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。
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.
出处
《第二军医大学学报》
CAS
CSCD
北大核心
2006年第7期768-770,共3页
Academic Journal of Second Military Medical University
