ASTM E3395-23

1.1.1This 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.

1.1.2This 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.

1.1.3The 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.

1.2.1The values stated in SI units are to be regarded as standard in this document.

1.2.2When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL).