India made Tuberculosis diagnostic test 'TrueNat' gets WHO nod for better accuracy

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What is being seen as one of the major steps in eliminating tuberculosis, the WHO Global TB Programme has included an indigenously developed TrueNat tuberculosis technology, developed by Indian scientists , to detect TB and multi-drug resistant TB in view of its high diagnostic accuracy. TrueNat gives results within an hour while the conventional TB tests take at least 24 to 48 hours. The endorsement of indigenously developed diagnostic test by WHO has boosted country's efforts in the direction of Make In India campaign and in its endeavour to eliminate tuberculosis in the country by 2025.

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 TB test, is already part of the National TB Elimination Programme in India.

“It 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.

“It 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 ICMR official said.

Supported by the Department of Health Research (DHR), Union Ministry of Health and Department of Biotechnology (DBT), various indigenous technologies developed by Indian scientists and companies for detection of multi-drug resistant (MDR)/extensively drug-resistant (XDR) TB were reviewed, said the official.

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 recognised molecular assay Gene Xpert in terms of sensitivity and specificity and detection of rifampicin resistance.

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.

Nearly 100 crore people are suffering from TB globally. India accounts for around 27 per cent of these cases, according to a WHO report. The Government aims to rid India of TB by 2025, five years ahead of the target set under the UN Sustainable Development Goals.

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