Impact of rapid molecular diagnostic tests on time to treatment initiation and outcomes in patients with multidrug-resistant tuberculosis, Tamil Nadu, India

Trans R Soc Trop Med Hyg. 2016 Sep;110(9):534-541. doi: 10.1093/trstmh/trw060. Epub 2016 Oct 13.

Abstract

Background: India is replacing culture and drug sensitivity testing (CDST) with rapid molecular tests for diagnosing MDR-TB. We assessed the impact of rapid tests on time to initiation of treatment and outcomes in patients with MDR-TB compared with CDST.

Methods: A retrospective cohort study involving MDR-TB patients from six districts in Tamil Nadu state, who underwent CDST (2010-2011) and rapid tests (2012-2013).

Results: There were 135 patients in the CDST group and 389 in the rapid diagnostic test group. Median time from sputum receipt at the laboratory to initiation of MDR-TB treatment was 130 days (IQR 75-213) in the CDST group and 22 days (IQR 14-38) in the rapid diagnostic test group (p<0.001). Overall treatment success was 30% with CDST and 41% with rapid tests (p<0.05), but there was high loss to follow-up >30% in both groups and missing data were higher in CDST (13%) compared with rapid tests (3%). There were significantly higher risks of unfavourable treatment outcomes in males (aRR 1.3, 95% CI 1.1-1.5) and those with treatment initiation delays >30 days (aRR 1.3, 95% CI 1.0-1.6).

Conclusion: Rapid molecular diagnostic tests shortened the time to initiate treatment which was associated with reduced unfavourable outcomes in MDR-TB patients. This supports the policy to scale up these tests in India.

Keywords: India, Line probe assay; Multidrug-resistant tuberculosis; Rapid molecular tests; Treatment outcomes; Xpert MTB/RIF.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antitubercular Agents / therapeutic use*
  • Female
  • Humans
  • India / epidemiology
  • Male
  • Microbial Sensitivity Tests / methods
  • Middle Aged
  • Molecular Diagnostic Techniques* / methods
  • Mycobacterium tuberculosis / isolation & purification*
  • Policy Making
  • Public Health / methods
  • Retrospective Studies
  • Sputum / microbiology
  • Time-to-Treatment / organization & administration
  • Time-to-Treatment / statistics & numerical data*
  • Treatment Outcome
  • Tuberculosis, Multidrug-Resistant / diagnosis*
  • Tuberculosis, Multidrug-Resistant / drug therapy*
  • Tuberculosis, Multidrug-Resistant / epidemiology
  • Tuberculosis, Multidrug-Resistant / microbiology
  • Young Adult

Substances

  • Antitubercular Agents