16:04 GMT19 January 2021
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    A less time-consuming and more affordable diagnostic test, locally developed in India, for one of the world’s leading curable killer diseases, tuberculosis (TB), could soon come into commercial use.

    New Delhi (Sputnik) — Truenat MTB for drug-sensitive and rifampicin-resistant TB is entering the final leg of performance validation and operational feasibility testing by the Indian Council of Medical Research (ICMR) – the apex body in India for the formulation, coordination and promotion of biomedical research.

    Developed by a local diagnostics company with technical assistance and resources by the Foundation for Innovative New Diagnostics (FIND), Truenat MBT is a cost-effective molecular test that can be used ‘‘near-patient’’ as a means to curb the TB menace.

    The battery-operated, handheld machine takes about 25 minutes for DNA extraction and another 35 minutes for diagnosing TB. It takes an additional hour for testing rifampicin resistance. Compared with a one ml of sample needed when GeneXpert, a molecular test developed in the US,  is used, only about 0.5 ml is required for a test with Truenat MTB.

    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%.  The results of the study were published in January 2013 in the journal PLOS ONE.

    The other main advantage of Truenat MTB over GeneXpert is that only when samples are tested positive for TB will tests for rifampicin resistance be carried out. That way, the use of reagents may be reduced and will help make testing cheaper.

    With the Truenat MTB test, sputum sample can be tested as soon as a patient starts showing symptoms. The entire set-up, being battery operated and portable, can be deployed even at “low infrastructure” settings of peripheral health care facilities as compared to other available test methods that required special laboratories within a controlled environment. Therefore, it is being pitched as the best TB test variant for wide-scale use in India and other countries of South-East Asia which accounts for 50% of global TB burden.

    Six countries – India, Indonesia, China, Nigeria, Pakistan and South Africa – account for 60 percent of the new TB cases in the world.  India, China and the Russian Federation account for 45 pe cent of multi-drug resistant cases in the world, according to WHO data.

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    Tags:
    diagnostics, Tuberculosis (TB), test, cost, India
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