Sysmex XE-2100血细胞分析仪自建检测系统的建立及应用研究

Establishment of the Sysmex XE-2100 Hematology Analyzer Self-built Detection System and Its Application

目的建立SysmexXE-2100血细胞分析仪自建检测系统，并探讨其结果的可比性。方法以国产试剂为基础建立SysmexXE-2100血细胞分析仪自建检测系统。参照美国临床和实验室标准协会（CLSI）EP9-A2文件将其与配套检测系统进行比对分析，建立线性回归方程和计算相对系数（r），并计算各项目医学决定水平处的相对偏倚％（SE％），以1／2CLIA’88为实验室允许总误差（TEa）的临床可接受范围判断自建检测系统与配套检测系统结果的可比性。同时将仪器白细胞分类（DC）结果与人工镜检结果进行比较。结果两套检测系统测定结果（CBC）间相关性良好（r=0．9967～0．9998，t配对=--0．1052～O．2524，P值均〉O．05）。自建检测系统在医学决定水平处相对偏倚在允许范围之内。白细胞分类计数仪器法与人工镜检方法比较，嗜中性粒细胞、淋巴细胞结果的相关性较好（r均〉0．97）。而在测定单核细胞、嗜酸性粒细胞、嗜碱性粒细胞时相关性稍差（r=0．7997～O．9138）。结论自建检测系统测定结果与配套检测系统结果具有良好的可比性，可应用于临床，显著降低成本。

Objective To set up the Sysmex XE-2100 hematology analyzer self-built detection system,and to study the compa- rability of its results. Methods The Sysmex XE-2100 hematology analyzer self-built detection system based on domestic rea- gents was established. According to the Clinical and Laboratory Standard Institute （CLSI） EP9-A2 document,the difference between self-built and matching detection system was analyzed, which included the correlation coefficient （r）, regres- sionequation and the system error （SE%） at medicine deciding level. Judge the comparability of different systems according to the half of CLIA＇88 standard. The results of white blood cell differential count （DC） on the two detection systems and mi- croscopic examination method were compared also. Results The relationship between the results of the two detection sys- tems were close （r=0. 996 7-0. 999 8,tpaired = -0. 105 2-0. 252 4,P〉0. 05）. The SE% of self-built detection system at medicine deciding level were all acceptable. Evaluation results of DC indicated a good correlation between the two detection systems and microscopic examination method （r〉0.97） for neutrophil, lymphocyte, while less correlation （r=0. 799 7- 0. 913 8） for monocyte,eosinophil,basophile. Conclusion The results of CBC and DC were in good agreement between the two systems. The self-built detection system could be used in clinical medicine laboratory and may significantly reduce costs.