This specification prescribes a statistically based testing approach for evaluating the performance of nucleic acid-based detection systems used in bacterial pathogen screening of suspicious visible powders. Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system is intended to provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident.

This specification provides a common set of parameters that system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities may use to match the capabilities of biological assessment tools with user needs. The testing approach ties performance of the system to a specified lower confidence bound (LCB) on the probability of detection (POD) at a known confidence level (CL). Testing shall be conducted to one of two performance levels: (1) ≥95 % POD with 95% CL, or (2) ≥90 % POD with 90% CL. Four testing modules shall be used to evaluate system performance: biological agent nucleic acid inclusivity testing; biological agent nucleic acid exclusivity testing; suspicious powder testing; and whole organism biological agent spiked suspicious powder testing. The specification also describes three different testing tiers that shall test the full panel of suspicious powders and the whole representative biological agent spiked into powders.

1.1 General: 

1.1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match the capabilities of biological assessment tools with user needs.

1.1.2 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams and Urban Search and Rescue (US&R) teams, use in explosive or other hazardous environments or atmospheres, use with personal protective equipment (PPE), use by firefighters or law enforcement officers or both, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all nucleic acid-based detection systems.

1.2 Operational Concepts—Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident. A field-deployable system should withstand the rigors associated with uses including, but not limited to, high- and low-temperatures and storage conditions, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field.

1.3 Nucleic Acid-Based System Detection Capabilities—Manufacturers or independent third-party testing entities shall document and verify, through testing, the capabilities of the system.

1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. Liquid concentrations of the biohazard materials are presented in number of biological agents or genome equivalents per volume for pathogens such as bacteria and spores (biological agents/mL, genome equivalents/mL (GE/mL), colony forming units/mL (CFU/mL), or spores/mL).

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.

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.