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日本隐匿性乙型肝炎病毒(HBV)感染者血液成分所导致的输血传播 HBV 感染的残余风险。

Residual risk of transfusion-transmitted hepatitis B virus (HBV) infection caused by blood components derived from donors with occult HBV infection in Japan.

机构信息

From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross, Tokyo, Japan.

出版信息

Transfusion. 2013 Jul;53(7):1393-404. doi: 10.1111/j.1537-2995.2012.03909.x. Epub 2012 Oct 4.

DOI:10.1111/j.1537-2995.2012.03909.x
PMID:23033944
Abstract

BACKGROUND

Nucleic acid amplification testing (NAT) for hepatitis B virus (HBV) during blood screening has helped to prevent transfusion-transmitted HBV infection (TT-HBV) in Japan. Nevertheless, 4 to 13 TT-HBV infections arise annually.

STUDY DESIGN AND METHODS

The Japanese Red Cross (JRC) analyzed repository samples of donated blood for TT-HBV that was suspected through hemovigilance. Blood donations implicated in TT-HBV infections were categorized as either window period (WP) or occult HBV infection (OBI) related. In addition, we analyzed blood from 4742 donors with low antibody to hepatitis B core antigen (anti-HBc) and antibody to hepatitis B surface antigen (anti-HBs) titers using individual-donation NAT (ID-NAT) to investigate the relationship between anti-HBc titer and proportion of viremic donors.

RESULTS

Introduction of a more sensitive NAT method for screening minipools of 20 donations increased the OBI detection rate from 3.9 to 15.2 per million, while also the confirmed OBI transmission rate increased from 0.67 to 1.49 per million. By contrast the WP transmission rate decreased from 0.92 to 0.46 per million. Testing repository samples of donations missed by minipools of 20 donations NAT showed that 75 and 85% of TT-HBV that arose from WP and OBI donations, respectively, would have been interdicted by ID-NAT. The ID-NAT trial revealed that 1.94% of donations with low anti-HBc and anti-HBs titers were viremic and that anti-HBc titers and the frequency of viremia did not correlate.

CONCLUSIONS

The JRC has elected to achieve maximal safety by discarding all units with low anti-HBc and anti-HBs titers that account for 1.3% of the total donations.

摘要

背景

乙型肝炎病毒(HBV)血液筛查中的核酸扩增检测(NAT)有助于预防日本的输血传播乙型肝炎病毒感染(TT-HBV)。然而,每年仍有 4 至 13 例 TT-HBV 感染发生。

研究设计与方法

日本红十字会(JRC)通过血液监测分析了 Repository 中涉嫌 TT-HBV 的血液样本。与窗口期(WP)或隐匿性乙型肝炎病毒感染(OBI)相关的 TT-HBV 感染血液捐献分为两类。此外,我们还使用个体供体 NAT(ID-NAT)分析了 4742 名乙型肝炎核心抗原抗体(抗-HBc)和乙型肝炎表面抗原抗体(抗-HBs)滴度低的供体血液,以研究抗-HBc 滴度与病毒血症供体比例之间的关系。

结果

引入一种更敏感的筛查 20 人份混合池的 NAT 方法,将 OBI 的检出率从每百万分之 3.9 增加到 15.2,同时确认的 OBI 传播率从每百万分之 0.67 增加到 1.49。相比之下,WP 传播率从每百万分之 0.92 降低至每百万分之 0.46。对 20 人份混合池 NAT 检测漏检的捐献 Repository 样本进行测试表明,WP 和 OBI 捐献引起的 TT-HBV 中,分别有 75%和 85%可通过 ID-NAT 阻断。ID-NAT 试验表明,1.94%低抗-HBc 和抗-HBs 滴度的捐献者存在病毒血症,且抗-HBc 滴度与病毒血症频率不相关。

结论

JRC 选择通过丢弃所有低抗-HBc 和抗-HBs 滴度的单位,达到最大安全性,这些单位占总捐献量的 1.3%。

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