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适用于基因改造病毒和病毒载体的具有已证实功效的消毒剂。

Suitable Disinfectants with Proven Efficacy for Genetically Modified Viruses and Viral Vectors.

机构信息

Laboratory Prof. Dr. G. Enders MVZ GbR, Rosenbergstr. 85, 70193 Stuttgart, Germany.

Expert Committee on Virus Disinfection of the German Association for the Control of Viral Diseases (DVV) e.V. and the Society for Virology (GfV) e.V., 69126 Heidelberg, Germany.

出版信息

Viruses. 2023 Oct 30;15(11):2179. doi: 10.3390/v15112179.

Abstract

Viral disinfection is important for medical facilities, the food industry, and the veterinary field, especially in terms of controlling virus outbreaks. Therefore, standardized methods and activity levels are available for these areas. Usually, disinfectants used in these areas are characterized by their activity against test organisms (i.e., viruses, bacteria, and/or yeasts). This activity is usually determined using a suspension test in which the test organism is incubated with the respective disinfectant in solution to assess its bactericidal, yeasticidal, or virucidal activity. In addition, carrier methods that more closely reflect real-world applications have been developed, in which microorganisms are applied to the surface of a carrier (e.g., stainless steel frosted glass, or polyvinyl chloride (PVC)) and then dried. However, to date, no standardized methods have become available for addressing genetically modified vectors or disinfection-resistant oncolytic viruses such as the H1-parvovirus. Particularly, such non-enveloped viruses, which are highly resistant to disinfectants, are not taken into account in European standards. This article proposes a new activity claim known as "virucidal activity PLUS", summarizes the available methods for evaluating the virucidal activity of chemical disinfectants against genetically modified organisms (GMOs) using current European standards, including the activity against highly resistant parvoviridae such as the adeno-associated virus (AAV), and provides guidance on the selection of disinfectants for pharmaceutical manufacturers, laboratories, and clinical users.

摘要

病毒消毒对于医疗设施、食品工业和兽医领域非常重要,特别是在控制病毒爆发方面。因此,这些领域都有标准化的方法和活性水平。这些领域通常使用的消毒剂的特点是对测试生物(即病毒、细菌和/或酵母)具有活性。该活性通常使用悬浮试验来确定,其中将测试生物与相应的消毒剂在溶液中孵育,以评估其杀菌、杀酵母或杀病毒活性。此外,还开发了更能反映实际应用的载体方法,其中将微生物施加到载体(例如不锈钢磨砂玻璃或聚氯乙烯(PVC))的表面上,然后进行干燥。然而,迄今为止,尚无标准化方法可用于处理基因修饰载体或耐消毒的溶瘤病毒,例如 H1 细小病毒。特别是,这些高度耐消毒剂的非包膜病毒在欧洲标准中未被考虑在内。本文提出了一种新的活性声称,称为“杀病毒活性 PLUS”,总结了使用当前欧洲标准评估化学消毒剂对基因修饰生物(GMO)的杀病毒活性的可用方法,包括针对高度耐腺相关病毒(AAV)等细小病毒科的活性,并为制药制造商、实验室和临床用户选择消毒剂提供了指导。

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