Researchers developed a urine test that accurately detects active tuberculosis in patients who are not coinfected with HIV.
Writing in Science Translational Medicine, Lance A. Liotta, MD, PhD, codirector of the center for applied proteomics and molecular medicine at George Mason University, and colleagues said their new test increases the sensitivity of lipoarabinomannan (LAM) detection by up to 1,000-fold.
According to Liotta and colleagues, although LAM is reliably shed into urine during active TB infection, past tests could detect the TB antigen only in patients who were coinfected with HIV, not in patients who were HIV negative.
“An accurate screening test for active pulmonary tuberculosis is urgently needed for patients who are not coinfected with HIV,” they wrote. “Ideally, such a test would use a noninvasive body fluid such as urine to facilitate utilization in a low-resource setting.”
TB is the world’s No. 1 infectious disease killer, causing 1.5 million reported deaths worldwide in 2014, according to Liotta and colleagues. The respiratory disease was the focus of a recent WHO conference in Moscow and will be just the fifth global health topic to be spotlighted in a U.N. General Assembly high-level meeting late in 2018.
For their study, Liotta and colleagues used a copper complex reactive dye, RB221, embedded in open-mesh hydrogel nanoparticle cages to trap LAM in urine. The technology, which they said improves LAM detection by 100- to 1,000-fold, was used to test pretreatment urine in 48 HIV-negative Peruvian patients with microbiologically confirmed active TB infections.
According to Liotta and colleagues, the new test detected TB infections in the Peruvian patients with a greater than 95% sensitivity and a specificity greater than 80% compared with controls — results they said would need to be validated in a larger cohort.
“This technology has broad implications for pulmonary TB screening, transmission control and treatment management for HIV-negative patients,” they wrote. – by Gerard Gallagher
Disclosures: Liotta and two other authors report being inventors on two U.S. patents owned by George Mason University related to nanocage particles used in the study and owning shares in Ceres Nanosciences, which licensed the rights of the patents. All other authors report no relevant financial disclosures.