On January 16, 2020, Indian Council of Medical Research announced a significant development that the WHO Global TB Programme has included an Indian Molecular assay 'TrueNat' as initial test for TB and MDR-TB in view of its high diagnostic accuracy1 .
In a continual effort to eradicate tuberculosis, health care professionals around the globe had made various policies and serious efforts at ground level too. It is a moment of pride for the Department of Health Research (DHR), Indian Council of Medical Research (ICMR) when WHO promoted an indigenous diagnostic technology developed by Indian scientists - "TrueNat" for diagnosis of TB and MDR/XDR–TB.
DHR and Department of Biotechnology (DBT) have reviewed various indigenous technologies for detection of TB and most promising kits were subjected to a double-blind validation in comparison to standard tests at 4 national reference laboratories of the country. After an extensive review and validation studies the 'TrueNat' was found competitive to internationally recognized molecular assay 'Gene Xpert' in terms of sensitivity and specificity and detection of rifampicin resistance. Further this testing was followed by National TB Elimination Programme after recommendations from ICMR.
ICMR conducted the interim analysis and funded the test in four countries (India, Ethiopia, Peru, and Papua-New Guinea). Based upon the data available from the analysis, WHO included 'TrueNat' into its global TB programme to diagnose TB by replacing sputum smear microscopy. 'TrueNat' assay kit is highly cost effective and can be used in a lab without AC and runs on solar operated battery as compared to the internationally recognized assay 'Gene Xpert'
The entry of 'TrueNat' in WHO global TB programme will help provide affordable TB detection and support TB elimination in developing countries and low income countries. The announcement is an achievement for Indian scientists for development of cost-effective and convenient diagnostic kits for TB.
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