title: PrimaTB STAT-PAK assay, a novel, rapid lateral-flow test for tuberculosis in nonhuman primates.
abstract: Tuberculosis (TB) is the most important zoonotic bacterial disease in nonhuman primates (NHP). The current diagnostic method, the intradermal palpebral tuberculin test, has serious shortcomings. We characterized antibody responses in NHP against Mycobacterium tuberculosis to identify immunodominant antigens and develop a rapid serodiagnostic test for TB. A total of 422 NHP were evaluated, including 243 rhesus (Macaca mulatta), 46 cynomolgus (Macaca fascicularis), and 133 African green (Cercopithecus aethiops sabaeus) monkeys at five collaborative centers. Of those, 50 monkeys of the three species were experimentally inoculated with M. tuberculosis. Antibody responses were monitored every 2 to 4 weeks for up to 8 months postinfection by MultiAntigen Print ImmunoAssay with a panel of 12 recombinant antigens. All of the infected monkeys produced antibodies at various levels and with different antigen recognition patterns. ESAT-6 and MPB83 were the most frequently recognized proteins during infection. A combination of selected antigens which detected antibodies in all of the infected monkeys was designed to develop the PrimaTB STAT-PAK assay by lateral-flow technology. Serological evaluation demonstrated high diagnostic sensitivity (90%) and specificity (99%). The highest rate of TB detection was achieved when the skin test was combined with the PrimaTB STAT-PAK kit. This novel immunoassay provides a simple, rapid, and accurate test for TB in NHP.
authors.affiliation: Chembio Diagnostic Systems, Inc., 3661 Horseblock Road, Medford, NY 11763, USA. klyashchenko@chembio.com
authors.forename: Konstantin P
authors.initials: KP
authors.lastname: Lyashchenko
authors.forename: Rena
authors.initials: R
authors.lastname: Greenwald
authors.forename: Javan
authors.initials: J
authors.lastname: Esfandiari
authors.forename: David
authors.initials: D
authors.lastname: Greenwald
authors.forename: Carol A
authors.initials: CA
authors.lastname: Nacy
authors.forename: Susan
authors.initials: S
authors.lastname: Gibson
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Didier
authors.forename: Marc
authors.initials: M
authors.lastname: Washington
authors.forename: Peter
authors.initials: P
authors.lastname: Szczerba
authors.forename: Sherri
authors.initials: S
authors.lastname: Motzel
authors.forename: Larry
authors.initials: L
authors.lastname: Handt
authors.forename: John M
authors.initials: JM
authors.lastname: Pollock
authors.forename: James
authors.initials: J
authors.lastname: McNair
authors.forename: Peter
authors.initials: P
authors.lastname: Andersen
authors.forename: Jan A M
authors.initials: JA
authors.lastname: Langermans
authors.forename: Frank
authors.initials: F
authors.lastname: Verreck
authors.forename: Sean
authors.initials: S
authors.lastname: Ervin
authors.forename: Frank
authors.initials: F
authors.lastname: Ervin
authors.forename: Candace
authors.initials: C
authors.lastname: McCombs
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis* / Q000276:immunology; D000942:Antigens, Bacterial / Q000276:immunology; D001426:Bacterial Proteins / Q000276:immunology; D002522:Chlorocebus aethiops; D007118:Immunoassay / Q000379:methods; D008252:Macaca fascicularis; D008253:Macaca mulatta; D008565:Membrane Proteins / Q000276:immunology; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D018419:Primate Diseases / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology*; D012680:Sensitivity and Specificity; D014374:Tuberculin Test / Q000379:methods; D014376:Tuberculosis / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology / Q000662:veterinary*
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C093276:ESAT-6 protein, Mycobacterium tuberculosis; C094904:MPB83 protein, Mycobacterium; D008565:Membrane Proteins