Sysmex血细胞分析仪白细胞分类计数校准方法的建立与验证

目的 对Sysmex五分类血细胞分析仪白细胞分类计数进行校准,并通过仪器之间比对验证,使检测结果准确可靠。方法 采用手工显微镜计数法作为白细胞分类计数参考方法对5份新鲜全血白细胞分类计数百分比进行定值,用定值新鲜全血对Sysmex XE-2100,XS-800i和 XN-20(A1)血细胞分析仪的分类系数进行校准,之后用20份新鲜全血进行仪器间比对实验。结果 各仪器白细胞分类计数结果均在手工显微镜白细胞分类计数结果95%可信区间内。与参比仪器XE-2100相比,XS-800i NEUT%,LYM%,MON%,EOS%和BASO%相关系数r分别为0.99,0.99,0.98,0.98和0.59; XN-20(A1)NEUT%,LYM%,MON%,EOS%和BASO%相关系数r分别为0.99,0.99,0.97,0.98和0.55; XS-800i和XN-20(A1)白细胞分类计数NEUT%,LYM%,MON%和EOS%均100%在可信区间之内,XS-800i白细胞分类计数BASO%结果95%在可信区间之内,XN-20(A1)白细胞分类计数BASO%结果90%在可信区间之内。结论 该校准验证方案及比对结果满足WS/T 246-2005《白细胞分类计数参考方法》各项指标要求。为了保证血细胞分析仪白细胞分类计数结果的准确性以及不同实验室间白细胞分类计数的结果互认,要定期对仪器白细胞分类计数结果与手工显微镜分类计数结果进行比对分析。

Establishment of Method and Verification for Leukocyte Differential Count of Sysmex Hematology Analyzer

Objective To calibrate the leukocyte differential counts and compare between all sysmex hematology analyzers,making the results accurate and reliable.Methods Used the manual visual microscope method as a reference method for leukocyte differential count to detect the fresh blood and then did assignment.The target value,calibrating the leukocyte differential counts of Sysmex XE-2100,XS-800i and XN-20(A1)with themanual value fresh blood,was calibrated and then compared hematology analyzers with another fresh blood.Results The leukocyte differential counts of all hematology analyzers were within the 95% confidence intervalof the manual visual microscope method.Comparing with the reference system,the correlation coefficient(r)of NEUT%,LYM%,MON%,EOS% and BASO% of XS-800i analyzer were 0.99,0.99,0.98,0.98 and 0.59,respectively.The correlation coefficient(r)of NEUT%,LYM%,MON%,EOS% and BASO% of XN-20(A1)analyzer were 0.99,0.99,0.97,0.98 and 0.55,respectively.XS-800i and XN-20(A1)NEUT%,LYM%,MON% and EOS% were within confidence interval 100%.XS-800iBASO% were within confidence interval 95%.XN-20(A1)BASO% were within confidence interval 90%.Conclusion This scheme could meet theWS/T 246-2005 demands.In order to ensure the accuracy and the results of mutual recognition of the leukocyte differential counts,the comparison analysis of the results of the manual visual microscope method and hematology analyzer were made.