CELL-DYN Sapphire血液分析仪有核红细胞检测的性能评价

Performance evaluation of nucleated red blood cell by the CELL-DYN Sapphire automated hematology analyzer

目的对CD-Sapphire血液分析仪自动检测有核红细胞(NRBC)的分析性能和准确性进行评估。方法对该仪器检测NRBC的本底计数、携带污染率、精密度、线性范围等方面进行验证,并以手工显微镜镜检法为参考方法,与仪器法进行比对,以评价其准确性。结果NRBC的本底值为0.00,携带污染率为0.0%,批内精密度为3.18%(低值)、2.79%(中值)、1.27%(高值),批间精密度为3.08%(高值),NRBC检测的线性验证范围为(0~40.5)×10^9/L(r=0.9986,P<0.05)。以手工镜检法为标准,与仪器法检测NRBC比对的一致性范围为-5.874~8.167NRBC/100个WBC,偏移为1.146NRBC/100个WBC;线性回归方程为Y=0.9840X-0.4902,相关系数r=0.9970,P<0.05。结论AbbottCELL-DYNSapphire全自动血液分析仪检测NRBC的敏感性高、精密度良好、与手工镜检法比对的准确性高,能满足临床实验室对NRBC的检测要求。

Objective Evaluation of the analytical performance and accuracy of automatic detection of nucleated erythrocytes (NRBC) by a CD-Sapphire blood analyzer.Methods According to the professional standard,the background count,the carryover contamination rate,the precision,the linear range of automatic detection of NRBC by CD-Sapphire were evaluated,and with manual microscopy count NRBC as the reference method,its accuracy on auto-detection NRBC was evaluated.Results The background counts were 0.00,the carryover contamination rate was 0.0%,The within-run precision is 3.18%(low value),2.79%(medium value),1.27%(high value),the daytime precision is 3.08%( high value),The linear validation range for NRBC detection is (0-40.5)×10^9/L ( r =0.998 6,P <0.05),and with manual microscopy count NRBC as the reference method,its consistency range is -5.874-8.167 NRBC / 100 WBC and Offset is 1.146 NRBC / 100 WBC.The linear regression equation is Y =0.984 0 X -0.490 2,the correlation coefficient is 0.997 0( P < 0.05 ).Conclusion automatic detection of nucleated erythrocytes (NRBC) by Abbott Cell-DYN -Sapphire blood analyzer have the high sensitivity,the good precision,and the excellent accuracy,it could satisfy the requirement of detected NRBC for clinical laboratories.