不同检测系统测定载脂蛋白结果的可比性研究

目的通过对不同检测系统进行方法比对分析,探讨各系统检测载脂蛋白结果是否具有可比性。方法参照NCCLS《EP9-A文件》的要求,以可溯源的检测系统为目标检测系统,均采用免疫透射比浊法测定载脂蛋白A、载脂蛋白B(apo-A、apo-B),对本院3个不同检测系统进行RNA-DOX质控物(水平2和水平3)各测定20次和测定新鲜血清标本40份。结果RNADOX质控物和新鲜血清标本apo-A、apo-B测定经随机区组设计资料的方差分析,各检测系统间的差异均有统计学意义(P<0.001)。各检测系统测定新鲜血清标本的apo-A、apo-B可靠性系数α分别为0.9688、0.9809,各系统间的相关系数均大于0.950。各检测系统测定apo-A、apo-B的精密度CV均<10%,以可溯源的检测系统1为目标检测系统,临床可接受性能评价检测系统2和系统3均未超出临床接受范围。结论3个不同检测系统测定载脂蛋白结果具有可比性。当同一实验室同一检验项目存在2个以上的检测系统时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。

Comparability research on apolipoprotein results among different kinds of detection systems

Objective To discuss the comparability of apolipoprotein results among different detection systems.Methods Three different kinds of biochemistry detection systems were used to detect apolipoprotein A and apolipoprotein B(apo-A,apo-B) concentration in 2 levels of Randox quality controls and 40 clinical sera according to EP9-A file. The collected data were dealt with statistical analysis.Results Analysis of variance showed apolipoprotein results from different control and patients sera had significant difference in different detection systems (P<0.01).The correlation coefficient of each detection system was all above 0.950 and the reliability coefficient of them was 0.968 8 and 0.980 9.Target system 1 was regarded as standard detection system and evaluated the acceptability of other detection systems.As a result,detection system 2 and detection system 3 were accepted by clinical assessment.Conclusion The precision and comparability of apolipoprotein results in the 3 kinds of detection systems accorded to clinical requirement and the evaluation of clinical acceptability.