ASTM E3395-23 - Standard Test Method for Characterizing Performance of Field Screening Devices for the Identification of Biological Agents
Standard Test Method for Characterizing Performance of Field Screening Devices for the Identification of Biological Agents
| Standard number: | ASTM E3395-23 |
| Released: | 01.11.2023 |
| Status: | Active |
| Pages: | 7 |
| Section: | 15.08 |
| Keywords: | assays; bacteria; biodetection; biological agent; biothreat; confidence interval; detection; field screening device; first responder; lower confidence bound; microorganism; nucleic acid; probability of detection; virus; |
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.