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目的通过对乙型肝炎病毒核酸相关抗原(hepatitis B virus nucleic acid related antigen,HBV NRAg)与HBeAg和乙型肝炎病毒DNA(hepatitis B virus DNA,HBV DNA)之间的比较,探讨HBV NRAg在评价病毒复制中的应用价值。方法收集157例HBsAg阳性血清,采用酶联免疫吸附试验(ELISA)、化学发光微粒子免疫测定(CMIA)和荧光定量PCR法分别对血清进行HBV NRAg、HBeAg和HBV DNA含量检测。同时对188例HBsAg阴性血清进行HBV NRAg特异性检测。结果 157例HBsAg阳性血清中,HBV NRAg,HBeAg和HBV DNA阳性率分别为75.79%(119/157)、37.57%(59/157)和51.59%(81/157),HBV NRAg与HBeAg和HBV DNA比较,差别有统计学意义(χ2=19.88,P=0.000;χ2=46.69,P=0.000)。分别在HBeAg和HBV DNA阳性病例中,HBV NRAg S/CO值与HBeAg S/CO值和HBV DNA基因组拷贝数呈正相关(r=0.506,P=0.000;r=0.499,P=0.000)。在一致性评价中,HBV NRAg同HBeAg和HBV DNA两个指标联合用于评价病毒复制的一致性较好(Kappa=0.52),其阳性符合率为94.79%,总符合率为78.98%。HBV NRAgELISA检测特异性为99.40%。结论 HBV NRAg可作为临床评价HBV复制以及乙肝治疗效果监测的初筛指标,适合在各个层次的医院开展检测。
Objective To investigate the relationship between HBV NRAg and hepatitis B virus nucleic acid related antigen (HBV NRAg) and HBeAg and hepatitis B virus DNA (HBV DNA) Application value in replication. Methods A total of 157 cases of HBsAg positive sera were collected and serum levels of HBV NRAg, HBeAg and HBV DNA were detected by enzyme - linked immunosorbent assay (ELISA), chemiluminescence microparticle immunoassay (CMIA) and real - time fluorescence quantitative PCR. At the same time, 188 cases of HBsAg negative serum HBV NRAg specific detection. Results The positive rates of HBV DNA, NRAg, HBeAg and HBV DNA in 157 cases of HBsAg positive sera were 75.79% (119/157), 37.57% (59/157) and 51.59% (81/157), respectively. The positive rates of HBV NRAg, HBeAg and HBV DNA The difference was statistically significant (χ2 = 19.88, P = 0.000; χ2 = 46.69, P = 0.000). HBV NRAg S / CO values were positively correlated with HBeAg S / CO values and HBV DNA copy number in HBeAg and HBV DNA positive cases (r = 0.506, P = 0.000; r = 0.499, P = 0.000). In concordance assessment, HBV NRAg with HBeAg and HBV DNA combined with two indicators for the evaluation of viral replication consistency (Kappa = 0.52), the positive coincidence rate was 94.79%, the total coincidence rate was 78.98%. HBV NRAg ELISA detection specificity of 99.40%. Conclusion HBV NRAg can be used as a primary screening index for clinical evaluation of HBV replication and hepatitis B therapeutic efficacy, suitable for testing at all levels of hospitals.