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作废 ASTM E1286-00(2006)
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Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014) 单纯疱疹病毒或其DNA鉴定标准指南(2014年)
发布日期: 2006-11-01
废止日期: 2014-08-05
1.1本指南涵盖了足以鉴定用于生物技术的单纯疱疹病毒1型和2型(单纯疱疹病毒1型和单纯疱疹病毒2型)或单纯疱疹病毒1型DNA和单纯疱疹病毒2型DNA纯化标本的实验室表征程序。对于需要识别HSV DNA样本的情况,本指南和的表征标准就足够了。 1.2本指南不包括在HSV感染的宿主细胞中识别HSV。为了将本指南应用于这种情况,首先需要使用HSV纯化的标准技术从此类样本中分离病毒。本指南不包括HSV DNA片段或包含HSV DNA片段的载体的特征。 1.3本指南不包括识别特征中使用的具体方法。 它没有解决疱疹病毒制剂所需纯度的问题:这取决于病毒的特定生物技术用途。 1.4 警告- 涉及单纯疱疹病毒的实验室工作可能对人员有害。建议使用生物安全2级设施 () . 应根据NCCLS M29-T2和其他建议遵守安全指南 () . 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全和健康实践,并确定监管限制的适用性。 ====意义和用途====== 本指南适用于生物技术实验室,只要有必要识别被认为主要含有HSV或其DNA的生物制剂。用于鉴定的表征标准应由受过分子病毒学培训的个人执行。 本指南不用于临床实验室鉴定从患者标本中分离出的HSV。
1.1 This guide covers laboratory characterization procedures sufficient to identify purified specimens of HSV types 1 and 2 (HSV-1 and HSV-2) or HSV-1 DNA and HSV-2 DNA used in biotechnology. For cases in which identification of HSV DNA specimens is required, the characterization criteria of and of this guide are sufficient. 1.2 This guide does not cover the identification of HSV in HSV-infected host cells. To apply this guide to such a case, it would first be necessary to isolate the virus from such samples using standard techniques of HSV purification. This guide does not cover characterization of segments of HSV DNA or of vectors containing HSV DNA segments. 1.3 This guide does not cover the specific methodology used in the identification characterization. It does not address the question of degree of purity required for herpes virus preparations: this would vary depending on the particular biotechnology use of the virus. 1.4 Warning- Laboratory work involving herpes simplex viruses can be hazardous to personnel. Biosafety 2 level facilities are recommended () . Safety guidelines shall be adhered to according to NCCLS M29-T2 and other recommendations () . This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== This guide is intended for use in a biotechnology laboratory whenever the necessity arises for identifying a biological preparation believed to contain primarily HSV or its DNA. The characterization criteria used for the identification shall be performed by an individual trained in molecular virology. This guide is not meant to be used in a clinical laboratory for the identification of HSV isolated from patient specimens.
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