Impact and operational feasibility of TrueNat^™ MTB/Rif under India’s RNTCP

Abstract

Background: The Revised National Tuberculosis Control Programme (RNTCP) in Andhra Pradesh, India, introduced TrueNat™ MTB/Rif, a rapid molecular test for detecting Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance at 193 TB units (TUs) in October 2018. We evaluated its impact on TB diagnosis and assessed the operational feasibility of its deployment at point-of-care (POC) settings.Methods: We compared the number of presumptive TB cases tested and the number (proportion) of microbiologically positive before (January–August 2018) and after (January–August 2019) the deployment of TrueNat. We interviewed laboratory technicians and Senior TB Laboratory Supervisor from 25 randomly selected TUs to assess operational feasibility.Results: In 2018, 10.5% (range 8.9–13.1) of 245,989 presumptive cases tested were positive. In 2019, of the 185,435 presumptive cases tested, 13.7% (range 9.6–18.9) were positive. The proportion of presumptive TB cases in whom MTB was detected using TrueNat was 14.4% (range 10.0–21.2). TrueNat significantly increased case detection (incidence rate ratio [IRR] 1.30; 95%CI 1.15–1.46), yielding an additional 18 TB cases per 100 000 population. Laboratory technicians became comfortable in performing TrueNat after a median of 10 tests (interquartile range 5–17.5). Invalid reports declined from 6.8% to 3.6%.Conclusion: The deployment of TrueNat as POC diagnostic test improved case detection and was operationally feasible under RNTCP.

Evaluating diagnostic performance of Truenat MTB Plus for gastrointestinal tuberculosis

“…Further, 70% of the technical staff reported it to be similar or technically less demanding than Xpert. 41 In contrast to these two assays, the cost per It is important to note that although TruPlus fared well in diagnosing GITB in the current study, its negative predictive value was substantially low (69% in the current study). This means that TruPlus, just like Xpert, can only be used for ruling-in GITB, but a negative result cannot rule-out GITB.…”

“…In a cost–benefit analysis by Lee et al ., 42 Truenat was found to have improved linkage‐to‐care and was cost‐effective in the public sector health care of India as a point‐of‐care test. Further, 70% of the technical staff reported it to be similar or technically less demanding than Xpert 41 . In contrast to these two assays, the cost per sample for MPCR was observed to be much cheaper ($10) in the present study; however, it is limited to detection of M. tuberculosis only, without rifampicin susceptibility and requires more hands‐on techniques.…”

“…TruRif was also reported to successfully identify > 90% mutations associated with rifampicin resistance globally. 41 Thus, TruPlus could help in bringing about the required change for TB elimination efforts by identifying those "missing" and "resistant" cases.…”

“…An important factor behind these “missed” cases could be the inherent limitations of the available diagnostic armamentarium to reach these people living in areas with poor connectivity and resources. TruRif was also reported to successfully identify > 90% mutations associated with rifampicin resistance globally 41 . Thus, TruPlus could help in bringing about the required change for TB elimination efforts by identifying those “missing” and “resistant” cases.…”

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

“…In addition, it is not uncommon for nondeterminate results to be higher than normal when a new system is introduced, with improvements seen as operators gain experience with the systems. A recent study found technicians reporting comfort with assay operations after a median of 10 tests, with an associate reduction in invalid test results [ 26 ]. In terms of patient-important outcomes, quicker turnaround from testing to treatment can be expected when testing is conducted at primary healthcare centres.…”