Kenya’s national TB with support from USAID, STOP TB launch new TB diagnostic tool

KENYA— The Ministry of Health (MoH) Kenya National Tuberculosis (TB) Program and its partners have launched a new diagnostic tool to expand TB diagnosis and management of Antimicrobial Resistance.

In a bid to accelerate the uptake of innovative diagnostic and treatment solutions and improve access to TB services a massive rollout of newer diagnostic equipment valued at 3M USD.

The MoH National TB Program, USAID Kenya, Stop TB Partnership, and Centre for Health Solutions – Kenya (CHS) launched the New Tools Project (iNTP) which includes the installation of 78 Truenat equipment and 8 digital chest X-ray distributed across 47 Counties on need basis.

Installation of Truenat MTB/RIF assay- the latest innovations in Tuberculosis (T.B) diagnostic to strengthen TB care and prevention and serve as an important tool in the diagnosis of Tuberculosis and rifampicin resistance through the Introducing New Tools Project (iNTP).

The Truenat machines are portable, battery-operated molecular TB tests 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.

According to Kennedy Muimi, CHS, USAID Tuberculosis Accelerated Response and Care II (USAID TB ARC II) activity Senior technical officer said, “Truenat MTB/RIF Assay Testing will be very impactful in Kenya’s TB detection and elimination program because of its ability to accurately diagnose the disease at the point of care.”

Muimi added that the TB diagnostic tool provides 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.

New tools to try and curtail rising AMR TB cases

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, beginning in Kenya.

The main factor contributing to the country’s low case detection rate is the limited access to rapid molecular testing, especially in 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.

The tool identifies TB infection quickly and reduces the time it takes to initiate TB preventive therapy, especially among high-risk groups such as healthcare workers, TB household contacts, and prisoners.

Truenat was recommended by WHO in 2020 as the first near-point-of-care rapid molecular test for the detection of TB and rifampicin resistance.

In 2022, Kenya piloted the use of Truenat machines and deployed 38 machines in various public health facilities across the country under ‘the Introducing New Tools Project’.

The study project aimed at improving access to rapid molecular testing through the introduction of diagnostic tests which can efficiently work in peripheral health facilities as a replacement for sputum smear microscopy as mandated by WHO.

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.

As a simple 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.

Currently TB management decision tools in Kenya

The National TB Prevalence Survey (2016) showed that TB 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.

Currently, TB testing services in Kenya are mostly done on the GeneXpert® TB tests supplied by Cepheid.

Moreover, methods for identifying drug resistance profiles for multi-drug resistance T.B (XDR-TB) are very complex to perform since they can take up to 16 weeks to deliver results, and as a result, are often completely unavailable to patients.

As efforts are intensified to ensure that Kenya becomes Tuberculosis (TB) free by 2035 the government is working to ensure that all TB treatment sites are made diagnosis sites.

According to Emily Vukusa, Kakamega County TB, Leprosy and Lung Disease Coordinator, before the installation of the Truenat machine in Navakholo patients had a challenge with TB diagnosis as the facility did not have a GeneXpert machine in the entire Sub- County.

“Before the installation of the Truenat machine in the facility T.B. samples were sent out for GeneXpert tests by a rider which was very inefficient and unreliable due to the bad roads. It was taking more than five days to get the results,” Vukusa added.

Having the Truenat machine at Navakholo, TB case identification has improved in the Sub- County and all facilities in the sub-county now refer their samples to the site.

In 2022 after the facility got the machine, the center diagnosed 121 cases compared to 76 diagnoses done in 2021.

The presence of the machine has improved bacteriological diagnosis given TB is a laboratory diagnosis as per WHO guidelines.

Screening and diagnosis of T.B. are also interrupted by the scarcity of human resources forcing screenings to be done mainly at the T.B. outpatient departments and antiretroviral therapy (ART) clinics with less emphasis on integrating it into other health facilities clinics.

Truenat rollout in Kenya will help in TB diagnostics scale-up, network strengthening, and optimization in the overall context of existing gaps that limit access to and utilization of high-quality diagnostic services to inform intervention to address these gaps.

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