Cobas500与Olympus640检测系统血清酶测定值可比性研究

目的通过对不同实验室不同检测系统血清酶测定结果进行偏倚评估和方法比对,研究不同检测系统间血清酶测定结果是否具有可比性,为不同实验室检验结果的互认提供依据。方法以美国临床实验室标准化委员会(NCCLS)EP9-A2文件指南的规定对不同检测系统进行比对。将罗氏Cobas500生化分析仪、罗氏原装试剂、C.f.a.s校准品和质控品组成的检测系统作为目标系统(比较方法 ),Olympus640生化分析仪作为待评系统(实验方法 )。分别在两个不同检测系统测定罗氏质控血清PNU(生理值)、PPU(病理值)和45份新鲜血清的血清酶,评估两个检测系统的精密度,计算实验方法与比较方法间的相对偏差,以CLIA′88规定的室间质评允许误差范围的1/2为标准,判断不同检测系统之间血清酶测定结果的可比性。结果两个系统间血清酶测定结果经配对t检验分析差异无统计学意义,5项血清酶检测结果的系统误差临床可以接受。结论两个检测系统5种血清酶测定结果除丙氨酸氨基转移酶高值外均具有可比性,临床可接受性能可以接受。

Study on comparability of measured values of serum enzymes by Copas500 and Olympus640 detection systems

Objective To conduct the bias evaluation and methodological comparison on detection results of serum enzymes by different detection systems in different laboratories and to study the comparability of serum enzymes detection results between different detection systems to provide the basis for the mutual recognition of measured results in different laboratories.Methods According to the stipulation of EP9-A2 on the United States Committee for Clinical Laboratory Standards（NCCLS）,the different detection systems were compared. The Roche Cobas500 biochemical analyzer,Roche original reagents,c.f.a.s calibrators and quality controlling products were taken as the target system （comparative method）,and the Olympus640 biochemical analyzer as the evaluating system （experimental method）.The physiological value（PNU） and pathological value（PPU） in the Roche quality controlling serum and serum enzymes in 45 fresh serum samples were detected by the two different detection systems. The precision of the two systems was evaluated,the relative deviation between the experimental method and comparative method was calculated and the comparability of enzyme detection results between different systems was judged with the permissible error range of 1/2 stipulated by CLIA＇88 External Quality Assessment as the standard.Results The difference of enzyme detection results between the two different detection systems had no statistical significance by the paired t test. The systematic error of 5 serum enzymes detection results was clinically acceptable.Conclusion The detection results of 5 serum enzymes by two different detection systems possess the comparability except the high value of ALT. The clinical acceptability is acceptable.