PRIMAGAM®
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About PRIMAGAM®
PRIMAGAM® is a rapid in vitro blood-based assay of cell mediated immunity through the measurement of IFN-γ by a two stage laboratory procedure. The major benefit of using a PRIMAGAM® assay is that the tuberculin Purified Protein Derivative (PPD) is not administered directly into an animal, preventing the potential for adverse reactions as a result of extreme hypersensitivity to PPD. The test results are representative of an animal’s true immune status. Moreover, contrary to other used methods, the immune status of the animal is not affected by the test and retesting of suspect animals can be done immediately. PRIMAGAM® is used widely either in combination with, or as an alternative to, the intradermal Eyelid Skin test.
Test procedure
The PRIMAGAM® test involves two stages. In the first stage, small aliquots of heparinized whole blood are incubated simultaneously with Bovine PPD, Avian PPD or negative (nil) control antigens. In the second stage, IFN-γ produced by the stimulated lymphocytes in whole blood cultures is measured using a monoclonal antibody-based enzyme immunoassay (EIA). Lymphocytes from uninfected non-human primates do not produce measurable quantities of IFN-γ. IFN-γ present in the sample binds to antibodies against IFN-γ bound to a solid support and is visualized with a second anti-IFN-γ antibody labeled with an enzyme that generates a color signal. Color development is proportional to the amount of bound IFN-γ.
Performance
PRIMAGAM® has been evaluated during an outbreak of Tuberculosis in 54 cynomolgus (Macaca fascicularis) and 22 rhesus (Macaca mulatta) macaque monkeys. Overall sensitivity in the two groups was shown to be 92% with 100% specificity. Another evaluation in a separate colony, presumed free of Tb from history and a regular skin testing regime, also resulted in 100% specificity.
In 2007, PRIMAGAM® was fully licensed by the US Department of Agriculture (USDA) for the testing of Cynomolgus and Rhesus Macaques.
