In a significant development, WHO Global Tuberculosis Programme has included an Indian molecular assay as initial test for detecting the disease and for identifying resistant strains of the TB bacteria.
The assay named TrueNet has been included in the rapid communication document on
Molecular Assays released by WHO’s Global TB Programme. It is a new molecular test that
diagnosed TB as well as tests for resistance to the drug rifampicin in about 90 minutes.
The development is a fruition of efforts on the part of Indian Council of Medical Research
(ICMR) to promote indigenous technologies for diagnosis of TB and multi-drug and
extensively drug resistant TB (MDR/ XDR TB).
A team of experts reviewed various technologies developed by Indian scientists and
companies for detection of MDR/XDR TB, with support from Department of Health Research
in Union Ministry of Health and Family welfare, and Department of Biotechnology in Union
Ministry of Science and Technology. The expert shortlisted most promising kits and
conducted double blind validation in comparison to standard tests at four national
reference laboratories of the country.
After a stringent review and a series of validation and subsequent feasibility studies and
continuous follow-up, the TrueNat assay was found to be on par with internationally
recognized molecular assay Gene Xpert in terms of sensitivity and specificity and detection
of rifampicin resistance. Subsequently, National TB Elimination Programme took it up, after
recommendations from ICMR.
In another major effort, as part of WHO pre-qualification process, a multi-central,
prospective field evaluation study was conducted in four countries – India, Ethiopia, Peru,
and Papua-New Guinea. It was coordinated by Foundation for Innovative New Diagnostics
(FIND), a global non-profit organisation driving innovation in the development and delivery
of diagnostics to combat major diseases affecting the world’s poorest population. ICMR
funded the Indian centres of the study.
Based on the interim analysis of the data, WHO included TrueNat as test to diagnose TB,
replacing sputum smear microscopy, and to sequentially detect rifampicin resistance. The
study has completed enrolment at all sites and the final analysis would be undertaken soon.
Announcing the development, a press release from Indian Council of Medical Research said
that the TrueNat assay kit is highly cost effective as compared to the globally accepted
GeneXpert test and can be used in peripheral centres without an air-conditioned laboratory.
It also runs on battery, which can be solar powered.
Secretary, Department of Health Research and Director General, Indian Council of Medical
Research, Dr. Balram Bhargava, said, “Endorsement of TrueNat by WHO would enable other low and middle income countries to procure it for TB and Rifampicin resistance thus
supporting TB elimination in developing countries”. (India Science Wire)