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Abstract：
All Chinese blood centers have implemented mini pool (MP) HBV nucleic acid testing (NAT) together with HBsAg ELISA in routine donor screening since 2015. The prevalence of occult hepatitis B virus infection (OBI) in donors from different regions varies, and the molecular characterization of the HBV DNA and clinical outcomes of these OBIs remain largely unexplored.
Blood donations from Heyuan city in Southern China were screened by HBsAg ELISA and HBV MP8 NAT. Donations with HBsAg-/HBV DNA+ were collected for this study. Molecular characterizations of HBV DNAs were further analyzed by various DNA amplification assays including quantitative PCR (qPCR) and nested PCR, amplifying the basic core and pre-core promoter regions (BCP/PC). The HBsAg (S) region from HBV DNA was isolated by high-volume nucleic acid extraction. Notable mutations were identified by comparison to the HBV reference sequences. The clinical outcomes of the donors with OBIs were further followed for nearly 3 years.
Seventy OBIs from 44,592 donations (0.15%) that we identified and reported previously were enrolled for this current study. HBV sequences were obtained from 44/70 OBIs, and genotyping analysis showed that 42/44 (95.2%) OBIs were genotype B, and 2/44 (4.8%) were genotype C. Interestingly, mutation analysis revealed that various mutations including M133L/T, F134L, P142L, V168A, R169H, S174N, L175S, and V177A of HBV DNA affecting HBsAg detection were observed in genotype B OBIs. Two notable mutations, T47K and L53S, were identified in genotype C OBIs. Follow-up studies showed that 3/31 (9.7%) OBIs converted to HBsAg+ as chronic infections while 1/31 (3.2%) HBV DNA was undetectable (classified as recovery) and 27/31 (87.1%) remained as OBIs.
Various notable mutations affecting HBsAg detection were observed in blood donors with OBIs in Heyuan city of Southern China. Follow-up studies showed that most OBIs remained as OBIs with fluctuating or low viral loads. Higher sensitive HBV ID NAT is recommended for donor screening to further reduce the transmission risk of OBIs.
Blood donations from Heyuan city in Southern China were screened by HBsAg ELISA and HBV MP8 NAT. Donations with HBsAg-/HBV DNA+ were collected for this study. Molecular characterizations of HBV DNAs were further analyzed by various DNA amplification assays including quantitative PCR (qPCR) and nested PCR, amplifying the basic core and pre-core promoter regions (BCP/PC). The HBsAg (S) region from HBV DNA was isolated by high-volume nucleic acid extraction. Notable mutations were identified by comparison to the HBV reference sequences. The clinical outcomes of the donors with OBIs were further followed for nearly 3 years.
Seventy OBIs from 44,592 donations (0.15%) that we identified and reported previously were enrolled for this current study. HBV sequences were obtained from 44/70 OBIs, and genotyping analysis showed that 42/44 (95.2%) OBIs were genotype B, and 2/44 (4.8%) were genotype C. Interestingly, mutation analysis revealed that various mutations including M133L/T, F134L, P142L, V168A, R169H, S174N, L175S, and V177A of HBV DNA affecting HBsAg detection were observed in genotype B OBIs. Two notable mutations, T47K and L53S, were identified in genotype C OBIs. Follow-up studies showed that 3/31 (9.7%) OBIs converted to HBsAg+ as chronic infections while 1/31 (3.2%) HBV DNA was undetectable (classified as recovery) and 27/31 (87.1%) remained as OBIs.
Various notable mutations affecting HBsAg detection were observed in blood donors with OBIs in Heyuan city of Southern China. Follow-up studies showed that most OBIs remained as OBIs with fluctuating or low viral loads. Higher sensitive HBV ID NAT is recommended for donor screening to further reduce the transmission risk of OBIs.
摘要：
自2015年以来，所有中国血液中心都在常规供体筛查中实施了迷你池（MP）HBV核酸检测（NAT）和HBsAgELISA。隐匿性乙型肝炎病毒感染（OBI）在不同地区的捐献者中的患病率各不相同，HBVDNA的分子特征和这些OBIs的临床结果仍未被探索。
通过HBsAgELISA和HBVMP8NAT筛查来自中国南方河源市的献血。本研究收集HBsAg-/HBVDNA+的捐赠。HBVDNA的分子特征通过各种DNA扩增测定进一步分析，包括定量PCR（qPCR）和巢式PCR，扩增基本核心和前核心启动子区(BCP/PC)。通过大量核酸提取从HBVDNA分离HBsAg(S)区。通过与HBV参考序列比较来鉴定显著的突变。OBIs供体的临床结果进一步随访了近3年。
我们以前确定和报告的44,592例捐赠（0.15％）中的70例OBIs被纳入本研究。HBV序列来自44/70OBIs，和基因分型分析显示42/44(95.2%)OBIs为B基因型,和2/44（4.8％）是基因型C，有趣的是，突变分析显示各种突变，包括M133L/T，F134L,P142L,V168A,R169H,S174N,L175S,在基因型BOBIs中观察到HBVDNA的V177A影响HBsAg检测。两个显著的突变,T47K和L53S,在基因型COBIs中鉴定。后续研究表明，3/31（9.7％）OBIs转化为HBsAg+作为慢性感染，而1/31（3.2％）HBVDNA检测不到（分类为恢复）和27/31（87.1％）作为OBIs。
在中国南方河源市的OBIs献血者中观察到影响HBsAg检测的各种显著突变。后续研究表明，大多数OBIs仍然是OBIs，具有波动或低病毒载量。建议将更高敏感性的HBVIDNAT用于供体筛查，以进一步降低OBI的传播风险。
通过HBsAgELISA和HBVMP8NAT筛查来自中国南方河源市的献血。本研究收集HBsAg-/HBVDNA+的捐赠。HBVDNA的分子特征通过各种DNA扩增测定进一步分析，包括定量PCR（qPCR）和巢式PCR，扩增基本核心和前核心启动子区(BCP/PC)。通过大量核酸提取从HBVDNA分离HBsAg(S)区。通过与HBV参考序列比较来鉴定显著的突变。OBIs供体的临床结果进一步随访了近3年。
我们以前确定和报告的44,592例捐赠（0.15％）中的70例OBIs被纳入本研究。HBV序列来自44/70OBIs，和基因分型分析显示42/44(95.2%)OBIs为B基因型,和2/44（4.8％）是基因型C，有趣的是，突变分析显示各种突变，包括M133L/T，F134L,P142L,V168A,R169H,S174N,L175S,在基因型BOBIs中观察到HBVDNA的V177A影响HBsAg检测。两个显著的突变,T47K和L53S,在基因型COBIs中鉴定。后续研究表明，3/31（9.7％）OBIs转化为HBsAg+作为慢性感染，而1/31（3.2％）HBVDNA检测不到（分类为恢复）和27/31（87.1％）作为OBIs。
在中国南方河源市的OBIs献血者中观察到影响HBsAg检测的各种显著突变。后续研究表明，大多数OBIs仍然是OBIs，具有波动或低病毒载量。建议将更高敏感性的HBVIDNAT用于供体筛查，以进一步降低OBI的传播风险。
