In many clinical settings, the medical value of a diagnostic result is tied directly to how quickly it can be linked to patient management and/or treatment decisions. Despite notable advances in recent years, molecular diagnostics applications for infectious disease detection have yet to reach their full potential. Often performed in specialized laboratories far removed from where patient care decisions are made, specimens usually spend more time in transit than in actually being analyzed. Further, once samples do arrive in the lab, additional delays are incurred by batch processing. The chief limitations of current first-generation molecular diagnostics approaches are not due to the underlying technology, but rather in how this technology is implemented.

Fortunately, next generation technologies for nucleic acid detection are now evolving in the direction of modern clinical chemistry analyzers, the most successful of which allow for random access, high throughput, and STAT testing capability. This presentation will focus on a case study of a next generation molecular diagnostic test that addresses the needs above, specifically surrounding tuberculosis and drug resistance. The Xpert MTB/Rif test accomplishes this in an easy to use diagnostic cartridge. Xpert MTB/Rif was endorsed by the WHO in 2010 and has now reached 108 countries worldwide.