Implementation and Operational Research: Clinical Impact of the Xpert MTB/RIF Assay in Patients With Multidrug-Resistant Tuberculosis

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Abstract

Background:

The Xpert MTB/RIF assay has been widely implemented in South Africa for rapid tuberculosis (TB) screening. However, its usefulness in management and improving treatment outcomes in patients with multidrug-resistant TB (MDR-TB) remains undefined. The aim of this study was to evaluate the clinical impact of introduction of the Xpert MTB/RIF assay in patients with MDR-TB.

Methods:

We enrolled 921 patients with MDR-TB, who presented to a specialist drug-resistant TB facility in KwaZulu-Natal, South Africa, pre- and post-rollout and implementation of the Xpert MTB/RIF assay. Clinical, laboratory, chest radiograph, and follow-up data from 108 patients with MDR-TB, post-introduction of the Xpert MTB/RIF assay (Xpert group) in November 2010, were analyzed and compared with data from 813 MDR-TB patients from the pre-MTB/RIF assay period (Conventional group), July 2008–2010. Primary impact measure was “treatment success” (World Health Organization definition) at 24 months. Secondary outcomes were time to treatment initiation and disease morbidity.

Results:

There were no significant differences in treatment success rates between the pre-Xpert MTB/RIF and post-Xpert MTB/RIF groups (54% versus 56.5%, P = 0.681). Median time to treatment initiation was 20 days (interquartile range, 13–31) in the Xpert group versus 92 days (interquartile range, 69–120) in the Conventional group (P < 0.001).

Conclusions:

Although use of Xpert MTB/RIF assay significantly reduces the time to initiation of MDR-TB treatment, it had no significant impact on treatment outcomes of patients with MDR-TB. Studies on the impact of the Xpert MTB/RIF assay usage on transmission of MDR-TB are required.

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