The World Health Organisation (WHO) has endorsed a technology developed by Indian scientists to detect tuberculosis and multi-drug resistant TB in view of its high diagnostic accuracy, health ministry officials said on Thursday. The WHO’s Global TB Programme has included TrueNat TB test — a new molecular test that detects tuberculosis as well as resistance to the drug Rifampicin in about 90 minutes — in its rapid communication document on molecular investigative procedure in laboratory medicine and pharmacology.
According to Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava, the endorsement of the technology by WHO would enable low and middle-income countries to procure TrueNat for tuberculosis and Rifampicin resistance, thus supporting elimination of the disease in developing countries. “The TrueNat assay kit is highly cost-effective compared to GeneXpert and can be used in peripheral centres without an air conditioned laboratory as it runs on battery which can be solar powered. “The kit works in two steps. In the first step, the DNA is extracted from the sputum and the second stage involves detection of tuberculosis and multi-drug resistant TB,” a senior health ministry official said.
Supported by the Department of Health Research (DHR), Ministry of Health and DBT, various indigenous technologies developed by Indian scientists and companies for detection of multi-drug resistant (MDR)/extensively drug-resistant (XDR) TB were reviewed, an ICMR statement said. The most promising kits were selected by an expert group and those were subjected to a double-blind validation in comparison to standard tests at four national reference laboratories of the country.
After a stringent review, a series of validation, subsequent feasibility studies and continuous follow-up, the ‘TrueNat MTB & Rif’ assay was found to be on par with the internationally recognized molecular assay Gene Xpert in terms of sensitivity and specificity and detection of rifampicin resistance. This was taken up by National TB Elimination Programme after recommendations from ICMR. As part of WHO’s pre-qualification process, ICMR funded Indian centres of the FIND-coordinated multi-central, prospective field evaluation study in four countries — India, Ethiopia, Peru and Papua-New Guinea.
Based on the interim analysis of 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. The study has completed enrolment at all sites and a final analysis would be undertaken soon by FIND, Geneva, the statement said. “It is a matter of pride for ICMR, Department of Health Research, New Delhi, as this was a long journey for promoting Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR–TB developed by Indian scientists,” it added.