上转发光免疫层析法定量检测乙型肝炎病毒外膜大蛋白的临床价值研究

Study on clinical value of HBV large envelope protein detected by up-converting phoshor immune chromatography assay

目的评价上转发光免疫层析法定量检测乙型肝炎病毒外膜大蛋白（HBV—LP）在乙型肝炎患者中的应用价值。方法利用一种新的基于上转发光法的免疫层析检测技术（UPT）检测500份乙肝病毒感染患者血清样品HBV．LP含量，并采用实时荧光定量PCR法检测HBVDNA；化学发光法检测乙肝五项指标。结果500例乙肝病毒感染患者HBV-LP与HBVDNA阳性率分别为58．0％和42．2％，两者间差异有统计学意义（P〈0．01），其中215份HBeAg阴性患者血清中，HBVDNA与HBV—LP的阳性率分别为29．3％和37．2％，两者差异无统计学意义（P〉0．05）；HBeAg阳性检出率为57．0％，与HBVDNA阳性检出率差异有统计学意义（P〈0．01）。结论上转发光免疫层析法检测乙肝病毒外膜大蛋白对HBeAg阴性和HBVDNA低拷贝患者体内病毒复制及预后评价有重要价值，联合检测HBVDNA、HBV—LP和HBeAg有利于乙肝病毒复制水平的判断和抗病毒治疗终点的确定。

Objective To evaluate the application value of the up-converting Phoshor technology immunoehromatography for HBV large envelope protein （HBV-LP） quantitative determination strip in hepatitis B patients. Methods Serum HBV-LP was detected by a new UPT-based immunoehromatograhpie technology, and HBV DNA was quantitively detected by real time fluorescent quantitation polymerase chain reaction （RT-PCR） , HBV five serum markers were detected by chemiluminescence method. Results In 500 cases of patients with hepatitis B, HBV-LP and HBV DNA positive rates were 58.0% and 42.2% respectively, there was significant difference between the positive rate of HBV DNA and that of HBeAg（P 〈 0.01）; In 215 cases of HBeAg negative specimens, the positive rates of HBV DNA and HBV-LP were 29. 3% and 37.2% respectively, the difference was statistically significant （P 〉 0. 05 ） ; and HBeAg positive rate was 57.0% ,there was significant difference between the positive rate of HBV DNA and that of HBeAg （P 〈 0.01 ）. Conclusion HBV-LP detected by UPT method can be used for the evaluation of viral replication and prognosis of patients with HBeAg negative and HBV DNA low copies patients. Combing detection of HBV DNA, HBV-LP and HBeAg is conducive to the judgment of HBV replication level and determination of antiviral treatment end point.