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在核酸检测筛查时代,接受血浆衍生因子浓缩物治疗的出血性疾病患者中,细小病毒 B19 传播的证据。

Evidence for the transmission of parvovirus B19 in patients with bleeding disorders treated with plasma-derived factor concentrates in the era of nucleic acid test screening.

机构信息

Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.

出版信息

Transfusion. 2013 Jun;53(6):1217-25. doi: 10.1111/j.1537-2995.2012.03907.x. Epub 2012 Sep 24.

Abstract

BACKGROUND

Parvovirus B19 (B19V) is a small, nonenveloped virus that typically causes a benign flu-like illness that occurs most frequently in childhood. The virus is resistant to current viral inactivation steps used in the manufacture of antihemophilic factor concentrates and B19V transmission through these products has been documented. Since 2000, B19V nucleic acid test (NAT) screening of plasma pools has been implemented to further decrease the viral burden in these products, but no study has examined populations using these products to assess the impact of the screening on B19V transmission.

STUDY DESIGN AND METHODS

Blood specimens obtained from participants of a surveillance system established in federally supported specialized bleeding disorders clinics were used in a B19V seroprevalence study.

RESULTS

A total of 1643 specimens from 1043 participants age 2 to 7 years born after B19V NAT screening was implemented were tested. Age-specific prevalence rates were generally higher for subjects exposed to either plasma-derived products alone or in combination with other products compared to subjects with no exposure to antihemophilic products. Overall, compared to participants unexposed to blood or blood products, those exposed to plasma-derived products alone were 1.7 times more likely to have antibodies to B19V (p = 0.002).

CONCLUSION

These results are consistent with continued B19V transmission through plasma-derived factor concentrates. Effective viral inactivation and detection processes are needed to protect users of these products from infection with B19V or other new or emerging viruses.

摘要

背景

细小病毒 B19(B19V)是一种小型无包膜病毒,通常会引起良性流感样疾病,最常发生在儿童时期。该病毒能抵抗目前在抗血友病因子浓缩物生产中使用的病毒灭活步骤,并且已经有通过这些产品传播 B19V 的记录。自 2000 年以来,已经对血浆池进行 B19V 核酸检测(NAT)筛查,以进一步降低这些产品中的病毒负担,但尚无研究检查使用这些产品的人群,以评估筛查对 B19V 传播的影响。

研究设计和方法

使用在联邦支持的专门出血性疾病诊所建立的监测系统中获得的参与者的血液标本进行 B19V 血清流行率研究。

结果

共检测了来自 1043 名 2 至 7 岁参与者的 1643 份样本,这些参与者出生于 B19V NAT 筛查实施之后。与未接触抗血友病产品的受试者相比,单独或组合接触血浆衍生产品的受试者的年龄特异性患病率通常更高。总体而言,与未接触血液或血液制品的参与者相比,单独接触血浆衍生产品的参与者对 B19V 的抗体阳性率高 1.7 倍(p = 0.002)。

结论

这些结果与通过血浆衍生的因子浓缩物持续传播 B19V 一致。需要有效的病毒灭活和检测过程来保护这些产品的使用者免受 B19V 或其他新出现或新兴病毒的感染。

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