A comparison of multidrug-resistant tuberculosis treatment commencement times in MDRTBPlus line probe assay and Xpert® MTB/RIF-based algorithms in a routine operational setting in Cape Town

Pren Naidoo; Elizabeth du Toit; Rory Dunbar; Carl Lombard; Judy Caldwell; Anne Detjen; S Bertel Squire; Donald A Enarson; Nulda Beyers

doi:10.1371/journal.pone.0103328

A comparison of multidrug-resistant tuberculosis treatment commencement times in MDRTBPlus line probe assay and Xpert® MTB/RIF-based algorithms in a routine operational setting in Cape Town

PLoS One. 2014 Jul 31;9(7):e103328. doi: 10.1371/journal.pone.0103328. eCollection 2014.

Authors

Pren Naidoo¹, Elizabeth du Toit¹, Rory Dunbar¹, Carl Lombard², Judy Caldwell³, Anne Detjen⁴, S Bertel Squire⁵, Donald A Enarson⁴, Nulda Beyers¹

Affiliations

¹ Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
² Medical Research Council, Cape Town, South Africa.
³ Cape Town Health Directorate, Cape Town, South Africa.
⁴ The International Union Against TB and Lung Disease, Paris, France.
⁵ Liverpool School of Tropical Medicine, Liverpool, United Kingdom.

Abstract

Background: Xpert MTB/RIF was introduced as a screening test for all presumptive tuberculosis cases in primary health services in Cape Town, South Africa.

Study aim: To compare multidrug-resistant tuberculosis (MDR-TB) treatment commencement times in MDRTBPlus Line Probe Assay and Xpert MTB/RIF-based algorithms in a routine operational setting.

Methods: The study was undertaken in 10 of 29 high tuberculosis burden primary health facilities, selected through stratified random sampling. An observational study was undertaken as facilities transitioned to the Xpert MTB/RIF-based algorithm. MDR-TB diagnostic data were collected from electronic laboratory records and treatment data from clinical records and registers. Kaplan Meier time-to-event analysis was used to compare treatment commencement time, laboratory turnaround time and action delay between algorithms. A facility-level paired analysis was done: the median time-to-event was estimated per facility in each algorithm and mean differences between algorithms compared using a paired t-test. Cox proportional hazards regression was used to assess the effect of patient-level variables on treatment commencement time. The difference between algorithms was compared using the hazard ratio.

Results: The median treatment commencement time in the Xpert MTB/RIF-based algorithm was 17 days (95% CI 13 to 22 days), with a median laboratory turnaround time (to result available in the laboratory) of <1 day (95% CI<1 to 1 day). There was a decrease of 25 days (95% CI 17 to 32 days, p<0.001) in median MDR-TB treatment commencement time in the Xpert MTB/RIF-based algorithm. We found no significant effect on treatment commencement times for the patient-level variables assessed.

Conclusion: MDR-TB treatment commencement time was significantly reduced in the Xpert MTB/RIF-based algorithm. Changes in the health system may have contributed. However, an unacceptable level of delay remains. Health system and patient factors contributing to delay need to be evaluated and addressed to optimise test benefits.

Publication types

Comparative Study
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Algorithms*
Antitubercular Agents / therapeutic use*
Humans
South Africa
Tuberculosis, Multidrug-Resistant / drug therapy*

Substances

Antitubercular Agents

Grants and funding

This research was supported by a United States Agency for International Development (USAID) Cooperative Agreement (TREAT TB – Agreement No. GHN-A-00-08-00004-00). The contents are the responsibility of the authors and do not necessarily reflect the views of USAID. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.