目的建立以IU为单位的乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)国家参考品。方法从我国多个省份血液中心和采浆站收集血清、血浆样品300份,应用5家国产和2家进口HBcAb诊断试剂初步筛选,并采用WHO国际HBcAb标准品进行标定...目的建立以IU为单位的乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)国家参考品。方法从我国多个省份血液中心和采浆站收集血清、血浆样品300份,应用5家国产和2家进口HBcAb诊断试剂初步筛选,并采用WHO国际HBcAb标准品进行标定,同时验证初步筛选获得的参考品的稳定性及适用性。结果建立了HBcAb国家参考品,包括阴性参考品15份、阳性参考品15份、灵敏度参考品1份、精密性参考品1份。其中灵敏度参考品经WHO国际HBcAb标准品标化后定量为5 IU/ml,19家发光试剂和酶联免疫试剂的最低检出限均值分别为0.67及0.53 IU/ml。参考品经4℃、常温、37℃保存及反复冻融后与置-20℃保存的参考品在阳性参考品符合率、阴性参考品符合率、最低检出限及精密性等方面的结果均一致。5家国产试剂检测阴性参考品符合率均为15/15,阳性参考品符合率均为15/15,其中3家试剂的最低检测限高于1.0 IU/ml,精密性CV均<20%。结论成功建立了以IU为单位的HBcAb国家参考品,且具有良好的稳定性及适用性,为提高HBcAb诊断试剂的质量奠定了基础。展开更多
Transfusion-transmitted infections including hepatitis B virus(HBV) have been a major concern in transfusion medicine. Implementation of HBV nucleic acid testing(NAT) has revealed occult HBV infection(OBI) in blood do...Transfusion-transmitted infections including hepatitis B virus(HBV) have been a major concern in transfusion medicine. Implementation of HBV nucleic acid testing(NAT) has revealed occult HBV infection(OBI) in blood donors. In the mid-1980 s, hepatitis B core antibody(HBc) testing was introduced to screen blood donors in HBV non-endemic countries to prevent transmission of non-A and non-B hepatitis. That test remains in use for preventing of potential transmission of HBV from hepatitis B surface antigen(HBs Ag)-negative blood donors, even though anti-hepatitis C virus testshave been introduced. Studies of anti-HBc-positive donors have revealed an HBV DNA positivity rate of 0%-15%. As of 2012, 30 countries have implemented HBV NAT. The prevalence of OBI in blood donors was estimated to be 8.55 per 1 million donations, according to a 2008 international survey. OBI is transmissible by blood transfusion. The clinical outcome of occult HBV transmission primarily depends on recipient immune status and the number of HBV DNA copies present in the blood products. The presence of donor anti-HBs reduces the risk of HBV infection by approximately five-fold. The risk of HBV transmission may be lower in endemic areas than in non-endemic areas, because most recipients have already been exposed to HBV. Blood safety for HBV, including OBI, has substantially improved, but the possibility for OBI transmission remains.展开更多
目的探讨初诊慢性乙型肝炎(chronic hepatitis B,CHB)患者血清乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)水平与肝脏炎症程度间的关系。方法初诊CHB患者436例,分别采用雅培I2000和M2000试剂检测血清乙型肝炎病毒表面抗原(h...目的探讨初诊慢性乙型肝炎(chronic hepatitis B,CHB)患者血清乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)水平与肝脏炎症程度间的关系。方法初诊CHB患者436例,分别采用雅培I2000和M2000试剂检测血清乙型肝炎病毒表面抗原(hepatitis B surface antigen,HBsAg)、乙型肝炎病毒E抗原(hepatitis Be antigen,HBeAg)、HBcAb水平及乙型肝炎病毒(hepatitis B virus,HBV)-DNA,依据肝穿刺活检组织病理对患者肝脏炎症程度进行G分级;Spearman法分析血清HBcAb水平与血清学指标的相关性;logistic回归分析血清HBcAb水平对肝脏炎症G分级的影响;ROC曲线评估血清HBcAb诊断中重度肝脏炎症(G_(2-4))的效能。结果 CHB患者血清HBcAb水平随肝脏炎症程度G分级G_(0-1)级[(10.33±2.16)S/CO]、G_2级[(11.01±1.95)S/CO]、G_3级[(11.57±1.51)S/CO]、G_4级[(11.85±2.21)S/CO]逐渐升高(P<0.05);187例HBeAg阳性患者中,G_(0-1)级[(8.95±2.72)S/CO]、G_2级[(10.35±2.08)S/CO]、G_3级[(11.53±1.65)S/CO]患者血清HBcAb水平逐渐升高(P<0.05);249例HBeAg阴性患者中,G_(0-1)级[(11.13±1.23)S/CO]、G_2级[(11.45±1.75)S/CO]、G_3级[(11.64±1.19)S/CO]及G_4级[(11.85±2.21)S/CO]患者血清HBcAb水平比较差异无统计学意义(P>0.05);Spearman相关性分析结果显示,血清HBcAb水平与HBeAg阳性患者G分级呈正相关(r=0.414,P<0.001)、与HBsAg水平呈负相关(r=-0.440,P<0.001),HBcAb水平与HBeAg阴性患者G分级无线性相关(r=0.096,P=0.136);多因素logistic回归分析结果显示,高血清HBcAb是HBeAg阳性患者发生中重度肝脏炎症的危险因素(OR=1.392,95%CI:1.190~1.627,P<0.001),其对HBeAg阴性患者肝脏炎症程度G分级无明显影响(OR=1.311,95%CI:0.933~1.843,P=0.083);ROC曲线分析结果显示,血清HBcAb以10.11S/CO为最佳截断值,诊断中重度肝脏炎症的AUC为0.72(95%CI:0.639~0.799,P<0.001),灵敏度为75.6%,特异度为56.4%。结论血清HBcAb水平与HBeAg阳性初诊CHB患者肝脏炎症程度明显相关,其水平升高是HBeAg阳性CHB�展开更多
文摘Transfusion-transmitted infections including hepatitis B virus(HBV) have been a major concern in transfusion medicine. Implementation of HBV nucleic acid testing(NAT) has revealed occult HBV infection(OBI) in blood donors. In the mid-1980 s, hepatitis B core antibody(HBc) testing was introduced to screen blood donors in HBV non-endemic countries to prevent transmission of non-A and non-B hepatitis. That test remains in use for preventing of potential transmission of HBV from hepatitis B surface antigen(HBs Ag)-negative blood donors, even though anti-hepatitis C virus testshave been introduced. Studies of anti-HBc-positive donors have revealed an HBV DNA positivity rate of 0%-15%. As of 2012, 30 countries have implemented HBV NAT. The prevalence of OBI in blood donors was estimated to be 8.55 per 1 million donations, according to a 2008 international survey. OBI is transmissible by blood transfusion. The clinical outcome of occult HBV transmission primarily depends on recipient immune status and the number of HBV DNA copies present in the blood products. The presence of donor anti-HBs reduces the risk of HBV infection by approximately five-fold. The risk of HBV transmission may be lower in endemic areas than in non-endemic areas, because most recipients have already been exposed to HBV. Blood safety for HBV, including OBI, has substantially improved, but the possibility for OBI transmission remains.
文摘目的探讨初诊慢性乙型肝炎(chronic hepatitis B,CHB)患者血清乙型肝炎病毒核心抗体(hepatitis B core antibody,HBcAb)水平与肝脏炎症程度间的关系。方法初诊CHB患者436例,分别采用雅培I2000和M2000试剂检测血清乙型肝炎病毒表面抗原(hepatitis B surface antigen,HBsAg)、乙型肝炎病毒E抗原(hepatitis Be antigen,HBeAg)、HBcAb水平及乙型肝炎病毒(hepatitis B virus,HBV)-DNA,依据肝穿刺活检组织病理对患者肝脏炎症程度进行G分级;Spearman法分析血清HBcAb水平与血清学指标的相关性;logistic回归分析血清HBcAb水平对肝脏炎症G分级的影响;ROC曲线评估血清HBcAb诊断中重度肝脏炎症(G_(2-4))的效能。结果 CHB患者血清HBcAb水平随肝脏炎症程度G分级G_(0-1)级[(10.33±2.16)S/CO]、G_2级[(11.01±1.95)S/CO]、G_3级[(11.57±1.51)S/CO]、G_4级[(11.85±2.21)S/CO]逐渐升高(P<0.05);187例HBeAg阳性患者中,G_(0-1)级[(8.95±2.72)S/CO]、G_2级[(10.35±2.08)S/CO]、G_3级[(11.53±1.65)S/CO]患者血清HBcAb水平逐渐升高(P<0.05);249例HBeAg阴性患者中,G_(0-1)级[(11.13±1.23)S/CO]、G_2级[(11.45±1.75)S/CO]、G_3级[(11.64±1.19)S/CO]及G_4级[(11.85±2.21)S/CO]患者血清HBcAb水平比较差异无统计学意义(P>0.05);Spearman相关性分析结果显示,血清HBcAb水平与HBeAg阳性患者G分级呈正相关(r=0.414,P<0.001)、与HBsAg水平呈负相关(r=-0.440,P<0.001),HBcAb水平与HBeAg阴性患者G分级无线性相关(r=0.096,P=0.136);多因素logistic回归分析结果显示,高血清HBcAb是HBeAg阳性患者发生中重度肝脏炎症的危险因素(OR=1.392,95%CI:1.190~1.627,P<0.001),其对HBeAg阴性患者肝脏炎症程度G分级无明显影响(OR=1.311,95%CI:0.933~1.843,P=0.083);ROC曲线分析结果显示,血清HBcAb以10.11S/CO为最佳截断值,诊断中重度肝脏炎症的AUC为0.72(95%CI:0.639~0.799,P<0.001),灵敏度为75.6%,特异度为56.4%。结论血清HBcAb水平与HBeAg阳性初诊CHB患者肝脏炎症程度明显相关,其水平升高是HBeAg阳性CHB�
