As India races to meet its ambitious target of eliminating Tuberculosis (TB) by 2025, the Indian Council of Medical Research’s (ICMR) regional center in Dibrugarh, Assam, has made a significant breakthrough: It has developed an affordable precise TB testing technology priced at just Rs 35, which employs a CRISPR-based system to detect the deadly disease using a patient’s sputum sample.
This innovative testing method, known as the ‘CRISPR-Cas12a-based system’, is not only cost-effective but also efficient. It offers a rapid and precise diagnosis, a critical advancement in the fight against TB, especially in resource-limited settings. The low cost and ease of use make it a promising tool for widespread implementation, potentially accelerating India’s progress toward its TB elimination goal, said an official from the ICMR.
In contrast, conventional TB tests, such as culture, microscopy, and nucleic acid-based techniques, are often time-consuming and require sophisticated equipment. For example, TB cultures can take up to 42 days to confirm a negative result, and other methods may suffer from issues related to sensitivity, specificity, speed, and cost.
“However, the new testing technology can analyze over 1,500 samples in a single run within approximately two and a half hours, offering a significant improvement over traditional diagnostic methods,” said the official about the diagnostic tool developed by Regional Medical Research Centre at Dibrugarh, one of the 26 permanent institutes of ICMR in the country.
. “Current diagnostic methods often exhibit limitations in terms of sensitivity, specificity, speed and cost, emphasizing the need for innovative approaches. Conventional diagnostic techniques for TB commonly rely on culture (which requires 42 days to confirm as TB negative), microscopy, and nucleic acid-based methods. These are time-consuming and may require sophisticated equipment. Additionally, some molecular diagnostic methods, while offering improved sensitivity, may lack the desired specificity or face challenges associated with cost and ease of handling,” said an official from the ICMR.
India has the highest TB burden in the world, accounting for an estimated one-fifth of global cases.
The new CRISPR-Cas12a-based system, branded as ‘GlowTBPCRKit,’ includes an amplification step using a thermal cycler and the ‘RapidGlow’ device. This approach aims to address the limitations of current diagnostic tools by providing a more accurate, rapid, and cost-effective solution for detecting Mycobacterium tuberculosis.
The ICMR is now seeking Expressions of Interest (EoI) from organisations, companies, and manufacturers to commercialize this technology. The ICMR-RMRCNE institute will offer expert guidance and technical support throughout the production and commercialization phases.
According to the India TB report 2024 released by the Union Health Ministry in March, the incidence rate in India had fallen from 237 per lakh population in 2015 to 199 per lakh population in 2022, while the mortality rate had declined from 28 per lakh population in 2015 to 23 per lakh population in 2022.