Abstract
BackgroundTruenat is a novel molecular assay that rapidly detects tuberculosis (TB) and rifampicin-resistance. Due to the portability of its battery-powered testing platform, it may be valuable in peripheral healthcare settings in India.MethodsUsing a microsimulation model, we compared four TB diagnostic strategies for HIV-negative adults with presumptive TB: (1) sputum smear microscopy in designated microscopy centers (DMCs) (SSM); (2) Xpert MTB/RIF in DMCs (Xpert); (3) Truenat in DMCs (Truenat DMC); and (4) Truenat for point-of-care testing in primary healthcare facilities (Truenat POC). We projected life expectancy, costs, incremental cost-effectiveness ratios (ICERs), and 5-year budget impact of deploying Truenat POC in India’s public sector. We defined a strategy “cost-effective” if its ICER was <US$990/year-of-life saved (YLS). Model inputs included: TB prevalence, 15% (among those not previously treated for TB) and 27% (among those previously treated for TB); sensitivity for TB detection, 89% (Xpert) and 86% (Truenat); per test cost, $12.63 (Xpert) and $13.20 (Truenat); and linkage-to-care after diagnosis, 84% (DMC) and 95% (POC). We varied these parameters in sensitivity analyses.ResultsCompared to SSM, Truenat POC increased life expectancy by 0.39 years and was cost-effective (ICER $210/YLS). Compared to Xpert, Truenat POC increased life expectancy by 0.08 years due to improved linkage-to-care and was cost-effective (ICER $120/YLS). In sensitivity analysis, the cost-effectiveness of Truenat POC, relative to Xpert, depended on the diagnostic sensitivity of Truenat and linkage-to-care with Truenat. Deploying Truenat POC instead of Xpert increased 5-year expenditures by $270 million, due mostly to treatment costs. Limitations of our study include uncertainty in Truenat’s sensitivity for TB and not accounting for the “start-up” costs of implementing Truenat in the field.ConclusionsUsed at the point-of-care in India, Truenat for TB diagnosis should improve linkage-to-care, increase life expectancy, and be cost-effective compared with smear microscopy or Xpert.
Highlights
With approximately 2.8 million cases annually, India has the world’s highest incidence of tuberculosis (TB) [1]
Used at the point-of-care in India, Truenat for TB diagnosis should improve linkage-to-care, increase life expectancy, and be cost-effective compared with smear microscopy or Xpert
We considered a strategy cost-effective if its incremental cost-effectiveness ratios (ICERs) was less than US$990/ year-of-life saved (YLS), an opportunity-based cost-effectiveness threshold that is 50% of India’s 2017 gross domestic product (GDP) per capita (S1 Appendix)
Summary
With approximately 2.8 million cases annually, India has the world’s highest incidence of tuberculosis (TB) [1]. New rapid molecular diagnostics could dramatically increase TB detection and linkage-tocare, which are key components of both the World Health Organization’s (WHO) End TB Strategy and India’s National Strategic Plan for Tuberculosis Elimination 2017–2025 [1,3]. Truenat (Molbio Diagnostics/Bigtec Labs, Goa/Bengaluru, India), is a new chip-based, micro real-time polymerase chain reaction (PCR) test that detects tubercle bacilli in sputum samples in approximately one hour [1,9,10]. Due to the portability of this testing platform, Truenat may be valuable in peripheral healthcare settings, such as designated microscopy centers (DMCs) and primary healthcare facilities in India. Due to the portability of its battery-powered testing platform, it may be valuable in peripheral healthcare settings in India
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