Pruss Axel, Kao Moujahed, Gohs Uwe, Koscielny Jürgen, von Versen Rüdiger, Pauli Georg
Institute for Transfusion Medicine, Tissue Bank, University Hospital Charité, Medical Faculty of the Humboldt-University Berlin, Berlin, Germany.
Biologicals. 2002 Jun;30(2):125-33. doi: 10.1006/biol.2002.0326.
In the production of bone grafts intended for transplantation, basic safety measures to avoid the transmission of pathogens are selection and serological screening of donors for markers of virus infections. As an additional safety tool we investigated the effect of gamma irradiation on the sterility of human bone diaphysis transplants and evaluated its impact on the virus safety of transplants. Model viruses were included in the study to determine the dose necessary to achieve a reduction factor for the infectivity titres of at least 4 log(10) at a temperature of -30+/-5 degrees C. The following viruses were used: human immunodeficiency virus type 2 (HIV-2), hepatitis A virus (HAV), and poliovirus (PV-1), and the following model viruses: pseudorabies virus (PRV) as a model for human herpesviruses, bovine viral diarrhoea virus (BVDV) for HCV, and bovine parvovirus (BPV) for parvovirus B19. A first approach was to determine the D(10) values (kGy) for the different viruses (virus inactivation kinetics: BPV 7.3; PV-1 7.1; HIV-2 7.1; HAV 5.3; PRV 5.3; BVDV <3.0 kGy). Based on these results, inactivation of these viruses was studied in experimentally contaminated human bone transplants (femoral diaphyses). For BPV, the most resistant one of the viruses studied, a dose of approximately 34 kGy was necessary to achieve a reduction of infectivity titres of 4 log(10). We therefore recommend a dose of 34 kGy for the sterilisation of frozen bone transplants.
在生产用于移植的骨移植材料时,避免病原体传播的基本安全措施是对供体进行选择并进行病毒感染标志物的血清学筛查。作为一项额外的安全手段,我们研究了伽马射线辐照对人骨干移植材料无菌性的影响,并评估了其对移植材料病毒安全性的影响。研究中纳入了模型病毒,以确定在-30±5℃温度下使感染性滴度降低因子至少达到4 log(10)所需的剂量。使用了以下病毒:2型人类免疫缺陷病毒(HIV-2)、甲型肝炎病毒(HAV)和脊髓灰质炎病毒(PV-1),以及以下模型病毒:作为人类疱疹病毒模型的伪狂犬病病毒(PRV)、作为丙肝病毒模型的牛病毒性腹泻病毒(BVDV)和作为细小病毒B19模型的牛细小病毒(BPV)。第一步是确定不同病毒的D(10)值(千戈瑞)(病毒灭活动力学:BPV 7.3;PV-1 7.1;HIV-2 7.1;HAV 5.3;PRV 5.3;BVDV<3.0千戈瑞)。基于这些结果,在实验性污染的人骨移植材料(股骨干)中研究了这些病毒的灭活情况。对于所研究的病毒中抵抗力最强的BPV,需要约34千戈瑞的剂量才能使感染性滴度降低4 log(10)。因此,我们建议对冷冻骨移植材料进行灭菌的剂量为34千戈瑞。