摘要
目的通过同一实验室两台化学发光仪器间测定血清β-hCG的方法比对和预期偏倚评估,探讨两台化学发光仪器之间测定数据是否具有可比性,或检测结果的偏倚是否在允许范围内,以确保测定结果具有可比性和一致性,为实验室不同仪器测定结果互认提供依据。方法 2009年11月2日6日,参考美国CLSIEP9-A2文件,以Roche cobase601为参比方法 ,Roche cobase411为待评方法 ,用40份患者新鲜血清标本,测定血清β-HCG,对两台仪器之间的预期偏倚进行评估。结果相关系数r=0.9988,截距a=3.48,斜率b=1.03,以20%为允许限,两仪器测定的结果在允许范围内。结论两仪器测定血清β-HCG的偏倚在实验室允许范围内,测定具有很好的相关性,结果具有可比性。
Objective To compare two different Electro-chemiluminescence （ECL） assays for the detection of human chorionic gonadotropin β （β-HCG） and judge whether the bias are in permissible range,in order to ensure they are comparable and identical between different ECL assays,and to provide evidence to mutual affirmation between different laboratories. Methods According to CLIS EP9-A2,the β-HCG results of 40 patient samples were compared between Roche cobas e 411 （candidate method） and Roche cobas e 601 （reference method）,and the expected bias was evaluated between two different analyzers in November 2 to 6,2009. Results The correlation analyse showed that the correlation coefficient was 0.9988,intercept was 3.48 and slope was 1.03. When 20% as permissive limit,the results of two different analyzers was comparable and identical. Conclusion The bias of β-HCG results between two different analyzers is acceptable,and the results between two different analyzers have good correlation and comparability.
出处
《华西医学》
CAS
2010年第6期1117-1119,共3页
West China Medical Journal
关键词
电化学发光
比对
Β-HCG
Electro-chemiluminescence
Comparison
Human chorionic gonadotropin β
