VATIS UPDATE Article

The Indian Council of Medical Research (ICMR) is entering the final leg of performance validation and operational feasibility testing of cheaper, locally developed molecular diagnostic test, Truenat MTB, for drug-sensitive and rifampicin-resistant TB. Truenat is developed by the Molbio Diagnostics, India. The company was provided with technical assistance and resources by the Foundation for Innovative New Diagnostics (FIND) to help commercialise Truenat MTB.

ICMR plans to take the test to Public Health Centres, which currently use smear samples to test for TB, with a sensitivity level of only 50%, which is about half of what the newer method has achieved. The diagnostic tool uses sputum samples for diagnosing TB is being tested in the field in 100 designated microscopy centres in 50 districts in 10 States. The one-month study will look at nearly 18,000 samples and the results are expected next month.

The diagnostic tool has already been installed in 80% of designated microscopy centres for testing. Validation study carried by ICMR at four sites in India tested nearly 5,000 samples from 2,500 patients. The samples were also tested for resistance to the drug rifampicin and the results have been encouraging. Based on the results of a preliminary test carried out on 191 patient samples in 2013, the sensitivity of Truenat MTB was found to be over 91% and the specificity was 100%.