ASTM E3395-23 PDF

Full title and description

Standard Test Method for Characterizing Performance of Field Screening Devices for the Identification of Biological Agents (ASTM E3395-23). This test method defines procedures, sample preparation, and analysis protocols to characterize the analytical performance of nucleic acid–based field screening devices (FSDs) used to detect and identify biological agents under controlled, reproducible conditions that emulate field analysis by first responders and law enforcement.

Abstract

ASTM E3395-23 provides a standardized laboratory-based test method for measuring the detection and identification performance of nucleic acid–based field screening devices for biological agents. Used together with Specification E3394 (which defines test sample panels and statistical considerations), E3395-23 covers sample preparation, test execution, and reporting conventions (including units expressed as copies/mL or genome equivalents/mL) so vendors, test laboratories, procuring authorities, and responders can compare and understand device performance in a reproducible way.

General information

• Status: Active
• Publication date: November 1, 2023 (E3395-23); last updated / recorded in the ASTM catalog December 5, 2023.
• Publisher: ASTM International
• ICS / categories: 13.300 (Protection against dangerous goods); Committee E54 — Homeland Security Applications (Subcommittee E54.01)
• Edition / version: E3395-23 (2023 edition)
• Number of pages: 7

Scope

This test method describes procedures to characterize the analytical performance of nucleic acid–based field screening devices (FSDs) for detection and identification of biological agents. It specifies sample preparation and analysis protocols to be used when evaluating devices with the test samples and statistical approach described in Specification E3394. The method is intended to produce reproducible, laboratory-controlled performance measures that are analogous to field use by federal, state, local, tribal, and territorial (SLTT) responders and law enforcement.

Key topics and requirements

• Characterization of nucleic acid–based FSDs for detection and identification of biological agents.
• Sample preparation and analysis procedures aligned with Specification E3394 test panels (inclusivity, exclusivity, environmental interference).
• Use of SI units and concentration reporting in copies/mL or genome equivalents/mL (GE/mL).
• Statistical evaluation of device performance (probability of detection, confidence bounds) as prescribed by the companion specification.
• Procedures designed to emulate field analytical workflows while conducted under controlled laboratory conditions.
• Emphasis on minimizing false positives and false negatives for operational decision-making by responders.

Typical use and users

Primary users include device manufacturers and developers, independent test laboratories, procurement officers, public-safety agencies, first-responder organizations (fire, HAZMAT, law enforcement), homeland security and public-health practitioners, and standardization groups. The standard supports product development, performance claims, comparative testing, procurement specifications, and regulatory or operational evaluations of field screening devices.

Related standards

Closely related documents include ASTM E3394 (Standard Specification for Field Screening Devices Used for Identification of Biological Agents), ASTM E2458 (Practices for Bulk and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents and Toxins), ASTM E3095 (Guide for Surrogate Materials for Field Evaluation of Nucleic Acid‑Based On‑Site Biological Assessment Technologies), and operational guidance such as ASTM E2770. These standards and guides are often used together to define test samples, sampling practices, surrogate materials, and response procedures.

Keywords

field screening device, FSD, biological agent, biodetection, nucleic acid, assay, inclusivity, exclusivity, probability of detection, confidence interval, genome equivalents, copies per mL, first responder, biothreat detection, E3395-23

FAQ

Q: What is this standard?

A: ASTM E3395-23 is a test method that specifies laboratory procedures to characterize the analytical performance of nucleic acid–based field screening devices used to detect and identify biological agents.

Q: What does it cover?

A: It covers sample preparation and analysis protocols, reporting units (copies/mL or GE/mL), and the statistical approach for evaluating device detection and identification performance when tested with the sample panels and criteria defined in Specification E3394.

Q: Who typically uses it?

A: Device manufacturers, independent testing laboratories, procurement and acquisition teams, first-responder and public-safety organizations, and agencies involved in biosurveillance, emergency response, and homeland security.

Q: Is it current or superseded?

A: E3395-23 is the 2023 edition and is listed as current/active in the ASTM catalog (E3395-23). Users should confirm the latest status through ASTM if they require the most recent maintenance or revision information.

Q: Is it part of a series?

A: Yes. E3395-23 is intended to be used in conjunction with Specification E3394 (which defines test samples and statistical considerations) and other related ASTM guides and practices (for example E2458, E3095, and operational guides such as E2770) that cover sampling, surrogate materials, and response procedures.

Q: What are the key keywords?

A: field screening device (FSD), biological agent, nucleic acid, biodetection, inclusivity/exclusivity, probability of detection, copies/mL, genome equivalents, first responder, E3395-23.