摘要
目的探讨两种分析仪产前筛查AFP和β-hCG测定结果的可比性。方法随机采集198例孕中期(15~20周)孕妇血清,三个批号的质控血清由伯乐公司提供,孕妇血清和质控血清分别在Roche cobas e601电化学发光分析仪(A分析仪)和Beckman Coulter Accesss DXI800磁性微粒化学发光免疫分析仪(B分析仪)进行检测,比较两种分析仪测定结果的差异及神经管缺陷(NTD)和唐氏综合征(Down's)高风险检出情况。结果两种分析仪对血清AFP和β-hCG水平测定结果,经配对t检验,差异有统计学意义(t=2.773~3.645,P<0.05),经不同水平质控物的验证校准,偏倚在允许范围,两种分析仪测定结果的相关系数r^2均≥0.95。两种分析仪测定198例孕妇血清标本,均检出唐氏综合征高风险5例、神经管缺陷高风险4例,经卡方检验,差异无统计学意义(P=1.000)。结论两种分析仪虽检测原理不同,但筛查结果符合临床要求,两种分析仪间仍存在系统误差,需加强对各影响因素的控制。
Objective To evaluate the comparability of test results of human serum AFP and β-hCG by two instrument. Methods The serum samples collected from 198 pregnant women with 15 -20 weeks and 3 batches of control serum were divided into two group randomly. One group samples were detected with Roche cobas e601 chemiluminescent immunoassay analyzer, the other group with Beckman Coulter Aecesss DXIS00. The comparison of high risk of Down＇ s syndrome （DS） and neural tube defects （NTD） between two instruments were carried out. Results There was obvious significance on detection of serum AFP and β-hCG levels between two instruments （P 〈 0.05 ）. It was verified by different levels of quality control materials bias within the scope of the permit. Five cases of DS high-risk and four cases of NTD high risk in 198 serum samples were all detected by two struments without significant difference between them （P = 1. 000）. Conclusion The results of prenatal screening by two instruments meet the clinical requirements.
出处
《标记免疫分析与临床》
CAS
2014年第6期743-745,共3页
Labeled Immunoassays and Clinical Medicine
基金
河北省唐山市科学技术研究与发展计划指导项目(项目编号:10130254c)
