DxH900血细胞分析仪性能及报警评价

An Evaluation of the Performance of the DxH 900 Hematology Analyzer and Flagging Efficiency

目的评价DxH900血细胞分析仪性能及报警信息。方法参照《WS/T 406-2012临床血液学检验常规项目分析质量要求》,对DxH900血细胞分析仪进行性能验证;评价白细胞分类性能及异常细胞报警信息有效性。结果DxH900测定RBC、Hb和MCV的批内及批间精密度(CV)均≤1.0%,WBC和PLT的批内CV≤2.0%,批间CV≤1.6%。WBC、RBC、Hb和MCV准确度偏差≤5.4%,PLT的偏差≤14%。WBC、RBC、Hb和PLT的携带污染率≤0.45%,以上4项在临床标本覆盖浓度范围内,斜率在1±0.03以内,且R^(2)>0.99;以显微镜镜检为“金标准”,白细胞分类与显微镜镜检结果相比,中性粒细胞、淋巴细胞和嗜酸粒细胞的相关性较好(r分别为0.913、0.897和0.728,P<0.01),其次为单核细胞及嗜碱性粒细胞(r分别为0.586,0.588,P<0.01);发现异型淋巴细胞及淋巴增殖性疾病的灵敏度达100%,阴性预测值100%;当WBC≥4.0×10^(9)/L时,原始细胞报警灵敏度达100%,阴性预测值100%。结论DxH900血细胞分析仪各项性能良好,符合WS/T406-2012文件要求,适用于临床标本检测,尤其适用于血液系统疾病的筛查。

Objective To evaluate the performance of DxH900 hematology analyzer for complete blood cell(CBC)by detecting its performance indicators and the reliability of alarm messages.Methods Performance validation were performed in accordance with WS/T406-2012 Analytical Quality Specifications for routine tests in clinical hematology and we evaluated the flags and results reported by the DxH900 analyzer.Results Intra-imprecision results showed:the coefficient of variation(CV)of RBC,Hb,and MCV were less than 1.0%,the CV of WBC and PLT were not more than 2.0%;Inter-imprecision results showed:the CV of RBC,Hb,and MCV were not more than 1.0%,the CV of WBC and PLT were not more than 1.6%.The relative standard deviation(RSD)of the accuracy values of WBC,RBC,Hb,and MCV were not more than 5.4%,and the result of PLT was not more than 14%.The carryover rate of WBC,RBC,Hb,and PLT were not more than 0.45%,and in the concentration range covered by clinical specimens,while the slope of the linear relations were within 1±0.03,and R^(2)>0.99;The correlation between leukocyte differential count about the neutrophils,lymphocytes,and eosinophils between the DxH900 and microscopic method were good(r=0.913,0.897 and 0.728,respectively,P<0.01),followed by monocytes and basophils(r=0.586 and 0.586,P<0.01);Flagging performance exhibited a very high sensitivity(100%)for atypical lymphocytes and lymphoproliferative diseases and a very high negative predictive value(100%).When WBC≥4.0×10^(9)/L,the sensitivity was very high(100%)for primitive cells and the negative predictive value was also very high(100%).Conclusion DxH900 analyzer shows a good performance in all aspects and can meet the quality requirements of clinical tests.