符合要求。方法以Sysmex XS-800i血液分析仪为实验仪器,执行空白检测;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;全血细胞计数(CBC)结果通过定期与规范操作检测系统进行比对来评估其测量准确度;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,其白细胞分类参考方法检测结果的可信区间采用精确概率法进行计算。结果各参数空白值、批内精密度、日间精密度、携带污染率均满足仪器要求。线性验证WBC、RBC、HGB、PLT均满足a值在1±0.05范围内,相关系数(r)≥0.975的要求。准确度:WBC 6.63%,RBC 2.97%,HGB 3.39%,HCT 2.78%,MCV 3.37%,MCH 3.33%,MCHC 2.80%,PLT 10.24%;中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞、嗜碱性粒细胞分类计数合格率100%,满足白细胞分类计数准确度的要求。结论 Sysmex XS-800i血液分析仪的使用性能经评估符合要求。

Objective To evaluate the blank value, precision, carryover rate,linearity and accuracy of Sysmex XS-800i, and to check whether performance evaluation of Sysmex XS-800i hematology analyzer meet the machine requirement. Methods Fresh whole blood anticoagulated by EDTA-K2 was used to test the inter batch precision. Two different levels of hematology quality con- trol were used to test the inter day precision. The accuracy of white blood classification was evaluated through five classification of white blood cell differential count. The credibility intervals of the white blood classification results from the reference method were calculated with exact probability. Results The blank value,inter batch precision,inter day precision,carryover rate all met the ma- chine requirements. Linear verification in WBC, RBC, HGB,PLT all met the requirement of a value between 1 4-0.05 and correlation coefficient r^0. 975. The accuracy in WBC was 6. 630/00, RBC 2.97~, HGB 3.39~, HCT 2. 78~, MCV 3.37% MCH 3.33 %, MCHC 2.80%and PLT 10.24%. Conclusion The performance evaluation results indicate Sysmex XS-800i hematology analyzer can satisfy the machine requirement.