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.
