ASTM E3395-23 PDF

SIGNIFICANCE AND USE 5.1 Prompt and accurate identification of harmful biological agents on-scene is crucial to decision making for taking action and responding to incidents involving biological agents. 5.2 The detection and identification of a biological agent will inform how responders prepare for on-site activity (for example, selection of PPE and necessary precautionary actions), treat exposures, secure and decontaminate the incident site, and inform follow up actions to be taken after the incident has occurred. 5.3 Inclusivity and exclusivity test panels are used to ensure that biological agents targeted by the FSD can be detected (inclusivity) and that biological agents not targeted by the FSD are not detected (exclusivity). The environmental test panel is used to determine if there are potential interferences that could result in a false negative result when spiked whole biological agent is present. SCOPE 1.1 General: 1.1.1 This test method provides a procedure for characterizing the performance of nucleic acid-based field screening devices (FSDs) for the detection and identification of biological agents, when utilizing the test samples and statistical considerations described in Specification E3394. 1.1.2 This test method describes sample preparation and analysis protocols to use when characterizing the performance of nucleic acid-based field screening devices for the detection and identification of biological agents. 1.1.3 The intent of this test method is to provide a methodology to analyze samples in a manner that is analogous to how they are to be analyzed in the field by federal and state/local/tribal/territorial (SLTT) law enforcement and first responders, but under more controlled and reproducible conditions than those generally achievable when conducting field testing. The analysis of testing results as described in this test method and in Specification E3394 allow for a systematic way of measuring the statistical performance of FSDs. 1.2 Units: 1.2.1 The values stated in SI units are to be regarded as standard in this document. 1.2.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/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.