Scientific Support Office, American Red Cross, Gaithersburg, Maryland 20877, USA.
Transfusion. 2012 Feb;52(2):440-6. doi: 10.1111/j.1537-2995.2011.03283.x. Epub 2011 Aug 2.
The American Red Cross implemented hepatitis B virus (HBV) minipool (MP)-nucleic acid testing (NAT) in June 2009, in addition to existing tests for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc). The value of all three tests was evaluated.
HBsAg, anti-HBc, and HBV DNA (Ultrio MP-NAT, Gen-Probe/Novartis) donation results were analyzed during a 12-month period (July 1, 2009-June 30, 2010). Additional testing by individual-donation (ID) polymerase chain reaction (PCR) to confirm donor infection was performed when any HBV screening test was reactive or positive, except in the case of HBsAg neutralization-positive, anti-HBc-reactive samples. Numbers of blood donations identified as reactive or positive versus nonreactive or negative were compared.
Of about 6.5 million donations, 699 were defined as from HBV-infected donors, of which 64% (444) were reactive for all three markers. More than 99% (697) had reactivity to one or both serologic tests with 68% (477) showing reactivity by MP-NAT. Only two donations were DNA-positive, seronegative NAT-yield donations (1 per 3.23 million), fewer than expected (p = 0.0075). Among MP-NAT-reactive donors, only small numbers represented early infection (2 or 0.4% with negative serology and 10 or 2.1% who were HBsAg confirmed positive, anti-HBc nonreactive). Of the 142 occult HBV-infected donors, 85% were MP-NAT nonreactive requiring ID-PCR for detection (121 or 54.5% of all MP-NAT nonreactives vs. 21 or 4.4% of all MP-NAT reactives).
The HBV DNA-positive yield rate from MP-NAT was lower than expected, likely representing the rarity of such findings even in very large studies. With the implementation of HBV MP-NAT, the value of maintaining anti-HBc for the detection of low-level HBV DNA-positive donors was confirmed; however, HBsAg screening showed no blood safety value.
美国红十字会于 2009 年 6 月实施了乙型肝炎病毒（HBV）微池（MP）-核酸检测（NAT），并补充了乙型肝炎表面抗原（HBsAg）和乙型肝炎核心抗原抗体（抗-HBc）的现有检测。对所有三项检测的价值进行了评估。
在 12 个月期间（2009 年 7 月 1 日至 2010 年 6 月 30 日）分析了 HBsAg、抗-HBc 和 HBV DNA（Ultrio MP-NAT，Gen-Probe/Novartis）的供体检测结果。当任何 HBV 筛选试验呈阳性或阳性时，除 HBsAg 中和阳性、抗-HBc 阳性样本外，通过个体供体（ID）聚合酶链反应（PCR）进行了额外的确认供体感染的检测。与非反应性或阴性相比，确定为反应性或阳性的血液捐献数量进行了比较。
在大约 650 万次献血中，有 699 次被定义为来自 HBV 感染供体，其中 64%（444 次）对所有三种标志物均有反应。超过 99%（697 次）对一种或两种血清学检测有反应，其中 68%（477 次）通过 MP-NAT 显示有反应。只有两份 DNA 阳性、NAT 阴性的供体捐献（每 323 万份中有 1 份），低于预期（p = 0.0075）。在 MP-NAT 反应性供体中，只有少数代表早期感染（2 或 0.4%的血清学阴性和 10 或 2.1%的 HBsAg 确认为阳性，抗-HBc 无反应）。在 142 例隐匿性乙型肝炎感染供体中，85%的 MP-NAT 无反应，需要 ID-PCR 进行检测（121 或所有 MP-NAT 无反应者的 54.5%，21 或所有 MP-NAT 反应者的 4.4%）。
HBV DNA 阳性的 MP-NAT 阳性率低于预期，这可能代表即使在非常大的研究中也很少有此类发现。随着 HBV MP-NAT 的实施，证实了维持抗-HBc 用于检测低水平 HBV DNA 阳性供体的价值；然而，HBsAg 筛查显示没有血液安全性价值。
