The Foundation for Innovative New Diagnostics (FIND), Molbio Diagnostics and the Indian Council of Medical Research (ICMR) announced today that the World Health Organization (WHO) has now endorsed three of their rapid molecular Truenat™ assays for initial diagnosis of tuberculosis (TB) and subsequent detection of rifampicin resistance in adults and children with signs and symptoms of pulmonary TB. Both Truenat MTB and Truenat MTB Plus detect Mycobacterium tuberculosis bacteria for TB diagnosis, while Truenat MTB-RIF Dx identifies resistance to rifampicin, the most commonly used first-line treatment. All three tests are run on the portable, battery-operated Truenat device and provide results in less than an hour.
TB remains the leading cause of death from an infectious disease worldwide, with around 10 million cases and 1.5 million deaths in 2018. Drug-resistant TB poses a particular threat, with growing resistance to rifampicin and other drugs that treat TB. In 2018, around half a million new cases of rifampicin-resistant TB were diagnosed. To reach the target of ending TB by 2030, urgent action is needed to close the gap in TB diagnosis and treatment, particularly in low-resource settings. Bringing sensitive TB diagnosis and drug susceptibility testing closer to patients is a key priority for global TB control, but requires robust point-of-care diagnostic tests that are easily implementable at lower levels of the healthcare system.
The Truenat tests use real-time micro polymerase chain reaction (PCR) technology. Truenat devices function in a wide range of environmental conditions with minimal user input, making them suitable for use in primary healthcare settings that typically have fewer facilities than the reference laboratories in which rapid molecular tests are usually conducted.
Truenat was developed by Bigtec Labs, the R&D subsidiary of Molbio Diagnostics. ICMR conducted multicentre validation of Truenat MTB and Truenat MTB-RIF Dx assays followed by the feasibility study under the national programme and found them to be on par with the internationally recognized Xpert® MTB/RIF molecular assay (Cepheid, Sunnyvale, USA) in terms of sensitivity and specificity, and detection of rifampicin resistance. Truenat assays have now been incorporated into the India National TB Elimination Programme (NTEP) after recommendations from ICMR.
The performance and accuracy of the Truenat assays has been assessed by FIND in a real-world multicentre diagnostic accuracy study conducted in India, Peru, Ethiopia, and Papua New Guinea. The study determined the diagnostic accuracy of the Truenat tests when performed in peripheral laboratories, compared with culture as the reference standard as well as the internationally recognized Xpert MTB/RIF Ultra and Xpert MTB/RIF assays. These FIND results also indicate that the Truenat tests have accuracy comparable with Xpert MTB/Ultra and Xpert MTB/RIF, and can be performed in peripheral laboratories and primary health centres, at temperatures up to 40 °C and in the absence of reliable electricity. Alongside endorsement by WHO, the Truenat tests are listed by the Global Fund to Fight AIDS, Tuberculosis and Malaria as eligible for procurement and are also planned to be added to the diagnostics catalogue of the Stop TB Partnership’s Global Drug Facility (GDF).
We are thrilled to have WHO endorsement of Truenat as a point-of-care platform that would help universal access to TB molecular diagnostics in countries with endemic TB. India has already leveraged the power of Truenat to decentralize TB detection and we look forward to working with other national TB programmes to help achieve their TB elimination goals.”
Sriram Natarajan, CEO of Molbio Diagnostics
“It is a matter of pride for ICMR, Department of Health Research (DHR) New Delhi as this was a long journey for ICMR in advancing indigenous diagnostic technologies for diagnosis of TB and MDR/XDR-TB developed by Indian scientists. Truenat is already accepted for use under the NTEP in India. Endorsement of Truenat by WHO will enable other low-and middle-income countries to procure Truenat for diagnosis of TB and rifampicin resistance, thus supporting TB elimination in developing countries,” said Dr Balram Bhargava, Secretary DHR and Director General ICMR.
Dr César Ugarte-Gil, a lead investigator at the Universidad Peruana Cayetano Heredia site in Lima, Peru, said, “Delays and quality in diagnosis affects the TB cascade of care, and the WHO endorsement of Truenat provides a robust molecular testing option available for primary health centers, where most of the people with TB are seeking care. With a prompt diagnosis we not only help the people with TB, but also we can reduce the risk of transmission in the community.”
The new WHO guidance addresses the need for expanding access to rapid testing that represents the most critical barrier for millions of people who seek care for TB and drug-resistant TB. We now need to work together towards ensuring universal access to rapid molecular tests. This will impact positively on reducing transmission and enabling faster access to accurate life-saving treatment that will lead to better outcomes for those affected.”
Dr Tereza Kasaeva, Director of the WHO Global TB Programme
“Every year, millions of people with TB miss out on quality care, usually because their infection remains undiagnosed,” said Catharina Boehme, CEO of FIND. “The WHO endorsement of Truenat will enable molecular diagnostics – today’s gold standard test type – to be made available in primary care settings that are much more easily accessible for many people than a hospital or specialist TB centre. This will have a great impact on reducing life-threatening delays in the diagnosis and treatment of TB.”
The independent evaluation studies conducted by FIND were supported by the Indian Council of Medical Research (ICMR) and the Bill & Melinda Gates Foundation.