WHO endorses TB test developed by Indian scientists
A novel diagnostic test for tuberculosis has been endorsed by the World Health Organisation beholding to its “high diagnostic accuracy”. 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 a molecular investigative procedure in laboratory medicine and pharmacology.
This TB test has been developed by Goa-based Molbio Diagnostics. They received the technical assistance and resources from the Geneva-based Foundation for Innovative New Diagnostics (FIND) to help commercialise it.
A senior health ministry official said that the TrueNat TB test kit is highly cost-effective as compared to the American GeneXpert. “It can be used in peripheral centres without an AC lab and runs on solar-powered battery, he adds.
The kit works in two steps. The first step extracts DNA from sputum and the second stage involves the detection of tuberculosis and multi-drug resistant TB.
“Endorsement of the TrueNat by the WHO would enable other low and middle-income countries to procure TrueNat for TB and Rifampicin resistance and support TB elimination programme in developing countries,” said Dr Balram Bhargava, Secretary DHR and DG ICMR.
The department of Health Research with support from the Ministry of Health and DBT has picked the TrueNat kit after reviewing several indigenous technologies developed by Indian scientists and companies for detection of MDR/XDR TB.
The review was conducted at four national laboratories in the country, where scientists compared the new test to current diagnostics for tuberculosis.
“After a stringent review, series of validation, feasibility studies and continuous follow-up, the ‘TrueNat M.TB & Rif’ assay was found to be at par with the internationally recognized molecular assay Gene Xpert in terms of sensitivity, specificity and detection of Rifampicin resistance. It was also taken up by National TB Elimination Programme after recommendation by the ICMR,” the ICMR said in a statement.
Along with this, the ICMR has also funded the Indian centres of the FIND-coordinated multi-central, prospective field evaluation study in India, Ethiopia, Peru, Papua-New Guinea for the new TB test. The final analysis of the data collected from this study would be done soon by FIND in Geneva.
Source: The Week, Deccan Herald.