An Evaluation of the Performance of the DxH 900 Hematology Analyzer and Flagging Efficiency
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 R2＞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 × 109/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.
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