CAJ | 학술논문

目的：对两台同型号全自动血细胞分析系统 Sysmex XT-2000i 的检测结果进行比对分析和偏倚评估，实现结果的互通。方法参考美国临床实验室标准化委员会（NCCLS）EP9-A2文件的要求，采用参考仪器和测试仪器对患者新鲜全血白细胞（WBC）、红细胞（RBC）、血红蛋白（HGB）、红细胞比容（HCT ）、血小板（PLT ）、红细胞平均体积（MCV）6项指标进行检测，制作散点图，计算回归方程、相关系数（r2）、预期偏倚和95％置信区间相对偏倚。以美国临床实验室改进法案修正案（CLIA′88）中规定允许误差（Ea）的1/2为标准，评估结果之间的可比性。结果两系统的批内精密度良好，WBC 、RBC 、HGB 、HCT 、PLT 、MCV6项指标的 r2分别为0．9987，0．9933，0．9967，0．9968，0．9945，0．9919，r2均大于0．95，两者总的相关性良好。检测系统各项目医学决定水平的相对偏倚均小于1/2 Ea ，结果可被临床接受。结论本实验室内两台同型号全自动血细胞分析系统 Sysmex XT-2000i 检测结果相关性良好，可实现检测结果的互通。
목적：대량태동형호전자동혈세포분석계통 Sysmex XT-2000i 적검측결과진행비대분석화편의평고，실현결과적호통。방법삼고미국림상실험실표준화위원회（NCCLS）EP9-A2문건적요구，채용삼고의기화측시의기대환자신선전혈백세포（WBC）、홍세포（RBC）、혈홍단백（HGB）、홍세포비용（HCT ）、혈소판（PLT ）、홍세포평균체적（MCV）6항지표진행검측，제작산점도，계산회귀방정、상관계수（r2）、예기편의화95％치신구간상대편의。이미국림상실험실개진법안수정안（CLIA′88）중규정윤허오차（Ea）적1/2위표준，평고결과지간적가비성。결과량계통적비내정밀도량호，WBC 、RBC 、HGB 、HCT 、PLT 、MCV6항지표적 r2분별위0．9987，0．9933，0．9967，0．9968，0．9945，0．9919，r2균대우0．95，량자총적상관성량호。검측계통각항목의학결정수평적상대편의균소우1/2 Ea ，결과가피림상접수。결론본실험실내량태동형호전자동혈세포분석계통 Sysmex XT-2000i 검측결과상관성량호，가실현검측결과적호통。
Objective To analyze the results of two hematocyte analyzers Sysmex XT-2000i and evaluate the bias .Methods According to National Committee for Clinical Laboratory Standards (NCCLS) EP9-A2 ,the hemato-cyte analyzers were used to measure the white blood cell (WBC) ,red blood cell (RBC) ,platelet (PLT ) ,hemoglobin (HGB) ,hematocrit(HCT ) and mean corpuscular volume(MCV )of fresh blood .The results in the reference instru-ment and test instrument were recorded ,and regression equations correlation coefficient (r2 ) ,predicted bias and 95%confidence interval were calculated .According to the "Clinical Laboratory Improvement Amendments " (CLIA′88) , half of allowable error(Ea)was applied as a standard to evaluated the comparability of results and clinical acceptabili -ty .Results The two systems had good intra batch precision .The r2 of WBC ,RBC ,HGB ,HCT ,PLT ,MCV were 0 .998 7 ,0 .993 3 ,0 .996 7 ,0 .996 8 ,0 .994 5 and 0 .991 9 respectively ,which were both more than 0 .95 .Therefore the overall correlation was good .The relative bias of the two systems were all less than 1/2 of CLIA′88 allowable error , which were clinically acceptable .Conclusion The two systems in the clinical laboratory of Tongling People's Hospital exists well correlation .