3台不同血常规分析仪检测结果的临床验证

Clinical validation of detection results of three different blood routine analyzers

目的通过对该科室的3台不同型号的全自动血细胞分析仪的测定结果进行比对分析,评价这3台仪器的可比性是否达到临床要求。方法用Sysmex 2100全自动血细胞分析仪作为参考仪器,Sysmex 1000i和雅培1800作为实验仪器,采用仪器原厂质控物及患者的新鲜抗凝血标本,在该实验室这3台仪器上连续检测40d,分析白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、红细胞压积(HCT)和血小板(PLT)的检测结果。结果 3台仪器检测结果经F检验统计分析,差异无统计学意义(P>0.05),结果偏倚在1/2美国临床医学检验部门修正法规(CLIA′88)的最大允许误差范围内。结论这3台仪器的检测结果具有可比性,能达到临床的要求。

Objective To evaluate whether the comparability of 3 automatic blood cell analyzers meet the clinical requirements by conducting the comparative study on the detection results of these instruments.Methods With the Sysmex 2100 automatic blood cell analyzer as the reference instrument,Sysmex 1000i and Abbott 1800 as the experimental instrument,the original quality control provided by the instrument factory and the patient′s fresh anticoagulant blood samples in the laboratory were adopted to monitor for continuous 40 d by these three instruments and the detection results of WBC,RBC,HGB,HCT and PLT were analyzed.Results The detection results of these 3 instruments were statistically tested by the F test,the differences showed no statistical significance （P 〉0.05）and the bias was in 1/2 of the maximum permissible error range in America department clinical test revised regulations （CLIA′88）.Conclusion The detection results by these 3 instruments are comparable and can meet the clinical requirements.