Paul-Ehrlich-Institut, Langen, Germany.
Transfusion. 2012 Jul;52(7):1490-7. doi: 10.1111/j.1537-2995.2012.03573.x. Epub 2012 Feb 17.
Parvovirus B19 (B19V) is a common contaminant of human plasma donations. Three B19V genotypes have been defined based on their DNA sequence. Reliable detection of Genotype 3 DNA has proved problematic because of unexpected sequence variability. B19V Genotype 3 is found primarily in West Africa, but was recently detected in plasma from a North American donor. The safety of plasma-derived medicinal products, with respect to B19V, relies on exclusion of high-titer donations, combined with virus clearance at specific manufacturing steps. Studies on inactivation of B19V are difficult to perform and inactivation of Genotype 3 has not yet been investigated.
Inactivation of B19V Genotypes 3 and 1 by pasteurization of human serum albumin and incubation at low pH was studied using a cell culture assay for infectious virus particles. Infected cells were detected by reverse transcription-polymerase chain reaction analysis of virus capsid mRNA. Neutralization of B19V Genotype 3 was investigated using human immunoglobulin preparations.
Genotypes 1 and 3 displayed comparable inactivation kinetics during pasteurization of albumin at 56°C, as well as by incubation at various low-pH conditions (pH 4.2 at 37°C and pH 4.5 at 23°C, respectively) used in immunoglobulin manufacturing. Both Genotypes were readily neutralized by pooled immunoglobulin preparations of North American or European origin.
Pasteurization and low-pH treatment were equally effective in inactivating B19V Genotypes 1 and 3. Neutralization experiments indicated that pooled immunoglobulin of North American or European origin is likely to be equally effective in treatment of disease induced by both genotypes.
细小病毒 B19（B19V）是人类血浆捐献物的常见污染物。根据其 DNA 序列，已定义了三种 B19V 基因型。由于意外的序列变异，可靠检测基因型 3 DNA 一直存在问题。B19V 基因型 3 主要存在于西非，但最近在来自北美的供体血浆中检测到。就 B19V 而言，血浆衍生药物的安全性依赖于排除高滴度捐献物，结合特定生产步骤的病毒清除。B19V 失活研究难以进行，并且尚未研究基因型 3 的失活。
使用细胞培养测定法检测感染性病毒颗粒，研究巴氏消毒法和在低 pH 值下孵育对人血清白蛋白中 B19V 基因型 3 和 1 的灭活作用。通过病毒衣壳 mRNA 的逆转录聚合酶链反应分析检测感染细胞。使用人免疫球蛋白制剂研究 B19V 基因型 3 的中和作用。
在 56°C 巴氏消毒白蛋白以及在免疫球蛋白生产中使用的各种低 pH 值条件下（分别为 37°C 时 pH 4.2 和 23°C 时 pH 4.5），基因型 1 和 3 的失活动力学相似。两种基因型都容易被北美或欧洲来源的免疫球蛋白制剂中和。
巴氏消毒法和低 pH 值处理对灭活 B19V 基因型 1 和 3 同样有效。中和实验表明，来自北美或欧洲的免疫球蛋白混合制剂可能对两种基因型引起的疾病的治疗同样有效。
