David Alland, MD, Contributes to Development of Next-Generation Ultra TB Test

The research lab of NJMS faculty member David Alland, MD, has contributed to the development of a new version of the Xpert MTB/RIF test, the Xpert® MTB/RIF Ultra (Ultra), for the diagnosis of TB and rifampicin resistance. The World Health Organization (WHO) issued a recommendation that Ultra can be used as an alternative to the existing Xpert MTB/RIF test for diagnosing TB and detecting rifampicin resistance in all settings.

TB killed 1.8 million people in 2015 and caused TB disease in 10.4 million. An estimated 580,000 TB patients were also resistant to rifampicin, a critical first-line TB drug. However, less than 70 percent of new TB cases and only 25 percent of drug-resistant cases were diagnosed or treated in 2015, leaving significant gaps in our understanding of the disease and its global effect on the population. The WHO expert evaluation found that the new Ultra test showed improved performance in detecting TB in difficult-to-diagnose and vulnerable populations, such as children and people living with HIV, and in those with extra-pulmonary TB.

”Ultra performance approaches that of liquid culture, but is faster and easier to use at the point of care,” said Alland, who is a professor of medicine and director of the NJMS Center of Emerging Pathogens.

The existing test, Xpert MTB/RIF, was introduced in 2010 and transformed the landscape of TB diagnosis by offering rapid, sensitive diagnosis of TB and rifampicin resistance. As of 2016, more than 23 million Xpert MTB/RIF tests have been procured in 130 countries and multidrug-resistant TB (MDR-TB) detection has more than tripled. However, sensitivity of Xpert MTB/RIF is imperfect in smear-negative and HIV-associated TB, and some limitations also remain in the determination of rifampicin-resistance status using the existing test.

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