FDA develops cost-effective way to identify bioterror agents used in hoax incidents

Researchers at the Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) are developing a quick, cost-effective way to screen for and identify bioterror agents and other substances used in hoax incidents.

The testing method uses a technology called mass spectrometry. This technique identifies and quantifies compounds, based on the structure and chemical properties of their molecules, quickly and with a very high degree of accuracy.

The testing process works in a way similar to the FBI's fingerprint library for criminals. A researcher can take patterns generated by a mass spectrometer's analysis of a substance to be identified and compare them to a database of known substances, for immediate recognition.

"Our new technique, along with fingerprinting, offers a rapid and valuable assessment of a range of bioterror and hoax samples," said NCTR's Dr. Jon Wilkes, Ph.D., the lead author of the study. "We hope to see the testing put into place by government and industry in the near future. Anytime we can run tests more quickly, we can benefit public health and safety." NCTR will continue to build the "finger print" data base.

This project serves as a prime example of scientific work conducted under the FDA's Critical Path Initiative -- work that is intended from its conception for widespread use.

Although other testing methods, such as DNA testing, are available, they are costly and involve lengthy processes that can delay by days detection of micro-organisms that can cause disease. This new technique is very fast, taking about 7 minutes for each sample on the mass spectrometer following three to eight hours of sample preparation time. Sample preparation is beyond the scope of this paper.

Although this new test (screening technique) can not distinguish living from nonliving microbiological organisms (whether cells are dead or alive), the test can process a large number of samples rapidly. The per test cost is as little as $2 each whereas DNA methods cost from $15 to $50 per test and take from 24 hours from start to finish including sample growth or culture.

The speed and cost-effectiveness of the tests make their use feasible for FDA enforcement work as well as for industry. Researchers found that the testing method could be used to distinguish biological and chemical samples of all sorts, addressing the analytical needs of the food industry, law enforcement and military authorities as well as regulatory agencies

Already, NCTR has examined the mass spectrometric fingerprints of a variety of chemical and biological materials that could be used in a biological attack. These include two types of food poisoning bacteria -- Vibrio parahaemolyticus, (associated with illness from eating oysters)) and Salmonella enterica, (bacteria often found in poultry causes gastrointestinal illness) -- and inert substances such as flour and corn starch.

Mass spectrometry generally is used to characterize a pure substance. This use of this technique to evaluate complex mixtures such as bacteria or food is more novel.

NCTR is working with an industrial partner under an FDA Cooperative Research and Development Agreement (CRADA) to commercialize the method for food manufacturing quality control as well as counter-terror applications.

FDA recently published the research article about the new testing method in the journal Rapid Communications Mass Spectrometry, "Pyrolysis Mass Spectrometry for Distinguishing Potential Hoax Materials from Bioterror Agents." Dr. Wilkes is the leader of FDA's counterbioterror team in the Divisions of Systems Toxicology and Microbiology at NCTR. The authors include his FDA colleagues Fatemeh Rafii, Ph.D., John B. Sutherland, Ph.D., Mr. Larry G. Rushing, and Dan A Buzatu, Ph.D., all of whom have been conducting research in this area at NCTR since l995.

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