WHO nod for Truenat rapid molecular assays for TB

Representational image

Representational image   | Photo Credit: Liliia Lysenko

World Health Organisation (WHO) has now endorsed three rapid molecular Truenat assays for initial diagnosis of tuberculosis (TB) and subsequent detection of rifampicin resistance in adults and children with signs and symptoms of pulmonary TB.

This according to a release issued by the Indian Council of Medical Research (ICMR) along with Foundation for Innovative New Diagnostics (FIND) and Molbio Diagnostics.

Truenat assays have now been incorporated into the India National TB Elimination Programme (NTEP) after recommendation from ICMR.

Quick results

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.

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

In 2018, around half-a-million new cases of rifampicin-resistant TB were diagnosed.

The independent evaluation studies conducted by FIND were supported by the Indian Council of Medical Research (ICMR) and the Bill & Melinda Gates Foundation, the ICMR said.

In field conditions

“Truenat tests use real-time micro polymerase chain reaction (PCR) technology. Truenat devices function in a wide range of environmental conditions with minimal user input, making them suitable for use in primary healthcare settings that typically have fewer facilities than reference laboratories in which rapid molecular tests are usually conducted.

Truenat was developed by Bigtec Labs, the R&D subsidiary of Molbio Diagnostics. ICMR conducted multicentre validation of Truenat MTB and Truenat MTB-RIF Dx assays followed by a feasibility study under the national programme and found them to be on par with the internationally recognised Xpert MTB/RIF molecular assay in terms of sensitivity and specificity, and detection of rifampicin resistance, notes the release.

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Printable version | Aug 9, 2020 6:19:39 PM |

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