IAI Accepts, published online ahead of print on 13 October 2008

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Infect. Immun. doi:10.1128/IAI.00520-08
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Identification of a Surrogate Marker for Infection in the African Green Monkey Model of Inhalation Anthrax

Cynthia A. Rossi, Melanie Ulrich, Sarah Norris, Douglas S. Reed, M. Louise M. Pitt, and Elizabeth K. Leffel^*

Diagnostics Systems Division, Research Support Division, Center for Aerobiological Sciences, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD, USA

^* To whom correspondence should be addressed. Email: leffele{at}nbacc.net.

In 2001 a bioterrorism attack involving Bacillus anthracis spore-laced letters resulted in 22 cases of inhalation anthrax with five fatalities. This incident identified gaps in our health care system and precipitated a renewed interest in identifying both therapeutics and rapid diagnostic assays. To address those gaps, availability of appropriate, well-characterized animal models that resemble the human disease are needed. In addition, a rapid assay for a reliable diagnostic marker is key to the success of these efforts. In this study, we exposed African green monkeys to B. anthracis spores; examined clinical signs and physiological parameters to include fever, heart rate, complete blood counts and bacteremia; and evaluated the PCR and electrochemiluminescence (ECL) immunoassay for the biomarkers protective antigen and capsule. Results demonstrated that although there were neither objective clinical nor physiological signs that consistently identified either infection or onset of clinical anthrax disease, the African green monkey is a suitable animal model exhibiting a disease course similar to that observed to the rhesus model and humans. We also demonstrated that detecting the biomarkers, protective antigen and capsule, correlated with bacterial loads in the blood of these nonhuman primates. The ECL immunoassay described is simple and sensitive enough to provide results in one to two hours, making this assay a viable option for use in diagnosis of anthrax leading to timely initiation of treatment, which is a key component of B. anthracis therapeutic development.

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