ASTM E3243-21

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
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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 tested in each applicable TM).
This specification is under the jurisdiction of ASTM Committee E54 on Homeland Security Applications and is the direct responsibility of Subcommittee E54.01 on
CBRNE Detection and Decontamination.
Current edition approved May 1, 2021. Published July 2021. DOI: 10.1520/E3243-21.
1. Scope 1.2.1 Units—When creating multicomponent test samples
for TM 2, TM3, and TM4, all % compositions are stated as
1.1 General:
weight/volume percent (mg/mL) for both solid and liquids.
1.1.1 This specification provides system designers,
1.3 This standard does not purport to address all of the
manufacturers, integrators, procurement personnel, end-users,
safety concerns, if any, associated with its use. It is the
practitioners, and responsible authorities a common set of
responsibility of the user of this standard to establish appro-
parameterstomatchthecapabilitiesofchemicaldetectiontools
priate safety, health, and environmental practices and deter-
with user needs for their specific application.
mine the applicability of regulatory limitations prior to use.
1.1.2 This specification describes required test sample 1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
compositions, amounts, and a statistically-based testing ap-
ization established in the Decision on Principles for the
proach to be used for evaluating the performance of field
Development of International Standards, Guides and Recom-
fentanyl and fentanyl-related detection equipment and assays
mendations issued by the World Trade Organization Technical
asdescribedinTestMethodE3290.Thisspecificationdoesnot
Barriers to Trade (TBT) Committee.
address the estimation of limit of detection.
1.1.3 This specification is not meant to provide for all uses.
2. Referenced Documents
Manufacturers, purchasers, and end-users will need to deter-
2.1 ASTM Standards:
minespecificrequirementsincluding,butnotlimitedto,useby
E2771Terminology for Homeland Security Applications
hazardous material (HAZMAT) teams; use in explosive or
E3131Specification for Nucleic Acid-Based Systems for
other hazardous environments or atmospheres; use with per-
Bacterial Pathogen Screening of Suspicious Visible Pow-
sonal protective equipment (PPE); use by firefighters, law
ders
enforcementofficers,orFEMAUrbanSearch&Rescueteams,
E3290Test Method for Establishing Performance of Equip-
special electromagnetic compatibility needs, extended storage
ment and Assays for Field Detection of Fentanyl and
periods, and extended mission time. These specific require-
Fentanyl-Related Compounds
ments may or may not be generally applicable to all chemical
2.2 Other Standards:
detection systems.
18 USC 178Definitions
Eurachem/CITAC Guide CG 4:2012Quantifying Uncer-
1.2 Operational Concepts—Chemical detection systems are
tainty in Analytical Measurement, Third edition
used to detect or identify chemical hazards to support short-
ISO 17034General requirements for the competence of
term tactical decision-making to protect responders and the
reference material producers
public. The system should provide low false-positive and
false-negative rates. Uses of these systems include survey,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
surveillance, and screening of samples, particularly during a
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsetoasuspectedfentanylorfentanyl-relatedcompound.
Standards volume information, refer to the standard’s Document Summary page on
A field-deployable system should withstand the rigors associ- the ASTM website.
Available from U.S. Government Printing Office, Superintendent of
ated with uses including, but not limited to, operation and
Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
storage in high and low temperatures, shock and vibration,
www.access.gpo.gov.
radio frequency interference, and rapid changes in operating Available from the Eurachem organization, https://www.eurachem.org/
index.php/publications/guides/quam.
temperature and humidity. Note that this specification does not
Available from International Organization for Standardization (ISO), ISO
address testing the potential impact of the rigors associated
Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
with use of systems in the field. Switzerland, https://www.iso.org.
E3243−21
3. Terminology 3.1.12 non-target compound, n—collection of diluents/
cutting agents, dyes/colorants, and other drugs that are not
3.1 Definitions:
target fentanyl or fentanyl-related substances.
3.1.1 accuracy, n—closeness of agreement between a test
3.1.12.1 Discussion—Non-target compounds should not
result and the accepted reference value. E2771
give a positive test result for fentanyl or fentanyl-related
3.1.2 analog, n—equivalent to analogue.
substances;thisisconsideredafalsepositiveresult.Ideally,all
3.1.3 analogue, n—a substance not specifically designated
non-target compounds should result in negative detection
for control in Drug Enforcement Agency (DEA) Schedules I
results for fentanyl and fentanyl-related compounds.
throughVmaystillbesubjecttotheControlledSubstancesAct
3.1.13 precursor, n—a chemical compound used to synthe-
(CSA) as a controlled substance analogue. A controlled sub-
size fentanyl and fentanyl-related compounds.
stance analogue is a substance not otherwise approved by the
Food and Drug Administration (FDA) or scheduled under the
3.1.14 probability of detection (POD), n—proportion of
CSA that has (1) a chemical structure substantially similar to
positive analytical outcomes for a qualitative method for a
that of a controlled substance in Schedule I or II, or (2)an
given matrix containing a target compound at a given concen-
actual or intended effect that is “substantially similar to or
tration.
greater than the stimulant, depressant, or hallucinogenic ef-
3.1.14.1 Discussion—Note that, for non-target compounds,
fect.ofacontrolledsubstanceinscheduleIorII.”Asubstance
the POD can be defined as the proportion of negative (for
that meets those criteria and is intended for human consump-
fentanyl and fentanyl-related compounds) analytical outcomes
tionistreatedasacontrolledsubstanceinScheduleI.Synthetic
for a qualitative method for a given matrix at a given
opioids related to fentanyl may qualify as controlled substance
6 concentration. This allows the performance outcomes to be
analogues.
applicable to the non-target compounds (TM4) case and still
3.1.4 assay, n—quantitative or qualitative test used to deter-
usethesameLCBandCLmeasuresofperformancetolimitthe
mine the presence or absence of a chemical compound.
number of false positives appropriately. Alternatively, one
3.1.5 bulk sample, n—total sample amount (including the
could instead set an upper confidence bound on the probability
sum of target and non-target compounds) that is visible to the
of a false positive (proportion of false-positive analytical
naked eye.
outcomesforaqualitativemethodforagivenmatrixatagiven
3.1.5.1 Discussion—The amount of sample available for
concentration of non-target compounds) with an appropriate
testing bulk samples according to this standard is >1 µg and
CL using a similar method as that presented in Annex A3,
<10 mg.
except using the upper limit for the upper confidence bound.
This definition differs slightly from that in Specification
3.1.6 compound, n—chemicalsubstanceunderevaluationin
E3131, making it more general.
this specification.
3.1.7 confidence interval (CI), n—range of values created
3.1.15 reach-back support, n—service that allows equip-
using a procedure that, when repeated many times, on distinct
ment users in the field to be in real-time contact with subject
data sets, generated from the same underlying stochastic
matter experts (SMEs) to provide advice on assessment of
process, will bracket the true measure of performance, such as
analysis results, including, but not limited to identification of
POD and the proportion of times stated. E3131
one or more substances in an unknown sample.
3.1.8 confidence level (CL), n—probability value associated
3.1.15.1 Discussion—This service is often available 24 h a
with a CI; the percentage of intervals that can be expected to
day/7 days per week via paid subscription through an equip-
include the true population parameter in the long run.
ment (instrument or assay) manufacturer. For example, a field
chemical detection instrument like a Raman spectrometer may
3.1.9 fentanyl-related substances, n—fentanyl-related sub-
be used to scan an unknown sample suspected of containing
stances include any substance that is structurally related to
narcotics. The user can send the resulting data to reach-back
fentanyl (see Annex A2). E3131
supportforreview,interpretation,orboth.TheSMEsproviding
3.1.10 lower confidence bound (LCB), n—lowest value of a
the support can identify poor quality data and recommend
one-sided CI created using a procedure that when repeated
settings for a successful rescan, perform advanced data analy-
many times, on distinct data sets, generated from the same
sis techniques to identify chemicals present in the sample, and
underlying stochastic process, will include the true measure of
quickly provide decision-support capabilities and guidance in
performance a proportion of times equal to the stated
response to end-user requests and inquiries. Reach-back ser-
probability. E3131
vices are commonly used for aiding in the interpretation of
3.1.10.1 Discussion—TheLCBensuresthatthePODattains
ambiguous data and for confirmation of positive results (espe-
a satisfactory value for the CL selected and determines the
cially those with which decisions of consequence may be
minimum number of samples that shall be analyzed.
taken).
3.1.11 measurement process, n—process used to detect a
3.1.16 reference material, n—substance sufficiently homog-
material or determine if a system or instrument performs as
enous and stable with respect to one or more specified
intended. E3131
propertiesthathasbeenestablishedtobefitforitsintendeduse
in the measurement process; properties can be quantitative or
Seehttps://crsreports.congress.gov/product/pdf/LSB/LSB10404. qualitative. ISO 17034
E3243−21
3.1.17 sensitivity, n—change in the response of a measuring 3.2.12 HPMS—high pressure mass spectrometry.
instrument divided by the corresponding change in the stimu-
3.2.13 IMS—ion mobility spectrometry.
lus. Eurachem/CITAC Guide CG 4:2012
3.2.14 ISO—International Organization for Standardization.
3.1.18 specificity/selectivity, n—ability of a measurement
3.2.15 LCB—lower confidence bound.
procedure to determine accurately and specifically the analyte
3.2.16 MS—mass spectrometry.
of interest in the presence of other components in the sample
matrix under the stated conditions of the test. 3.2.17 NIOSH—National Institute for Occupational Safety
Eurachem/CITAC Guide CG 4:2012 and Health.
3.1.19 target compound, n—any of a collection of fentanyl 3.2.18 POD—probability of detection.
and fentanyl-related compounds.
3.2.19 PPE—personal protective equipment.
3.1.20 test event, n—a test event describes the TMs, the
3.2.20 SERS—surface enhanced Raman spectroscopy.
samples within those TMs that are included in the test event,
3.2.21 SME—subject matter expert.
thetotalnumberofsamplestobeanalyzedfromeachTM,and
whether trace or bulk sample amounts will be used.
4. Overview
3.1.21 test module (TM), n—set of samples with particular
4.1 See Table 1 and its footnotes for an overview of
characteristics used to establish the performance of the detec-
planning and conducting an instrument or assay evaluation.
tion technology.
Table 1 and the eight associated footnotes provide a summary
3.1.21.1 Discussion—TMs include target compound
ofallaspectsofthisspecificationandincludereferencestoTest
samplesatthreedifferentpercentsamplecompositions(≥95%,
Method E3290.
10%, and 1%), non-target samples that do not contain
4.2 Bulk and trace sample amounts reflect two different
fentanylorfentanyl-relatedcompounds,andfentanylsynthesis
scenarios commonly encountered in the field. Trace sample
precursors or other compounds used for synthesis.
amounts are typical of samples that may be acquired by
3.1.22 test sample, n—amount and identity of a particular
swabbing or wiping a surface, a person’s hands, the knot or
substance (target and non-target compounds) prepared for
outer surface of a bag suspected of containing drugs, and so
testing.
forth. Bulk sample amounts reflect samples that are visible to
the naked eye that are often encountered in the field. It should
3.1.23 testing tier, n—level of effort, including the selection
be noted that results obtained from sampling the outside of
of samples and number of experimental tests, involved in
packaging materials do not necessarily reflect what is actually
determining the performance of an instrument or assay.
inside the packaging.
3.1.23.1 Discussion—Testing involves either all 14 samples
from each applicable TM or the first four samples from each
4.3 There are currently several types of detection technolo-
applicable TM.
gies used for field detection of fentanyl and fentanyl-related
compounds including gas chromatography/mass spectrometry
3.1.24 trace sample, n—total sample amount, including
(GC/MS),massspectrometryalone(thatis,high-pressuremass
target and non-target compounds, ≤1µg, used for testing.
spectrometry(HPMS)),ionmobilityspectrometry(IMS),Fou-
3.1.24.1 Discussion—In this specification, a trace sample is
rier transform infrared spectroscopy (FTIR), Raman
intended to represent a sample not visible to the naked eye, a
spectroscopy, surface enhanced Raman spectroscopy (SERS),
situation commonly encountered by first responders. For prac-
colorimetric assays, and immunoassays.
tical purposes, it is assumed that the sizes represented by bulk
and trace samples sufficiently cover the range of situations
4.4 Not all TMs listed in Annex A1 are appropriate for
encountered in the field where the testing equipment may be
every technology/product type.While bulk detection technolo-
used.
giescannotdetecttracequantities(≤1µgtotalsampleamount),
mosttracedetectiontechnologiescantestabulksample(>1µg
3.2 Acronyms:
and <10mg total sample amount) with appropriate sample
3.2.1 ATR—attenuated total reflectance.
preparation/dilution. In general, trace detection technologies
3.2.2 CDC—Centers for Disease Control.
that can also test bulk samples with proper dilution include
3.2.3 CSA—Controlled Substances Act.
GC/MS, HPMS, and IMS. Bulk-only detection technologies
include Raman and FTIR spectroscopy. While SERS,
3.2.4 CI—confidence interval.
immunoassays, and colorimetric assays can detect bulk
3.2.5 CL—confidence level.
amountsofsample,theyalsomaybecapableofdetectingtrace
3.2.6 DEA—Drug Enforcement Agency.
amounts of sample. In general, SERS, immunoassays, and
colorimetric assays cannot identify specific chemicals, so
3.2.7 FDA—Food and Drug Administration.
TM 5 is not applicable.
3.2.8 FTIR—Fourier transform infrared (also known as
4.5 Depending on the type of technology, the samples in
Fourier transform infrared spectroscopy).
eachofthefiveTMscanbeanalyzedas“trace”samples(<1µg
3.2.9 GC—gas chromatography.
ofsampleusedfortesting)orbulksamples(>1µgand<10mg
3.2.10 GC/MS—gas chromatography/mass spectrometry.
of sample used for testing). The exact amount of sample used
3.2.11 HAZMAT—hazardous material team. for testing is according to instrument or assay manufacturer
E3243−21
TABLE 1 Overview of Specification E3243: Planning an Instrument or Assay Evaluation
This is the total amount of all target (fentanyl and fentanyl-related compounds) and non-target sample components combined in a final prepared sample. Prepare
and mix all test samples as described in Test Method E3290. The methodology in this specification applies to trace, bulk, $95 % fentanyl and fentanyl-related
compounds, and multi-component test samples.
TM1, TM2, and TM3 only require that a detection technology indicates that any fentanyl or fentanyl-related compound is present. No specific compound identifica-
tion or quantification is necessary. TM4 requires that a detection technology does not exceed an acceptable number of false-positive results for fentanyl or fentanyl-
related compounds in a given number of tests. See 3.1.14 and 5.2 for further clarification on the number of allowed false positives. TM5 requires a detection technol-
ogy to correctly identify the specific compound. No quantification is necessary. All TMs are shown in Annex A1.
The minimum passing LCB and CL considered in this specification are 0.85 and 80 %, respectively. These minimum LCB and CL requirements can be met or ex-
ceeded with 4, 14, or 31 test samples for each chosen TM. See Table 4 through Table 6 in Section 5 for details. Determine the number of samples to be tested prior
to a test event and do not increase it once testing begins. For example, if it is decided to conduct four tests (anticipating no failures) to achieve an LCB of 0.85 with
80 % CL and a failure occurs, additional tests beyond the four planned cannot be conducted. Testing must start over. Testing results that do not meet or exceed the
0.85/80 % LCB/CL have failed to achieve the minimum performance level in this specification.
The purpose of Testing Tier 2 is to reduce testing burden by significantly reducing the variety of compounds that must be procured and mixed. Although Testing Tier
2 only contains four different samples from each TM, the total number of tests conducted can still be chosen. See 4.14 for further clarification.
Prepare and mix all test samples following the methodology described in Test Method E3290. Record protocols and all calculations for any laboratory operations (for
example, weighing and mixing). Identify any solvents used (including water) for those detection technologies that dissolve or suspend a sample prior to analysis as
standard practice. Identify suitable positive and negative control samples that will be used during testing based on manufacturer guidance.
Document protocols and results as described in Test Method E3290.
As described in Test Method E3290 and as recommended by the manufacturer and when available, test a positive and negative control sample at least once per 10
samples analyzed or at least once each day that testing is performed, whichever is greater.
E3243−21
TABLE1 Continued
As described in Test Method E3290: In the final report, state which test event was conducted (Maximum Tier 1, Maximum Tier 2, Moderate Tier 1, Moderate Tier 2,
or Minimal as described in 4.14), which TMs and test samples were included, and any control samples that were tested. Save all associated raw data, data analysis,
and reporting outputs provided to the user by the instrument or assay after testing a sample. Report two testing results for field detection products that include reach-
back technical support: (1) the instrument or assay direct readout result obtained immediately after a test event and (2) the result provided by reach-back support.
Reach-back support must provide a verbal or written result within 60 min of obtaining the data for each sample or the result counts as a failed test. It is acceptable to
plan with the reach-back provider for when you will be sending data. Include in the final report the written report from the reach-back provider, which references and
documents the verbal result that was provided. For field-detection products that do not include reach-back support, report only one testing result (the instrument or
assay direct readout result obtained immediately after a test). Results are qualitative only (not quantitative) and reported as: (1) a sample contains fentanyl or
fentanyl-related compounds, (2) a sample does not contain fentanyl or fentanyl-related compounds, or (3) a sample contains the fentanyl synthesis precursor or re-
lated compound as specifically identified in TM5.
recommendation, but within the requirements above. Further 4.11 5.2andTables4,5,and6describeindetailthenumber
guidance can be found in Test Method E3290. Table 2 shows of tests and number of allowable failed results needed to
the TMs that shall be used to analyze trace samples with the demonstrate compliance with the requirements in this specifi-
detectiontechnologiesconsideredinthisspecification.InTable cation.
2, an ‘X’denotes technology not applicable for the conditions
4.12 Twodifferenttestingtiersarealsodefined:TestingTier
of the Test Module.
1 requires that all 14 different samples in each chosen TM are
4.6 Table3showstheTMsthatshallbeusedtoanalyzebulk
tested and Testing Tier 2 requires that only samples 1 to 4 in
sampleswiththedetectiontechnologiesconsidered.InTable3, each chosen TM are tested, thus reducing the cost and time
an ‘X’denotes technology not applicable for the conditions of burden of procuring and preparing a much larger number of
the Test Module. different sample mixtures. A testing entity may still choose to
test multiple replicates of those four samples to achieve a
4.7 Dependingonthecapabilitiesoftheinstrumentorassay,
higher LCB and CL. See 4.14 for further clarification. TMs
up to five TMs containing multiple samples each are used to
contain 14 different test samples, which are simply referred to
evaluate performance (see Table 2, Table 3, and Annex A1,
assamples.Asamplenumberisassignedtoeachsamplewithin
Tables A1.1-A1.5).
a TM. A sample with a lower number (for example, No. 1) is
4.8 TM1, TM2, and TM3 only require that a detection
more important (more commonly encountered) than a sample
technology indicates that any fentanyl or fentanyl-related
with a higher number.
compound is present. No specific compound identification or
4.12.1 The testing entity or agency requesting testing deter-
quantification is necessary.
mines whether Testing Tier 1 or Testing Tier 2 with every TM
4.8.1 See Annex A2 for a list of fentanyl and fentanyl-
theinstrumentorassaycanbeappliedtowillbeusedbasedon
relatedcompounds.Allinstrumentorassayresultsthatindicate
the coverage of different sample compositions desired for
the presence of any of these compounds, including any
testing.
compounds listed in TM1, are considered a successful test
4.13 The number of samples chosen to be tested for each
when testing samples from TM1, TM2, and TM3.
TMdependsonthedesiredLCBforthePODandCLselected.
4.9 TM4 requires that a detection technology does not
4.13.1 To achieve the lowest acceptable LCB and CL (0.85
exceedanacceptablenumberoffalsepositiveresultsinagiven
and 80%, respectively), four samples shall be tested a single
number of tests for fentanyl or fentanyl-related compounds
time from each of the applicable TMs with no failures
(see 3.1.12).
observed.
4.10 TM5 requires a detection technology to correctly 4.13.2 ToallowforachievingahigherLCBwithaCLequal
identify the specific compound. No quantification is necessary. to or higher than 80%, more tests are needed. It is recom-
Colorimetric assays, immunoassays, and SERS typically can- mended that users of this specification select the largest
not identify a specific compound, so TM5 is generally not number of tests practical for their application, as this will lead
applicable. to an LCB value that is closer to the calculated POD.
TABLE 2 Applicability of Detection Technologies by Test Module for Trace Sample Amounts (#1 µg)
Technology Class Test Module 1 Test Module 2 Test Module 3 Test Module 4 Test Module 5
>95 % Target 10 % Target 1 % Target Non-Targets Precursors
(0.95 µg) (100 ng) (10 ng) (1 µg) (1 µg)
GC/MS === = =
MS === = =
IMS === = =
A
Raman X XX X X
SERS === = X
FTIR X X X X X
Immunoassays === = X
Colorimetric === = X
assays
A
An ‘X’ denotes technology not applicable for the conditions of the Test Module.
E3243−21
TABLE 3 Applicability of Detection Technologies by Test Module for Bulk Sample Amounts (>1µg to <10 mg)
Technology Class Test Module 1 Test Module 2 Test Module 3 Test Module 4 Test Module 5
>95 % Target 10 % Target 1 % Target Non-Targets Precursors
(>1µgto10mg) (100 ng to 1 mg) (10ngto0.1mg) (>1 µg to <10 mg) (>1 µg to <10 mg)
GC/MS === = =
MS === = =
IMS === = =
Raman === = =
A
SERS === = X
FTIR === = =
Immunoassays === = X
Colorimetric === = X
assays
A
An ‘X’ denotes technology not applicable for the conditions of the Test Module.
Conducting14or31testsonsamplesfromeachapplicableTM 4.14.5.1 FourtestsofsamplesfromTM1,TM2,TM3,TM4,
are two alternatives that should be considered, as they provide and TM5 (as applicable depending on the capability of the
thesmallestnumberoftestsrequiredforachievinghigherLCB detectiontechnology)asfollows:SampleNumbers1to4,each
and CL values using the statistical approach in this specifica- tested once.
tion. Testing results that do not meet or exceed the 0.85/80%
5. Statistical Considerations
...