Development and analytical validation of a genus-specific Brucella real-time PCR assay targeting the 16S-23S rDNA internal transcribed spacer

Brucellosis is an economically important bacterial disease of both animals and humans. Annually, about 500,000 cases are reported for human brucellosis. However, true incidence is estimated to be 5,000,000 to 12,500,000 cases per year. The diagnosis of the disease remains a challenge and is underreported, due to inconsistency in reports of bacteriological and serological tests, which lack adequate sensitivity and specificity in the diagnosis of the disease. They also are ineffective in confirming brucellosis during early stages of the disease.