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HBV血清标志物e抗原假阴性的原因分析及对策
吴淑梅,林云,王辉,唐平,秦琴,沈茜
0
(第二军医大学长海医院实验诊断科,上海,200433)
摘要:
目的:分析ELISA法检测乙型肝炎病毒(HBV)标志物e抗原(HBeAg)出现假阴性的原因并探讨应对措施,防止HBeAg阳性漏检.方法:凡用ELISA法检测的HBV标志物5项指标结果为表面抗原(HBsAg)和核心抗体(抗-HBc)阳性(俗称1、5阳性)而HBeAg为阴性的,应用4家试剂2种方法联合复检HBeAg确认结果.具体措施:(1)对每天用A试剂检测的HBV标志物5项指标测得结果仅1、5阳性的样品,用A、B、C试剂(ELISA法)联合复检HBeAg.(2)无论A、B、C哪种试剂,只要HBeAg复检结果为阳性、弱阳性或样品测定D值在灰区范围的,必须用D试剂(化学发光法)进一步复检确认阳性,以D试剂复检结果为最终确认结果.结果:274份样品用A、B、C试剂复检HBeAg(室内质控值在控),A试剂结果仍然全部阴性,阳性漏检率为2.18﹪,B试剂结果5例阳性,阳性漏检率为0.36﹪,C试剂结果6例阳性(5例阳性与B试剂复检样品号码相同,1例A、B试剂复检为阴性C试剂复检为阳性),无阳性漏检.复检6例HBeAg阳性的样品用D试剂复检确认仍为阳性,无阳性漏检.结论:ELISA法A、B试剂存在比例不等的HBeAg假阴性.在日常工作中,对ELISA法测定的HBV标志物5项指标仅1、5阳性的样品结果,严格多家试剂联合复检HBeAg是非常必要的.
关键词:  肝炎病毒,乙型、HBeAg、假阴性反应、酶联免疫吸附测定、化学发光测定法
DOI:10.3724/SP.J.1008.2006.00768
投稿时间:2006-03-10修订日期:2006-06-26
基金项目:
Cause of HBeAg false-negative reaction and it countermeasures
WU Shu-mei,LIN Yun,WANG Hui,TANG Ping,QIN Qin,SHEN Qian
(第二军医大学长海医院实验诊断科,上海,200433)
Abstract:
Objective:To analyze the cause of HBeAg (one of HBV markers) false-negative reaction during ELISA examination and to discuss its countermeasures. Methods: The patients who were HBsAg (+) , HBcAb (+) and HBeAg (-) by ELISA examination were further detected with the reagents of 4 different manufacturers in 2 steps: (1) The serum samples positive of HBsAg and HBcAb by ELISA using reagent A were further detected by qualitative analysis and Double-antibody sandwich ELISA using reagent A , B and C. (2) Reagent D (chemiluminescence method) was used to confirm the diagnosis if the results were positive or weakly positive of HBeAg, or the D values were within a specific range by ELISA using reagent A, B or C. The result of reagent D was taken as the final result. Results: The 274 sera negative of HBeAg were still negative when using reagent A, with the false-negative rate being 2.18%; 5 sera were positive when using reagent B, with false-negative rate being 0.36% ; and 6 sera (including the 5 positive ones using reagent B and 1 negative case using reagent A and B) were positive when using reagent C, without false-negative case. All the 6 positive samples were confirmed by chemiluminescence using reagent D. Conclusion: It is suggested that ELISA examination using reagent A or B can lead to false-negative results of HBeAg. HBsAg (+), HBcAb (+) and HBeAg (-) sera in ELISA examination should be examined with combinations of reagents of different manufacturers.
Key words:  hepatitis B virus  HBeAg  false-negaitive reactions  enzyme-linked immunosorbent assay  chemiluminescent