Roth Nathan J, Schäfer Wolfram, Alexander Rick, Elliott Kevin, Elliott-Browne Wlenyeno, Knowles Jonathan, Wenzel Jürgen J, Simon Toby L
CSL Behring, King of Prussia, Pennsylvania.
CSL Behring GmbH, Marburg, Germany.
Transfusion. 2017 Dec;57(12):2958-2964. doi: 10.1111/trf.14285. Epub 2017 Aug 21.
Hepatitis E virus (HEV) is a small, nonenveloped, single-stranded, RNA virus of emerging concern in industrialized countries. HEV transmission through transfusion of blood components has been reported, but not via plasma-derived medicinal products (PDMPs) manufactured with virus inactivation and/or removal steps. This study aimed to determine the prevalence of HEV among US source plasma donors.
Samples were collected from US source plasma donors at centers across the United States and were initially screened for HEV RNA in 96-sample minipools using the Roche cobas HEV test on the cobas 8800 system. Assuming a sensitivity of 18.6 IU/mL, the minipool screening strategy allowed for reliable detection of individual donations with HEV RNA titers of more than 2 × 10 IU/mL. Reactive minipools were resolved to individual donations, which were further analyzed to quantify viral RNA concentration, determine HEV genotype, and immunoglobulin (Ig)G and IgM HEV antibody status.
A total of 128,020 samples were collected from 96 CSL Plasma centers in the United States, representing 27 states. The prevalence of HEV RNA-positive samples was 0.002% with three unique HEV-positive donors identified, all HEV Subgenotype 3a. Virus titers of HEV-positive samples were relatively low (10 -10 IU HEV RNA/mL). One positive donation was HEV IgG seropositive.
Routine screening of US source plasma donations for HEV would not substantially improve the safety of most PDMPs. The low prevalence and potential viral load of HEV, together with effective virus reduction steps in manufacturing processes, results in a low residual risk and acceptable safety margins for PDMPs derived from US plasma donors.
戊型肝炎病毒（HEV）是一种小型、无包膜、单链RNA病毒，在工业化国家日益受到关注。已有通过输血传播HEV的报道，但尚未见通过经过病毒灭活和/或去除步骤生产的血浆衍生药用产品（PDMP）传播的报道。本研究旨在确定美国血浆源捐献者中HEV的流行情况。
从美国各地中心的血浆源捐献者中采集样本，并首先使用罗氏cobas HEV检测在cobas 8800系统上对96份样本的微量池进行HEV RNA筛查。假设灵敏度为18.6 IU/mL，微量池筛查策略能够可靠检测出HEV RNA滴度超过2×10 IU/mL的个体捐献样本。对反应性微量池进行个体样本分析，进一步定量病毒RNA浓度、确定HEV基因型以及检测免疫球蛋白（Ig）G和IgM HEV抗体状态。
共从美国96个CSL血浆中心采集了128,020份样本，代表27个州。HEV RNA阳性样本的流行率为0.002%，鉴定出3名独特的HEV阳性捐献者，均为HEV 3a亚型。HEV阳性样本的病毒滴度相对较低（10 - 10 IU HEV RNA/mL）。1份阳性捐献样本HEV IgG血清学呈阳性。
对美国血浆源捐献进行HEV常规筛查不会显著提高大多数PDMP的安全性。HEV的低流行率和潜在病毒载量，以及生产过程中有效的病毒去除步骤，使得源自美国血浆捐献者的PDMP残留风险较低且安全边际可接受。
