不同检测系统血常规结果的可比性研究

目的探讨江苏省沭阳县人民医院4个不同检测系统间血常规检测结果是否具可比性,为检验结果互认和临床实验室认可提供依据。方法参考美国临床实验室标准化委员会的EP9-A文件,以Sysmex XT 1800i全自动血细胞分析仪及原装试剂、校准品和质控品组成的系统为目标系统,用患者新鲜乙二胺四乙酸二钾抗凝标本对不同实验检测系统的红细胞、血红蛋白、白细胞、血小板4项常规项目的检测结果与目标检测系统进行比对,计算实验检测系统(Y)和目标检测系统(X)之间的相对偏差,以美国临床医学检验部门修正法规(CLIA′88)允许总误差(TEa)的1/2为标准,判断检验结果的可比性。结果实验检测系统2(Y2)和实验检测系统3(Y3)血小板差异有统计学意义(P<0.05),<1/2TEa;实验检测系统3(Y3)血红蛋白偏低,差异有统计学意义(P<0.05),<1/2TEa;其余差异无统计学意义,<1/2TEa。结论不同检测系统的血常规结果某些项目存在不同程度的偏差,当用不同检测系统检测同一项目时,应进行方法比对和临床可接受性评价,以实现检验结果的可比性和结果互认。

The comparability study of blood routine results with different detection systems

Objective To discuss the conventional blood results between 4 different detection systems,and to provide basis for clinical laboratory accreditation. Methods The American clinical NCCLS＇s EP9 - A files to Sysmex XT 1800i automatic blood analyzer was referenced. The system was composed of original-binding reagents, calibration taste and quality control product. Results The detection system 2 （Y2） and experimental detection system 3 （Y3） PLT was significantly different （P〈0.05）, 〈 1/2TEa, experimental detection system 3 （Y3） Hb difference was sta tistically significant （P〈0.05）,〈1/2TEa. The rest was statistically significant, 〈 1/2TEa. Conclusion Different testing system of blood routine results some items have different degrees of deviation; and When using a different detection system testing the same projeet,should undertake methods to compare clinical acceptability evaluation,in order to realize the inspection result of comparison and the results＇ mutual recognition.