WHO Finds High Diagnostic Accuracy of ‘TrueNat’ To Diagnose TB: ICMR
In a significant development, WHO Global TB Programme has included an Indian Molecular assay TrueNat as initial test for TB and MDR-TB developed by Indian scientists, said Indian Council of Medical Research (ICMR) on Thursday.
According to WHO, the TrueNat TB test is a new molecular test that diagnosis TB as well as testing for resistance to the drug rifampicin in about 90 minutes and it has a high diagnostic accuracy.
The TrueNat assay kit is highly cost effective as compared to GeneXpert and can be used in peripheral centres without an AC lab and runs on battery which can be solar powered.
“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 Department of Health Research (DHR) and Director General of ICMR.
“It is a matter of pride for Indian Council of Medical Research (ICMR), Department of Health Research (DHR) as this was a long journey for promoting Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR–TB developed by Indian scientists,” said Dr Bhargava.
“After a stringent review and a series of validation and continuous follow-up, the ‘TrueNat’ assay was found to be at 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,” he said.
Most promising kits were selected by the ‘Expert Group’ and were subjected to a double blind validation in comparison to standard tests at 4 national reference laboratories of the country, said ICMR official.
“As a part of WHO prequalification process, the ICMR funded Indian centres in four countries (India, Ethiopia, Peru, Papua-New Guinea) did field evaluation study. Based on the interim analysis of the data, WHO included TrueNat as test to diagnose TB (i.e. replacing sputum smear microscopy) and to sequentially detect rifampicin resistance in view of its high diagnostic accuracy,” said the official.
The study has completed enrolment at all sites and the final analysis would be undertaken soon by Foundation for Innovative New Diagnostics (FIND),Geneva.