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美国献血者中血清学检测方法的多中心比较及人类疱疹病毒8型血清流行率估计

Multicenter comparison of serologic assays and estimation of human herpesvirus 8 seroprevalence among US blood donors.

作者信息

Pellett P E, Wright D J, Engels E A, Ablashi D V, Dollard S C, Forghani B, Glynn S A, Goedert J J, Jenkins F J, Lee T-H, Neipel F, Todd D S, Whitby D, Nemo G J, Busch M P

机构信息

Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

出版信息

Transfusion. 2003 Sep;43(9):1260-8. doi: 10.1046/j.1537-2995.2003.00490.x.

Abstract

BACKGROUND

As part of assessing the possibility of transfusion transmission of human herpesvirus 8 (HHV-8 or Kaposi's sarcoma-associated herpesvirus), HHV-8 seroprevalence was estimated among US blood donors, the performance of HHV-8 serologic tests was compared, and the presence of HHV-8 DNA was tested for in donated blood.

STUDY DESIGN AND METHODS

Replicate panels of 1040 plasma specimens prepared from 1000 US blood donors (collected in 1994 and 1995) and 21 Kaposi's sarcoma patients were tested for antibodies to HHV-8 in six laboratories. HHV-8 PCR was performed on blood samples from 138 donors, including all 33 who tested seropositive in at least two laboratories and 22 who tested positive in at least one.

RESULTS

The estimated HHV-8 seroprevalence among US blood donors was 3.5 percent (95% CI, 1.2%-9.8%) by a conditional dependence latent-class model, 3.0 percent (95% CI, 2.0%-4.6%) by a conditional independence latent-class model, and 3.3 percent (95% CI, 2.3%-4.6%) by use of a consensus-derived gold standard (specimens positive in two or more laboratories); the conditional dependence model best fit the data. In this model, laboratory specificities ranged from 96.6 to 100 percent. Sensitivities ranged widely, but with overlapping 95 percent CIs. HHV-8 DNA was detected in blood from none of 138 donors evaluated.

CONCLUSIONS

Medical and behavioral screening does not eliminate HHV-8-seropositive persons from the US blood donor pool, but no viral DNA was found in donor blood. Further studies of much larger numbers of seropositive individuals will be required to more completely assess the rate of viremia and possibility of HHV-8 transfusion transmission. Current data do not indicate a need to screen US blood donors for HHV-8.

摘要

背景

作为评估人类疱疹病毒8型(HHV-8或卡波西肉瘤相关疱疹病毒)经输血传播可能性的一部分,对美国献血者中的HHV-8血清流行率进行了估计,比较了HHV-8血清学检测的性能,并检测了献血中HHV-8 DNA的存在情况。

研究设计和方法

由1000名美国献血者(于1994年和1995年采集)和21名卡波西肉瘤患者制备的1040份血浆标本的重复样本在六个实验室进行了HHV-8抗体检测。对138名献血者的血样进行了HHV-8聚合酶链反应(PCR)检测,其中包括在至少两个实验室检测为血清阳性的所有33人以及在至少一个实验室检测为阳性的22人。

结果

通过条件依赖潜伏类模型估计美国献血者中HHV-8血清流行率为3.5%(95%置信区间,1.2%-9.8%),通过条件独立潜伏类模型为3.0%(95%置信区间,2.0%-4.6%),使用共识衍生的金标准(在两个或更多实验室呈阳性的标本)为3.3%(95%置信区间,2.3%-4.6%);条件依赖模型最符合数据。在该模型中,各实验室的特异性范围为96.6%至100%。敏感性差异很大,但95%置信区间有重叠。在评估的138名献血者的血液中均未检测到HHV-8 DNA。

结论

医学和行为筛查并未将HHV-8血清阳性者排除在美国献血者群体之外,但在献血者血液中未发现病毒DNA。需要对更多血清阳性个体进行进一步研究,以更全面地评估病毒血症发生率和HHV-8经输血传播的可能性。目前的数据表明无需对美国献血者进行HHV-8筛查。

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