Sysmex XE-2100全自动血液分析仪的性能验证

Performance Verification of Sysmex XE-2100 Automated Hematology Analyzer

目的:通过对Sysmex XE-2100全自动血液分析仪进行性能验证,了解和掌握该仪器的精密度、正确度、线性、携带污染率、功能灵敏度、可稀释范围、参考区间及手动与自动进样模式结果比对的性能。方法:以国际血液学标准化委员会、临床和实验室标准协会制定的评价方案为标准进行评价试验。结果:全血细胞计数精密度、正确度、线性良好,携带污染率低,功能灵敏度符合要求,可稀释范围回收率良好,参考区间适用。2种进样模式相关性好,与手工法白细胞分类结果比较,中性粒细胞、淋巴细胞、嗜酸性细胞的γ值均达0.9以上。异常细胞检测能力总有效性为95.4%。结论:Sysmex XE-2100全自动血液细胞分析仪各方面性能良好、测定准确可靠,可快速、有效地完成大批量标本的筛检。

Objective To learn the precision, correctness, linearity, residual contamination rate, function sensitivity, dilution range, reference interval, and manual or automatic sampling mode of Sysmex XE-2100 Automated Hematology Analyzer by per- formance verification. Mecdaods The verification was performed on the bases of the evaluation procedures from International Com- mittee for Standardization in Hematology and American Clinical Laboratory Standards Institute. ~ When used for complete blood count, the analyzer behaved well in precision, correctness, linearity, residual contamination avoidance, function sensitivity, dilution range and reference interval, and there was a high correlation between the two sampling modes; when used for manual leukocyte differential count, the analyzer had T values of neutrophilic granulocyte, achroacyte and eosinophile granulocyte more than 0.9, and the total effective rate for abnormal cell detection 95.4%. Conclusion Sysmex XE-2100 Automated Hematology Analyzer is effective, accurate and reliable, and can be used for mass samples screening.