ASTM E3394-23

• Abstract:

  SCOPE; 1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users, practitioners, and other responsible authorities with a common set of criteria to match field screening device capabilities with user requirements for specific applications. ; 1.2 This specification describes the required test sample compositions and amounts, and provides a statistically-based testing approach for evaluating FSD performance for the detection of biological agents as described in Test Method E3395. This specification does not address the estimation of limit of detection. ; 1.3 Units: ; 1.3.1 Values stated in SI units are to be regarded as standard in this specification. ; 1.3.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL). ; 1.4 Operational Concepts: ; 1.4.1 FSDs used for identifying potentially dangerous biological agents play an important role in the decision-making processes intended to protect responders and the general public. Suitable FSDs require low rates of false positives and false negatives. FSDs are used for surveillance and sample screening, and they are a particularly important tool in responding to incidents where a sample suspected of containing a biological agent is found. FSDs must be rugged enough to withstand storage and operating conditions that include, but are not limited to, temperature and humidity extremes, shock and vibration, radio frequency interference, and rapid thermal and humidity changes. This specification does not address testing to characterize operating limits or storage conditions. ; 1.5 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. Manufacturers, purchasers, and end-users will need to determine safety requirements including, but not limited to, use by hazardous material (HAZMAT) teams; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or the Federal Emergency Management Agency (FEMA) Urban Search & Rescue (US&R) teams, special electromagnetic compatibility needs, extended usage periods, and extended mission time. ; 1.6 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.

• Status: Published
• Publication Date: 31-Oct-2023
• Technical Committee: E54 - Homeland Security Applications
• Drafting Committee: E54.01 - CBRNE Detection and CBRN Protection

Overview

ASTM E3394-23: Standard Specification for Field Screening Devices Used for Identification of Biological Agents establishes essential criteria and performance requirements for field screening devices (FSDs) designed to detect potentially hazardous biological agents. Developed by ASTM Committee E54 on Homeland Security Applications, this international standard provides manufacturers, system designers, integrators, procurement personnel, and end users with a unified framework for matching device capabilities with practical user needs in diverse field applications.

This standard underpins the rapid, accurate identification of biological threats, supporting public health and responder safety by ensuring that FSDs meet rigorous performance benchmarks under real-world conditions.

Key Topics

• Field Screening Device Criteria: ASTM E3394-23 outlines clear requirements for FSD capabilities, including user interface, power supply, portability, operational readiness, and battery life. The devices must be able to perform independently and be suitable for field operations under varied and challenging environmental conditions.
• Performance Evaluation: The specification introduces statistically-based methods for assessing the probability of detection (POD), emphasizing the importance of both sensitivity (true positive rates) and specificity (minimizing false positives and negatives). Minimum performance metrics such as a lower confidence bound (LCB) of ≥0.85 at 80% confidence level are established.
• Testing Protocols: The standard describes the use of inclusivity, exclusivity, and environmental panels to assess FSD performance. It specifies test sample compositions, volumes (in copies/mL or genome equivalents/mL), and statistical replication approaches, referencing companion Test Method E3395.
• Operational Requirements: FSDs must be rugged, able to operate after exposure to vibration, shock, electromagnetic interference, and extreme environmental conditions. Devices must also be functional when handled by users in personal protective equipment (PPE).
• Data Management: Requirements for onboard data storage, exportability, and user access are defined to facilitate efficient reporting and archiving of field results.
• Documentation and Safety: Suppliers must provide detailed documentation, including operating instructions, safety guidelines, maintenance schedules, and consumable lists. End-users are responsible for establishing safety, health, and environmental practices.

Applications

ASTM E3394-23 guides the procurement, deployment, and assessment of biological field screening devices in a wide range of scenarios, such as:

• First Responder Use: Rapid presumptive identification of biological threat agents in emergency response, including incidents involving suspicious powders or unknown biological materials.
• Public Health Surveillance: Support for surveillance activities and immediate decision-making to protect both responders and the public.
• Hazardous Material Response: Use by HAZMAT teams, firefighters, law enforcement, and urban search and rescue teams in potentially contaminated environments.
• Critical Infrastructure Protection: Prescreening samples at ports, transportation hubs, government facilities, or large public events to detect threats before laboratory confirmation.
• Field and Facility Operations: Ensures that devices are suitable for diverse operational contexts and are manageable by personnel with varying levels of technical training.

Related Standards

For a comprehensive approach to field detection and biological threat identification, ASTM E3394-23 should be applied in conjunction with other critical standards, including:

• ASTM E3395: Test Method for Characterizing Performance of Field Screening Devices for the Identification of Biological Agents
• ASTM E3131: Specification for Nucleic Acid-Based Systems for Bacterial Pathogen Screening
• ASTM E2458: Practices for Bulk Sample Collection of Suspicious Biological Agents
• ASTM E3289/E3290: Guides and Test Methods for Field Detection of hazardous substances
• AOAC SMPR Standards: Performance requirements for PCR and DNA-based detection of various biological agents

These documents provide detailed methodologies for sample collection, analytical procedures, terminology, and validation of test methods, supporting robust implementation of ASTM E3394-23 across multiple industries and response environments.

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Keywords: field screening devices, biological agent detection, ASTM E3394-23, rapid biodetection, portable analysis, first responder safety, statistical performance evaluation, field bioidentification, standard specification, public health protection.

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: E3394 − 23
Standard Specification for
Field Screening Devices Used for Identification of Biological
Agents
This standard is issued under the fixed designation E3394; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Prompt and accurate identification of harmful biological agents on-scene is crucial to the public
health mission. Inaccurate results can place public health and safety at risk and disrupt essential public
services. In addition to utilizing instruments for screening for potential radiological, explosive, and
chemical hazards, first responders also rely on field screening devices (FSDs) to obtain on-scene
presumptive results of potential biological hazards, which can be later verified at a Centers for Disease
Control and Prevention (CDC) Laboratory Response Network (LRN) facility. This specification
covers such FSDs. Information regarding verification at an LRN is available at www.cdc.gov.
This specification describes a statistical testing approach for quantifying device performance and
defines sample composition and amounts. It does not provide protocols for sample preparation or the
testing of different types of devices, or reporting of results. These are described in the Test Method
E3395, a companion to this specification. Only issues related to the statistical impact of replication are
evaluated in this specification. Other issues, such as concerns over the biological, chemical, or other
experimental variability and their impact on detection are not considered.
1. Scope 1.4.1 FSDs used for identifying potentially dangerous bio-
logical agents play an important role in the decision-making
1.1 This specification provides system designers,
processes intended to protect responders and the general
manufacturers, integrators, procurement personnel, end users,
public. Suitable FSDs require low rates of false positives and
practitioners, and other responsible authorities with a common
false negatives. FSDs are used for surveillance and sample
set of criteria to match field screening device capabilities with
screening, and they are a particularly important tool in re-
user requirements for specific applications.
sponding to incidents where a sample suspected of containing
1.2 This specification describes the required test sample
a biological agent is found. FSDs must be rugged enough to
compositions and amounts, and provides a statistically-based
withstand storage and operating conditions that include, but are
testing approach for evaluating FSD performance for the
not limited to, temperature and humidity extremes, shock and
detection of biological agents as described in Test Method
vibration, radio frequency interference, and rapid thermal and
E3395. This specification does not address the estimation of
humidity changes. This specification does not address testing
limit of detection.
to characterize operating limits or storage conditions.
1.3 Units:
1.3.1 Values stated in SI units are to be regarded as standard
1.5 This standard does not purport to address all of the
in this specification.
safety concerns, if any, associated with its use. It is the
1.3.2 When creating test sample mixtures, all concentrations
responsibility of the user of this standard to establish appro-
are stated as copies/mL or genome equivalents/mL (GE/mL).
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.4 Operational Concepts:
Manufacturers, purchasers, and end-users will need to deter-
mine safety requirements including, but not limited to, use by
This specification is under the jurisdiction of ASTM Committee E54 on hazardous material (HAZMAT) teams; use with personal
Homeland Security Applications and is the direct responsibility of Subcommittee
protective equipment (PPE); use by firefighters, law enforce-
E54.01 on CBRNE Detection and CBRN Protection.
ment offıcers, or the Federal Emergency Management Agency
Current edition approved Nov. 1, 2023. Published December 2023. DOI:
10.1520/E3394-23. (FEMA) Urban Search & Rescue (US&R) teams, special
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E3394 − 23
electromagnetic compatibility needs, extended usage periods, holderia pseudomallei in Field-Deployable, Department
and extended mission time. of Defense Aerosol Collection Devices
1.6 This international standard was developed in accor- AOAC SMPR 2016.012 Standard Method Performance Re-
dance with internationally recognized principles on standard- quirements for Detection and Identification of Variola
ization established in the Decision on Principles for the Virus
Development of International Standards, Guides and Recom- 2.3 Other References:
mendations issued by the World Trade Organization Technical
18 US Code 178 Definitions
Barriers to Trade (TBT) Committee.
3. Terminology
2. Referenced Documents
3.1 Definitions:
2.1 ASTM Standards: 3.1.1 accuracy, n—closeness of agreement between a test
E2458 Practices for Bulk Sample Collection and Swab result and the accepted reference value. E2771
Sample Collection of Visible Powders Suspected of Being
3.1.2 assay, n—quantitative or qualitative test used to deter-
Biological Agents and Toxins from Nonporous Surfaces
mine the presence or absence of a chemical or biological
E2771 Terminology for Homeland Security Applications
material. E3131
E3131 Specification for Nucleic Acid-Based Systems for
3.1.2.1 Discussion—Amended the definition from Specifi-
Bacterial Pathogen Screening of Suspicious Visible Pow-
cation E3131 to include chemical as well as biological mate-
ders
rial.
E3289 Guide for Using Equipment and Assays for Field
3.1.3 biological agent, n—any microorganism (including,
Detection of Fentanyl and Fentanyl-Related Compounds
but not limited to bacteria, viruses, fungi, rickettsia, or proto-
E3290 Test Method for Establishing Performance of Equip-
zoa); infectious substance; or any naturally occurring,
ment and Assays for Field Detection of Fentanyl and
bioengineered, or synthesized component of any such micro-
Fentanyl-Related Compounds
organism or infectious substance capable of causing: (1) death,
E3395 Test Method for Characterizing Performance of Field
disease, or other biological malfunction in a human, an animal,
Screening Devices for the Identification of Biological
a plant, or other living organism; (2) deterioration of food,
Agents
water, equipment, supplies, or material of any kind; or (3),
2.2 AOAC Standards:
deleterious alteration of the environment. 18 USC 178
AOAC SMPR 2010.001 Standard Method Performance Re-
3.1.3.1 Discussion—Also termed biothreat agent.
quirements for Polymerase Chain Reaction (PCR) Meth-
3.1.4 biovar, n—a group of microorganisms, usually
ods for Detection of Francisella tularensisin Aerosol
bacteria, distinguishable from other strains of the same species
Collection Filters and/or Liquids
based on physiological or biochemical characteristics.
AOAC SMPR 2010.002 Standard Method Performance Re-
quirements for Polymerase Chain Reaction (PCR) Meth- 3.1.5 calibration, n—set of operations that establish, under
specified conditions, the relationship between the values of
ods for Detection of Yersinia pestisin Aerosol Collection
Filters and/or Liquids quantities indicated by a measurement instrument or measuring
system, or values represented by a material measure, or a
AOAC SMPR 2010.003 Standard Method Performance Re-
quirements for DNA-Based Methods of Detecting Bacil- reference material, and the corresponding values realized by
standards (1).
lus anthracis in Field-Deployable, Department of Defense
Aerosol Collection Devices
3.1.6 confidence interval, CI, n—range of values created
AOAC SMPR 2016.006 Standard Method Performance Re-
using a procedure that, when repeated many times, on distinct
quirements for DNA-Based Methods of Detecting Bacil-
data sets, generated from the same underlying stochastic
lus anthracis in Field-Deployable, Department of Defense
process, will bracket the true measure of performance, such as
Aerosol Collection Devices
probability of detection (POD), the proportion of times stated
AOAC SMPR 2016.007 Standard Method Performance Re-
in the confidence level. E3131
quirements for Detection of Francisella tularensis in
3.1.6.1 Discussion—This definition differs slightly from that
Aerosol Collection Devices
in Specification E3131 by explicitly linking the interval to the
AOAC SMPR 2016.008 Standard Method Performance Re-
confidence level.
quirements for DNA-Based Methods of Detecting Ye-
3.1.7 confidence level, CL, n—probability value associated
rsinia pestis in Field-Deployable, Department of Defense
with a CI; the percentage of intervals that can be expected to
Aerosol Collection Devices
include the true population parameter in the long run. E3131
AOAC SMPR 2016.010 Standard Method Performance Re-
3.1.8 environmental panel, n—collection of materials and
quirements for DNA-Based Methods of Detecting Burk-
compounds that can be found in the environment (indoor or
outdoor).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Government Publishing Office (GPO), 732 N. Capitol St.,
the ASTM website. NW, Washington, DC 20401, http://www.gpo.gov.
3 5
Available from AOAC International, 2275 Research Blvd., Suite 300, The boldface numbers in parentheses refer to a list of references at the end of
Rockville, MD 20850-3250, http://www.aoac.org. this standard.
E3394 − 23
3.1.8.1 Discussion—The environmental panel is determined 3.1.19 lower confidence bound, LCB, n—lowest value of a
by the entity directing testing and will include samples one-sided CI created using a procedure that, when repeated
representative of aerosol backgrounds in the locations of many times on distinct data sets generated from the same
interest. This specification does not include discussion of underlying stochastic process, will include the true measure of
aerosol filter sample collection, sample preparation conditions, performance a proportion of times equal to the stated
or methods that may be necessary to extract collected material probability. E3131
into a suitable liquid for analysis using nucleic acid-based 3.1.19.1 Discussion—The LCB ensures that the POD attains
methods. The environmental panel is used as a more “real- a satisfactory value for the CL selected and determines the
world” test of a detection system’s performance when it is minimum number of samples that shall be analyzed. Slight
spiked with a whole biological agent. The environmental panel modification from Specification E3131.
should not result in false positive or false negative results and
3.1.20 measurement process, n—step, or series of system-
should not cause failure of control samples.
atic steps, used to detect a material or determine if a system or
3.1.9 exclusivity panel, n—collection of near-neighbor bio- instrument performs as intended. E3289
logical agents, viruses, or nucleic acids used during testing.
3.1.21 multiplex assay, n—assay that is capable of measur-
E3131
ing multiple biological agents or multiple targets for a single
3.1.9.1 Discussion—Results from tests involving members
agent in a single test sample. E3131
of the exclusivity panel, if carried out, are subject to the same
3.1.21.1 Discussion—This definition differs slightly from
statistical analysis and performance requirements described in
the one in Specification E3131 by including multiple targets.
this specification as samples containing biological agents of
3.1.22 near neighbor, n—organism, virus, or nucleic acid
interest.
that is similar to a desired target biological agent but should not
3.1.10 false negative, n—failure to detect a compound
result in a positive detection result. E3131
within a sample when it is present at a concentration well
3.1.22.1 Discussion—Exclusivity panel members include
above the limit of detection. E3289
near neighbors.
3.1.10.1 Discussion—This definition differs slightly from
3.1.22.2 Discussion—Results from tests involving near
the one in Guide E3289 by emphasizing concentrations above
neighbors, if carried out, are subject to the same statistical
the limit of detection.
analysis and performance requirements described in this speci-
3.1.11 false positive, n—detection of a compound within a fication as samples containing biological agents of interest.
sample when it is not present. E3289
3.1.23 operator, n—person operating an on-site field screen-
3.1.12 field screening, n—analysis conducted at a location, ing device. E3131
other than in a laboratory, to provide preliminary results for the
3.1.24 panel, n—collection of samples used during testing.
presence a biological threat agent within a sample at the
3.1.24.1 Discussion—Examples of panels include inclusiv-
species level.
ity panel, exclusivity panel, and environmental panel.
3.1.12.1 Discussion—The result from this analysis is re-
3.1.25 probability of detection, POD, n—proportion of posi-
ferred to as a field screen result.
tive analytical outcomes in a stated number of tests for a
3.1.13 field screening device, n—a portable analytical plat-
qualitative method for a given matrix at a given concentration.
form to be used by field or facility personnel for onsite
3.1.26 risk, n—the probability of suffering a loss or harm or
analysis.
injury; peril. E2458
3.1.14 field screen result, n—the initial discovery produced
3.1.27 sensitivity, n—ability of a measurement procedure to
from field screening.
correctly yield a positive result or detection for a compound of
3.1.15 genome, n—the complete set of genetic material of a
interest when it is present in a test sample.
human, animal, plant, or other living thing.
3.1.28 serovar, n—a group of closely related microorgan-
3.1.16 genome equivalents, GE, n—number of genome
isms differentiated by their surface antigens.
copies present in a given mass of nucleic acid (deoxyribo-
3.1.29 stochastic process, n—term used to describe obser-
nucleic acid (DNA) or ribonucleic acid (RNA)) that can be
vations governed by a random mechanism which cannot be
calculated by converting the size of a genome in base pairs to
precisely predicted.
micrograms of DNA or RNA.
3.1.30 strain, n—isolates or variants of the target biological
3.1.17 inclusivity panel, n—collection of closely related
agent(s) that the method can detect (inclusivity strains) or
biological agents, viruses or nucleic acids used during testing.
should not detect (exclusivity strains). E3131
E3131
3.1.31 test sample, n—amount and identity of a particular
3.1.17.1 Discussion—Tests involving members of the inclu-
substance (target and non-target compounds) prepared for
sivity panel, if carried out, are subject to the statistical analysis
and performance requirements described in this specification. testing. E3290
3.1.32 true negative, n—correctly reporting the absence of a
3.1.18 limit of detection, LOD, n—lowest amount of analyte
in a sample that can be detected with stated probability. E3131 compound within a sample when it is not present.
3.1.33 true positive, n—correctly detecting a compound
From https://dictionary.cambridge.org/us/dictionary/english/genome. within a sample when it is present.
E3394 − 23
3.2 Acronyms: sented with a binary response by biological agent (for example,
3.2.1 BIT—built-in test “[Agent] Identified” or “No biological agents identified”).
Identified biological agents shall be reported by species.
3.2.2 CDC—Centers for Disease Control and Prevention
5.2.2 Results shall not be presented in basic mode as
3.2.3 CI—confidence interval
numerical, spectral, colorimetric lines, or other means that
3.2.4 CL—confidence level
require interpretation or analysis. Data that requires a higher
3.2.5 FEMA—Federal Emergency Management Agency skill level to interpret shall be accessible, separately from the
basic operator UI.
3.2.6 FSD—field screening device
5.2.3 The user interface shall provide state-of-health alerts
3.2.7 GE—genome equivalents
(such as calibration needed, and possibly others), and the
3.2.8 GPS—global positioning system
battery charge level. Separate indications shall be provided
3.2.9 IP—ingress protection code, part of an alphanumeric when the FSD is ready to process a sample and when a sample
code denoting the protection rating of an electrical or mechani-
is being processed. The FSD should provide optional instruc-
cal enclosure tions that guide users to load samples.
3.2.10 LCB—lower confidence bound
5.3 Access Modes:
3.2.11 LRN—Laboratory Response Network
5.3.1 FSDs shall have at least two different access modes as
follows:
3.2.12 PCR—polymerase chain reaction
5.3.1.1 Basic Mode—In basic mode, the FSD shall perform
3.2.13 POD—probability of detection
all instrument functions aside from those that affect alarm
3.2.14 PPE—personal protective equipment
notifications, measurement sensitivity or thresholds, or identi-
3.2.15 RG—risk group
fication results.
5.3.1.2 Advanced Mode—In advanced mode, a device ad-
3.2.16 RH—relative humidity
ministrator may control parameters that can affect the result of
3.2.17 UI—user interface
a measurement (for example, routine function control, calibra-
3.2.18 US&R—urban search and rescue
tion parameters, alarm thresholds). Access to advanced mode
3.2.19 VNTR—variable number tandem repeat
shall be protected via password or biometric authentication.
3.2.20 WHO—World Health Organization
5.4 Warm-up Time:
5.4.1 From a cold start, the FSD shall be available to
4. Biological Agent Identification
process samples within 10 min.
4.1 Biological identification capabilities of FSDs shall be
5.4.2 Upon startup, the FSD performs self-diagnosis or
tested against the agents in the inclusivity, exclusivity, and
built-in test (BIT), if such test is available. A BIT may be
environmental panels presented in Annex A1. For an FSD to
comprised of internal negative or positive controls that indicate
pass, identification performance, measured as the estimated
instrument readiness for sample processing.
LCB on the POD, shall meet or exceed the 0.85/80 % LCB/CL
5.5 Maximum Time-to-Result:
requirements as presented in Section 12.
5.5.1 The time-to-result is the time after the sample has been
collected and when the identification result is reported. The
5. Performance Requirements
time-to-result shall not exceed 60 min. The time-to-result
5.1 General:
includes sample preparation or processing time needed after
5.1.1 FSDs shall be capable of operating independently
sample collection but prior to introduction to the instrument, if
from any peripheral device, remote station, or external
any.
software, and shall be unaffected by any malfunction of a
5.6 Battery Power:
peripheral device.
5.6.1 FSDs should have ability to run on battery power for
5.1.2 FSDs shall be able to draw power from fixed electrical
field applications. On battery power, FSDs should be able to
infrastructure or from batteries. FSDs that are capable of
perform at least 3 assays or perform analyses of samples for
drawing power from either fixed electrical infrastructure or
5 h, whichever is longer, per full battery charge.
from batteries are also acceptable.
5.1.3 FSDs should be hand- or person-portable (see Section
5.7 Data Handling, Management, and Storage:
7) so that a single individual can handle the task of analyzing
5.7.1 Specialized software shall not be necessary to store,
and interpreting results from testing.
transfer, access, view, or interpret identification data. Users
5.1.4 FSD should be operable while in motion.
shall have the ability to enter sample identifier information.
5.1.5 FSD identification methods should be automated, have
However, entry of this information should not be required to
multiplexed assay capability, and allow for integrated sample
accommodate use cases where this action becomes operation-
preparation and collection.
ally impractical or difficult. Data shall be exportable in .csv or
5.2 User Interface: tab-delimited format to allow for short- or long-term archiving
5.2.1 Input commands, status indicators, and results shall be and retrieval. Exportable data shall, at a minimum, include the
presented in a manner interpretable by operators with a identification results and the time and date of measurement.
minimal level of training. Identification results shall be pre- Geospatial data should be recorded when instruments feature
E3394 − 23
GPS. Measurement data may vary based on individual manu- 5.12.1 The manufacturer shall report the detection method
facturer assay methods. used in the FSD (for example, real-time fluorescence, melt
curve, end-point fluorescence).
5.7.2 Prior to transport to LRN, it shall be established that
sample does not pose a chemical, explosive or radiological 5.12.2 The following documentation shall be supplied with
hazard. The responding agency should coordinate with their the FSD:
local LRN for specific instructions.
5.12.2.1 Operating instructions and restrictions,
5.7.3 Appropriate biohazard sample handling and packag- 5.12.2.2 Consumables or spare parts list,
ing must be adhered to per LRN guidance. 5.12.2.3 Troubleshooting guide,
5.7.4 Users shall have the ability to review results from 5.12.2.4 Description and protocol for communication meth-
previously completed assays. FSD shall have the capacity of
ods of transmitting and receiving data,
storing a minimum of 100 total PCR results on its internal 5.12.2.5 Electrical power or battery requirements,
storage.
5.12.2.6 Hazard and safety information, and
5.7.5 Specialized software shall not be necessary for facili-
5.12.2.7 Module/accessory connection instructions, if appli-
tating file offload. Data transfer shall be facilitated via a
cable.
universal port (for example, USB-B/USB-C) that enables file
transfer to a flash drive or an external hard drive. FSDs should
6. Other Requirements
have the ability to connect and transfer data over network
6.1 Electromagnetic Performance Requirements:
protocols via static network address.
6.1.1 Instrument shall be unaffected by radio frequency
5.7.6 Encryption may be employed by users on data after
from 80 MHz to 2500 MHz.
file transfer if required by the locality or the agency responsible
6.1.2 Instrument shall be capable of operating under the
for storing it.
following radiated emissions:
5.8 Visual Indicators:
6.1.2.1 >100 μV/m at 3 m, from 30 MHz to 88 MHz,
5.8.1 Alarms or notifications shall be presented by multiple
6.1.2.2 >150 μV/m at 3 m, from 88 MHz to 216 MHz,
indicators (for example, visual, audible, tactile) to ensure PPE
6.1.2.3 >200 μV/m at 3 m, from 216 MHz to 960 MHz, and
or other circumstances do not interfere with a user’s awareness
6.1.2.4 >500 μV/m at 3 m, greater than 960 MHz.
of an alarm condition. Indications that an analysis has been
6.1.3 Instrument shall be unaffected by a magnetic field of
completed shall persist until a user takes action to acknowledge
100 A/m, 60 Hz field.
the event.
6.1.4 Instrument shall be unaffected by 66 kV contact
5.8.2 Displays shall be backlit or self-lit for viewability in
electrostatic discharge on handle, user buttons, maintenance
low-light conditions. The display brightness and contrast shall
access, and sample points.
allow viewability in bright sunlight (>10 000 lx).
6.2 Mechanical Performance Requirements:
5.9 Usability with Personal Protective Equipment:
6.2.1 Instrument biological species identification perfor-
5.9.1 The FSD at a minimum shall be operable by users
mance should be unaffected after being subjected to:
wearing level B PPE. Ease of display viewing should be
6.2.1.1 A vibration environment subjecting the FSD to a
considered for users that may be wearing a respirator and in 2
spectral density of 0.01 g /Hz with endpoints of 5 Hz and
high or low light levels, including direct sunlight. Any input
500 Hz for a period of 1 h.
buttons should be large enough to use and be adequately
6.2.1.2 Mechanical shock of 50 g peak acceleration applied
separated from each other when wearing two pairs of gloves
for 11 ms in directions along the X, Y, or Z axes.
(for example, nitrile and butyl rubber). Touchscreen interface
6.3 Environmental Performance Requirements:
shall not be the only input option.
6.3.1 Biological identification capabilities in the FSD:
5.10 Shelf-life of Assays:
6.3.1.1 Shall function in temperatures from 15 °C to 30 °C
5.10.1 Biothreat assay shelf life shall be no less than 6
(59 °F to 86 °F) at <80 % relative humidity (RH), and
months and should be at least 1 year from date of manufacture.
6.3.1.2 Should function in temperatures from 4 °C to 40 °C
5.10.2 Assay reagents should be storable at ambient tem-
(39.2 °F to 104 °F) at <95 % relative humidity (RH).
peratures between 15 °C and 30 °C. Cold chain storage is
6.3.2 Dust and moisture protection for the general enclosure
infeasible for many end users of FSDs.
(electronics, batteries, etc.) and sample chamber should be
5.11 Sustainability: ingress protection IP51 rated or higher.
5.11.1 The FSD should not require maintenance more fre-
7. Dimensions, Mass, and Permissible Variations
quently than quarterly (every 3 months). The FSD shall not
require daily or weekly maintenance or calibration. FSDs are 3
7.1 The FSD shall have a size that is within 1.5 ft
expected to be stored instruments that are used on an as-needed
(0.042 m ).
basis during a response.
7.2 The FSD should weigh less than 25 lb (11.3 kg).
5.12 Documentation Supplied:
7.2.1 While lower weight is preferable for portability, other
factors, such as space available for transportation, decontami-
nation needs, equipment carried by personnel, and possibly
See https://chemm.hhs.gov/ppe.htm. others, may be considered when selecting an FSD.
E3394 − 23
8. Workmanship, Finish, and Appearance 12.1.1 The statistical approach uses a score CI, to define
the number of tests that shall be conducted so that a desired
8.1 Exterior markings on the monitor should be limited to
POD estimate, as indicated by the value of a given LCB in a
markings necessary for operation, the manufacturer’s unique
one-sided interval with a specified CL, can be achieved.
serial number, and voltage and current requirements. Markings
Testing shall be conducted to establish instrument or assay
shall not be erased following decontamination with 10 %
performance so that LCB ≥ 0.85 and CL ≥ 80 %. Results from
bleach solution for at least 20 min contact time.
selecting and executing one of the testing plans presented in
8.2 The FSD should have no uncovered openings to any
12.6 of this specification can be used to determine if the chosen
interior space other than necessary for completing the sample
level of statistical performance has been met. Testing results
analysis. Openings for the assay should be covered when the
that do not meet or exceed the 0.85/80 % LCB ⁄CL have failed
unit is not in use or is in standby.
to achieve the minimum performance level established in this
specification.
9. Sampling
12.2 The binary nature of the FSD response, where the
9.1 Responders should prepare and follow a sampling plan
agent is reported as present in a sample or not, means that a
suitable for the site/incident to which they are responding. It is
POD can be estimated from results of a prescribed number of
suggested to consult with appropriate experts (advisors).
individual tests. Tests shall be conducted using samples where
the agent of interest is present at limits well above the limit of
10. Number of Tests and Retests
detection (LOD), as determined by manufacturer’s specifica-
10.1 Refer to Section 12, Statistical Considerations, for the
tions. The POD is estimated as the ratio of samples with
number of replicates of a sample to test and for acceptance
positive detections divided by the total number of samples
criteria. Refer to instrument manufacturers’ user guides for
tested. Requiring that the lower confidence bound (LCB) on
criteria describing when to rerun a test.
the POD meets or exceeds a certain value ensures that a
sufficient number of tests is conducted. For a fixed confidence
11. Specimen Preparation
level, the POD is estimated to be no less than the LCB
11.1 This specification does not address specimen prepara-
calculated from the sample test data. The minimum perfor-
tion that may be necessary if a sample is in solid form (for
mance requirements in this specification ensure that the esti-
example, on a filter).
mated POD is at least as good as the LCB.
11.2 This specification assumes that test samples are avail-
12.3 To achieve an LCB ≥ 0.85 and CL ≥ 80 %:
able in a
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