Fundação Pró-Sangue Hemocentro de São Paulo, São Paulo, Brazil.
Laboratory of Medical Investigation in Pathogenesis and Targeted Therapy in Oncoimmunohematology (LIM-31), Department of Hematology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Transfusion. 2021 May;61(5):1495-1504. doi: 10.1111/trf.16344. Epub 2021 Mar 9.
The present study determined the HBV antigen, antibody, and DNA status in blood donations deemed to be HBV positive. Individuals with an occult HBV infection (OBI), defined as being positive for HBV DNA but negative for HBV surface antigen (HBsAg), as well as those with active infection (HBsAg-positive), were identified and characterized.
From a total pool if 198,363 blood donations, we evaluated in a cross-sectional study, 1106 samples that were positive in screening tests for antibody to HBV core antigen (HBcAb), HBsAg, and/or HBV DNA by nucleic acid testing (NAT-HBV). The presence of genetic variants in the HBV pol/S gene in individuals with an active HBV infection was also determined.
OBIs were detected in six of 976 samples (0.6%) that were positive only for HBcAb. The rate of HBV active infection was 0.024% (48/198,363) and there was a predominance of HBV sub-genotype A1 (62.2%, 28/45), followed by D3 (17.8%, 8/45). Mutations in the S gene were found in 57.8% (26/45) and immune escape mutations in 37.8% (17/45) of active HBV-infected donors. Among them, T123N, G145A, and D144G high-impact immune escape mutations were identified.
Highly sensitive molecular tests improve the capacity to detect OBIs. When NAT is performed in pooled samples, HBcAb test has value in the detection of donors with OBI and improves transfusion safety. Mutations in the S gene are frequent in HBsAg-positive blood, including those associated with diagnostic failure and vaccine escape mutations.
本研究旨在确定被认为是乙型肝炎病毒（HBV）阳性的献血者的 HBV 抗原、抗体和 DNA 状况。确定并描述了隐匿性 HBV 感染（OBI）个体，即 HBV DNA 阳性但 HBV 表面抗原（HBsAg）阴性，以及具有活性感染（HBsAg 阳性）的个体。
在一项横断面研究中，我们对来自 198363 份血样的总池进行了评估，筛选出 1106 份通过核酸检测（NAT-HBV）检测到抗 HBV 核心抗原（HBcAb）、HBsAg 和/或 HBV DNA 抗体阳性的样本。还确定了具有活性 HBV 感染个体中 HBV pol/S 基因的遗传变异情况。
在仅 HBcAb 阳性的 976 份样本中发现了 6 例 OBI（0.6%）。HBV 活性感染率为 0.024%（48/198363），HBV 亚基因型 A1 占主导地位（62.2%，28/45），其次是 D3（17.8%，8/45）。在 45 例活动性 HBV 感染供体中发现 S 基因发生突变的占 57.8%（26/45），免疫逃逸突变占 37.8%（17/45）。其中，鉴定出 T123N、G145A 和 D144G 高影响免疫逃逸突变。
高度敏感的分子检测可提高 OBI 的检测能力。当在混合样本中进行 NAT 时，HBcAb 检测在检测 OBI 供体方面具有价值，可提高输血安全性。在 HBsAg 阳性血液中，S 基因的突变很常见，包括与诊断失败和疫苗逃逸突变相关的突变。
