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FDA Consumer magazine

November-December 2006

New FDA Test Detects Fake Bioterror Agents

Some people have made phony terrorist threats involving bioterror agents such as anthrax (Bacillus anthracis). But the agents really turn out to be harmless substances. These actions have resulted in considerable economic loss and social anxiety. In a bid to alleviate the problem, researchers at the Food and Drug Administration's National Center for Toxicological Research (NCTR) are developing a quick, cost-effective way to distinguish fake materials from authentic bioterror agents.

The testing method uses a technology called mass spectrometry. This technique identifies and quantifies compounds quickly and accurately. The testing process is similar to that used in the Federal Bureau of Investigation'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 with a database of known substances for immediate recognition.

An article about the new testing method published in the July 14, 2006, issue of the journal Rapid Communications in Mass Spectrometry described how researchers analyzed a variety of chemical and biological materials that could be used in a biological attack, including nonbacterial substances that could be spiked with or mistakenly identified as bioterror agents in a hoax attack.

"Our new technique, along with fingerprinting, offers a rapid and valuable assessment of a range of bioterror and hoax samples," says the NCTR's Jon Wilkes, Ph.D., lead study author and leader of the FDA's counter-bioterror team in the NCTR's Divisions of Systems Toxicology and Microbiology. Other authors of the study are Fatemeh Rafii, Ph.D., John B. Sutherland, Ph.D., Larry G. Rushing, and Dan A. Buzatu, Ph.D. They have been conducting research in this area at the NCTR since l995.

"We hope to see the testing put into place by government and industry in the near future," Wilkes says. "Anytime we can run tests more quickly, we can benefit public health and safety." The NCTR will continue to build the "fingerprint" database.

Although other testing methods, such as DNA testing, are available, they are costly and involve lengthy processes that can delay by days the detection of microorganisms that can cause disease. This new technique is very fast, taking about seven minutes for each sample on the mass spectrometer, after a half-hour to eight hours of sample preparation time. The test can process a large number of samples rapidly. The cost is as little as $2 for each test, whereas DNA methods cost from $15 to $50 per test and take about 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. FDA 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, military authorities, and regulatory agencies.

The NCTR already has examined the mass spectrometric fingerprints of a variety of chemical and biological materials that could be used in a biological attack. Examples are two types of food poisoning bacteria: Vibrio parahaemolyticus, associated with illness from eating oysters, and Salmonella enterica, bacteria often found in poultry that cause gastrointestinal illness. Mass spectrometry generally is used to characterize a pure substance. The use of this technique to evaluate complex mixtures such as bacteria or food is more novel.

The NCTR is working with Litmus, LLC, Little Rock, Ark., under an FDA Cooperative Research and Development Agreement (CRADA) to commercialize the method for food-manufacturing quality control, as well as for counter-terror applications.

Read the article: "Pyrolysis Mass Spectrometry for Distinguishing Potential Hoax Materials from Bioterror Agents."

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