Chembio Diagnostics, Inc. announced that its U.S. Department of Agriculture (USDA)-licensed products, CervidTB STAT-PAK(R) and DPP(R) VetTB, have been approved as primary and secondary tests for bovine tuberculosis by the USDA Animal and Plant Health Inspection Service (APHIS) in order to provide the farmed deer industry with more options for meeting the testing requirements for captive cervids (elk and deer) within the regulations. Based on published results of independent validation studies conducted by the USDA-APHIS, the company's tests can reliably detect the presence or absence of antibodies to bovine tuberculosis in several species of captive cervids. Therefore, the agency has recommended that the captive cervid regulations be amended to recognize these two tests as official tuberculosis tests.

This amendment was made effective as of January 9, 2013 without prior notice and opportunity for public comment in order to immediately provide additional testing options to regulated entities that are required to have their captive cervids tested. Public comments may be submitted to APHIS until March 11, 2013. Testing for tuberculosis in cervids is currently performed using tuberculin skin tests.

The single cervical test (SCT) is the primary (screening) test, whereas the comparative cervical test (CCT) is the secondary test. Limited and conflicting information is available regarding the accuracy of the skin testing in captive cervids. However, according to a published USDA study, 25/28 confirmed M. bovis-infected elk in Nebraska had false-negative results on the SCT(3) .

In addition, animal handling challenges resulting in high morbidity and mortality are not uncommon, as captive cervids may be required to be captured and restrained for testing up to four different times depending on test results.