PrimaTB STAT-PAK assay, a novel, rapid lateral-flow test for tuberculosis in nonhuman primates.
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.
Lyashchenko
Konstantin P
KP
Chembio Diagnostic Systems, Inc., 3661 Horseblock Road, Medford, NY 11763, USA. klyashchenko@chembio.com
Greenwald
Rena
R
Esfandiari
Javan
J
Greenwald
David
D
Nacy
Carol A
CA
Gibson
Susan
S
Didier
Peter J
PJ
Washington
Marc
M
Szczerba
Peter
P
Motzel
Sherri
S
Handt
Larry
L
Pollock
John M
JM
McNair
James
J
Andersen
Peter
P
Langermans
Jan A M
JA
Verreck
Frank
F
Ervin
Sean
S
Ervin
Frank
F
McCombs
Candace
C
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*
D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C093276:ESAT-6 protein, Mycobacterium tuberculosis; C094904:MPB83 protein, Mycobacterium; D008565:Membrane Proteins