A technology is developed by Indian scientists to detect tuberculosis and multi-drug resistant TB. The health Minister on Thursday officially said the technology has endorsed by the World Health Organisation (WHO) in the view of its high diagnostic accuracy.
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The Global TB Programme of WHO included the TrueNat TB test in its rapid communication document on the molecular investigative procedure in laboratory medicine and pharmacology. The TrueNat TB test is a new molecular test that detects tuberculosis and Rifampicin drug resistance in about 90 minutes.
Dr. Balram Bhargava the Director-General of Indian Council of Medical Research (ICMR) said the WHO’s endorsement of the technology would enable low and middle-income countries to procure TrueNat for tuberculosis and Rifampicin resistance. Hence, will support the elimination of the disease in developing countries.
Compared to GeneXpert, the TrueNat assay kit is highly cost-effective as it can be used in peripheral centers without an air-conditioned laboratory. As it runs on a battery that can be solar-powered.
A senior health ministry official said, “The kit works in two steps. In the first step, the DNA is extracted from the sputum and the second stage involves the detection of tuberculosis and multi-drug resistant TB.”
ICMR statement said various indigenous technologies that were developed by Indian scientists and companies for detection of multi-drug resistant (MDR)/extensively drug-resistant (XDR) TB were reviewed. And were supported by the Department of Health Research (DHR), and the Ministry of Health and DBT.
A group of experts was selecting the most promising kits and the group was subjected to a double-blind validation in comparison to standard tests at four national reference laboratories of the country.
The ‘TrueNat MTB & Rif’ assay was found to be on par after a precise review, a series of validation, subsequent feasibility studies, and continuous follow-up.
After the recommendations from ICMR, this was taken up by National TB Elimination Programme.
As part of WHO’s pre-qualification process, ICMR funded Indian centers of the FIND-coordinated multi-central, prospective field evaluation study in four countries, such as India, Ethiopia, Peru, and Papua-New Guinea.
WHO replaced the sputum smear microscopy with TrueNat as a test to diagnose TB and sequentially to detect rifampicin resistance in view of its high diagnostic accuracy, in context to an interim analysis of data. The study has completed enrolment at all sites and the final analysis would be undertaken soon by FIND, Geneva, the statement said.
It also added, “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 the diagnosis of TB and MDR/XDR-TB developed by Indian scientists.”
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