利用新鲜全血对血细胞分析仪进行校准及结果比对

目的:利用新鲜全血对不同血细胞分析仪进行校准和结果比对,使各仪器检测结果一致并可溯源到国际参考方法。方法:首先用配套校准物SCS-1000校准Sysmex XT-2000i的手动检测模式并作为可溯源的检测系统和参考仪器对健康人新鲜全血定值,然后用定值的新鲜全血对Sysmex XT-2000i血细胞分析仪的自动检测模式和Sysmex XS-800i进行校准,并于校准后进行临床病人新鲜血样的比对实验。结果:校准前Sysmex XT-2000i血细胞分析仪自动检测模式的RBC、HGB、PLT项目和Sysmex XS-800i血细胞分析仪的HGB项目与参考仪器(sysmex XT-2000i手动检测模式)的偏倚(%)超过中华医学会检验分会校准判断标准允许范围,分别为1.65、1.51、3.68和2.62。校准后则WBC、RBC、HBG、HCT、MCV、PLT各项参数结果与参考仪器偏倚(%)均在允许范围内。同时进行临床病人新鲜血样的比对实验结果也表明,校准后比对仪器与参考仪器各项参数偏倚(%)均在ClIA88允许范围的1/2内。结论:利用新鲜全血对不同血细胞分析仪进行校准和结果比对,可以纠正仪器的系统偏差,使各仪器检测结果一致并可溯源到国际参考方法。

The Use of Fresh Whole Blood for Blood Cell Analyzer Calibration and Alignment

Objective:To calibration and compare the different hematology analyzer using fresh whole blood,insure the results of specimen can trace to the resource of international reference method.Methods:First,the sysmex XT-2000i was chosen as the target analyzer after its manual mode calibration by SCS-1000,then using the reference analyzer to settle a value of the fresh blood.When the sysmex XT-2000i auto-detecting mode and sysmex XS-800i analyzer were calibrated with fresh whole blood,we compared the hematology analyzer with fresh whole blood of clinical patients.Results:Before the calibration,the bias(%) on RBC,HGB,PLT of sysmex XT-2000i and HGB of sysmex XS-800i were higher than the inspection calibration standard of Chinese Medical Association(1.65,1.51,3.68,and 2.62). Respectively,after the calibration.the results were agreed with the relative bias(%) for allowed.The compared tests shoved that after the calibration the bias(%) of clinical patient fresh blood sample on each hematology analyzers were lower than one half of CLIA88 allowable. Conclusion:The method that using fresh whole blood calibrated different hematology analyzer can correct the systematic bias,and the results were consistent and can trace to the resource of international reference method.