Kleinman S H, Strong D M, Tegtmeier G G E, Holland P V, Gorlin J B, Cousins C, Chiacchierini R P, Pietrelli L A
Kleinman Biomedical Research, Victoria, British Columbia, Canada.
Transfusion. 2005 Aug;45(8):1247-57. doi: 10.1111/j.1537-2995.2005.00198.x.
The risk of hepatitis B virus (HBV) transmission by blood transfusion (estimated at 1 in 63,000-1 in 205,000 units in the United States) exceeds that of hepatitis C virus (HCV) or human immunodeficiency virus (HIV). Reduction of window-period HBV transmissions through detection of HBV DNA-positive units by minipool nucleic acid testing (MP NAT) would be expected to decrease this risk.
A large multicenter study of the COBAS AmpliScreen HBV test (Roche Molecular Systems) was conducted on minipools of 24 blood donation specimens. The yield of HBV DNA-positive, hepatitis B surface antigen (HBsAg)-negative window-period donations was determined relative to current and newly licensed HBsAg assays. Donors with selected HBV DNA, HBsAg, and anti-hepatitis B core antigen (HBc) results were further evaluated.
The detection rate of window-period units was 1 in 352,451 (95% confidence interval, 1 in 2,941,176-1 in 97,561). Assay specificity was high (99.9964%). HBV DNA was detected in 84 percent of HBsAg-positive, anti-HBc-positive donations by MP NAT and in 94 percent when individual-donation (ID) NAT was added. HBV DNA was detected in 0.03 percent of HBsAg-negative, anti-HBc-positive donations by MP NAT and in 0.41 percent when ID NAT was added.
Implementation of HBV MP NAT will provide an increment in safety relative to HBV serologic screening, similar to that for HCV and in excess of that for HIV. Our data indicate that the implementation of HBV MP NAT would likely interdict 39 HBV window-period units and prevent 56 cases of transfusion-transmitted HBV infection annually. The current data indicate that HBV MP NAT should not lead to discontinuation of anti-HBc testing but that discontinuation of HBsAg testing with retention of anti-HBc testing may be possible.
输血传播乙型肝炎病毒（HBV）的风险（在美国估计为每63,000 - 205,000单位中有1例）超过丙型肝炎病毒（HCV）或人类免疫缺陷病毒（HIV）。通过微量池核酸检测（MP NAT）检测HBV DNA阳性单位来减少窗口期HBV传播，有望降低这种风险。
对24份献血标本的微量池进行了一项关于COBAS AmpliScreen HBV检测（罗氏分子系统公司）的大型多中心研究。相对于当前和新获批的乙型肝炎表面抗原（HBsAg）检测方法，确定了HBV DNA阳性、HBsAg阴性窗口期献血的检出率。对具有选定的HBV DNA、HBsAg和抗乙型肝炎核心抗原（HBc）结果的献血者进行了进一步评估。
窗口期单位的检测率为1/352,451（95%置信区间，1/2,941,176 - 1/97,561）。检测方法的特异性很高（99.9964%）。通过MP NAT在84%的HBsAg阳性、抗-HBc阳性献血中检测到HBV DNA，添加个体献血（ID）NAT时这一比例为94%。通过MP NAT在0.03%的HBsAg阴性、抗-HBc阳性献血中检测到HBV DNA，添加ID NAT时为0.41%。
实施HBV MP NAT相对于HBV血清学筛查将提高安全性，类似于HCV筛查且超过HIV筛查。我们的数据表明，实施HBV MP NAT每年可能会阻断39个HBV窗口期单位，并预防56例输血传播的HBV感染。目前的数据表明，HBV MP NAT不应导致停止抗-HBc检测，但停止HBsAg检测并保留抗-HBc检测可能是可行的。
