凝血因子 VIII 浓缩物中的丙型肝炎病毒核糖核酸

Hepatitis C virus RNA in factor VIII concentrates.

作者信息

Guo Z P, Yu M W

机构信息

Laboratory of Plasma Derivatives, Food and Drug Administration, Rockville, Maryland.

出版信息

Transfusion. 1995 Feb;35(2):112-6. doi: 10.1046/j.1537-2995.1995.35295125732.x.

DOI:10.1046/j.1537-2995.1995.35295125732.x

PMID:7825205

Abstract

BACKGROUND

Hepatitis C virus (HCV) RNA was measured in commercial factor VIII concentrates, that is, antihemophilic factor (human) (AHF), to allow the retrospective evaluation of the effect of various virus-inactivation procedures. The impact on AHF of recent anti-HCV screening of plasma was also investigated.

STUDY DESIGN AND METHODS

A total of 183 lots of AHF made by six United States-licensed manufacturers from anti-HCV-unscreened (1976-1991) or screened (1992-1993) plasma were examined. Detection and quantitation of HCV RNA were achieved by reverse transcription and nested polymerase chain reaction at limiting dilution. Anti-HCV in AHF was also measured.

RESULTS

Earlier AHF lots subjected to non-virus-inactivated treatment (36 lots), dry heat (11 lots), or heating in n-heptane (4 lots) had relatively high levels of HCV RNA. Most (76%) wet-heated lots prepared before 1992 contained HCV RNA. No HCV RNA was detected in lots purified by immunoaffinity and subsequently heated or solvent/detergent (S/D)-treated. However, trace levels of HCV RNA were detected in S/D-treated lots made by one of four manufacturers before 1992. Since the start of anti-HCV plasma screening in 1992, 38 lots prepared by six manufacturers were negative for HCV RNA. Prevalence of anti-HCV was also associated with earlier concentrates and with S/D-treated lots from that single manufacturer.

CONCLUSION

Anti-HCV screening of plasma by manufacturers in conjunction with current virus-inactivation procedures, wet-heating or S/D treatment (either process with or without affinity purification), appears to reduce HCV RNA to undetectable levels in AHF.

摘要

背景

对商业性凝血因子 VIII 浓缩物，即抗血友病因子（人）（AHF）进行丙型肝炎病毒（HCV）RNA 检测，以便对各种病毒灭活程序的效果进行回顾性评估。还研究了近期血浆抗 HCV 筛查对 AHF 的影响。

研究设计与方法

检查了由美国六家获得许可的制造商用未筛查抗 HCV（1976 - 1991 年）或已筛查（1992 - 1993 年）血浆制成的总共 183 批 AHF。通过逆转录和有限稀释下的巢式聚合酶链反应实现 HCV RNA 的检测和定量。还检测了 AHF 中的抗 HCV。

结果

早期未经病毒灭活处理（36 批）、干热（11 批）或在正庚烷中加热（4 批）的 AHF 批次 HCV RNA 水平相对较高。1992 年之前制备的大多数（76%）湿热处理批次含有 HCV RNA。在通过免疫亲和纯化随后加热或经溶剂/去污剂（S/D）处理的批次中未检测到 HCV RNA。然而，在 1992 年之前由四家制造商之一生产的经 S/D 处理的批次中检测到痕量 HCV RNA。自 1992 年开始血浆抗 HCV 筛查以来，六家制造商制备的 38 批产品 HCV RNA 呈阴性。抗 HCV 的流行率也与早期浓缩物以及该单一制造商的经 S/D 处理的批次有关。