不同检测系统血小板测定结果的可比性研究

目的探讨7个血液分析检测系统血小板测定结果的可比性。方法以可溯源的B ayer120全自动血液分析仪及其配套的校准物、试剂和质控物为目标检测系统,与其它6个检测系统(Cou lter、CD 3500、B ayer60、3台CD 1700血液分析仪及其配套的校准物、试剂和质控物)为待评检测系统。在21个工作日内分别测定3种水平的四川通广全血质控物各10次、7次、7次和不同浓度新鲜全血样本55份。通过医学决定水平和相应回归方程计算目标检测系统与待评系统之间的相对偏差(%SE),以美国临床实验室修正法规(CL IA′88)规定的室间质量评价允许误差(T±25%)范围的1/2(T±12.5%)为标准,判断不同检测系统之间的可比性。结果3种水平的四川通广全血质控物和新鲜血标本经随机区组设计资料的方差分析各组间的总体差异均有显著性(P<0.001),各水平质控物的变异系数(CV%)和总CV值均小于CL IA′88允许误差范围的1/3(T±8.3%)。新鲜全血样本各系统间测定结果的信度系数a为0.996 4,各检测系统间相关系数均大于0.975;临床可接受性能评价均为部分或全部超过CL IA′88允许范围的1/2。结论各检测系统血小板测定的精密度符合临床要求,各检测系统间均存在不可比性,应采取改进措施,以保证检验结果具有可比性。

Comparability Study on PLT Results among Different Kinds of Detection System

Objective Explore the bias of platelet(PLT) results among 7 blood detection systems.Methods 7 different kinds of blood counting detection systems(Bayer120,three suits of CD1700,Coulter,CD3500 and Bayer60) were used to detect PLT concentration in 3 kinds of quality control specimen and 55 clinical blood samples.The collected data were deal with statistics analysis.Results Analysis of variance showed the PLT results from different control and fresh blood had significant difference in different detection systems(P<0.001).The correlation coefficient of each detection system was above 0.975 except detection system 7 and the reliability coefficient of them all were close to 1.Bayer120 was regarded as target detection system and evaluated the acceptability of other detection systems.As a result,other systems were partly accepted or couldn't be accepted by clinic assessment.Conclusion The precision of PLT results in the 7 kinds of detection system accorded to clinic requirement.However,incomparability existed in the evaluation of clinical acceptability.