Dodd Roger Y, Nguyen Megan L, Krysztof David E, Notari Edward P, Stramer Susan L
American Red Cross, Holland Laboratory, Rockville, Maryland.
American Red Cross, Scientific Affairs, Gaithersburg, Maryland.
Transfusion. 2018 Sep;58(9):2166-2170. doi: 10.1111/trf.14784. Epub 2018 Aug 24.
In the United States, blood donor testing for hepatitis B surface antigen (HBsAg) was initiated in the early 1970s. More recently, testing for antibody to hepatitis B core antigen (anti-HBc) and hepatitis B virus (HBV) DNA have been added. The incidence of hepatitis B has been declining. This study reviews the current status of testing and questions the need for continuation of HBsAg testing.
From July 2011 to June 2015, a total of 22.4 million donations were serologically tested for HBsAg and anti-HBc and for HBV-DNA by nucleic acid testing (NAT). All reactive results were evaluated and a subset of donations that were either potential NAT yield (seronegative) or serologically positive but nonreactive by HBV NAT in minipools (MPs) of 16 were further evaluated by individual donation (ID)-NAT. Samples with detectable HBV DNA were defined as actively infected and considered potentially infectious.
Routine testing plus supplemental ID-NAT identified 2035 samples representing active infection including 1965 with anti-HBc, 1602 with HBsAg, and 1453 with HBV DNA by MP-NAT, for respective rates per hundred-thousand donations of 9.10, 8.78, 7.16, and 6.50, continuing the downward trend previously observed. There were 29 HBV DNA-yield samples (1:771,389), 35 HBsAg-yield samples (anti-HBc nonreactive), and 404 with occult hepatitis B infection. There were six samples with HBsAg and HBV DNA detectable only by ID-NAT in the absence of anti-HBc; additional testing was consistent with extremely low or negligible levels of DNA.
Point estimates of HBV infection rates among blood donors continue to decline, as do those for incidence and residual risk. Elimination of HBsAg screening would have negligible impact, with a risk less than 1 per 4 million donations.
在美国，20世纪70年代初开始对献血者进行乙型肝炎表面抗原（HBsAg）检测。最近，又增加了乙型肝炎核心抗体（抗-HBc）和乙型肝炎病毒（HBV）DNA检测。乙型肝炎的发病率一直在下降。本研究回顾了检测的现状，并对继续进行HBsAg检测的必要性提出质疑。
2011年7月至2015年6月，共对2240万份献血进行了HBsAg、抗-HBc血清学检测以及核酸检测（NAT）检测HBV-DNA。对所有反应性结果进行了评估，对16人份混合样本（MPs）中潜在NAT阳性（血清学阴性）或血清学阳性但HBV NAT无反应的一部分献血样本，进一步通过单份献血（ID）-NAT进行评估。检测到HBV DNA的样本被定义为活动性感染，并被认为具有潜在传染性。
常规检测加上补充的ID-NAT共鉴定出2035份代表活动性感染的样本，其中1965份有抗-HBc，1602份有HBsAg，1453份通过MP-NAT检测到HBV DNA，每十万份献血的相应发生率分别为9.10、8.78、7.16和6.50，延续了之前观察到的下降趋势。有29份HBV DNA阳性样本（1:771,389），35份HBsAg阳性样本（抗-HBc无反应），以及404份隐匿性乙型肝炎感染样本。有6份样本仅通过ID-NAT检测到HBsAg和HBV DNA，而无抗-HBc；进一步检测显示DNA水平极低或可忽略不计。
献血者中HBV感染率的点估计值继续下降，发病率和残余风险的点估计值也是如此。取消HBsAg筛查的影响可忽略不计，风险低于每400万份献血中有1例。
