Xpert^® MTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: hype or hope?

Abstract

Despite the identification of Mycobacterium tuberculosis as the cause of tuberculosis (TB) more than a century ago, diagnosing TB in resource-poor countries remains a challenge, especially in people living with HIV. In the past decade, important research investments have been made towards the development of new diagnostics for TB and the Xpert^® MTB/RIF assay (Cepheid, CA, USA) has emerged as one of the most promising. In this article, we review the current knowledge on Xpert MTB/RIF, discuss the potential value of Xpert MTB/RIF as a point-of-care diagnostic for drug-sensitive and drug-resistant TB, and outline the potential indications for the assay in resource-limited, high-HIV burden settings. We also discuss key research questions that need to be addressed prior to possible large-scale implementation of the assay.

Keywords::

• diagnostics
• GeneXpert^®
• HIV
• NAAT
• nucleic acid amplification test
• resource-limited countries
• tuberculosis
• Xpert^® MTB/RIF

Financial & competing interests disclosure

Annelies Van Rie receives funding from NIH Fogarty (IU2R TW 007370), and NIH NICHD (1R01HD058972). Annelies Van Rie and Liesl Page-Shipp are also funded by NIH FHI (ICOHRTA AIDS/TB U2RTW007370 and U2RTW007373). Liesl Page-Shipp and Ian Sanne receive funding from PEPFAR in a grant by USAID to Right to Care (674-A-00-08-00007-00), and Lesley Scott and Wendy Stevens receive funding from USAID/PEPFAR in a grant to RHRU. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.