Rapid, Point-of-Care Diagnosis of Tuberculosis With Novel Truenat Assay: Cost-Effectiveness and Budgetary Impact Analysis for India’s Public Sector

Background: Truenat is a novel, battery-powered molecular assay that rapidly detects tuberculosis (TB) and rifampicin-resistance. Due to its portability, it may be valuable in peripheral healthcare settings in India, the country with the largest TB burden in the world. \nMethods: Using a microsimulation model, we compared four TB diagnostic strategies for HIV-negative adults with suspected 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, 17%; 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.\nResults: Compared 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 detection and not accounting for the “start-up” costs of implementing Truenat in the field. Findings may not be generalizable to settings of high HIV prevalence.\nConclusions: 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.