不同检测系统测定总胆汁酸的比对试验

目的通过对不同检测系统进行方法比对分析,探讨各系统之间检测总胆汁酸(TBA)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,均采用循环酶法测定TBA,对该院3个不同检测系统进行朗道质控物(水平2和水平3)各测定20次和测定新鲜血清标本45份。结果朗道质控物和新鲜血清标本TBA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TBA可靠性系数α为0.9837,各系统间的相关系数均>0.975,各检测系统测定TBA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检测结果超过T±15%范围,系统3部分超过T±15%范围。结论3个不同检测系统测定TBA结果存在不可比性,应对其实施整改措施,使结果具有可比性。

Comparability research on TBA results among different kinds of detection systems

Objective To discuss the comparability of total bibe acidl(TBA) results among different detection systems.Methods 3 different kinds of coagulation detection systems were used to detect TBA concentration in 2 levels of Randox quality controls and 45 clinical sera according to EP9-A file.The collected data were dealt with statistical analysis.Results The analysis of variance showed TBA resulls from different control and patients sera had significant diffefence in different detection systems (P<0.01).The correlation coefficient of each detection system was above 0.975 and its reliability coefficient was 0.9837.Target system 1 was regarded as standard detection system and used to evaluate the acceptability of other detection systems.As a result,detection system 2 was not accepted and detection system 3 was partly accepted by clinical assessment.Conclusion The precision of TBA results in the 3 kinds of detection systems accorded to clinical requirement.However,incomparability existed in the evaluation of clinical acceptability.