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通过抗乙型肝炎核心抗原检测拦截的乙型肝炎病毒DNA阳性、乙型肝炎表面抗原阴性献血:加拿大血液服务机构的经验

Hepatitis B virus DNA-positive, hepatitis B surface antigen-negative blood donations intercepted by anti-hepatitis B core antigen testing: the Canadian Blood Services experience.

作者信息

O'Brien Sheila F, Fearon Margaret A, Yi Qi-Long, Fan Wenli, Scalia Vito, Muntz Irene R, Vamvakas Eleftherios C

机构信息

National Epidemiology and Surveillance, Canadian Blood Services, 1800 Alta Vista Drive, Ottawa, Ontario, Canada. sheila.o'

出版信息

Transfusion. 2007 Oct;47(10):1809-15. doi: 10.1111/j.1537-2995.2007.01396.x.

DOI:10.1111/j.1537-2995.2007.01396.x
PMID:17880605
Abstract

BACKGROUND

The benefit of introducing anti-hepatitis B core antigen (HBc) screening for intercepting potentially infectious donations missed by hepatitis B surface antigen (HBsAg) screening in Canada was studied.

STUDY DESIGN AND METHODS

Anti-HBc testing of all donations was implemented in April 2005, along with antibody to hepatitis B surface antigen (anti-HBs) and hepatitis B virus (HBV) DNA supplemental testing of anti-HBc repeat-reactive, HBsAg-negative donations. The proportion of potentially infectious donations intercepted by anti-HBc over the initial 18 months of testing was calculated based on three assumptions relating infectivity of HBV DNA-positive units to anti-HBs levels. Lookback was conducted for all DNA-positive donations.

RESULTS

Of 493,344 donors, 5,585 (1.13%) were repeat-reactive for the presence of anti-HBc, with 29 (0.52%) being HBV DNA-positive and HBsAg-negative. The proportion of potentially infectious donations intercepted by anti-HBc screening was 1 in 17,800 if all HBV DNA-positive donations were infectious, 1 in 26,900 if infectivity was limited to donations with an anti-HBs level of not more than 100 mIU per mL, and 1 in 69,300 if only donations with undetectable anti-HBs were infectious. For 279 components in the lookback study, no traced recipients were HBsAg-positive and 7 recipients were anti-HBc-reactive in association with 4 donors, 3 of whom had an anti-HBs level of more than 100 mIU per mL and 1 of whom had a level of 61 mIU per mL.

CONCLUSION

Implementation of anti-HBc screening reduced the risk of transfusing potentially infectious units by at least as much as had been expected based on the literature. The lookback did not provide proof of transfusion transmission of HBV from HBV DNA-positive, anti-HBc-reactive, HBsAg-negative donors but it did not establish lack of transmission either.

摘要

背景

研究了在加拿大引入抗乙型肝炎核心抗原(HBc)筛查对于拦截乙型肝炎表面抗原(HBsAg)筛查遗漏的潜在感染性献血的益处。

研究设计与方法

2005年4月对所有献血进行了抗-HBc检测,同时对重复反应性、HBsAg阴性的献血进行了乙型肝炎表面抗原抗体(抗-HBs)和乙型肝炎病毒(HBV)DNA补充检测。根据与HBV DNA阳性单位传染性与抗-HBs水平相关的三个假设,计算了抗-HBc在最初18个月检测中拦截的潜在感染性献血的比例。对所有DNA阳性献血进行了追溯调查。

结果

在493,344名献血者中,5,585名(1.13%)抗-HBc呈重复反应性,其中29名(0.52%)HBV DNA阳性且HBsAg阴性。如果所有HBV DNA阳性献血都具有传染性,抗-HBc筛查拦截的潜在感染性献血比例为1/17,800;如果传染性仅限于抗-HBs水平不超过100 mIU/mL的献血,则为1/26,900;如果仅抗-HBs检测不到的献血具有传染性,则为1/69,300。在追溯研究的279份成分血中,没有追踪到的受血者HBsAg阳性,7名受血者抗-HBc反应性与4名献血者相关,其中3名献血者的抗-HBs水平超过100 mIU/mL,1名献血者的抗-HBs水平为61 mIU/mL。

结论

抗-HBc筛查的实施降低了输注潜在感染性单位的风险,降低程度至少与文献预期的一样。追溯调查没有提供HBV从HBV DNA阳性、抗-HBc反应性、HBsAg阴性献血者输血传播的证据,但也没有确定不存在传播。

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