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biological agents in the presence of large quantities of other microbial contamination and interferents, in addition to the achievement of infectious-dose-level sensitivity.

In the area of patient diagnostics, there is a clear need for methods capable of detecting infective does levels (e.g., 10–100 cells or virions) of most biowarfare agents at a speed that allows for effective therapeutic strategies to be administered (e.g., antibiotics, vaccination, supportive therapy). Furthermore, these new methods must also be able to detect "friendly" microbes that have acquired virulence factors by natural or genetic engineering methods and those that have been microencapsulated to disguise their identity (such as the detection of virulence factors or toxin production). Ideally, this technology will be incorporated into a diagnostic system capable of identifying many more common pathogens, assuring frequent use of the system and eliminating the need for clinicians to make a specific request for a very seldom-used assay.

The committee therefore has identified the following research and development needs:

6–1

In the area of patient diagnostics, the Public Health Service should encourage federal research agencies to leverage burgeoning commercial development of faster, cheaper, easier assays of common pathogens rather than independently developing diagnostic technology for the less common pathogens thought to be good candidates for bioterrorism.

6–2

In the area of environmental detection, the Public Health Service should closely monitor military biodetection R&D efforts for inexpensive or multipurpose biodetectors that might be appropriate for purchase or loan by civilian agencies rather than developing threat agent-specific assays from the ground up.

6–3

Both of these leveraging efforts will require the federal government to conduct or support:

 

Basic research to identify characteristics which might be used to develop more effective probes and/or enhance probe performance for known biowarfare agents and especially genetically altered microbes. Understanding of microbial metabolism, sporulation, toxin production and excretion, regulation of virulence factors, and bacteriophage interaction are crucial in this respect. New approaches for preventive and therapeutic strategies are also likely from this basic understanding.

 

Scenario-specific testing of detection performance and comparisons under standard conditions for characterization of the sensitivity, specificity, reliability, response constraints, and usability (ease of use, cost, robustness, useful life, response time, and human effort and experience required).



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