By Sam Doe
IIn July 2022, the Ministry of Health’s National TB Programme, USAID Kenya, Stop TB Partnership, Centre for Health Solutions – Kenya (CHS), through the Introducing New Tools Project (iNTP), installed a Truenat machine to strengthen TB diagnosis in the Navakholo Sub-County Hospital.
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. Previously, the facility used microscopy and referred samples to the Kakamega County Referral Hospital for GeneXpert testing, located over 80 kilometres away. The sample networking could have been more optimal due to the poor terrain.
“Before the Truenat machine was installed in the facility, TB samples were sent out for GeneXpert tests by a rider, which was very inefficient and unreliable due to the bad roads. It took more than five days to get the results. This led to late diagnosis and community disease transmission.”
Emily Vukusa
She adds, “Due to having a Truenat machine at Navakholo, TB case identification has improved in the sub-county. All facilities in the sub-county now refer their samples to the site.”
Since the installation of the Truenat machine in 2022, the Navakholo facility has diagnosed 121 TB cases, a significant increase from the 76 cases in 2021. This machine has not only improved bacteriological diagnosis, aligning with WHO guidelines but also enhanced patient management by identifying rifampicin resistance. Of the 121 cases diagnosed, 78% were confirmed through bacteriological diagnosis, demonstrating the machine’s effectiveness in TB detection and patient care.
“When we compare our previous diagnostic tests and microscopy with Truenat, Truenat has improved our TB case finding across the sub-county. Truenat is more sensitive than microscopy, so the chances of missing TB are minimal.”
The Truenat machine’s unique feature of functioning off-grid has been a significant advantage for the Navakholo facility, given the area’s unreliable electricity supply. This adaptability ensures that the machine can be used in various healthcare settings, including those with limited resources, thereby improving access to TB diagnosis and patient care.
Battle for five years
Thirty-two-year-old Ruth Waithera, a mother of two boys and a resident of the area, is one of the beneficiaries of the Truenat machine at Navakholo. When she presented at the facility after coughing up blood while doing laundry, she expected to be diagnosed with TB as she had battled the disease five years ago after having similar symptoms as those experienced that day, but not as fast as it happened.
“One day in November 2022, I started coughing at night, but the cough went away. The following morning, while doing laundry, the cough returned, but this time, it was accompanied by bloody sputum. It reminded me of the similar symptoms I had in 2017 and was diagnosed with TB. I immediately decided to come to Navakholo, where I was requested to produce sputum for testing”
Ruth Waithera
She adds, “Unlike my experience in 2017 where I had to endure a week of uncertainty, this time the results were back quickly, confirming I had TB. After counselling on the importance of completing treatment and how not to spread the disease to others, I was initiated on treatment the same day. Since then, I have been progressing well. The coughing is gone. My weight has increased from 55 to 58 kilograms, and I look forward to completing treatment to be completely cured.” This quick turnaround in diagnosis and treatment initiation has brought a sense of relief and comfort to patients like Ruth, making their journey towards recovery smoother and less stressful.
Her husband and children were also tested for TB using the Truenat machine. None of them had developed active TB disease, and because they were her contacts and she had active TB disease, they were put on TB preventive therapy treatment to protect them from developing active TB disease.
“We are all progressing well with our treatments. I am grateful that the TB services are now readily available, free of charge, and closer to home,” Ruth concludes.
The Ministry of Health Kenya (MoH), The National Tuberculosis, Leprosy and Lung Disease Programme (NTLD-P), the United States Agency for International Development (USAID), the Stop TB Partnership and Centre for Health Solutions – Kenya (CHS) and other partners have come together to roll out the piloting of Truenat MTB/RIF assay—the latest innovations in Tuberculosis (TB) diagnostics. This collaborative effort is a testament to the collective commitment to strengthen TB care and prevention and serve as an essential tool in the diagnosis of Tuberculosis and rifampicin resistance through the Introducing New Tools Project (iNTP).
WHO recommendation
AAccording 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 Truenat MTB/RIF assay to improve access to TB diagnosis. 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 vital populations.
“Truenat MTB/RIF Assay Testing will be a game-changer in Kenya’s TB detection and elimination programme. 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, is a significant step forward. It is very effective in our setting because most cases are found in rural and remote areas, and it works in limited resource settings. Diagnosis and treatment initiation can happen on the same day”
Muimi said, instilling a sense of optimism and hope for the future of TB diagnosis and treatment in Kenya.
Under the Introducing New Tools Project (iNTP), Molbio Diagnostics, manufacturers of Truenat MTB/RIF Assay, in collaboration with Stop TB Partnership, USAID, and the United Nations Office for Project Services (UNOPS), will undergo a multi-country roll-out of Truenat in 11 countries with high-burden TB cases, Kenya being one of them, Muimi further revealed 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 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 healthcare 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.”
WHO recommended Truenat in 2020 as the first near-point-of-care rapid molecular test for detecting TB and rifampicin resistance.
He says that Kenya is piloting the 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 tests which can efficiently work in peripheral health facilities as a replacement for sputum smear microscopy as mandated by WHO.
“The Introducing New Tools Project (iNTP) is a collaboration between the Ministry of Health National TB Programme, the United States Agency for International Development (USAID), Stop TB Partnership, and the Centre for Health Solutions—Kenya (CHS)”
Kennedy Muimi
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, “It is battery-powered and uses room-temperature stable reagents. It generates TB results in one hour and is designed for operation in peripheral laboratories with minimal infrastructure and minimally trained lab technicians.”
He added that it has a higher sensitivity rate and can be an essential tool for diagnosing Tuberculosis and rifampicin resistance. It can also be used as the first-line diagnostic test to evaluate presumptive TB.
According to Sellestine Ochieng, Marketing Team Lead, Steplabs Technical Ltd—Molbio representatives in Kenya, although screening among children is often performed during medical encounters, presumptive TB case identification and subsequent diagnostic capacity are limited, especially at the lower levels of the healthcare system.
Screening and Diagnosis
She explains that this is because it is challenging to collect sputum specimens from infants and young children, and the laboratory tests used to find TB in sputum are less likely to have a positive result in children. This is because children are more likely to have TB disease caused by a smaller number of bacteria (paucibacillary disease).
“Truenat has developed the detection of TB from stool specimens primarily for paediatric cases”
Sellestine Ochieng, Marketing Team Lead, Steplabs Technical Ltd—Molbio
Truenat MTB/RIF Assay Testing systems have built-in batteries that allow eight hours of use, can be used in temperatures up to 40 degrees Celsius, and have built-in connectivity functionalities.
The National TB Prevalence Survey (2016) showed that, given its low sensitivity, microscopy misses nearly 50% of Kenya’s Tuberculosis (TB) cases. Health facilities in the private sector contribute significantly to the missing TB cases since 42% of patients with TB symptoms first seek care from private providers.
The platform can test over 40 diseases, including COVID-19, TB, HCV, HBV, HIV, HPV, Dengue, Malaria, Influenza, Herpes, and Typhoid.
TB testing services in Kenya mostly use the GeneXpert® TB tests supplied by Cepheid. By contrast, current methods for identifying drug resistance profiles for multi-drug-resistant TB (XDR-TB) are very complex to perform since they can take up to 16 weeks to deliver results, which are often only sometimes available to patients.
As efforts intensify 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. Through Global Fund support, the government should procure Truenat diagnostics to bridge the diagnostic technology gaps and reach everyone who may need TB diagnosis services everywhere in the country.
According to Evelyne Kibuchi, Stop TB Partnership—an advocacy arm of the national TB unit in Kenya—the low health worker suspicion index, erratic supply of equipment and supplies, and lack of awareness among members of the public are hindering prompt TB diagnosis.
“We should increase diagnostic sites in the hard-to-reach areas and adhere to existing TB diagnostic guidelines to reach our elimination targets.” While the primary aim of tuberculosis (TB) control programmes is to reduce the transmission from infectious TB cases, late diagnosis prolongs the length of exposure to an infectious patient, therefore escalating the spread of TB to other members of the public”
Evelyne Kibuchi
She adds that barriers to access to health centers, especially in the periphery counties where patients are forced to travel long distances enduring poor road conditions, add up to the hidden costs of care to already financially impoverished patients, impeding diagnosis goals.
Screening and diagnosis of TB are also interrupted by a need for more human resources. Screenings are forced to be done mainly at the TB outpatient departments and antiretroviral therapy (ART) clinics, with less emphasis on integrating them into other health facilities’ clinics. “Shortages of laboratory supplies, especially due to problems of quantifications and procurements, are a problem for diagnosis,” Evelyne said.
Truenat has yet to be nationally rolled out in Kenya to help in 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 interventions to address these gaps.