1.1本指南适用于蓖麻毒素标准物质的制造商和用户。蓖麻毒素标准物质具有良好的特性，可用于测试检测设备和校准实验室测量值。除生物活性测定外，预计蓖麻毒素标准物质还将通过生化方法进行表征。 1.2本规程详细介绍了使用无细胞翻译（CFT）测定法测量蓖麻毒素生物活性的方法（4）。 1.3 CFT分析已开发用于任何需要测定或确认蓖麻毒素生物活性的生物技术实验室。 1.4 CFT试验已由美国陆军传染病医学研究所（USAMRIID）VP-016验证细胞自由翻译试验用于检测蓖麻毒素生物活性，符合食品和药物管理局（21 CFR第58部分）的良好实验室规范（GLP）规定（5）。 严格遵守协议是测试结果有效性的必要条件。 1.5附录X1和附录X2还提供了使用基于细胞的分析和使用合成酶底物测量蓖麻毒素生物活性的指南。 1.6蓖麻毒素是一种2类选择剂，获得蓖麻毒素标准必须遵守疾病控制中心（CDC）的规定。蓖麻毒素列在select agent list（42 CFR第72部分）中。根据《公共卫生安全准备法案》（CRS报告RL31263《公共卫生安全和生物恐怖主义准备和应对法案》（P.L.107-188）:现有法律的规定和变更），蓖麻毒素的拥有、转移和使用受到限制。蓖麻毒素仓库的使用受到限制（美国爱国者法案，第107-56页）。蓖麻毒素也是《生物武器公约》和《化学武器公约》（CRS报告RL31559扩散控制制度: 背景和状态）。 1.7以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.8 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。 蓖麻毒素是一种极其危险的毒素。具体危险信息见第9节。 ====意义和用途====== CFT试验提供了一种灵敏可靠的方法来检测蓖麻毒素生物活性，结果可以在3小时内产生。该试验测量了蓖麻毒素生物活性的量，与已知蓖麻毒素标准进行比较，并提供了活性蓖麻毒素的定量测量。 分别在10 ng/mL和170 ng/mL下测量使用CFT分析的蓖麻毒素定量下限和定量上限（5）。 本规程侧重于标准物质的测量，而非环境样品的测量。环境样品的测量可能需要额外的控制运行，以确保样品（也称为基质）中存在的额外材料会干扰测量。 如果使用适当的控制以确保有效结果，则CFT分析可用于确定法医或生物恐怖分子样本中是否存在活性蓖麻毒素（5）。 本文中描述的方法测量蓖麻毒素的生物活性，而不检测给定样本中是否存在灭活蓖麻毒素。 蓖麻毒素标准物质有许多应用，例如测试检测装置、实验室仪器、环境采样方法、消毒研究和基础研究。

1.1 This guide is intended for the manufacturers and users of ricin reference material. Ricin reference materials are well-characterized materials that can be used to test detection devices and calibrate laboratory measurements. It is anticipated that ricin reference materials will be characterized by biochemical methods in addition to the measurement of biological activity. 1.2 This practice details the measurement of ricin biological activity using a cell-free translation (CFT) assay (4). 1.3 The CFT assay has been developed for use in any biotechnology laboratory where determination or confirmation of ricin biological activity is required. 1.4 The CFT assay has been validated by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) VP-016 Validation of Cell-Free Translation Assay for the Detection of Ricin Toxin Biological Activities in compliance (5) with Good Laboratory Practices (GLP) Regulations of the Food and Drug Administration (21 CFR Part 58). Strict adherence to the protocol is necessary for validity of the test results. 1.5 Appendix X1 and Appendix X2 also provide guidance for the measurement of the biological activity of ricin using cell-based assays and the use of synthetic enzyme substrates. 1.6 Ricin is a category 2 select agent and acquisition of the ricin standard must adhere to the Center for Disease Control (CDC) regulations. Ricin is listed on the select agent list (42 CFR Part 72). The possession, transfer, and use of ricin are restricted under the Public Health Security Preparedness Act (CRS Report RL31263 Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provision and Changes to Preexisting law). Access to stores of ricin is limited (USA Patriot Act, P.L. 107-56). Ricin is also a prohibited substance under the Biological Weapons Convention and the Chemical Weapons Convention (CRS Report RL31559 Proliferation Control Regimes: Background and Status). 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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. Ricin is an extremely dangerous toxin. See Section 9 for specific hazards information. ====== Significance And Use ====== The CFT assay provides a sensitive and reliable method to detect ricin biological activity and results can be generated within 3 h. The assay measures the amount of ricin biological activity when compared to a known ricin standard and provides a quantitative measurement for active ricin. The lower limit of quantitation and the upper limit of quantitation for ricin using the CFT assay was measured at 10 ng/mL and 170 ng/mL, respectively (5). This practice is focused on the measurement of reference materials and not environmental samples. Additional control runs may be needed for measurements of environmental samples to ensure that the presence of additional materials in the samples (also referred to as the matrix) will interfere with the measurements. The CFT assay may be used to determine the presence of active ricin in forensic or bioterrorist samples if the appropriate controls are utilized to ensure valid results (5). The methods described in this document measure the biological activity of ricin and do not detect the presence of inactivated ricin in a given sample. Ricin reference materials have a number of applications, such as testing detection devices, laboratory instruments, environmental sampling methods, disinfection studies, and basic research.