ASTM E3290-21

Standard Test Method for Establishing Performance of Equipment and Assays for Field Detection of Fentanyl and Fentanyl-Related Compounds

SCOPE
1.1 General:  
1.1.1 This test method provides a procedure for characterizing the performance of field portable fentanyl detection equipment and assays when utilizing the test samples and statistical considerations described in Specification E3243.  
1.1.2 This test method describes sample preparation and analysis protocols to use when characterizing the performance of various types of field fentanyl detection equipment or assays in a laboratory environment including gas chromatography/mass spectrometry (GC/MS), high pressure mass spectrometry (HPMS), ion mobility spectrometry (IMS), Fourier Transform Infrared (FTIR) spectroscopy, Raman spectroscopy, colorimetric assays, and immunoassays.  
1.1.3 The intent of this test method is to analyze samples in a manner that is analogous to how they are analyzed in the field by Federal and State/Local/Tribal/Territorial (SLTT) law enforcement and first responders, but under much more controlled and reproducible conditions than those that would generally be achievable when conducting field testing.  
1.2 Units:  
1.2.1 When creating test sample mixtures, all concentrations are stated as weight/weight percent (mg/mg) for solid sample mixture test samples, and weight/volume (mg/mL) for solid and liquid test samples that are dissolved in a solvent. When creating diluted liquid test samples (for example, for detection of compounds solubilized in solvent prior to analysis), all concentrations are stated as volume/volume percent (for example, µL/mL).  
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: E3290 − 21
Standard Test Method for
Establishing Performance of Equipment and Assays for
Field Detection of Fentanyl and Fentanyl-Related
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Compounds
This standard is issued under the fixed designation E3290; 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
Asaresultofthewidespreaduseofsyntheticopioids,firstrespondersandotherresponsepersonnel
mayencounterfentanylandfentanyl-relatedcompoundswhileworkinginthefield.Toensurethatfirst
responders can identify these compounds in the field, it is critical for end-users to understand the
performance metrics of detection equipment and assays to ensure these products meet the intended
end-user needs. It is also necessary to understand the potential effects on detection systems when
common cutting agents and other interferents, including drugs (for example, heroin), are present in
samples.
The test methods presented in this standard are intended for equipment and assays commonly
employed in the field for the detection of suspected drugs that may contain fentanyl and
fentanyl-related compounds. The test methods presented here are not intended for laboratory
equipment, but rather for testing of field detection equipment in a laboratory setting.The test methods
are also not intended to reflect testing approaches that would be performed in the field (for guidance
on using field detection equipment in the field, the user is referred to the companionASTM standard
Guide E3289). This test method is a companion standard to Specification E3243. The specification
describes a statistical testing approach to quantify performance and defines test sample compositions
and amounts. However, Specification E3243 does not describe in detail sample preparation methods
or specific protocols for conducting testing with different types of instruments and assays. These
methods and protocols are described in detail in this test method.
1. Scope 1.1.3 The intent of this test method is to analyze samples in
amannerthatisanalogoustohowtheyareanalyzedinthefield
1.1 General:
by Federal and State/Local/Tribal/Territorial (SLTT) law en-
1.1.1 This test method provides a procedure for character-
forcement and first responders, but under much more con-
izing the performance of field portable fentanyl detection
trolled and reproducible conditions than those that would
equipment and assays when utilizing the test samples and
generally be achievable when conducting field testing.
statistical considerations described in Specification E3243.
1.1.2 This test method describes sample preparation and 1.2 Units:
analysis protocols to use when characterizing the performance 1.2.1 Whencreatingtestsamplemixtures,allconcentrations
ofvarioustypesoffieldfentanyldetectionequipmentorassays are stated as weight/weight percent (mg/mg) for solid sample
in a laboratory environment including gas chromatography/ mixture test samples, and weight/volume (mg/mL) for solid
mass spectrometry (GC/MS), high pressure mass spectrometry and liquid test samples that are dissolved in a solvent. When
(HPMS), ion mobility spectrometry (IMS), Fourier Transform creating diluted liquid test samples (for example, for detection
Infrared (FTIR) spectroscopy, Raman spectroscopy, colorimet- of compounds solubilized in solvent prior to analysis), all
ric assays, and immunoassays. concentrations are stated as volume/volume percent (for
example, µL/mL).
1.3 This standard does not purport to address all of the
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This test method is under the jurisdiction of ASTM Committee E54 on
safety concerns, if any, associated with its use. It is the
Homeland Security Applications and is the direct responsibility of Subcommittee
responsibility of the user of this standard to establish appro-
E54.01 on CBRNE Detection and Decontamination.
priate safety, health, and environmental practices and deter-
Current edition approved May 1, 2021. Published July 2021. DOI: 10.1520/
E3290-21. mine the applicability of regulatory limitations prior to use.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E3290 − 21
1.4 This international standard was developed in accor- 3.1.5 confidence level, CL, n—probability value associated
dance with internationally recognized principles on standard- with a CI; the percentage of intervals that can be expected to
ization established in the Decision on Pri
...