Made-in-India TB diagnostic tests validated by ICMR

In a boost to India’s fight against tuberculosis, apex health research body ICMR has validated new indigenously developed tools that could bolster the country’s diagnostic capacity and offer a cheaper detection option.

Eliminating tuberculosis (TB) depends crucially on the ability to detect early, accurately, and universally, to initiate patients on treatment and curb community transmission.

Among the recently validated tools is Quantiplus MTB FAST detection kit, developed by Huwel Lifesciences in Telangana, the Indian Council of Medical Research (ICMR) said in a note.

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Quantiplus is the first open system RT-PCR assay validated for the detection of lung TB as it can run on any existing PCR machine and is not limited to proprietary platforms.

“This means, laboratories across India, even those without specialised ‘closed’ equipment, can now expand rapid molecular TB testing using standard PCR machines,” a source explained.

Furthermore, Quantiplus can test as many as 96 samples simultaneously. Detecting TB in adults via sputum samples, this innovation not only enhances capacity but stands to make a dramatic difference in costs and estimates suggest it could reduce the price of TB testing by as much as one-fifth, the source said.

This new approach empowers public sector laboratories to scale up testing without incurring heavy investment in new machinery, enabling broader, more affordable access.

The second homegrown innovation validated by the ICMR is UniAMP MTB Nucleic Acid Test Card, also manufactured by Huwel Lifesciences, the ICMR note stated.

This marks a milestone in patient-friendly diagnostics as now patients can be tested using non-invasive tongue swabs instead of sputum samples which are difficult to produce, especially for children and the elderly, an official source said.

Traditionally, TB diagnosis has required invasive or difficult procedures to obtain quality sputum samples but tongue swabs provide a more comfortable, non-invasive alternative, and offer the possibility of doorstep TB diagnosis, supporting large-scale community screening efforts and widening the reach of life-saving TB care.

“Through ICMR’s rigorous and streamlined validation process, we are ensuring that innovative TB diagnostics are validated quickly. This effort reflects India’s resolve to strengthen indigenous research and innovation, close gaps in early detection and treatment, and ultimately help the country to move closer to eliminating tuberculosis as a public health challenge,” Dr Nivedita Gupta, Head, Communicable Diseases Division, ICMR, said.

These new tools follow upgrades in existing tools, Truenat and PathoDetect, that help decentralise high-precision Nucleic Acid Amplification Tests (NAAT).

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This expansion can reduce delays in TB diagnosis and ensure effective treatment of both drug-sensitive TB patients and those resistant to anti-TB drugs, she added.

The validation of these innovations – encompassing lab systems, decentralised testing, and non-sputum-based point-of-care diagnostics – reflects the government’s commitment towards nurturing a thriving domestic scientific ecosystem.

Should these technologies be deployed at scale, they hold the promise of being gamechangers – making TB testing faster, cheaper, and much more accessible to those who need it most.