Said Zeinab N, Sayed Manal H El, Salama Iman I, Aboel-Magd Enas K, Mahmoud Magda H, Setouhy Maged El, Mouftah Faten, Azzab Manal B, Goubran Heidi, Bassili Amal, Esmat Gamal E
Zeinab N Said, Enas K Aboel-Magd, Microbiology and Immunology Department, Faculty of Medicine (for Girls), Al-Azhar University, 11511 Cairo, Egypt.
World J Hepatol. 2013 Feb 27;5(2):64-73. doi: 10.4254/wjh.v5.i2.64.
To identify blood donors with occult hepatitis B virus (HBV) infection (OBI) to promote safe blood donation.
Descriptive cross sectional study was conducted on 3167 blood donors negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) and human immunodeficiency virus Ab. They were subjected to the detection of alanine aminotransferase (ALT) and aspartate transaminase (AST) and screening for anti-HBV core antibodies (total) by two different techniques; [Monoliza antibodies to hepatitis B core (Anti-HBc) Plus-Bio-Rad] and (ARC-HBc total-ABBOT). Positive samples were subjected to quantitative detection of antibodies to hepatitis B surface (anti-HBs) (ETI-AB-AUK-3, Dia Sorin-Italy). Serum anti-HBs titers > 10 IU/L was considered positive. Quantitative HBV DNA by real time polymerase chain reaction (PCR) (QIAGEN-Germany) with 3.8 IU/mL detection limit was estimated for blood units with negative serum anti-HBs and also for 32 whose anti-HBs serum titers were > 1000 IU/L. Also, 265 recipients were included, 34 of whom were followed up for 3-6 mo. Recipients were investigated for ALT and AST, HBV serological markers: HBsAg (ETI-MAK-4, Dia Sorin-Italy), anti-HBc, quantitative detection of anti-HBs and HBV-DNA.
525/3167 (16.6%) of blood units were positive for total anti-HBc, 64% of those were anti-HBs positive. Confirmation by ARCHITECT anti-HBc assay were carried out for 498/525 anti-HBc positive samples, where 451 (90.6%) confirmed positive. Reactivity for anti-HBc was considered confirmed only if two positive results were obtained for each sample, giving an overall prevalence of 451/3167 (14.2%) for total anti-HBc. HBV DNA was quantified by real time PCR in 52/303 (17.2%) of anti-HBc positive blood donors (viral load range: 5 to 3.5 x 10(5) IU/mL) with a median of 200 IU/mL (mean: 1.8 x 10(4) ± 5.1 x 10(4) IU/mL). Anti-HBc was the only marker in 68.6% of donors. Univariate and multivariate logistic analysis for identifying risk factors associated with anti-HBc and HBV-DNA positivity among blood donors showed that age above thirty and marriage were the most significant risk factors for prediction of anti-HBc positivity with AOR 1.8 (1.4-2.4) and 1.4 (1.0-1.9) respectively. Other risk factors as gender, history of blood transfusion, diabetes mellitus, frequent injections, tattooing, previous surgery, hospitalization, Bilharziasis or positive family history of HBV or HCV infections were not found to be associated with positive anti-HBc antibodies. Among anti-HBc positive blood donors, age below thirty was the most significant risk factor for prediction of HBV-DNA positivity with AOR 3.8 (1.8-7.9). According to HBV-DNA concentration, positive samples were divided in two groups; group one with HBV-DNA ≥ 200 IU/mL (n = 27) and group two with HBV-DNA < 200 IU/mL (n = 26). No significant difference was detected between both groups as regards mean age, gender, liver enzymes or HBV markers. Serological profiles of all followed up blood recipients showed that, all were negative for the studied HBV markers. Also, HBV DNA was not detected among studied recipients, none developed post-transfusion hepatitis (PTH) and the clinical outcome was good.
OBI is prevalent among blood donors. Nucleic acid amplification/HBV anti core screening should be considered for high risk recipients to eliminate risk of unsafe blood donation.
识别隐匿性乙型肝炎病毒(HBV)感染(OBI)的献血者,以促进安全献血。
对3167名乙型肝炎表面抗原(HBsAg)、丙型肝炎抗体(HCV Ab)和人类免疫缺陷病毒抗体均为阴性的献血者进行描述性横断面研究。对他们进行丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)检测,并采用两种不同技术筛查抗-HBV核心抗体(总抗体);[乙型肝炎核心抗体(抗-HBc)单克隆抗体Plus - 伯乐公司]和(抗-HBc总抗体 - 雅培公司)。对阳性样本进行乙型肝炎表面抗体(抗-HBs)定量检测(ETI - AB - AUK - 3,Dia Sorin公司 - 意大利)。血清抗-HBs滴度>10 IU/L被视为阳性。对血清抗-HBs阴性的血液样本以及32例抗-HBs血清滴度>1000 IU/L的样本,采用实时聚合酶链反应(PCR)(德国QIAGEN公司)进行HBV DNA定量检测,检测限为3.8 IU/mL。此外,纳入265名受血者,其中34名进行了3 - 6个月的随访。对受血者进行ALT、AST、HBV血清学标志物检测:HBsAg(ETI - MAK - 4,Dia Sorin公司 - 意大利)、抗-HBc、抗-HBs定量检测及HBV - DNA检测。
525/3167(16.6%)的血液样本抗-HBc总抗体呈阳性,其中64%抗-HBs阳性。对498/525例抗-HBc阳性样本采用ARCHITECT抗-HBc检测法进行确认,其中451例(90.6%)确认阳性。只有每个样本获得两个阳性结果时,抗-HBc反应性才被视为确认阳性,抗-HBc总抗体总体患病率为451/3167(14.2%)。对52/303例(17.2%)抗-HBc阳性献血者采用实时PCR进行HBV DNA定量检测(病毒载量范围:5至3.5×10⁵ IU/mL),中位数为200 IU/mL(平均值:1.8×10⁴±5.1×10⁴ IU/mL)。68.6%的献血者中抗-HBc是唯一标志物。对献血者中与抗-HBc和HBV - DNA阳性相关的危险因素进行单因素和多因素逻辑分析显示,30岁以上和已婚是预测抗-HBc阳性的最显著危险因素,比值比(AOR)分别为1.8(1.4 - 2.4)和1.4(1.0 - 1.9)。未发现其他危险因素如性别、输血史、糖尿病、频繁注射、纹身、既往手术、住院、血吸虫病或HBV或HCV感染家族史阳性与抗-HBc抗体阳性有关。在抗-HBc阳性献血者中,30岁以下是预测HBV - DNA阳性的最显著危险因素,AOR为3.8(1.8 - 7.9)。根据HBV - DNA浓度,将阳性样本分为两组;第一组HBV - DNA≥200 IU/mL(n = 27),第二组HBV - DNA<200 IU/mL(n = 26)。两组在平均年龄、性别、肝酶或HBV标志物方面均未检测到显著差异。所有随访的受血者血清学特征显示,所有研究的HBV标志物均为阴性。此外,在研究的受血者中未检测到HBV DNA,无一例发生输血后肝炎(PTH),临床结局良好。
OBI在献血者中普遍存在。对于高危受血者应考虑进行核酸扩增/HBV抗核心抗体筛查,以消除不安全献血风险。