ASTM E3131-17

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:E3131 −17
Standard Specification for
Nucleic Acid-Based Systems for Bacterial Pathogen
1
Screening of Suspicious Visible Powders
This standard is issued under the fixed designation E3131; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Evaluation of nucleic acid-based detection systems is necessary to ensure that they can achieve
required performance metrics for the intended application.These systems should be evaluated in both
laboratory and field settings to determine performance, including potential for false positive or
negative results, probability of detection (POD), and potential impacts of other substances on system
performancesuchascommonlyencounteredsuspiciouspowders.Laboratoryevaluationsestablishthe
best-case performance for a product and also serve as a means to eliminate from consideration those
products that have deficiencies or limitations before extensive cost and effort is expended for field
testing. Testing should be conducted under conditions recommended by the manufacturer. The
statistical derivation used in this specification assumes that conditions during testing remain stable.
Independent testing of biothreat or biological agent detection systems helps to establish the
reliability of results and improves first-responder and supporting agencies’confidence in these tools.
It is important that testing requirements balance the need for proven systems with the need for a
process that is not cost or time prohibitive and allows the evaluation of new technologies and assays
as they are developed. This is particularly true for nucleic acid-based detection systems because new
technologiesandproductscontinuetoemergeonthemarketandexistingassaysmayberevisedwhich
necessitates retesting.
This specification describes a statistically based testing approach for evaluating the performance of
nucleic acid-based detection systems. The approach ties performance of the system to a specified
lower confidence bound (LCB) on the POD at a known confidence level (CL) (see Fig. 1).
Testing shall be conducted to one of two performance levels (see Figs. 2 and 3): (1) ≥95% POD
with 95% CL, or (2) ≥90% POD with 90% CL. Four testing modules shall be used to evaluate
system performance (see Table 1): (1) Test Module 1—Biological agent nucleic acid inclusivity
testing; (2) Test Module 2—Biological agent nucleic acid exclusivity testing; (3) Test Module
3—Suspiciouspowdertesting(commonlyencounteredhoaxpowdersandenvironmentalmaterialthat
could interfere with test results, controls, or cause a false positive result); and (4) Test Module
4—Wholeorganismbiologicalagentspikedsuspiciouspowdertesting(impactofothermaterialonthe
ability to detect target biological agents or cause a false negative result). See Table 2 for a listing of
suspicious powders and the Annexes for the representative biological agents that shall be tested.
Three different testing tiers are also defined to reduce testing burden by allowing testing of
biological agent strain panels with fewer panel members (see Table 1). Inclusivity and exclusivity
testing tier panels are provided in Annex A4 and Annex A5. All three testing tiers shall test the full
panel of suspicious powders (Table 2) and the whole representative biological agent (see AnnexA7)
spiked into powders.
While the greatest extensiveness of test panel inclusivity and exclusivity strains and highest POD
and CL are always desirable, time and budget constraints often do not permit this extent of testing.
While some detection systems may not be able to achieve the highest performance metrics, it is still
valuable to know the level to which they can perform.
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E3131−17
1. Scope
1.1 General:
1.1.1 This specification provides system designers,
manufacturers, integrators, procurement personnel, end users/
practitioners, and responsible authorities a common set of
parameters to match the capabilities of biological assessment
tools with user needs.
1.1.2 This specification is not meant to provide for all uses.
Manufacturers, purchasers, and end users will need to deter-
minespecificrequirementsincluding,butnotlimitedto,useby
hazardous material (HAZMAT) teams and Urban Search and
Rescue (US&R) teams, use in explosive or other hazardous
environments or atmospheres, use
...