The recent terrorism events, in addition to the ease of travel that allows infectious diseases to spread, and technology developments drive the renewed interest in clinical and environmental infectious disease diagnostics. The combined public health and bio-terrorism markets of several bacterial and protozoan diseases are estimated to be nearly $100 million.

This report, the final volume of the Diagnostics for Emerging Infectious Disease Threats series, focuses on diagnostic testing for 11 bacterial and protozoal diseases in clinical and environmental testing:

• Anthrax
• Brucella spp - Brucellosis
• Clostridium botulinim - Botulism
• Clostridium perfringens
• Coxiella burnetti - Q Fever
• Staphyloccoccal Enterotoxin B
• Tuberculosis
• Vibrio cholerae
• Yersinia pestis - Plague
• Malaria
• Chagas disease (trypanosomiasis, South American)

The technologies being used and developed in the United States and worldwide are discussed. Information has been collected from numerous industry, government, and academic sources. Sensitivity, specificity, cost, speed, and volume of testing are all factors that regulate and drive the diagnostic technology development. For many of the bacterial diseases, the availability as well as use of a diagnostic that is faster than culture, which will be defined as rapid, is new. The definition of a rapid test in this report includes dipsticks, immunoassay, and PCR methods.

For this discussion about diagnostics, infectious disease testing is classified into 2 economic segments: 1) environmental and 2) clinical. Within the clinical testing category, Brucella, Q fever, chagas, malaria, and tuberculosis are considered significant economic parts. Anthrax and plague are classified as emerging. Botulism, perfringens, cholerae, and staphyloccocal enterotoxin B (SEB) clinical testing exists.

More than 70 companies with a diagnostic or developing a diagnostic in these areas with a diverse range of technological approaches, including ELISAs, lateral flow immunoassays (dipsticks), PCR, nucleic acid sequence based assays (NASBAs), DNA hybridization, ECL, indirect hemagglutination, complement fixation, and DNA Chips.

Information for this report has been collected from various industry, government, and academic sources. Interviews with numerous industry, government, and clinical participants form the core of the information. In addition, searches of the trade, business, and clinical literature were conducted to validate conclusions and fill in background, product, and company financial data where possible.

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