World TB Day 2022: India To Begin Door-To-Door Tuberculosis Screening Campaign Using Truenat Platform

Door-to-door TB screening campaign will help detect and diagnose millions of patients that go undiagnosed every year, says Sriram Natarajan, CEO of Molbio Diagnostics.

The Government of India is launching a special door-to-door TB screening campaign today on the occasion of World TB Day, which is observed globally on 24 March every year. Molbio Diagnostics' innovative technology platform Truenat would be deployed as a frontline tool in the government's effort towards scaling up TB testing in the country. Truenat is a point-of-care portable, battery-operated, IoT-enabled, real-time PCR platform that can provide test result in less than 1 hour. It was endorsed by World Health Organization (WHO) in 2020 as the world's first point-of-care rapid molecular diagnostic platform for diagnosis of TB and multidrug resistance.

We spoke to Sriram Natarajan, CEO, Founder and Director, Molbio Diagnostics, to learn more about this technology and the role they are going to play in India's door-to-door tuberculosis screening campaign. Excerpts follow

Q. Can you briefly explain the process of TB screening using Truenat?

In 2020, Truenat became the world's first point-of-care molecular diagnostic platform to get endorsed by the World Health Organization (WHO) as a replacement to smear microscopy for the diagnosis of tuberculosis. The platform is also validated and recommended by the Indian Council of Medical Research (ICMR) and has been adopted by the Indian National Tuberculosis Elimination Program (NTEP) as a frontline tool for diagnosis of TB and Rifampicin resistance.

The Truenat test is performed using a set of 2 single-use disposable consumables a universal micro-fluidic cartridge for purification and extraction of nucleic acids from a clinical sample using the Trueprep AUTO device and a disease-specific microPCR chip pre-loaded with reagents for the PCR reaction on the extracted nucleic acids using the Truelab microPCR analyzer. This lab-in-a-suitcase platform functions in a wide range of environmental conditions with minimal user input, making it suitable for use in primary healthcare settings, providing an automated reporting system and having a real-time data transfer capability for centralized monitoring and analysis for disease surveillance.

The Truenat technology is based on detection of nucleic acids (RNA/DNA) from infectious agent(s) using Taqman chemistry (Real-Time Polymerase Chain Reaction). The platform comprises of a portable pair of instruments Trueprep AUTO universal nucleic acid extraction device for a 20-minute fully automated sample prep and Truelab analyzer for a 35-minute 40-cycle real time PCR. The Truelab real time microPCR analyzer is available in three variants - UnoDx, Duo and Quattro that can perform 1, 2 and 4 tests at a time, respectively.

Q. Other than TB screening, what are the other uses of this technology?

Truenat is an innovative real-time PCR platform designed and developed as a rapid, point-of-care solution for testing multiple diseases, that can be deployed across the health care chain right up till the primary level. Truenat can test over 30 different diseases, with tests for over 30 additional diseases in the pipeline. The platform has helped increase rapid testing of various other infectious diseases such as Dengue, Chikungunya, H1N1, Hepatitis and is now playing a critical role in the fight against COVID-19 across India and the world.

Q. Why there is a need for launching door-to-door tuberculosis screening campaign in India?

India is accounted for the largest proportion of people worldwide diagnosed with TB and drug-resistant TB and the big proportion of under-reported or undiagnosed TB cases. The World Health Organization (WHO) advocated for the 'systematic screening' of high-risk population subgroups to increase TB case detection in its 'End TB' strategy.

Systematic screening covers screening for TB at the health facilities or outside the health facilities or both. A proactive screening approach, i.e. active case findings of all individuals within high-risk groups outside health facilities for TB symptoms and linking those with symptoms to TB diagnostic services with an intention to diagnose and treat TB cases could reduce the diagnostic delay and limit out-of-pocket expenditure and reduce TB incidence.

As the key component of active case finding campaign under the National Tuberculosis Elimination Programme (NTEP), the Government of India is all set to launch a special door-to-door TB screening initiative on 24 March 2022 which is globally observed as World TB Day. Under this initiative, over the next two to three weeks, health workers will be visiting the vulnerable population that is potentially exposed to the infection and test those found to have symptoms of the disease. The indigenously developed Truenat platform has been deployed as a frontline tool in the government's effort towards scaling up testing in the country.

Q. What are you expecting from this initiative or collaboration with the government?

This collaboration with the government and ongoing expansion in the roll out of this technology across India will ensure that patients will not have to travel long distances and wait long hours to have access to early and accurate diagnosis. This campaign will definitely help detect and diagnose millions of patients that go undiagnosed every year and curb the further spread of the disease.