ASTM E3095-2017
基于核酸现场生物评价技术的现场评价用替代材料的标准指南

Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies

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标准号

ASTM E3095-2017

发布日期

2017年

实施日期

废止日期

无

中国标准分类号

A40

国际标准分类号

13.300

发布单位

US-ASTM

适用范围

4.1x00a0;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.

4.2x00a0;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.

4.3x00a0;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 operatorx2019;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.

4.4x00a0;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.

4.5x00a0;This guide should be used in accordance with Practices E2458 and Guide E2770.

4.6x00a0;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).

4.7x00a0;This guide is not meant to provide performance characterization of biological agent assays used with on-site biological assessment technologies.

1.1x00a0;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, t......