Abstract # 13162 Event # 151:

Scheduled for Friday, August 10, 2018 03:45 PM-04:00 PM: (Chula Vista ) Oral Presentation


TB-PLEX – A NEW GENERATION MULTIPLEX ANTIBODY DIAGNOSTIC TEST FOR DETECTION OF TUBERCULOSIS IN NONHUMAN PRIMATES

R. K. Dhawan1, M. Wunderlich1, R. Ravindran2 and I. Khan2
1Charles River Laboratories, BioAssay Services, 251 Ballardvale Street, Wilmington, MA 01887, USA, 2Center for Comparative Medicine, University of California, Davis, CA 95762
line
     Tuberculosis (TB) in nonhuman primates (NHP’s) is highly contagious and often produces rapid disease. Identification of animals infected with Mycobacterium tuberculosis (M. tb.) in a timely manner is therefore critical. NHP’s are periodically tested using the tuberculin skin test (TST) and/or the Primagam® blood assay. However, these tests lack desirable sensitivity, specificity, efficiency and/or throughput. TB-Plex, a blood based multiplex immunoassay with 10 antigens/assays for detection of antibodies in M. tb. infected animals was developed for routine NHP colony surveillance. Antibody levels were examined in serum/plasma samples from several cohorts of well characterized specific pathogen-free (SPF) colonies. Field trial on sera from >800 healthy macaques (rhesus and cynomolgus) were used in the validation study to determine specificity of the TB-Plex assay. The cut-offs were calculated and overall specificity of the test was found to be nearly 98%. The panel was screened for sensitivity using experimentally infected rhesus (M. tb. strains: Erdman, n=6 and H37RV, n=4) and cynomolgus macaques (Erdman, n=9). The panel sensitivity was between 80-100% at various time points (8, 12, 16 and 24 weeks) during seroconversion. In conclusion, a blood based test was validated which is highly sensitive and specific for screening of M. tb. in NHP’s and can be performed in a user friendly and high throughput format.