Rapid, Point-of-care Diagnosis of Tuberculosis with Novel Truenat Assay: Cost-effectiveness and Budgetary Impact Analysis for India’s Public Sector

Background: Point-of-care (POC) tuberculosis (TB) diagnostics may dramatically improve TB outcomes. Truenat is a new, battery-powered RT-PCR device that rapidly detects TB and rifampin resistance. Due to its portability, it may be valuable in peripheral healthcare settings. We evaluated the cost-effectiveness of Truenat in peripheral labs (designated microscopy centres [DMCs]) and public healthcare facilities in India.

Methods: We used the CEPAC-International microsimulation model to compare 4 TB diagnostic strategies for adult, HIV-negative patients with suspected TB: 1) sputum smear microscopy in DMCs (SSM); 2) Xpert MTB/RIF in DMCs (Xpert); 3) Truenat in DMCs (Truenat DMC); and 4) Truenat in public healthcare facilities (Truenat POC). We projected life expectancy (LE), costs, incremental cost-effectiveness ratios (ICERs), and 5y budget impact of full scale-up. A strategy was cost-effective if its ICER was <US$990/year of life saved (YLS) (i.e., <50% of India annual per capita GDP). Model inputs included: TB prevalence, 20%; sensitivity for TB detection, 92% for Xpert and 89% for Truenat; costs per test, $12.70 for Xpert and $13.20 for Truenat; linkage to care after diagnosis, 84% for DMC-based tests and 95% for POC. We varied these parameters in sensitivity analyses.

Results: Compared to SSM, other strategies increased TB case detection by >6%; Truenat POC increased LE by ~0.3y with ICER $210/YLS (Table 1). Compared to Xpert, Truenat DMC decreased LE and cost, but Truenat POC improved LE by 0.05y and was cost-effective. In multi-way sensitivity analysis at 5y horizon, Truenat POC, at 89% diagnostic sensitivity and linkage to care >86%, was cost-effective and sometimes cost-saving compared to Xpert (Fig 1). The cost-effectiveness of Truenat, relative to Xpert, depended on the interplay of sensitivity and linkage to care. Public-sector implementation of Truenat POC increased healthcare expenditures by $360 million compared to full scale-up of Xpert (Fig 2). Treatment costs, not diagnostic test costs, accounted for most of the difference.

Conclusion: When used at the point of care, Truenat for TB diagnosis should improve linkage to care, increase LE, and be cost-effective compared with SSM or Xpert and, thus, should be more widely utilized in India.