ASTM E3095-17
(Guide)Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies
Standard Guide for Surrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies
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 surrog...
SCOPE
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 ...
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Standards Content (Sample)
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.
Designation: E3095 − 17
Standard Guide for
Surrogate Materials for Field Evaluation of Nucleic Acid-
1
Based On-Site Biological Assessment Technologies
This standard is issued under the fixed designation E3095; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Emerging infectious disease and deliberate biological threats are ever-present concerns that can
affect the health and safety of the public. Constant vigilance and cooperation among law enforcement,
public health, and public safety communities across the globe are required to respond to and minimize
the impact of these threats. Significant investments in technology innovation and development have
led to the availability of a large number of on-site biological assessment technologies to support the
missions of emergency response personnel. On-site biological assessment involves field-based
measurements of properties inherent to biological materials for presumptive analysis of suspected
biological agents; confirmatory analysis is performed by public health laboratories. Previously
published ASTM standards, including Guide E2770 and Practices E2458 as well as the DHS
Framework for a Biothreat Field Response Mission Capability, articulate the need for routine
evaluation of on-site biological assessment technologies to support the use of validated fielded assays.
However,therearelimitedmechanismstoreliablyandroutinelyassesstechnologyperformanceinthe
hands of users due to the ever-changing threat of emerging disease and the challenges of working in
the field with biological agents that can be used as threat materials. In these instances, surrogate
materials, that is, non-threat biological materials, can be utilized to provide a safer alternative to
biological agents for evaluating operational performance of a technology. These materials may go
through the entire workflow process, thereby allowing for assessment of and providing confidence in
routine operation of an on-site biological assessment technology, where the operational performance
encompasses the workflow, the technology, operator capabilities, proper controls, and integration of
results into a concept of operations such as described in Guide E2770. This guide describes important
factors to consider when developing, selecting, and using a surrogate material for a qualitative
confidence check or quantitative process assessment to evaluate on-site biological assessment
technologies. A process assessment requires additional quantification of the surrogate material as
compared to a confidence check. Surrogate materials are not meant to be used for proficiency testing
or validation of biological agent assays.
1. Scope materials, as well as the initial responder community and other
operators of the technologies.
1.1 This guide describes factors to consider when
developing, selecting, and using a surrogate material for
1.3 Thisguiderecommendstheuseofsurrogatematerialsto
evaluating the operational performance of nucleic acid-based
support training; improve the knowledge, skills, and confi-
on-site biological assessment technologies. Operational perfor-
dence of operators; and enable confidence check and process
mance includes the workflow, technology, operator, controls,
assessment demonstrations in support of jurisdictional bio-
and result reporting.
threat mission capabilities as recommended in Guide E2770,
Section 8.
1.2 Users of this guide include developers and manufactur-
ers of on-site biological assessment technologies or surrogate
1.4 Thisguiderecommendstheuseofsurrogatematerialsin
combination with a training program as articulated in Guide
1
This guide is under the jurisdiction of ASTM Committee E54 on Homeland
E2770 and coordinated among the initial responder
Security Applications and is the direct responsibility of Subcommittee E54.01 on
organization, hazardous materials response unit, Urban Search
CBRNE Sensors and Detectors.
and Rescue (US&R) team, National Guard Civil SupportTeam
Current edition approved Oct. 1, 2017. Published November 2017. DOI:
10.1520/E3095-17. (CST), Laboratory Response Network (LRN) reference
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E3095 − 17
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laboratory, local law enforcement, the Federal Bureau of 2.2 International Standards and Guidance:
Investigation (FBI), and other agen
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