How POC test kits could help end TB by 2030

Representatives anchoring the national TB programmes of 34 high TB burden countries, spanning Asia, Africa and Latin America, met recently in Goa to discuss ways to accelerate action towards achieving the TB-related UN Sustainable Development Goals (SDGs) and ending TB by 2030.

The discussions centered around how they could accelerate progress to achieve the commitments given by political representatives at the UN High-Level Meeting (UNHLM) in 2023. Several world leaders had committed that by the 2027 UNHLM on TB, they would achieve at least 80 per cent reduction in TB incidence by 2030, 90 per cent reduction in TB deaths by 2030, and zero catastrophic costs for TB-affected families. However, progress on these and other goals has been patchy, barring a few noteworthy projects.
The discussions and recommendations from the meeting resulted in the Goa Declaration, a joint accelerated action plan for TB elimination, which is to be submitted to WHO for consideration at the UN High-Level Meeting (UNHLM).

One of the key recommendations was prioritising of taking WHO recommended point-of-care TB screening and diagnostic tools to the people’s doorstep, over optimising existing centralised or semi-centralised or lab-dependent tools or models which often have access barriers, result in diagnostic delays, catastrophic costs, and drop out of people from the care cascade.

Another recommendation reads: Screening everyone for TB regardless of symptoms in high burden settings. With an alarming number of TB prevalence surveys showing that a large number of people with TB are asymptomatic, it is imperative to find all people with TB early enough by deploying evidence-based tools like ultraportable x-rays for population-wide screening (regardless of symptoms) and confirming those with presumptive TB on molecular test upfront. Linking all of them to care will help stop the infection-spread. Increasing use of mobile/ outreach clinic for population-based screening will help. Where appropriate, intensified TB screening of everyone (regardless of symptoms) should be done in private sector facilities too.

Significantly, the Declaration recommends making same day test and treat a reality for everyone with TB including key vulnerable populations. A test which confirms TB while the patient is still in the clinic allows health authorities a better chance to treat confirmed patients, reducing chances of TB infection within the community.

Presentations and discussions over the three day meet, shared data and experiences of the use of some such systems, which were cited in the Declaration as examples that ‘should be considered for a wider scale up in appropriate contexts – along with all other evidence- and science-based approaches to find, treat and prevent all TB.’

All examples featured Goa-based Molbio Diagnostics’ Truenat kit, a point of care (POC) micro-PCR based diagnostic kit, designed and Made in India, used in combination with Molbio’s portable digital X-ray unit, or similar POC interventions from medtech majors.
Endorsed by the WHO in July 2022, as initial tests to identify TB and detect rifampicin resistance in updated policy guidelines, Molbio’s Truenat system has been deployed in India and other high TB burden countries with similar poor/low resource settings.

As Sriram Natarajan, Founder and CEO, Molbio Diagnostics explains, Molbio’s Prorad ultraportable handheld digital X-ray device is being used as a mass screening, population level TB screening tool. Presumptive positive cases are then tested on Molbio’s battery operated Truenat, a real time quantitative micro-PCR system, which gives test results within the hour, at the point of testing, which could be a remote public health centre. Thus it allows health officials to test, report via a real-time data transfer capability through SMS/E-mail/data push and start treatment of TB patients based on the results on the same day.

Globally, the company has over 10,000 installations in over 80 countries, across both public and private sectors, of which India accounts for 6000+ devices. In India, Natarajan says that the company’s Truenat assay is now available at block level TB testing in some states. While Goa became the first state in the country to completely replace microscopy with upfront molecular testing from December 2020, other larger states using Truenat kits include Andhra Pradesh, Orissa, Uttarakhan, Tamil Nadu and Maharashtra.

The public health impact

The Goa Declaration lists several examples where the Truenat has helped health authorities ‘reach out to the unreached’. For instance, the Prorad ultraportable x-ray and Truenat molecular test machines in a backpack of motorcycle riders are reaching difficult to access areas in Delhi and Haryana.

There are early signs that the same day test and treat strategy is paying off. As per the India TB Report 2024, the estimated incidence of TB in 2023 increased slightly to 27.8 lakh from the previous year’s estimate of 27.4 lakh. The actual number of cases reported was 25.5 lakhs. Thus the gap between the estimated incidence and reported cases has reduced. Experts are attributing this reduction to better diagnosis, thanks to increased screening under the government’s Ni-kshay portal tracking all TB patients and the deployment of more accurate and faster POC tests like Molbio’s Truenat assays.

The data from other countries also seems promising. The Declaration quotes examples from the Philippines, Uganda, Bangladesh, Nigeria, Ethiopia, Tanzania, Zambia and Zimbabwe, where the percentage of TB patients missed in previous testing rounds reduced significantly when molecular tests were used. Data has shown that as new TB case notifications rise with the deployment of POC molecular tests, more people get treated and TB treatment success rates also rise in subsequent years.

For instance, consider the Philippines, where Fujifilm ultraportable x-ray and Molbio’s Truenat are being taken from islet to islet in Bantayan municipality in pump boats, to screen, diagnose and treat people with TB. The Goa Declaration document cites that as a result, TB screening of people with presumptive TB went up from 180 in 2021 (before new tools were deployed) to 3153 in 2024; new TB case notification rose from 110 in 2021 to 341 in 2023; and TB treatment success rate was 98 per cent in 2023. Philippines national treatment success rate was 80 per cent as per WHO Global TB Report 2023. TB services have also been made an integral part of a broad range of healthcare services provided by the Bantayan Rural Health Unit, such as, HIV, NCDs, mental health, immunisation, etc.

Beyond TB

While the benefits of same day screening, testing, reporting of TB can fast track the End TB programme and be a game changer, Natarajan reminds us that the Truenat system has already proved its worth in health emergencies, citing its extensive use during the COVID pandemic. In fact he claims that the Truenat kit helped prevent a pandemic, thanks to the quick detection of the Nipah virus in Kerala, allowing authorities to quickly quarantine the initial few patients and prevent the spread.

Summing up, he believes that from a long term capex point of view, the Truenat system is a good investment of public health funding, as the system can be used for multiple diseases. States like Andhra Pradesh and Orissa are going far beyond TB and deploying the same Truenat platform to test for infectious diseases like hepatitis B, hepatitis C, and H1N1.  He says the Truenat real-time PCR platform will continue to expand its basket of tests, beyond infectious diseases to non-communicable diseases such as breast cancer, sickle cell disease, diabetes, and more.

POC devices like hand-held X-ray machines and battery powered micro-PCR kits are evidence of the frugal engineering prowess of India’s medtech entrepreneurs. Their efforts have democratised access to diagnostics tools previously restricted to metros.
However, the speed of their roll out in India could be faster. Better coordination and integration of different health schemes will possibly result in a larger pool of funds, as the same infrastructure can be
optimally used across diseases.

(The author attended part of the United Against TB meeting in Goa on the invitation of Molbio Diagnostics)

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