1.1 概述: 1.1.1 该测试方法提供了一种程序，用于在使用规范中描述的测试样本和统计考虑因素时，表征用于检测和鉴定生物制剂的基于核酸的现场筛查设备（FSD）的性能 E3394 。 1.1.2 该测试方法描述了在表征用于检测和鉴定生物制剂的基于核酸的现场筛选设备的性能时使用的样品制备和分析方案。 1.1.3 该测试方法的目的是提供一种方法，以类似于联邦和州/地方/部落/地区（SLTT）执法部门和急救人员在现场分析样本的方式分析样本，但在比进行现场测试时通常可实现的条件更可控和可重复的条件下。 本试验方法和规范中所述的试验结果分析 E3394 允许以系统的方式测量FSD的统计性能。 1.2 单位: 1.2.1 以国际单位制表示的数值应视为本文件中的标准值。 1.2.2 当创建测试样品混合物时，所有浓度均以拷贝数/mL或基因组当量/mL（GE/mL）表示。 1.3 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 及时准确地识别现场的有害生物制剂对于采取行动和应对涉及生物制剂的事件的决策至关重要。 5.2 生物制剂的检测和识别将告知响应者如何准备现场活动（例如，选择个人防护装备和必要的预防措施）、处理暴露、保护和净化事件现场，并告知事件发生后要采取的后续行动。 5.3 包容性和排他性测试板用于确保能够检测到FSD靶向的生物制剂（包容性），并且不会检测到非FSD目标生物制剂（排他性）。环境测试板用于确定当存在加标的整个生物制剂时，是否存在可能导致假阴性结果的潜在干扰。

1.1 General: 1.1.1 This test method provides a procedure for characterizing the performance of nucleic acid-based field screening devices (FSDs) for the detection and identification of biological agents, when utilizing the test samples and statistical considerations described in Specification E3394 . 1.1.2 This test method describes sample preparation and analysis protocols to use when characterizing the performance of nucleic acid-based field screening devices for the detection and identification of biological agents. 1.1.3 The intent of this test method is to provide a methodology to analyze samples in a manner that is analogous to how they are to be analyzed in the field by federal and state/local/tribal/territorial (SLTT) law enforcement and first responders, but under more controlled and reproducible conditions than those generally achievable when conducting field testing. The analysis of testing results as described in this test method and in Specification E3394 allow for a systematic way of measuring the statistical performance of FSDs. 1.2 Units: 1.2.1 The values stated in SI units are to be regarded as standard in this document. 1.2.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL). 1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 Prompt and accurate identification of harmful biological agents on-scene is crucial to decision making for taking action and responding to incidents involving biological agents. 5.2 The detection and identification of a biological agent will inform how responders prepare for on-site activity (for example, selection of PPE and necessary precautionary actions), treat exposures, secure and decontaminate the incident site, and inform follow up actions to be taken after the incident has occurred. 5.3 Inclusivity and exclusivity test panels are used to ensure that biological agents targeted by the FSD can be detected (inclusivity) and that biological agents not targeted by the FSD are not detected (exclusivity). The environmental test panel is used to determine if there are potential interferences that could result in a false negative result when spiked whole biological agent is present.