DISCLAIMER

This paper, focusing on nucleic acid–based detection of bioaerosol agents, must be only a subset of a larger plan. This paper does not address foodborne, waterborne, vectorborne, or human-to-human transmission of infectious agents.

AUTHOR’S STRONG RECOMMENDATION FOR BOTH PLANNING AND IMPLEMENTATION

Because the committee is examining what would be entailed to provide an autonomous system that performed BioWatch assays and provided the Laboratory Response Network (LRN) of the Centers for Disease Control and Prevention (CDC) with the same amount of nucleic-acid sequence information, along with the same reliability and accuracy as the validated laboratory assays, in the author’s opinion the CDC/LRN and any others who will rely upon such information to make calls of detection of an agent need to be involved in each step in the planning and development of such an autonomous system.

CAVEAT: FULL, END-TO-END SYSTEM INTEGRATION IS DIFFICULT!

The author’s general premise is that the integration of disparate components into an automated bioagent detection and identification system that attempts to perform the same functions as trained laboratory personnel is extraordinarily difficult. Numerous high-quality commercial off-the-shelf instruments exist that perform the functions of the individual steps, yet field-tested and proven integrated systems are few. It is a particular challenge in any automated fluidic system to make 100 percent reliable fluidic interconnections along with the necessary methods to transport, meter, and process samples and reagents so that the laboratory-proven assays that normally are carried out by trained personnel with pipettes, filters, and centrifuges perform just as well in the automated system. Challenges to system integration can arise from something as basic as an output volume of one stage being incompatible with the next stage’s input volume or from differing buffer concentrations between one stage and the next or from a “short spin” on the centrifuge being needed



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