Research assessing the effectiveness of a new diagnostic test for the detection of tuberculosis (TB) is featured in the Sept. 1 edition of the New England Journal of Medicine. A rapid automated molecular test, which was developed as a result of a public-private partnership between scientists at the UMDNJ-New Jersey Medical School, Cepheid and the Foundation for Innovative New Diagnostics (FIND), showed excellent performance in the first large-scale field trial.
Dr. David Alland, Chief of Infectious Diseases at the UMDNJ-New Jersey Medical School, who led the development of the test in collaboration with Cepheid and FIND, was one of the co-authors of the article entitled, "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance." The study focused on the dual detection of TB and drug-resistant forms of TB, in individuals with and without human immunodeficiency virus infection (HIV). The test is known as the "Xpert MTB/RIF" test for Mycobacterium tuberculosis and resistance to rifampin (RIF).
Individuals from Lima, Peru; Baku, Azerbaijan; Cape Town and Durban, South Africa; and Mumbai, India participated in the study. Each of 1,730 individuals, suspected of having drug-sensitive or multidrug resistant pulmonary TB, provided three sputum specimens. The sputum samples were assessed with the Xpert MTB/RIF test, and these results were compared to conventional tests including sputum microscopy and bacterial culture. Researchers found that the Xpert MTB/RIF test diagnosed TB in less than two hours in 99.2 percent of the patients. Importantly, a single Xpert MTB/RIF test detected TB in 72.5 percent of individuals with TB who did not appear to have TB on conventional microscopic examination, but who were later found to have positive TB cultures.