1.1 本指南描述了在开发、选择和使用替代材料以评估基于核酸的现场生物评估技术的操作性能时需要考虑的因素。操作性能包括工作流、技术、操作员、控制和结果报告。 1.2 本指南的用户包括现场生物评估技术或替代材料的开发人员和制造商，以及该技术的初始响应者社区和其他运营商。 1.3 本指南建议使用替代材料来支持培训；提高操作员的知识、技能和信心； 并按照指南中的建议，支持置信度检查和过程评估演示，以支持管辖区生物威胁任务能力 E2770 ，第8节。 1.4 本指南建议结合指南中所述的培训计划使用替代材料 E2770 并在初始响应组织、危险品响应单位、城市搜索救援（US＆R）团队、国民警卫队民事支持团队（CST）、实验室响应网络（LRN）参考实验室、地方执法部门、联邦调查局（FBI）和管辖协议定义的其他机构之间进行协调。 1.5 本指南建议选择一种替代材料，以类似于现实世界应急响应场景中遇到的可疑生物制剂所施加的挑战的方式挑战工作流，同时将健康和安全风险降至最低。 1.6 本指南描述了使用替代材料对基于核酸的现场生物评估技术进行置信度检查时的注意事项。 1.7 本指南描述了当操作员能够获得针对替代材料的特征良好的基于核酸的分析时，使用替代材料进行过程评估所涉及的因素，该替代材料使操作员能够针对应用于- 现场生物评估。 1.8 本指南并不取代现场生物评估技术的第三方验证，以评估技术正确检测和识别生物制剂的能力。本指南建议，所有现场生物评估技术应按照国际公认的共识标准（例如，AOAC标准方法性能要求）进行证明，以符合本指南 E2770 和实践 E2458 . 1.9 就本指南而言，应根据惯例进行样本采集 E2458 . 1.10 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、健康和环境实践，并确定监管限制的适用性。 1.11 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本指南提供了关于如何选择替代材料并将其插入现场工作流程的指导，以进行置信度检查和过程评估- 现场生物评估技术，以证明该技术在操作员手中的现场环境中工作。 4.2 使用替代材料代替灭活或衰减的生物制剂（或其成分）是有益的，因为( 1. )易于生产和处理( 2. )易于获取和运输( 3. )在设备和设施限制最小的情况下使用材料的能力，例如，生物安全防护，以及( 4. )将潜在生物制剂污染人员、设备和环境的风险降至最低。 4.3 本指南涵盖了可用于确定目标的置信度检查和过程评估的基本设计( 1. )现场工作流程( 2. )现场生物评估技术的性能，以及( 3. )操作员在现场工作流程中处理材料的能力，以增加对每个组件的信心。这些演示使应急响应人员能够深入了解基于核酸的生物评估技术的日常操作，并有机会根据其管辖范围内定义的培训计划评估和展示其能力。 4.4 本指南可用于帮助操作员常规使用任何基于核酸的现场生物评估技术。使用替代材料，操作员能够对其在工作流中执行操作的能力获得信心，并在现场收集常规信息（例如，操作员表现、随时间变化的评估结果）。 4.5 本指南应按照惯例使用 E2458 和指南 E2770 . 4.6 本指南应根据替代材料的生物安全水平所需的适当风险降低措施（包括个人防护设备）使用（最好是生物安全水平1；该水平应与替代材料供应商核实）。 4.7 本指南并非旨在提供与现场生物评估技术一起使用的生物制剂分析的性能表征。

1.1 This guide describes factors to consider when developing, selecting, and using a surrogate material for evaluating the operational performance of nucleic acid-based on-site biological assessment technologies. Operational performance includes the workflow, technology, operator, controls, and result reporting. 1.2 Users of this guide include developers and manufacturers of on-site biological assessment technologies or surrogate materials, as well as the initial responder community and other operators of the technologies. 1.3 This guide recommends the use of surrogate materials to support training; improve the knowledge, skills, and confidence of operators; and enable confidence check and process assessment demonstrations in support of jurisdictional biothreat mission capabilities as recommended in Guide E2770 , Section 8. 1.4 This guide recommends the use of surrogate materials in combination with a training program as articulated in Guide E2770 and coordinated among the initial responder organization, hazardous materials response unit, Urban Search and Rescue (US&R) team, National Guard Civil Support Team (CST), Laboratory Response Network (LRN) reference laboratory, local law enforcement, the Federal Bureau of Investigation (FBI), and other agencies as defined by jurisdictional protocols. 1.5 This guide recommends the selection of a surrogate material that challenges the workflow in a way similar to the challenge imposed by suspected biological agents encountered in real-world emergency response scenarios while posing minimal health and safety risks. 1.6 This guide describes considerations when using a surrogate material for a confidence check of nucleic acid-based on-site biological assessment technologies. 1.7 This guide describes factors involved in the use of a surrogate material to perform a process assessment when the operator has access to well-characterized nucleic acid-based assays specific to the surrogate material that enable the operator to target the analytical process applied to on-site biological assessment. 1.8 This guide does not replace third-party validation of on-site biological assessment technologies to assess the ability of the technologies to correctly detect and identify a biological agent. This guide recommends that all on-site biological assessment technologies be demonstrated to perform according to internationally recognized consensus standards (for example, AOAC Standard Method Performance Requirements) as consistent with Guide E2770 and Practices E2458 . 1.9 For the purposes of this guide, sample collection should be performed according to Practices E2458 . 1.10 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. 1.11 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 ====== 4.1 This guide provides guidance on how a surrogate material can be selected and inserted into a field workflow for confidence checks and process assessments of on-site biological assessment technologies to demonstrate that the technology is working in the field environment in the hands of operators. 4.2 Use of a surrogate material instead of an inactivated or attenuated biological agent (or its components) is beneficial due to ( 1 ) ease of production and handling, ( 2 ) ease of acquisition and transportation, ( 3 ) the ability to use the material with minimal equipment and facility constraints, for example, biosafety containment, and ( 4 ) minimized risk of contamination of personnel, equipment and the environment with a potential biological agent. 4.3 This guide covers the basic design of confidence checks and process assessments that may be used to target ( 1 ) the workflow in the field, ( 2 ) the performance of the on-site biological assessment technology, and ( 3 ) the operator’s ability to process a material in the field workflow, in order to increase confidence in each component. These demonstrations provide emergency responders with insight into routine operation of a nucleic acid-based biological assessment technology and the opportunity to assess and demonstrate their capabilities according to a defined training program in their jurisdiction. 4.4 This guide may be used to aid operators in the routine use of any nucleic acid-based on-site biological assessment technology. Using a surrogate material, operators are able to gain confidence in their ability to perform operations in the workflow and gather routine information (for example, operator performance, assessment results over time) in the field. 4.5 This guide should be used in accordance with Practices E2458 and Guide E2770 . 4.6 This guide should be used according to the appropriate risk reduction measures (including personal protective equipment) that are needed for the biosafety level of the surrogate material (preferably Biosafety Level 1; the level should be verified with the provider of the surrogate material). 4.7 This guide is not meant to provide performance characterization of biological agent assays used with on-site biological assessment technologies.