ASTM E3095-17

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-
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
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
E3095 − 17
laboratory, local law enforcement, the Federal Bureau of 2.2 International Standards and Guidance:
Investigation (FBI), and other agencies as defined by jurisdic- ISO/IEC 17043:2010 ConformityAssessment – General Re-
tional protocols. quirements for Proficiency Testing Eurachem Guide: The
Fitness of Purpose of Analytical Methods: A Laboratory
1.5 This guide recommends the selection of a surrogate
Guide to Method Validation and Related Topics: Second
material that challenges the workflow in a way similar to the
edition (2014)
challenge imposed by suspected biological agents encountered
Standard Method Performance Requirements (SMPRs) from
in real-world emergency response scenarios while posing
the Stakeholder Panel for Agent Detection Assays
minimal health and safety risks.
(SPADA), AOAC International
1.6 This guide describes considerations when using a sur-
2.3 Clinical and Laboratory Standards Institute (CLSI)
rogate material for a confidence check of nucleic acid-based
Guidelines:
on-site biological assessment technologies.
EP17-A2 Evaluation of Detection Capability for Clinical
Laboratory Measurement Procedures; Approved
1.7 This guide describes factors involved in the use of a
Guideline—Second Edition (2012)
surrogate material to perform a process assessment when the
2.4 NIST Technical Notes:
operator has access to well-characterized nucleic acid-based
1776(2012) BestPracticesforSampleCollectionandTrans-
assays specific to the surrogate material that enable the
port During an Initial Response to Potential Biothreat
operator to target the analytical process applied to on-site
Materials
biological assessment.
2.5 DHS Documents:
1.8 This guide does not replace third-party validation of
Framework for a Biothreat Field Response Mission Capa-
on-site biological assessment technologies to assess the ability
bility (2012)
of the technologies to correctly detect and identify a biological
2.6 U.S. Government Standards:
agent. This guide recommends that all on-site biological
18 USC 178 Definitions
assessmenttechnologiesbedemonstratedtoperformaccording
to internationally recognized consensus standards (for
3. Terminology
example,AOACStandardMethodPerformanceRequirements)
3.1 Definitions:
as consistent with Guide E2770 and Practices E2458.
3.1.1 accuracy, n—the closeness of agreement between a
1.9 For the purposes of this guide, sample collection should
test result and the accepted reference value. E1301
be performed according to Practices E2458.
3.1.2 assay, n—collection of one or more reagents and
1.10 This standard does not purport to address all of the
materials that are used in a prescribed fashion to quantitatively
safety concerns, if any, associated with its use. It is the
or qualitatively characterize a biological material.
responsibility of the user of this standard to establish appro-
3.1.3 biological agent, n—any microorganism (including
priate safety, health, and environmental practices and deter-
but not limited to, bacteria, viruses, fungi, rickettsiae, or
mine the applicability of regulatory limitations prior to use.
protozoa), or infectious substance, or any naturally occurring,
1.11 This international standard was developed in accor-
bioengineered, or synthesized component of any such micro-
dance with internationally recognized principles on standard-
organismorinfectioussubstance,capableofcausing:(1)death,
ization established in the Decision on Principles for the
disease, or other biological malfunction in a human, an animal,
Development of International Standards, Guides and Recom-
a plant, or other living organisms; (2) deterioration of food,
mendations issued by the World Trade Organization Technical
water, equipment, supplies, or material of any kind; or, (3)
Barriers to Trade (TBT) Committee.
deleterious alteration of the environment. (18 USC 178)
3.1.4 competency assessment, n—evaluation of proficiency
2. Referenced Documents
of emergency response personnel across the range of
2.1 ASTM Standards:
E1301 Guide for Proficiency Testing by Interlaboratory
For referenced International Standards and Guidance standards, visit ISO,
Comparisons (Withdrawn 2012)
Eurachem, and JCGM websites, www.iso.org, www.bipm.org, www.eurachem.org,
E2458 Practices for Bulk Sample Collection and Swab
or contact ISO Customer Service at customerservice@iso.org, Eurachem Customer
Sample Collection ofVisible Powders Suspected of Being
Service on the website, or JCGM Customer Service at webmaster@bipm.org.
ForreferencedAOACInternationalSPADAstandards,visittheAOACwebsite,
Biological Agents and Toxins from Nonporous Surfaces
www.aoac.org, and follow to the SPADASMPRs link, or contactAOAC Customer
E2770 GuideforOperationalGuidelinesforInitialResponse
Service at AOAC@aoac.org.
to Suspected Biological Agents and Toxins
ForreferencedCLSIstandards,visittheCLSIwebsite,www.clsi.org,orcontact
CLSI Customer Service at customerservice@clsi.org.
For referenced NISTTechnical Note, visit the NISTPublication portal website,
http://www.nist.gov/customcf/get_phd.cfm?pub_id=909556.
2 8
For referenced ASTM standards, visit the ASTM website, www.astm.org, or For referenced DHS documents, visit the AOAC website, www.aoac.org, and
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM follow to the SPADA resources link, or contact AOAC Customer Service at
Standards volume information, refer to the standard’s Document Summary page on AOAC@aoac.org.
the ASTM website. Available from U.S. Government Printing Office, Superintendent of
The last approved version of this historical standard is referenced on Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
www.astm.org. www.access.gpo.gov.
E3095 − 17
knowledge, skills, and abilities identified in the training pro- 3.1.16 threat, n—an indication of possible violence, harm,
gram as related to performing duties associated with biothreat or danger and may include an indication of intent and
response; includes hands on assessment of proficiency panels, capability. E2770
field exercises, or drills performed in coordination with the
3.1.17 workflow, n—the process of assessing the presence of
receiving laboratory, and performed annually. E2770
a given target, including steps such as sample collection,
3.1.5 confidence check, n—the use of a surrogate material processing, and analysis.
for qualitative evaluation of operational performance of on-site
4. Significance and Use
biological assessment technologies, ranging in applicability
fromdevelopingperformancecharacteristicsofatechnologyto
4.1 This guide provides guidance on how a surrogate
checking operator capabilities. material can be selected and inserted into a field workflow for
3.1.5.1 Discussion—For confidence checks, a surrogate ma-
confidence checks and process assessments of on-site biologi-
terialdoesnotneedtobethoroughlycharacterizedforquantity. cal assessment technologies to demonstrate that the technology
is working in the field environment in the hands of operators.
3.1.6 emergency response, n—the performance of actions to
mitigate the consequences of an emergency for human health
4.2 Use of a surrogate material instead of an inactivated or
and safety, quality of life, the environment, and property. It
attenuated biological agent (or its components) is beneficial
may also provide a basis for the resumption of normal social
due to (1) ease of production and handling, (2) ease of
and economic activity. E2770
acquisitionandtransportation,(3)theabilitytousethematerial
with minimal equipment and facility constraints, for example,
3.1.7 limit of detection (LOD), n—the lowest amount of
biosafety containment, and (4) minimized risk of contamina-
analyte in a sample that can be detected with (stated)
tion of personnel, equipment and the environment with a
probability. CLSI EP17-A2
potential biological agent.
3.1.8 on-site biological assessment, n—measurements of
properties inherent to biological materials performed in the 4.3 This guide covers the basic design of confidence checks
field using rapid, field based procedures and assays. E2770 and process assessments that may be used to target (1) the
workflow in the field, (2) the performance of the on-site
3.1.9 on-site biological assessment technology, n—a rapid,
biological assessment technology, and (3) the operator’s ability
field based procedure or assay used to make measurements of
to process a material in the field workflow, in order to increase
properties inherent to biological materials.
confidence in each component. These demonstrations provide
3.1.10 operator, n—a person operating an on-site biological
emergency responders with insight into routine operation of a
assessment technology.
nucleic acid-based biological assessment technology and the
3.1.11 process assessment, n—the use of a surrogate mate-
opportunitytoassessanddemonstratetheircapabilitiesaccord-
rial to quantitatively evaluate performance characteristics of
ing to a defined training program in their jurisdiction.
on-site biological
...