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MICROBIAL IMMUNOLOGY

PrimaTB STAT-PAK Assay, a Novel, Rapid Lateral-Flow Test for Tuberculosis in Nonhuman Primates

Konstantin P. Lyashchenko, Rena Greenwald, Javan Esfandiari, David Greenwald, Carol A. Nacy, Susan Gibson, Peter J. Didier, Marc Washington, Peter Szczerba, Sherri Motzel, Larry Handt, John M. Pollock, James McNair, Peter Andersen, Jan A. M. Langermans, Frank Verreck, Sean Ervin, Frank Ervin, Candace McCombs
Konstantin P. Lyashchenko
1Chembio Diagnostic Systems, Inc., Medford, New York
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  • For correspondence: klyashchenko@chembio.com
Rena Greenwald
1Chembio Diagnostic Systems, Inc., Medford, New York
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Javan Esfandiari
1Chembio Diagnostic Systems, Inc., Medford, New York
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David Greenwald
1Chembio Diagnostic Systems, Inc., Medford, New York
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Carol A. Nacy
2Sequella, Inc., Rockville, Maryland
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Susan Gibson
3University of South Alabama, Mobile, Alabama
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Peter J. Didier
4Tulane National Research Primate Center, Covington, Louisiana
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Marc Washington
5Merck Research Laboratories, West Point, Pennsylvania
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Peter Szczerba
5Merck Research Laboratories, West Point, Pennsylvania
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Sherri Motzel
5Merck Research Laboratories, West Point, Pennsylvania
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Larry Handt
5Merck Research Laboratories, West Point, Pennsylvania
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John M. Pollock
6Veterinary Sciences Division, Belfast, United Kingdom
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James McNair
6Veterinary Sciences Division, Belfast, United Kingdom
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Peter Andersen
7Statens Serum Institut, Copenhagen, Denmark
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Jan A. M. Langermans
8Animal Science Group of Wageningen UR, Lelystad, The Netherlands
9Biomedical Primate Research Centre, Rijswijk, The Netherlands
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Frank Verreck
9Biomedical Primate Research Centre, Rijswijk, The Netherlands
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Sean Ervin
10Behavioural Sciences Foundation Laboratories, Basseterre, St. Kitts
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Frank Ervin
10Behavioural Sciences Foundation Laboratories, Basseterre, St. Kitts
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Candace McCombs
2Sequella, Inc., Rockville, Maryland
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DOI: 10.1128/CVI.00230-07
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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.

  • Copyright © 2007 American Society for Microbiology
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PrimaTB STAT-PAK Assay, a Novel, Rapid Lateral-Flow Test for Tuberculosis in Nonhuman Primates
Konstantin P. Lyashchenko, Rena Greenwald, Javan Esfandiari, David Greenwald, Carol A. Nacy, Susan Gibson, Peter J. Didier, Marc Washington, Peter Szczerba, Sherri Motzel, Larry Handt, John M. Pollock, James McNair, Peter Andersen, Jan A. M. Langermans, Frank Verreck, Sean Ervin, Frank Ervin, Candace McCombs
Clinical and Vaccine Immunology Sep 2007, 14 (9) 1158-1164; DOI: 10.1128/CVI.00230-07

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PrimaTB STAT-PAK Assay, a Novel, Rapid Lateral-Flow Test for Tuberculosis in Nonhuman Primates
Konstantin P. Lyashchenko, Rena Greenwald, Javan Esfandiari, David Greenwald, Carol A. Nacy, Susan Gibson, Peter J. Didier, Marc Washington, Peter Szczerba, Sherri Motzel, Larry Handt, John M. Pollock, James McNair, Peter Andersen, Jan A. M. Langermans, Frank Verreck, Sean Ervin, Frank Ervin, Candace McCombs
Clinical and Vaccine Immunology Sep 2007, 14 (9) 1158-1164; DOI: 10.1128/CVI.00230-07
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KEYWORDS

Antibodies, Bacterial
Mycobacterium tuberculosis
Primate Diseases
tuberculosis

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