Kenya pilots use of Truenat molecular platform for Tuberculosis diagnosis

By Samwel Doe Ouma @samweldoe
The Ministry of Health Kenya (MoH), The National Tuberculosis, Leprosy and Lung Disease Program(NTLD-P), United States Agency for International Development (USAID), Stop TB Partnership and Centre for Health Solutions – Kenya (CHS) and other partners have rolled out piloting of Truenat MTB/RIF assay- the latest innovations in Tuberculosis (T.B) diagnostic to strengthen TB care and prevention, serve as an important tool in the diagnosis of Tuberculosis and rifampicin resistance through the Introducing New Tools Project (iNTP).
According to Kennedy Muimi, CHS, USAID Tuberculosis Accelerated Response and Care II (USAID TB ARC II) activity Senior technical officer, supporting laboratory systems, Kenya is piloting use of Truenat MTB/RIF assay to improve access to TB diagnosis. The Truenat machines are portable, battery-operated molecular TB test that can be easily used in hard-to-reach areas where reliable electricity supply is not assured, or where there is a need to conduct community outreaches to diagnose TB among various key populations.
“Truenat MTB/RIF Assay Testing will be very impactful in the Kenya’s TB detection and elimination program because of its ability to accurately diagnose the disease at the point of care and provide test results in less than an hour for TB negative cases and less than two hours for the MTB detected cases that would require reflex Rifampicin resistance testing. It is very effective in our setting because most of our cases are found in rural and remote areas and it works in a limited resource settings, diagnosis and treatment initiation can happen on the same day,” Muimi said.
Under the ‘introducing New Tools Project (iNTP)’, Molbio Diagnostics manufacturers of Truenat MTB/RIF Assay in collaboration with Stop TB Partnership, USAID and United Nations Office for Project Services (UNOPS) to undergo a multi-country roll-out of Truenat in 11 countries with high burden TB cases, Kenya being one of them, Muimi further reveled to health Business in an interview in Nairobi.
Muimi says that one of the main factors contributing to the country’s low case detection rate is the limited access to rapid molecular testing especially in the private hospitals and lower-level healthcare facilities: only half of the people with TB get tested with a rapid molecular test at the time of diagnosis.
“Truenat MTB/RIF Assay Testing will provide patient-centric, and patient-led treatment monitoring among those already diagnosed with TB, identify TB infection quickly and reduce the time it takes to initiate TB preventive therapy, especially among high-risk groups such as health care workers, TB household contacts and prisoners,” he told Health business magazine in an interview adding that “We are doing a pilot study that will inform the world on recommendations ,challenges and advantages of the new tool.”
Truenat was recommended by WHO in 2020 as the first near point-of-care rapid molecular test for detection of TB and rifampicin resistance.
He says that Kenya is piloting use of truenat machines and has deployed 38 machines in various public health facilities across the country under ‘the introducing New Tools Project’ which aims at improving access to rapid molecular testing through the introduction of diagnostic test which can efficiently work in peripheral health facilities as a replacement of sputum smear microscopy as mandated by WHO.
“Introducing New Tools Project (iNTP), is a collaboration between the Ministry of Health National TB Program, the United States Agency for International Development (USAID), Stop TB Partnership and the Centre for Health Solutions – Kenya (CHS),” he explained.
The Truenat MTB/RIF Assay Testing systems will help to bridge gaps in molecular diagnosis for TB for populations in hard-to-reach areas where they have been installed and at relatively cheaper set-up costs in terms of infrastructure. Its impact on finding missing TB cases has been impressive, he added.
He added that “It is battery-powered and uses room-temperature stable reagents, generates TB results in one hour, and is designed for operation in peripheral laboratories with minimal infrastructure, and minimally trained lab technicians.”
It has a higher sensitivity rate and can serve as an important tool in the diagnosis of Tuberculosis and rifampicin resistance. It can be used as the first-line diagnostic test for the evaluation of presumptive TB, he added.
Truenat MTB/RIF Assay Testing systems have in-built batteries allowing for 8 hours of use, can be used in temperatures up to 40 degrees Celsius, and have inbuilt connectivity functionalities.
The National TB Prevalence Survey (2016) showed that Microscopy misses close to 50 percent of Kenya’s Tuberculosis (TB) cases given the low sensitivity. Health facilities in the private sector contribute significantly to the missing TB cases since 42 percent of patients with TB symptoms first seek care from private providers.