By Samwel Doe Ouma @samweldoe

In July 2022, the Ministry of Health’s National TB Program, 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 was using microscopy and referring samples to Kakamega County referral hospital for geneXpert which is located over 80 kilometers away. The sample networking was suboptimal due to the poor terrain.

“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. This led to late diagnosis and community disease transmission.”

She adds “As a result of having 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.”

In 2022 after we got the machine, we 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. Of the 121 cases reported in 2022, 78 percent were bacteriologically and only 22percent were clinically diagnosed.

The machine has also improved our management of patients as we are able to detect which patient is resistant to rifampicin.

“When we compare our previous diagnostic tests ‘microscopy’ with ‘Truenat’, Truenat has improved our TB case finding across the sub county. Truenat is more sensitive compared to microscopy hence chances of missing TB are very minimal.”

The Truenat machine capability to function off grid has also favored the facility since electricity is unreliable in the area.

32-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 in 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 day in the morning while doing laundry, the cough came back but this time while accompanied by a bloody sputum. It reminded me of the similar symptoms I had in 2017 and was diagnosed with TB. I immediately made up my mind and came to Navakholo where I was requested to produce a sputum for testing,” Ruth shares.

She adds, “Unlike my encounter in 2017 where I had to wait for results for like a week, this time the results were back quickly confirming I had TB. After counseling on the importance of completing treatment and how to not spread the disease to others, I was initiated on treatment the same day. Since then, I am 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.”

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 home,” Ruth concludes

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 rolled out piloting 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).

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.

According to 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 is limited, especially at the lower levels of the health-care system.

She explains that this is because of difficulty in collecting 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 due to the fact that 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 Pediatric cases,” she said.

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.

The platform can test over 40 diseases, such as COVID-19, TB, HCV, HBV, HIV, HPV, Dengue, Malaria, Influenza, Herpes and Typhoid.

Currently TB testing services in Kenya are mostly done on the GeneXpert® TB tests supplied by Cepheid, by contrast, current 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 T.B treatment sites are made diagnosis sites. Government through Global fund support should procure Truenat diagnostics to bridge the diagnostic technology gaps inorder to reach everyone who may need T.B diagnosis services everywhere in the country.

According to Evelyne Kibuchi, Stop T.B partnership- an advocacy arm of national T.B unit- Kenya, low health worker suspicion index, erratic supply of equipment and supplies ecosystem coupled with lack of awareness among members of the public is hindering prompt T.B diagnosis.

She said, “We should increase diagnostic sites in the hard-to-reach areas and adhere to existing T.B diagnostic guidelines to reach our elimination targets.” While the primary aim of tuberculosis (TB) control programs 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 T.B to other members of the public, Evelyne said.

Barriers to access to health centers especially in the periphery counties where patients are forced to travel long distance enduring poor road conditions are adding up the hidden costs of care to already financially impoverished patients therefore impeding diagnosis goals, she adds.

Screening and diagnosis of T.B is also interrupted by 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. “Shortages of laboratory supplies especially due to problems of quantifications and procurements is a problem to diagnosis,” Evelyne Said.

Currently, Truenat has not been 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 intervention to address these gaps.