无偿献血人群隐匿性乙型肝炎病毒感染调查*

目的 调查无偿献血人群隐匿性乙型肝炎病毒感染(OBI)情况。方法 2021年1月～2021年12月我站无偿献血者血液样本107397份,采用两种ELISA法检测试剂盒进行HBsAg的初次筛查,采用核酸检测(NAT)法对两次HBsAg结果均为阴性的样本进行HBV DNA检测。对血清HBsAg阴性而HBV DNA阳性样本进行HBV血清学标志物检测,并采用实时荧光定量聚合酶链式反应(PCR)法检测核酸和病毒基因分型。 结果 在筛查的107397例无偿献血人群血样本中,经血清标志物检测后确认为OBI 者29例(0.27‰);血清抗-HBc阳性者12例(35.3%),抗-HBe/抗-HBc阳性者8例(23.5%),抗-HBs/抗-HBc阳性者6例(17.7%),抗-HBs/抗-HBe/抗-HBc阳性者3例(8.8%);19～29岁年龄段献血人群OBI感染率为0.09‰,30～39岁人群为0.32‰,40～49岁人群为0.39‰,50～55岁年龄段献血人群OBI感染率为0.41‰,且该年龄段重复献血者OBI感染率为0.31‰;血清抗-HBs/抗-HBc阳性和抗-HBs/抗-HBe/抗-HBc OBI献血者血清病毒载量>1000 IU/mL的占比分别为33.3%和66.7%,显著高于血清仅抗-HBc阳性者(0.0%,P<0.05)或血清抗-HBe/抗-HBc阳性者(0.0%,P<0.05);在29例OBI献血者中,C基因型占比为62.1%,B基因型感染占比为27.6%。结论 在初筛血清HBsAg 阴性的献血人群中,可能还存在很低比率的OBI人群,对用血安全提出了挑战。全面进行病毒核酸检测的花费-效益关系需要认真研究,提高常规ELISA检测方法的灵敏度也是关键。

Prevalence of occult hepatitis B viral infections in blood donors

Objective The aim of this study was to investigate the prevalence of occult hepatitis B viral infections (OBI) in blood donors (BD). Methods 107397 blood samples were collected in our Blood Station between January and December 2021. The initial serum screening of HBsAg was conducted by two ELISA kits, and serum HBV DNA loads was assayed by NAT. For serum HBV DNA positive samples, serum HBV markers were repeatedly detected and HBV genotype was determined by real-time fluorescence quantitative polymerase chain reaction (PCR). Results Out of the 107397 blood samples, the OBI was found in 29 cases (0.27‰) as defined by serum HBV DNA positive; the re-testing of the positive blood showed that serum anti-HBc positive in 12 cases (35.3%), anti-HBe/anti-HBc positive in 8 cases (23.5%), anti-HBs/anti-HBc positive in 6 cases (17.7%) and anti-HBs/anti-HBe/anti-HBc positive in 3 cases (8.8%); the prevalence of OBI in individuals at 19-29 year old was 0.09‰, in those at 30-39 was 0.32‰, in at 40-49 was 0.39‰ and in at 50-55 was 0.41‰, and in persons at age of 50-55 with more than one time blood donor, the prevalence of OBI was 0.31‰; the percentages of serum HBV DNA loads greater than 1000 IU/mL in OBI individuals with serum anti-HBs/anti-HBc positive and with serum anti-HBs/anti-HBe/anti-HBc positive were 33.3% and 66.7%, significantly higher than 0.0% in those with serum anti-HBc positive (P<0.05) or with serum anti-HBe/anti-HBc positive (0.0%, P<0.05); out of the 29 OBI persons, the genotype C infection accounted for 62.1% and genotype B infection for 27.6%. Conclusion The prevalence of OBI in blood donors is a challenge for public health security, and the cost-efficacy of all-scale detection of serum HBV DNA loads in this setting needs further investigation. The quality and sensitivity of conventional ELISA kits should be improved.