In a significant development, an Indian molecular assay has been included as an initial test for the detection of tuberculosis disease and for identifying resistant strains of the TB bacteria, by the WHO Global Tuberculosis Programme.
WHO’s Global TB Programme released the rapid communication document on Molecular Assays which included this assay, named TrueNet. This is a new molecular test, which, in about 90 minutes, diagnosed TB as well as tests for resistance to the drug rifampicin.
To promote indigenous technologies for the diagnosis of TB and multi-drug and extensively drug-resistant TB (MDR/ XDR TB), this development is the fruition of efforts on the part of the Indian Council of Medical Research (ICMR).
With support from the Department of Biotechnology in Union Ministry of Science and Technology and the Department of Health Research in Union Ministry of Health and Family Welfare, a team of experts reviewed various technologies developed by Indian scientists and companies for the detection of MDR/XDR TB. The most promising kits were shortlisted by the experts and double-blind validation in comparison to standard tests at four national reference laboratories of the country was conducted.
In terms of sensitivity and specificity and detection of rifampicin resistance, the TrueNat assay was found to be on par with internationally recognized molecular assay Gene Xpert, after a stringent review and a series of validation and subsequent feasibility studies and continuous follow-up. Subsequently, after recommendations from ICMR, the National TB Elimination Programme took it up.
In four countries – Papua-New Guinea, Peru, Ethiopia, and India, a multi-central prospective field evaluation study was conducted in another major effort, as part of the WHO pre-qualification process. A global non-profit organization to combat major diseases affecting the world’s poorest population by driving innovation in the development and delivery of diagnostics, the Foundation for Innovative New Diagnostics (FIND) coordinated this. The Indian centers of the study were funded by ICMR.
WHO included TrueNat as a test to diagnose TB, replacing sputum smear microscopy, and sequentially detect rifampicin resistance based on the interim analysis of the data. The final analysis will be soon undertaken as the study has completed enrolment at all sites.
A press release from the Indian Council of Medical Research, announcing the development said that when compared to the globally accepted GeneXpert test, the TrueNat assay kit is highly cost-effective and it can be used in peripheral centers without an air-conditioned laboratory. It also runs on a solar-powered battery.
Dr. Balram Bhargava, Secretary, Department of Health Research and Director General, Indian Council of Medical Research, said, Endorsement of TrueNat by WHO would support TB elimination in developing countries as it would enable other low and middle-income countries to procure it for TB and Rifampicin resistance.”
SOURCE Indian test included in the WHO Global TB Programme