ASTM E3243-21

Standard Specification for Field Detection Equipment and Assays Used for Fentanyl and Fentanyl-Related Compounds

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 chemical detection tools with user needs for their specific application.  
1.1.2 This specification describes required test sample compositions, amounts, and a statistically-based testing approach to be used for evaluating the performance of field fentanyl and fentanyl-related detection equipment and assays as described in Test Method E3290. This specification does not address the estimation of limit of detection.  
1.1.3 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end-users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams; use in explosive or other hazardous environments or atmospheres; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or FEMA Urban Search & Rescue teams, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all chemical detection systems.  
1.2 Operational Concepts—Chemical detection systems are used to detect or identify chemical hazards to support short-term tactical decision-making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected fentanyl or fentanyl-related compound. A field-deployable system should withstand the rigors associated with uses including, but not limited to, operation and storage in high and low temperatures, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field.  
1.2.1 Units—When creating multicomponent test samples for TM 2, TM3, and TM4, all % compositions are stated as weight/volume percent (mg/mL) for both solid and liquids.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

General Information

• Status: Published
• Publication Date: 30-Apr-2021
• ICS: 71.040.40 - Chemical analysis
• Technical Committee: E54 - Homeland Security Applications
• Drafting Committee: E54.01 - CBRNE Detection and CBRN Protection

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:E3243 −21
Standard Specification for
Field Detection Equipment and Assays Used for Fentanyl
1
and Fentanyl-Related Compounds
This standard is issued under the fixed designation E3243; 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
One consequence of the widespread use of synthetic opioids is that first responders and other
personnel increasingly encounter them in the field. Within this class of compounds are fentanyl and
fentanyl-related compounds (some of which are referred to as analogs or analogues), which can
present significant safety hazards to first responders if proper protocols and PPE are not used. Thus,
the ability to detect fentanyl and fentanyl-related compounds reliably, and take appropriate protective
measures, is crucial. Evaluation of equipment and assays for field detection of fentanyl and
fentanyl-related compounds is necessary to assess if a system meets or exceeds performance metrics
for the intended application and end-user. Since fentanyl and fentanyl-related compounds are often
mixed with cutting agents or other drugs, it is also important to assess the effects of these compounds
on equipment and assay performance. The performance assessments described in this specification
will determine the potential for false-positive and false-negative results, a lower bound on the
probability of detection (POD), and potential impacts of other substances such as common diluents
(for example, cutting agents) and other drugs (for example, heroin) that are commonly mixed with
fentanyl.
The performance assessments presented herein are laboratory evaluations. Laboratory evaluations
with trained personnel are recommended to establish the best-case performance for a system without
confoundingperformanceissuesthatmightariseduringfieldtesting(forexample,lackofusertraining
or environmental conditions). Laboratory evaluations also serve to eliminate systems that have
deficiencies or limitations, before extensive cost and effort are expended for field testing for the
specific intended application.
This specification is a companion standard to Test Method E3290. This specification describes a
statistical testing approach to quantify performance and also defines test sample compositions and
amounts. However, it does not provide details for sample preparation, specific protocols for
conducting testing of different types of instruments and assays, or reporting. These details are
described in Test Method E3290.
The statistical approach used in this specification ties performance of an instrument or assay to a
specified lower confidence bound (LCB) on the POD at a known confidence level (CL). Testing is
conducted to establish a system’s performance over a set of possible performance outcomes of LCB
≥ 0.85 and CL ≥ 80%. The 0.85/80% LCB/CL is the minimum performance level that can be
considered as ‘pass’ for an instrument or assay. Testing results that do not achieve or exceed the
minimum level of 0.85/80% LCB/CL have failed to pass the performance established by this
specification.Testingresultscanproduceperformancelevelsabovetheminimum0.85/80%LCB⁄CL
and users shall report the highest LCB at or above 0.85 at the highest CL achieved.
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E3243−21
The performance level established in this specification requires that testing include all the test
modules (TMs) given in AnnexA1 that are applicable to the detection technology used. (See Table 2
and Table 3. An ‘X’ denotes technology not applicable for the conditions of the Test Module.) The
TMsincludesetsofsamplescontainingspecificnumbersandtypesoftargetornon-targetcompounds
and are used to measure the performance of the detection technology. The user (that is, an agency
directing testing or a testing entity) is ultimately responsible for deciding the number and extent of
sample types that will be tested, based on the following: (1) Desired level of performance (POD and
CL). Testing more samples can result in higher POD and CL as illustrated in Table 4 through Table
6.
(2) The variety of samples types to be tested is summarized in 4.10. Two different testing tiers may
be employed as described in 4.12: Tier 1 (all 14 different sample types are tested in each applicable
TM) vs. Tier 2 (only the first four of the different sample types are t
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