Abstract # 182:

Scheduled for Saturday, June 23, 2007 08:30 AM-08:45 AM: Session 17 (North Main Hall E) Oral Presentation


PRIMA-TB STAT-PAK® ASSAY, A NOVEL RAPID TEST FOR TUBERCULOSIS IN NONHUMAN PRIMATES

R. Greenwald1, K. Lyashchenko1, J. Esfandiari1, L. Stutzman1, S. Gibson2, P. Didier3 and C. McCombs4
1Chembio Diagnostic Systems, Inc., 3661 Horseblock Rd., Medford, NY 11763, USA, 2University of South Alabama, Mobile, Alabama, 3Tulane National Primate Center, Covington, Louisiana, 4Sequella, Inc., Rockville, Maryland
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     Tuberculosis is the most important zoonotic bacterial disease in nonhuman primates. The current diagnostic method, the intradermal palpebral tuberculin test, has considerable shortcomings. We characterized antibody responses against Mycobacterium tuberculosis and M. bovis in nonhuman primates to develop a rapid serodiagnostic test for tuberculosis. Twenty seven monkeys were infected: 14 rhesus (Macaca mulatta) and 7 cynomolgus macaques (Macaca fascicularis) inoculated with M. tuberculosis, and 6 rhesus monkeys inoculated with M. bovis. Antibody responses were monitored 4 months post infection by MultiAntigen Print ImmunoAssay (MAPIA™) using 19 recombinant antigens. All animals produced antibodies of variable levels and with differential antigen recognition patterns. Three proteins, ESAT-6, CFP10 and MPB83, were most frequently recognized and combination of these antigens was sufficient for antibody detection in all 27 infected monkeys. The antigen cocktail was optimized and used to develop a rapid serodiagnostic test for tuberculosis, PrimaTB STAT-PAK® kit, based on lateral-flow technology. At varying time points starting 4 weeks post-inoculation, 25 out of the 27 infected animals were reactive in the test. Only 3 false- positive samples were found among 195 sera from normal monkeys. The serodiagnostic kit is an improvement over the current tuberculin test in that it produces results within 20 minutes instead of the currently required 72 hours of repeated observations. This novel immunoassay can provide a rapid, simple, and accurate test for tuberculosis in nonhuman primates.