Date: 30-Jan-2020

WHO Global TB Programme includes ICMR-developed TrueNat as initial test for diagnosing TB

The World Health Organization's (WHO) Global TB Programme has included Indian Molecular assay TrueNat as initial test for diagnosing tuberculosis (TB) and Multi-drug-resistant tuberculosis (MDR-TB). Developed by Indian scientists, the TrueNat TB test is a new molecular test to diagnose TB as well as testing for resistance to the drug rifampicin in about 90 minutes. The Indian Council of Medical Research (ICMR) and Department of Health Research (DHR) have been promoting “Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR–TB”. It has also been supported by DHR and Department of Biotechnology (DBT) for promoting various indigenous technologies. “Endorsement of the TrueNat by WHO would enable other low and middle income countries to procure TrueNat for TB and rifampicin resistance thus supporting TB elimination in developing countries” said Dr. Balram Bhargava, secretary DHR and director general (DG) ICMR. After a stringent review and a series of validation and subsequent feasibility studies and continuous follow-up, the ‘TrueNat M TB & Rif' assay was found to be at part with the internationally recognised molecular assay Gene Xpert in terms of sensitivity and specificity and detection of rifampicin resistance. National TB Elimination Programme took it up after recommendations from ICMR. In another major effort as part of WHO pre qualification a multi-central, prospective field evaluation study was conducted in India, Ethiopia, Peru, and papua-New Guinea. Based on the interim analysis of the data, WHO included TrueNat as test to diagnose TB (replacing sputum smear microscopy) and to sequentially detect rifampicin resistance in view of its high diagnostic accuracy. ICMR funded the Indian Centers. The study has completed enrolment at all sites and the final analysis would be undertaken soon by FIND, Geneva. The TrueNat assay kit is highly cost effective as compared to GeneXpert and can be used in peripheral centers without an AC lab and runs on battery which can be solar powered.