论文部分内容阅读
目的评价自建中和试验检测乙型肝炎病毒e抗体(抗-HBe)的临床适用性。方法 2013年2月-5月用实验室自建中和试验检测系统检测酶联免疫吸附试验(ELISA)法检测灰区的抗-HBe不确定结果标本103份,确定其反应性。再从103份标本中随机抽取72份标本用电化学发光法进行检测,计算中和试验和电化学发光法相比较的Kappa值,评价两种方法的一致性。结果经中和试验确认,59份ELISA法抗-HBe阳性标本经中和试验确认为57份具有反应性;44份ELISA法抗-HBe阴性标本经中和试验确认后有26份显示有反应性。中和试验和电化学发光法检测抗-HBe的Kappa值为0.75,二者一致性较好。结论中和试验确认ELISA法检测抗-HBe的不确定结果,其分析性能能满足临床需求,且经济而实用。
Objective To evaluate the clinical applicability of self-built neutralization assay to detect hepatitis B virus e antibody (anti-HBe). Methods From February to May 2013, 103 samples of the uncertainty zone of anti-HBe in the gray zone were detected by enzyme-linked immunosorbent assay (ELISA) in a laboratory self-built neutralization test system, and their reactivity was determined. 72 samples were randomly selected from 103 samples and detected by electrochemiluminescence method. The Kappa value of neutralization test was compared with that of electrochemiluminescence. The consistency of the two methods was evaluated. The results of neutralization test confirmed that 59 ELISA anti-HBe positive samples by the neutralization test was confirmed as 57 with reactivity; 44 ELISA anti-HBe negative samples after neutralization test confirmed that after 26 showed reactivity . The Kappa value of anti-HBe detected by neutralization test and electrochemiluminescence was 0.75, the consistency between the two was good. Conclusions The neutralization test confirms the uncertainty of anti-HBe by ELISA and its analytical performance meets the clinical needs and is economical and practical.