【国外标准】 Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies

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.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.