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The World Health Organization (WHO) has endorsed rapid molecular Truenat assays by three research bodies, including ICMR, for initial diagnosis of tuberculosis (TB) and subsequent detection of rifampicin resistance in adults and children.

Rifampicin is a standardized drug that is used to treat Tuberculosis.

In a joint statement, the Foundation for Innovative New Diagnostics (FIND), Molbio Diagnostics and the Indian Council of Medical Research (ICMR) said the WHO has now endorsed three of their rapid molecular Truenat TM assays for initial diagnosis of TB and subsequent detection of rifampicin resistance in adults and children.

“Both Truenat MTB and Truenat MTB Plus detect Mycobacterium tuberculosis bacteria for TB diagnosis, while Truenat MTB-RIF Dx identifies resistance to rifampicin, the most commonly used first-line treatment.

“All three tests are run on the portable, battery-operated Truenat device and provide results in less than an hour,” they said in a statement.

Noting that TB remains the leading cause of death from an infectious disease worldwide, with around 10 million cases and 1.5 million deaths in 2018, they said drug-resistant TB poses a particular challenge, with growing resistance to rifampicin and other drugs that treat the disease.

“In 2018, around half-a-million new cases of rifampicin resistant TB were diagnosed. Urgent action is needed to close the gap in TB diagnosis and treatment, particularly in low-resource settings, to reach the WHO target of ending TB by 2030,” the statement said.

To that end, bringing sensitive TB diagnosis and drug susceptibility testing closer to patients is a key priority for global TB control, but requires robust point-of-care diagnostic tests that are easily implementable at lower levels of the healthcare system, it said.

“This is a matter of pride for ICMR, Department of Health Research (DHR), New Delhi. It was a long journey to advance indigenous diagnostic technologies for the diagnosis of TB and MDR/XDR-TB. Truenatis already accepted for use under the NTEP in India.

“Endorsement of Truenat by WHO will enable other low-and middle-income countries to procure Truenat for diagnosis of TB and rifampicin resistance, thus supporting TB elimination in developing countries,” the statement quoting Balram Bhargava, Secretary DHR and Director General – ICMR said.

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