1、Designation: E3095 17Standard Guide forSurrogate Materials for Field Evaluation of Nucleic Acid-Based On-Site Biological Assessment Technologies1This standard is issued under the fixed designation E3095; the number immediately following the designation indicates the year oforiginal adoption or, in t
2、he case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONEmerging infectious disease and deliberate biological threats are ever-present concer
3、ns that canaffect 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 minimizethe impact of these threats. Significant investments in technology innovation and devel
4、opment haveled to the availability of a large number of on-site biological assessment technologies to support themissions of emergency response personnel. On-site biological assessment involves field-basedmeasurements of properties inherent to biological materials for presumptive analysis of suspect
5、edbiological agents; confirmatory analysis is performed by public health laboratories. Previouslypublished ASTM standards, including Guide E2770 and Practices E2458 as well as the DHSFramework for a Biothreat Field Response Mission Capability, articulate the need for routineevaluation of on-site bio
6、logical assessment technologies to support the use of validated fielded assays.However, there are limited mechanisms to reliably and routinely assess technology performance in thehands of users due to the ever-changing threat of emerging disease and the challenges of working inthe field with biologi
7、cal agents that can be used as threat materials. In these instances, surrogatematerials, that is, non-threat biological materials, can be utilized to provide a safer alternative tobiological agents for evaluating operational performance of a technology. These materials may gothrough the entire workf
8、low process, thereby allowing for assessment of and providing confidence inroutine operation of an on-site biological assessment technology, where the operational performanceencompasses the workflow, the technology, operator capabilities, proper controls, and integration ofresults into a concept of
9、operations such as described in Guide E2770. This guide describes importantfactors to consider when developing, selecting, and using a surrogate material for a qualitativeconfidence check or quantitative process assessment to evaluate on-site biological assessmenttechnologies. A process assessment r
10、equires additional quantification of the surrogate material ascompared to a confidence check. Surrogate materials are not meant to be used for proficiency testingor validation of biological agent assays.1. Scope1.1 This guide describes factors to consider whendeveloping, selecting, and using a surro
11、gate material forevaluating the operational performance of nucleic acid-basedon-site biological assessment technologies. Operational perfor-mance includes the workflow, technology, operator, controls,and result reporting.1.2 Users of this guide include developers and manufactur-ers of on-site biolog
12、ical assessment technologies or surrogatematerials, as well as the initial responder community and otheroperators of the technologies.1.3 This guide recommends the use of surrogate materials tosupport training; improve the knowledge, skills, and confi-dence of operators; and enable confidence check
13、and processassessment demonstrations in support of jurisdictional bio-threat mission capabilities as recommended in Guide E2770,Section 8.1.4 This guide recommends the use of surrogate materials incombination with a training program as articulated in GuideE2770 and coordinated among the initial resp
14、onderorganization, hazardous materials response unit, Urban Searchand Rescue (US ApprovedGuidelineSecond Edition (2012)2.4 NIST Technical Notes:71776 (2012) Best Practices for Sample Collection and Trans-port During an Initial Response to Potential BiothreatMaterials2.5 DHS Documents:8Framework for
15、a Biothreat Field Response Mission Capa-bility (2012)2.6 U.S. Government Standards:918 USC 178 Definitions3. Terminology3.1 Definitions:3.1.1 accuracy, nthe closeness of agreement between atest result and the accepted reference value. E13013.1.2 assay, ncollection of one or more reagents andmaterial
16、s that are used in a prescribed fashion to quantitativelyor qualitatively characterize a biological material.3.1.3 biological agent, nany microorganism (includingbut not limited to, bacteria, viruses, fungi, rickettsiae, orprotozoa), or infectious substance, or any naturally occurring,bioengineered,
17、 or synthesized component of any such micro-organism or infectious substance, capable of causing: (1) death,disease, or other biological malfunction in a human, an animal,a plant, or other living organisms; (2) deterioration of food,water, equipment, supplies, or material of any kind; or, (3)deleter
18、ious alteration of the environment. (18 USC 178)3.1.4 competency assessment, nevaluation of proficiencyof emergency response personnel across the range of2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMS
19、tandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4For referenced International Standards and Guidance standards, visit ISO,Eurachem, and JCGM websites, www.iso.org, www.bip
20、m.org, www.eurachem.org,or contact ISO Customer Service at customerserviceiso.org, Eurachem CustomerService on the website, or JCGM Customer Service at webmasterbipm.org.5For referencedAOAC International SPADAstandards, visit theAOAC website,www.aoac.org, and follow to the SPADA SMPRs link, or conta
21、ct AOAC CustomerService at AOACaoac.org.6For referenced CLSI standards, visit the CLSI website, www.clsi.org, or contactCLSI Customer Service at customerserviceclsi.org.7For referenced NIST Technical Note, visit the NIST Publication portal website,http:/www.nist.gov/customcf/get_phd.cfm?pub_id=90955
22、6.8For referenced DHS documents, visit the AOAC website, www.aoac.org, andfollow to the SPADA resources link, or contact AOAC Customer Service atAOACaoac.org.9Available from U.S. Government Printing Office, Superintendent ofDocuments, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.acce
23、ss.gpo.gov.E3095 172knowledge, skills, and abilities identified in the training pro-gram as related to performing duties associated with biothreatresponse; includes hands on assessment of proficiency panels,field exercises, or drills performed in coordination with thereceiving laboratory, and perfor
24、med annually. E27703.1.5 confidence check, nthe use of a surrogate materialfor qualitative evaluation of operational performance of on-sitebiological assessment technologies, ranging in applicabilityfrom developing performance characteristics of a technology tochecking operator capabilities.3.1.5.1
25、DiscussionFor confidence checks, a surrogate ma-terial does not need to be thoroughly characterized for quantity.3.1.6 emergency response, nthe performance of actions tomitigate the consequences of an emergency for human healthand safety, quality of life, the environment, and property. Itmay also pr
26、ovide a basis for the resumption of normal socialand economic activity. E27703.1.7 limit of detection (LOD), nthe lowest amount ofanalyte in a sample that can be detected with (stated)probability. CLSI EP17-A23.1.8 on-site biological assessment, nmeasurements ofproperties inherent to biological mate
27、rials performed in thefield using rapid, field based procedures and assays. E27703.1.9 on-site biological assessment technology, na rapid,field based procedure or assay used to make measurements ofproperties inherent to biological materials.3.1.10 operator, na person operating an on-site biologicala
28、ssessment technology.3.1.11 process assessment, nthe use of a surrogate mate-rial to quantitatively evaluate performance characteristics ofon-site biological assessment using technologies that providequantitative results.3.1.11.1 DiscussionFor process assessments, a surrogatematerial should be well
29、characterized in terms of quantity.3.1.12 provider, na person or manufacturer who producesa surrogate material suitable for use in a confidence check orprocess assessment.3.1.13 specificity/selectivity, nthe ability of a measure-ment procedure to determine accurately and specifically theanalyte of i
30、nterest in the presence of other components in thesample matrix under the stated conditions of the test.Eurachem Guide3.1.14 surrogate material, na non-threat organism,particle, or substance detectable by a biological assessmenttechnology in a laboratory or field environment and capable ofchallengin
31、g the technology performance in place of a biologi-cal agent.3.1.14.1 DiscussionIn this guide, the focus is on nucleicacid-based assessment technologies and surrogate materialsthat can be detected using these technologies.3.1.14.2 DiscussionSubstances that interfere with assess-ment of a biological
32、agent are not considered surrogatematerials.3.1.15 target, na nucleic acid sequence in a material thatis used to demonstrate the presence of the material in a nucleicacid-based assay.3.1.16 threat, nan indication of possible violence, harm,or danger and may include an indication of intent andcapabil
33、ity. E27703.1.17 workflow, nthe process of assessing the presence ofa given target, including steps such as sample collection,processing, and analysis.4. Significance and Use4.1 This guide provides guidance on how a surrogatematerial can be selected and inserted into a field workflow forconfidence c
34、hecks and process assessments of on-site biologi-cal assessment technologies to demonstrate that the technologyis working in the field environment in the hands of operators.4.2 Use of a surrogate material instead of an inactivated orattenuated biological agent (or its components) is beneficialdue to
35、 (1) ease of production and handling, (2) ease ofacquisition and transportation, (3) the ability to use the materialwith minimal equipment and facility constraints, for example,biosafety containment, and (4) minimized risk of contamina-tion of personnel, equipment and the environment with apotential
36、 biological agent.4.3 This guide covers the basic design of confidence checksand process assessments that may be used to target (1) theworkflow in the field, (2) the performance of the on-sitebiological assessment technology, and (3) the operators abilityto process a material in the field workflow,
37、in order to increaseconfidence in each component. These demonstrations provideemergency responders with insight into routine operation of anucleic acid-based biological assessment technology and theopportunity to assess and demonstrate their capabilities accord-ing to a defined training program in t
38、heir jurisdiction.4.4 This guide may be used to aid operators in the routineuse of any nucleic acid-based on-site biological assessmenttechnology. Using a surrogate material, operators are able togain confidence in their ability to perform operations in theworkflow and gather routine information (fo
39、r example, opera-tor performance, assessment results over time) in the field.4.5 This guide should be used in accordance with PracticesE2458 and Guide E2770.4.6 This guide should be used according to the appropriaterisk reduction measures (including personal protective equip-ment) that are needed fo
40、r the biosafety level of the surrogatematerial (preferably Biosafety Level 1; the level should beverified with the provider of the surrogate material).4.7 This guide is not meant to provide performance charac-terization of biological agent assays used with on-site biologi-cal assessment technologies
41、.5. Suitable of a Surrogate Material5.1 A surrogate material should be readily available to theresponder community through a provider, such as the technol-ogy manufacturer, the assay developer, a reference materialprovider, or other entity.5.2 A surrogate material should have minimal health andsafet
42、y risks and should be appropriate for Biosafety Level 1facilities, when possible, in order to facilitate procurement andE3095 173use of the material in the field. In limited situations, surrogatematerials with higher health and safety risks may be necessaryand should be used in appropriate facilitie
43、s, such as BiosafetyLevel 2 facilities.5.3 Surrogate materials should fit into an existing workflowin order to challenge the technology in a similar manner toactual biological agents. As shown in Fig. 1, a representativeworkflow for an on-site biological assessment technology mayinclude multiple ste
44、ps. The surrogate material may be used indifferent forms depending on the step in the workflow in whichthe material will be used. A surrogate material inserted at thebeginning (for example, sampling in Fig. 1) may challenge theentire workflow, whereas a surrogate material inserted at asubsequent ste
45、p (for example, DNA extraction in Fig. 1) maychallenge the latter portion of the workflow.5.4 The target nucleic acid sequence(s) of the surrogatematerial should not be ubiquitous or found easily in theenvironment.5.5 The on-site biological assessment technology shouldpossess an assay or detection a
46、lgorithm unique to the surrogatematerial. Operators should contact technology manufacturer(s)to identify assays and surrogate materials that are available forthe on-site biological assessment technologies deployed bytheir jurisdiction. An operator should verify with technologymanufacturers that the
47、assays they provide have been demon-strated as fit for purpose using the surrogate material of choice.5.6 Surrogate materials should be sufficiently characterizedto enable confidence in the evaluation of the operationalperformance of the workflow. If not characterized by theprovider, the material sh
48、ould be characterized by the operatoror an entity designated by the operator.5.6.1 A surrogate material should be characterized for theassay target sequence(s) by the provider or another suitableentity. To preserve the technology developers ability to cus-tomize assay design, characterization of the
49、 surrogate materialmay include sequencing of the entire genome or targetedsequencing of the intended target(s), as knowing the targetsequence and assay specificity is essential to assay design. Thedetails of this characterization may be disclosed to the operatorat the discretion of the technology developer.5.6.2 A surrogate material should be characterized for thequantity of each target in a given sample size. The ability toestimate operator and technology performance metricsthroughout the workflow is dependent on knowing the numberof copies of each targ
