【摘要】 目的探讨2种化学发光检测系统(A:Cobas e 411,B:Beckman Dxi800)测定血清糖链抗原(CA)19-9结果的可比性。方法按照EP9-A2方案,收集江门市中心医院2013年7月8~18日检测CA19-9的新鲜血清,取40份不同浓度新鲜患者血清在2种化学发光检测系统上进行CA19-9检测,对结果进行统计分析。以A系统为基准系统对B系统作临床可接受性能评价。结果 2种系统检测结果经秩和检验差异无统计学意义(P>0.05)。B系统与A系统相关回归方程为YB=1.081 2 XA-4.848 4,r2=0.962 2。CA19-9在给定结果25U/mL和250U/mL处,B系统相对偏倚为11.28%和6.00%。以CA19-9生物学变异的最佳允许总误差22.1%为标准,临床全部可接受。结论使用Cobas e 411检测系统和Beckman Dxi800检测系统对CA19-9测定结果具有可比性。更多还原

【Abstract】 Objective To compare the results carbohydrate antigen 19-9(CA19-9)determined by two different chemiluminescence immunoassay(CLIA)systems(A:Cobas 411,B:Beckman Dxi800).Methods Referring to the EP9-A2document,40serum samples from different patients were collected and CA19-9levels were tested by the 2 different CLIA systems respectively.The collected data were processed by statistical analysis.A system was use as standard system to evaluate the acceptability of B system.Results There were no significant different between two different CLIA systems in rank sum test(P>0.05).Linear regression equations that B system for Asystem were YB =1.0812 XA-4.848 4,r2=0.962 2.In Specified concentration 25U/mL and 250U/mL of CA19-9,B relative bias is 11.28%and 6.00%.By CA19-9biological variation in the best total allowable error(TEa)22.1%for the standard. System B was completely acceptable.Conclusion There is comparability of two CLIA systems in the evaluation of clinical acceptability of CA19-9and the difference between them is acceptable.更多还原