Division of Hematology, Center for Biologics Evaluation and Research, FDA, Warren Grant Magnuson Clinical Center, NIH, Bethesda, Maryland 20892, USA.
Transfusion. 2010 Aug;50(8):1712-21. doi: 10.1111/j.1537-2995.2010.02591.x. Epub 2010 Feb 12.
Extremely high viremic levels of parvovirus B19 (B19V) can be found in acutely infected, but asymptomatic donors. However, reports of transmission by single-donor blood components are rare. In this prospective study, paired donor-recipient samples were used to investigate the transfusion risk.
Posttransfusion plasma or blood samples from recipients were tested for B19V DNA by polymerase chain reaction, generally at 4 and 8 weeks, and for anti-B19V immunoglobulin (Ig)G by enzyme immunoassay, at 12 and 24 weeks. To rule out infection unrelated to transfusion, pretransfusion samples and linked donor's samples for each B19V DNA-positive recipient were assayed for B19V DNA and anti-B19V IgG and IgM. To confirm transmission, sequencing and phylogenetic analysis were performed.
A total of 14 of 869 (1.6%) recipients were B19V DNA positive, but only 1 of 869 (0.12%; 95% confidence interval, 0.0029%-0.6409%) was negative for B19V DNA and anti-B19V IgG before transfusion and seroconverted posttransfusion. This newly infected patient received 5 × 10(10) IU B19V DNA in one red blood cell (RBC) unit from an acutely infected anti-B19V-negative donor in addition to RBCs from three other donors that cumulatively contained 1320 IU of anti-B19V IgG. DNA sequencing and phylogenetic analysis showed that sequences from the linked donor and recipient were identical (Genotype 1), thus establishing transfusion transmission.
The 0.12% transmission rate documented here, although low, could nonetheless result in hundreds or thousands of infections annually in the United States based on calculated confidence limits. Although most would be asymptomatic, some could have severe clinical outcomes, especially in neonates and those with immunocompromised or hemolytic states.
在急性感染但无症状的供体中,可以发现细小病毒 B19(B19V)极高的病毒血症水平。然而,由单个供体血液成分传播的报告却很少见。在这项前瞻性研究中,使用配对的供体-受者样本来研究输血风险。
受者的输血后血浆或血液样本通过聚合酶链反应检测 B19V DNA,通常在 4 周和 8 周进行,通过酶联免疫吸附试验检测抗 B19V 免疫球蛋白(Ig)G,在 12 周和 24 周进行。为了排除与输血无关的感染,对每个 B19V DNA 阳性受者的输血前样本和相关供体样本进行 B19V DNA 和抗 B19V IgG 和 IgM 检测。为了确认传播,进行了测序和系统发生分析。
在 869 名受者中,共有 14 名(1.6%)B19V DNA 阳性,但只有 1 名(0.12%;95%置信区间,0.0029%-0.6409%)在输血前 B19V DNA 和抗 B19V IgG 均为阴性,并在输血后发生血清转化。这名新感染的患者除了接受来自一名急性感染抗 B19V 阴性供体的 5×10(10)IU B19V DNA 的一个红细胞(RBC)单位外,还接受了来自另外三名供体的 RBC,这三个供体的 RBC 共含有 1320IU 的抗 B19V IgG。DNA 测序和系统发生分析显示,供体和受者的序列相同(基因型 1),从而确立了输血传播。
尽管传播率很低,但根据计算的置信限,这里记录的 0.12%的传播率每年仍可能导致美国数百或数千例感染。虽然大多数是无症状的,但有些可能会有严重的临床后果,特别是在新生儿和免疫功能低下或溶血性状态的患者中。