DETTD/OBRR/CBER/FDA, Bethesda, MD, USA.
Vox Sang. 2012 Aug;103(2):99-106. doi: 10.1111/j.1423-0410.2012.01598.x. Epub 2012 Mar 9.
Current nucleic acid tests (NAT) for blood donor screening use plasma as the test sample and, consequently, cannot detect virions bound to blood cells of infected donors. Hepatitis C virus (HCV) RNA and infectious virions have been detected in association with the cellular components of blood of patients with active liver disease; however, studies comparing HCV viral loads in whole blood and plasma have generated contradictory results. The aim of this study was to investigate the distribution of HCV in different compartments of the peripheral blood from HCV-infected blood donors, which may differ from that observed in patients with HCV-associated liver disease.
Hepatitis C virus-positive donor specimens were identified by NAT and antibody testing. HCV RNA was extracted from samples of whole blood and their corresponding components (RBC and plasma). Viral RNA was quantified by real-time qRT-PCR.
Hepatitis C virus was present in all blood components from infected donors from which RNA could be amplified. For the majority of samples, plasma (34/46) had the highest detectable concentration of HCV RNA, and RBC (37/46) had the lowest. Specimens with negative NAT and positive antibody assays also produced qRT-PCR negative results.
These results indicate that including the RBC fraction in the tested sample will not increase assay sensitivity. Although 10% of the specimens had a higher viral load in whole blood, there was no significant overall increase in sensitivity to justify changes in the specimen format. Thus, plasma specimens are well suited for blood donor screening for HCV.
目前用于献血者筛查的核酸检测(NAT)使用血浆作为检测样本,因此无法检测到感染供体结合在血细胞上的病毒粒子。丙型肝炎病毒(HCV)RNA 和感染性病毒粒子已与患有活动性肝病患者的血液细胞成分相关联被检测到;然而,比较全血和血浆中 HCV 病毒载量的研究产生了相互矛盾的结果。本研究旨在研究 HCV 在 HCV 感染献血者外周血不同成分中的分布情况,这可能与 HCV 相关肝病患者观察到的分布情况不同。
通过 NAT 和抗体检测鉴定 HCV 阳性供体标本。从全血及其相应成分(RBC 和血浆)中提取 HCV RNA。通过实时 qRT-PCR 定量检测病毒 RNA。
从可扩增 RNA 的所有受感染供体的血液成分中均存在 HCV。对于大多数样本,血浆(34/46)具有最高可检测到的 HCV RNA 浓度,而 RBC(37/46)具有最低浓度。NAT 阴性和抗体检测阳性的标本也产生了 qRT-PCR 阴性结果。
这些结果表明,将 RBC 部分纳入检测样本不会提高检测的灵敏度。尽管 10%的标本全血中的病毒载量更高,但总体灵敏度没有显著提高,因此不需要改变标本格式。因此,血浆标本非常适合 HCV 献血者筛查。