两种化学发光检测系统对糖链抗原19-9测定结果的可比性研究

Comparative study on two chemiluminescence immunoassay systems in detecting carbohydrate antigen 19-9

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＝1．0812XA -4．8484，r2＝0．9622。CA19-9在给定结果25 U/mL和250 U/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。

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-A2 document ,40 serum samples from different patients were collected and CA19-9 levels 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＆gt;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 25 U/mL and 250 U/mL of CA19-9 ,B relative bias is 11 .28% and 6 .00% .By CA19-9 biological 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 CA19-9 and the difference between them is acceptable .