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Indigenous rt-LAMP Assay Developed for Fast, Early Tuberculosis Diagnosis in India

India Developed Indigenous rt-LAMP Assay For Rapid, Early TB Detection

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India Developed Indigenous rt-LAMP Assay For Rapid, Early TB Detection
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Description

In a significant step towards strengthening India’s battle against tuberculosis, researchers at the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram have successfully developed a cutting-edge, indigenous real-time Loop-Mediated Isothermal Amplification (rt-LAMP) assay. This innovative diagnostic tool promises rapid, cost-effective, and highly accurate detection of Mycobacterium tuberculosis, the bacteria responsible for TB.

About rt-LAMP

The rt-LAMP assay is a next-generation molecular diagnostic technique, comparable to globally used technologies such as GeneXpert and Truenat. It is uniquely designed to detect TB DNA with high precision, even when bacterial presence is as low as 10 copies per microlitre, making it suitable for early-stage detection a critical factor in TB control and prevention.

Unlike the conventional real-time polymerase chain reaction (RT-PCR), which requires cycling through three temperature phases for DNA amplification, the rt-LAMP test operates at a constant temperature, typically around 60–65°C. This simplifies the testing process significantly, reducing the need for expensive and complex equipment.

rt-LAMP Works

  • Primer Use - The assay utilizes six primers, as opposed to two in RT-PCR. This enhances the specificity and speed of the reaction, reducing the chances of false results.

  • Rapid Results - Test results are produced within 10 to 20 minutes, a major improvement over traditional PCR methods that may take hours.

  • Fluorescent Dye Advantage - The team adopted a fluorescent dye (Syto 16), commonly used in cell biology, to detect amplified DNA. Unlike previous dyes that interfered with the LAMP reaction, Syto 16 does not inhibit the test, resolving the problem of false negatives that plagued earlier LAMP-based diagnostics.

Regulatory And Commercial Developments

  • The Central Drugs Standard Control Organisation (CDSCO) has approved the rt-LAMP assay for use.

  • The technology has been licensed to industrial partners for mass production, allowing for broader distribution and integration into healthcare systems.

  • The assay is currently undergoing validation by the Indian Council of Medical Research (ICMR).

  • The World Health Organization’s Health Technology Access Pool (HTAP) is also evaluating the technology, pending ICMR validation.

Importance For India TB Eradication Goals

Despite increasing molecular testing infrastructure, TB diagnosis in India remains heavily reliant on outdated methods:

  • In 2023, 79% of suspected TB cases were still being screened via sputum smear microscopy, a century-old technique with limited sensitivity.

  • Only 21% of cases were tested using molecular diagnostics, though the number of labs conducting such tests increased from 5,090 in 2022 to 6,496 in 2023.

The introduction of this cost-effective, rapid, and highly sensitive diagnostic tool could transform India’s TB screening landscape. It addresses several critical gaps:

  • Reduces dependence on smear microscopy.

  • Enables widespread deployment, even in resource-limited settings.

  • Accelerates case detection, helping to reduce transmission rates and improve treatment outcomes.

Support For National TB Elimination Programme (NTEP)

The National Strategic Plan (2017–2025) for TB elimination has set ambitious targets to reduce TB prevalence and mortality. The rt-LAMP assay directly supports these goals by:

  • Offering early and accurate diagnosis.

  • Being scalable and affordable, ideal for deployment across urban and rural India.

  • Encouraging a paradigm shift from outdated techniques to modern molecular diagnostics.

With this breakthrough, India takes a promising step closer to its goal of eliminating tuberculosis by 2025, improving public health resilience and reducing the national disease burden.


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