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目的探讨国内血站对献血员乙型肝炎病毒表面抗原(HBsAg)筛查的安全性和可靠性。方法收集经血站筛查HBsAg阴性的合格献血员血浆983份,用雅培ArchitectI2000电化学发光仪定量检测HBsAg;巢式PCR扩增乙肝病毒S区、C区、X区。诊断为隐匿性乙肝病毒感染者,巢式PCR扩增病毒PreS/S区,产物直接测序并与标准病毒序列对比分析病毒株变异。结果经雅培ArchitectI2000复检HBsAg弱阳性率为6.5%(64/983),HBsAg滴度中位数为0.17IU/ml;60.9%(39/64)病毒两个区扩增阳性,4.0%(39/983)健康献血员为隐匿性HBV携带者;35.9%(14/39)病毒PreS/S区段扩增阳性,未发现“a”决定簇内的变异株。结论目前经血站常规检测HBsAg为阴性的合格血液用敏感性更高的试剂仍能检测出HBsAg及HBV DNA。
Objective To investigate the safety and reliability of screening blood donors’ hepatitis B virus surface antigen (HBsAg) in blood stations in China. Methods A total of 983 HBsAg negative qualified blood donors were screened at the blood test station, HBsAg was detected by Abbott ArchitectI2000 electrochemiluminescence apparatus, and S, C and X regions of the hepatitis B virus were amplified by nested PCR. The diagnosis of occult hepatitis B virus infection, nested PCR amplification of PreS / S virus, the product was sequenced and compared with the standard virus sequence analysis of the variation of the virus strain. Results The positive rate of HBsAg was 6.5% (64/983) and the median of HBsAg titer was 0.17IU / ml on the Abbott ArchitectI 2000. The positive rate of HBsAg was 4.0% (39.9%) in 60.9% (39/64) / 983) healthy blood donors were occult HBV carriers; 35.9% (14/39) of the positive samples were positive for PreS / S and no mutants were found in the “a” determinant. Conclusion At present, the routine blood test of HBsAg-negative qualified blood in blood test station still can detect HBsAg and HBV DNA with more sensitive reagent.