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在两年内对一名捐赠者进行乙肝、丙肝和人类免疫缺陷病毒的个体捐赠者核酸检测筛查时出现一次窗口期捐赠。

One window-period donation in two years of individual donor-nucleic acid test screening for hepatitis B, hepatitis C and human immunodeficiency virus.

作者信息

Levi José Eduardo, Pereira Ricardo Antonio D'Almeida, Polite Márcia Bernardino de Carvalho, Mota Mariza Aparecida, Nunez Silvia Patricia, Pinho João Renato Rebello, Kutner José Mauro

机构信息

Hospital Israelita Albert Einstein - HIAE, São Paulo, SP, Brazil.

出版信息

Rev Bras Hematol Hemoter. 2013;35(3):167-70. doi: 10.5581/1516-8484.20130039.

DOI:10.5581/1516-8484.20130039
PMID:23904804
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3728127/
Abstract

OBJECTIVE

To describe general data on nucleic acid/serology testing and report the first hepatitis B-nucleic acid testing yield case of an immunized donor in Brazil.

METHODS

A total of 24,441 donations collected in 2010 and 2011 were submitted to individual nucleic acid testing for hepatitis B, hepatitis C and human immunodeficiency virus using the TaqMan((r)) MPX kit (Roche) on the Cobas s201 platform, in addition to routine screening for serological markers. Nucleic acid testing-reactive donations were further evaluated by real-time polymerase chain reaction using Cobas AmpliPrep/Cobas TaqMan hepatitis B virus, hepatitis C virus and human immunodeficiency virus tests.

RESULTS

Thirty-two donations were reactive by nucleic acid testing, 31 were also serologically reactive and one first-time donor was identified as having hepatitis B in the window period. Follow-up samples showed increasing titers of anti-HBs rising from 19 UI/mL in the index donation to 109 IU/mL seven months later attributable to his vaccination history. Curiously, this donor was never reactive for HbsAg nor for anti-HBc. In the yield donation, he was concomitantly reactive for syphilis (enzyme immunoassay and fluorescent treponemal antibody-absorption; venereal disease research laboratory non-reactive). Overall, six donors (0.02%) were characterized as occult hepatitis B. A total of 35% of the confirmed (recombinant immunoblot assay positive) hepatitis C donations were nucleic acid testing non-reactive and no human immunodeficiency virus "elite controller" was identified.

CONCLUSION

The yield rate (1:24,441; 95% confidence interval: 1:9,537 - 1:89,717) contrasts to the North American rate (1:410,540 donations) and strongly advocates the adoption of nucleic acid testing for hepatitis B in Brazil despite the increasing rate of anti-HBs reactive subjects due to the successful immunization program.

摘要

目的

描述核酸/血清学检测的一般数据,并报告巴西首例免疫供者的乙型肝炎核酸检测阳性病例。

方法

2010年和2011年采集的24441份血液样本,除进行常规血清学标志物筛查外,还使用Cobas s201平台上的TaqMan((r)) MPX试剂盒(罗氏公司)对乙型肝炎、丙型肝炎和人类免疫缺陷病毒进行个体核酸检测。核酸检测呈阳性的样本进一步采用Cobas AmpliPrep/Cobas TaqMan乙型肝炎病毒、丙型肝炎病毒和人类免疫缺陷病毒检测试剂盒进行实时聚合酶链反应评估。

结果

32份样本核酸检测呈阳性,其中31份血清学检测也呈阳性,1名首次献血者被确定处于乙型肝炎窗口期。随访样本显示抗-HBs滴度升高,从首次献血时的19 UI/mL升至7个月后的109 IU/mL,这归因于其疫苗接种史。奇怪的是,该供者的HbsAg和抗-HBc从未呈阳性。在此次阳性献血中,他同时梅毒检测呈阳性(酶免疫测定和荧光密螺旋体抗体吸收试验;性病研究实验室试验阴性)。总体而言,6名供者(0.02%)被判定为隐匿性乙型肝炎。确诊(重组免疫印迹试验阳性)的丙型肝炎献血样本中,共有35%核酸检测呈阴性,未发现人类免疫缺陷病毒“精英控制者”。

结论

阳性率(1:24441;95%置信区间:1:9537 - 1:89717)与北美地区的阳性率(1:410540次献血)形成对比,尽管由于成功的免疫计划导致抗-HBs阳性者比例增加,但这强烈支持巴西采用乙型肝炎核酸检测。

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