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iNTP Case Study: Truenat MAY | 2023
THE INTRODUCING NEW TOOLS PROJECT iNTP
Country in Focus: Uganda
Background
Uganda is one of thirty high TB and TB/
HIV burden countries, with an estimated
91,000 people falling ill with TB
annually according to the World Health
Organization (WHO)1. Despite achieving
82% TB detection and treatment
coverage in 2021, limited access to
WHO-recommended rapid molecular
diagnostics (RMD) and the impact of
COVID-19 have contributed to gaps in
TB case finding.
To help improve access to RMD, the Stop TB Partnership
provided 38 Truenat Duo systems and reagents for Uganda
through the introducing New Tools Project (iNTP) funded
by the United States Agency for International Development
(USAID). The introduction of this new diagnostic tool by
the Uganda National TB Reference Laboratory (NTRL) and
the National TB and Leprosy Programme (NTLP) aimed to
increase the detection of individuals with both rifampicin-
susceptible and rifampicin-resistant TB, as well as reduce
diagnostic and treatment delays. Implementation of
activities was supported by the USAID Infectious Disease
Detection and Surveillance (IDDS) Project.
1. WHO Global Tuberculosis Report 2022: https://www.who.int/publications/i/item/9789240061729
Early Experience in Implementation of Truenat
MTB Plus and MTB-RIF Dx Testing in Uganda
Continue reading...
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
Figure 1: Map of 38 Truenat implementation sites (red dots) in Uganda
MASAKA
BUTEBO
ALEBTONG
BUKEDEA
BUSIA
MOROTO
KABAROLE
MASINDI
KAMULI
BUDAKA
MARACHA
TORORO
KAGADI
KALANGALA
BUIKWE
LUWERO
KOLE
AMOLATAR
LAMWO
IBANDA
WAKISO
KAABONG
BUNYANGABU
IGANGA
NAKASONGOLA
KABERAMAIDO
NAMAYINGO
RUKUNGIRI
MUBENDE
BUVUMA
PAKWACH
RUBANDA
LUUKA
SOROTI
KALIRO
OMORO
RUKIGA
KWEEN
AMURU
KITGUM
KYEGEGWA
SERERE
KANUNGU
ZOMBO
BUKWO
KYENJOJO
JINJA
KAPCHORWA
BUTALEJA
AMURIA
SHEEMA
YUMBE
KASESE
RUBIRIZI
ADJUMANI
BUYENDE
KISORO
NTUNGAMO
MBARARA
NAKAPIRIPIRIT
GULU
BUKOMANSIMBI
KIBAALE
KIKUUBE
MPIGI
DOKOLO
MITOOMA
LWENGO
KAYUNGA
LYANTONDE
SSEMBABULE
BUDUDA
AGAGO
APAC
PALLISA
LIRA
KOTIDO
BUTAMBALA
KALUNGU
KATAKWI
KIRUHURA
BULIISA
KAMWENGE
MANAFWA
KYANKWANZI
NAPAK
BUHWEJU
NAMUTUMBA
KIBOGA
BUGIRI
OTUKE
KUMI
ARUA
SIRONKO
NEBBI
KAMPALA
PADER
MBALE
KAKUMIRO
ABIM
NGORA
MUKONO
KYOTERA
KABALE
AMUDAT
MAYUGE
BUSHENYI
NAKASEKE
MITYANA
ISINGIRO
NTOROKO
NWOYA
BUNDIBUGYO
KIRYANDONGO
NAMISINDWA
OYAM
KOBOKO
BULAMBULI
GOMBA
RAKAI
MOYO
KIBUKU
KASSANDA
HOIMA
KWANIA
KAPELEBYONG
NABILATUK
BUGWERI
RWAMPARA
KITAGWENDA
MADI
OKOLLO
KARENGA
OBONGI
KALAKI
KAZO
CENTRAL
EAST
CENTRAL
ELGON
TESO
WEST NILE
ACHOLI
KARAMOJA
LANGO
WESTERN
SOUTH WESTERN
MASAKA
BUTEBO
ALEBTONG
BUKEDEA
BUSIA
MOROTO
KABAROLE
MASINDI
KAMULI
BUDAKA
MARACHA
TORORO
KAGADI
KALANGALA
BUIKWE
LUWERO
KOLE
AMOLATAR
LAMWO
IBANDA
WAKISO
KAABONG
BUNYANGABU
IGANGA
NAKASONGOLA
KABERAMAIDO
NAMAYINGO
RUKUNGIRI
MUBENDE
BUVUMA
PAKWACH
RUBANDA
LUUKA
SOROTI
KALIRO
OMORO
RUKIGA
KWEEN
AMURU
KITGUM
KYEGEGWA
SERERE
KANUNGU
ZOMBO
BUKWO
KYENJOJO
JINJA
KAPCHORWA
BUTALEJA
AMURIA
SHEEMA
YUMBE
KASESE
RUBIRIZI
ADJUMANI
BUYENDE
KISORO
NTUNGAMO
MBARARA
NAKAPIRIPIRIT
GULU
BUKOMANSIMBI
KIBAALE
KIKUUBE
MPIGI
DOKOLO
MITOOMA
LWENGO
KAYUNGA
LYANTONDE
SSEMBABULE
BUDUDA
AGAGO
APAC
PALLISA
LIRA
KOTIDO
BUTAMBALA
KALUNGU
KATAKWI
KIRUHURA
BULIISA
KAMWENGE
MANAFWA
KYANKWANZI
NAPAK
BUHWEJU
NAMUTUMBA
KIBOGA
BUGIRI
OTUKE
KUMI
ARUA
SIRONKO
NEBBI
KAMPALA
PADER
MBALE
KAKUMIRO
ABIM
NGORA
MUKONO
KYOTERA
KABALE
AMUDAT
MAYUGE
BUSHENYI
NAKASEKE
MITYANA
ISINGIRO
NTOROKO
NWOYA
BUNDIBUGYO
KIRYANDONGO
NAMISINDWA
OYAM
KOBOKO
BULAMBULI
GOMBA
RAKAI
MOYO
KIBUKU
KASSANDA
HOIMA
KWANIA
KAPELEBYONG
NABILATUK
BUGWERI
RWAMPARA
KITAGWENDA
MADI
OKOLLO
KARENGA
OBONGI
KALAKI
KAZO
CENTRAL
EAST
CENTRAL
ELGON
TESO
WEST NILE
ACHOLI
KARAMOJA
LANGO
WESTERN
SOUTH WESTERN
The phased implementation of Truenat testing in Uganda took the following steps:
Implementation Experience
Site Selection: Sites were selected based on the concept of universal health coverage to expand
access to WHO-recommended RMDs among people in Uganda. The selection criteria also included
the expected numbers of individuals with presumed TB, distance from other RMD sites, and strategic
regional balance to cater for equitable distribution of resources among the population. In consultation
with the NTLP and implementing partners, priority was, therefore, given to primary healthcare facilities
(HCIVs & HCIIIs) with the highest outpatient department attendance and with longer distances from the
nearest GeneXpert sites, across various regions of the country.
Centralized Training: Twenty-five (25) NTRL and NTLP sta, including laboratory personnel, medical
ocers, procurement and supply management personnel, and monitoring and evaluation sta,
received training at the central level. This provided knowledge and skills on the role and use of Truenat
technology for diagnosis of TB and rifampicin-resistant TB.
Superuser Training: Ten laboratory scientists from the NTRL completed a five-day advanced training
program, which included theoretical and practical sessions, to enhance their competencies in the
Truenat diagnostic technology. The training aimed to equip these “superusers” with technical and
troubleshooting skills to support Truenat end-users with on- and o-site training and provide technical
assistance.
Installation and On-site Training: Between June and July 2022, certified Molbio technical sta,
supported by the NTRL team, performed the installation, and provided on-site training to laboratory sta,
clinicians, data management sta, medical stores personnel and counsellors. This two-day knowledge
and skills transfer activity was carried out per facility to provide the necessary competency among users.
It covered aspects such as laboratory performance, inventory management, waste management, quality
assurance, result interpretation, recording and reporting. In this way, users were educated on both the
opportunities and challenges associated with Truenat technology.
Continue reading...
Truenat testing has more
hands-on work compared
to GeneXpert. Since we are
only 2 sta in the laboratory,
it is going to be quite hard for
us to manage the workload.
However, due to the delays
we have been experiencing
when referring samples for
GeneXpert testing, we see this
as a better solution for our
patients since we can now
ensure same day diagnosis.
Mr. Magada David | Laboratory
Technologist, Buwasa HCIV
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
Between July and December 2022, Truenat technology
was used to conduct 16,413 MTB Plus tests, resulting in
the detection of 675 MTB positive samples (4.1% positivity
rate) and 26 rifampicin-resistant samples (3.8% of MTB
samples). The positivity rate was highest in July-August
(6.6%) but reduced later due to testing from community
outreach activities during the CAST TB (Community
Awareness, Screening, Testing, and Treatment to end TB
and Leprosy) campaign. The rate observed is comparable
to the positivity rate observed with other RMDs used in
Uganda including Xpert MTB/RIF Ultra (4.4%). Moreover,
the impact of Truenat testing was evident in the
significant increase in the proportion of individuals with
newly diagnosed TB who received a RMD at project sites
in the last quarter of 2022 compared to the same quarter
in 2021, when Truenat had not yet been implemented.
A median percentage point increase of 26.7% (IQR 0.9-
67.2) was observed across all sites, with all but four sites
showing a positive change (Figure 2).
Early Impact
Figure 2: Change in the proportion of individuals with newly diagnosed TB tested with a rapid molecular diagnostic as
the initial diagnostic test in the period prior to (Q4 2021) and during (Q4 2022) Truenat implementation
Continue reading...
0 40 80
Kumuli
Amuru
Luwero
Manafwa
Nakaseke
Wakiso
Kasese
Terego
Kabarole
Isingiro
Amudat
Yumbe
Katakwi
Kotido
Tororo
Butaleja
Sheema
Kalaki
Lira
Rukiga
Mbale
Bugiri
Ibanda
Kalangala
Lwengo
Sironko
Buliisa
Names of facilities
Dierence in proportion of individuals with newly diagnosed TB who were tested with a rapid molecular
diagnostic in the period before (Q4 2021) and during (Q4 2022) Truenat implementation
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
1. Training and Competence
Hands-on supportive visits were provided by superusers to address issues related to Truenat utilization, such as
recording, internal control, preventive maintenance, contamination monitoring, linkage of individuals diagnosed with TB
to treatment, waste management, and result turnaround time, demonstrating the positive impact of regular supportive
supervision on adherence to good clinical laboratory practices. In November 2022, a refresher training organized for
laboratory personnel further enhanced their competency in Truenat testing and provided a platform to share challenges
and experiences. Whilst regular training and learning opportunities can improve the competence of personnel,
addressing the challenge of understang will further optimize the utilization of the Truenat instruments.
Lessons Learned
Table 1: Errors encountered during installation of Truenat devices and their resolution
# Issue Machines that
encountered the
issue
Type:
Major/
Minor
Frequency How it was resolved Recommendation
1Failure to Elute DNA Trueprep Auto V2 Major* 6 Field Service Engineer
(FSE) flushed the device
Disperse test should be run
before any installation
2Printer failure to start Bluetooth printer Minor 4 Changed adapter
3Consistent invalid
results
Truelab Duo Major 2 Calibration of Truelab with
standard chip to restore
Bay reading to 3.41
Virtual troubleshooting
with site before FSE field
visit
4Failure of back and
home key to function
Truelab Duo Minor 1 Only encountered in
“power user” profile.
*Major means that testing was interrupted
2. Errors and Corrective Actions
The proportion of initial Trueprep errors was 1.3% (206/16,413), whilst the proportion of nondeterminate results (invalid,
error or indeterminate) was 2.1% (341/16,413) and 4.3% (27/630) on the MTB Plus and MTB-RIF Dx assays respectively.
The proportion of errors gradually reduced as users gained more hands-on competency with using the Truenat devices.
Several issues were encountered during installation of Truenat devices (Table 1). The most common errors observed
during field visits were Trueprep E1, E2, E4, E9 and E10 and Truelab E5.
3. Quality Management System
A. Specimen Referral
The specimen referral system operates on the Hub and spoke model. The Hubs have designated spokes with formalized
routing that is used for sample collection and result return. The NTRL is working with implementing partners to
support formal routing of Truenat sites in the Hub routing. In areas where Truenat has been accommodated into
the referral network, there has been notable decreases in driving distances, reduced wear and tear of motorcycles,
reduced fuel consumption and reduced result turn-around times for RMD testing.
B. Results Management
Initially, gaps existed in the recording of results due to the use of current versions of Health Management Information
Systems (HMIS) tools that do not entirely cover reporting of Truenat results. These challenges are expected to be
solved when new tools are rolled out and with full-scale implementation of the LabXpert DS diagnostic connectivity
solution.
Continue reading...
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
4. Connectivity System
With funding provided to the Makerere University Joint AIDS Program (MJAP) from USAID through the Stop TB
Partnership, the NTRL has successfully rolled out the LabXpert DS diagnostic connectivity solution on all Truenat devices.
This enables real-time monitoring of Truenat utilization, facilitates inventory management and allows for rapid return
of results to clinicians. However, several challenges were faced during the implementation process (Table 2). Already
the data transmitted has provided many interesting insights, that if well analyzed and utilized, can help to improve TB
diagnostic services. Therefore, if these challenges can be overcome, the NTRL will be able to improve the functioning of
the Truenat instrument network and provide better diagnostic services to individuals seeking care for TB.
C. Equipment and Maintenance
Equipment maintenance logs were created for each facility, and sta were tasked with conducting and documenting
periodic preventive maintenance. The sta were also advised to monitor the battery charge to protect its lifespan
(i.e., unplug the instruments when they are charged to 100% and plug them back in when they are around 50%).
The Molbio agent (Science Logistics) routinely provides remote and onsite support in case there is breakdown of
the Truenat devices. However, there were prolonged equipment downtimes of more than 10 days at some sites,
reaching 40 days in some cases. Discussions are ongoing between the Stop TB Partnership’s Global Drug Facility
and Molbio to identify solutions to reduce these delays.
D. External Quality Assessment (EQA)
All sites participated in three rounds of a SmartSpot proficiency testing (PT) scheme, with centralized monitoring
by regional coordinators based at the NTRL. Results were submitted online, and feedback reports downloaded
from the website regularly for each round in 2022. At the same time, the NTRL developed a Truenat PT scheme
using dried tube specimens and successfully passed validation in November 2022. Currently, all Truenat sites have
been enrolled into this scheme, which will be added on the scope of the existing ISO 17043 accreditation. This will
enhance capacity and minimize the resources required to manage and support laboratory quality management
systems for this new molecular diagnostic test.
Continue reading...
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
5. Power and Backup Systems
Some facilities face prolonged power outages which results in interruptions in testing. There is a need for surge
protectors to protect the instruments from damage due to power fluctuations, as well as power backup systems to
support uninterrupted testing in settings with extended power outages.
Continue reading...
Table 2: Challenges and lessons learned during implementation of the LabXpert DS connectivity solution
Challenge Lesson Learned
Configuration of Truenat instruments The Truenat connectivity process is more complex than
that of GeneXpert, involving more back and forth with
the manufacturer. Empowering local support teams with
knowledge of configurations and troubleshooting will
improve turnaround time (TAT) for Truenat connectivity.
Poor internet connectivity Given the decentralized positioning of Truenat instruments,
a major issue was poor internet connectivity in remote
areas, which slowed down or even failed data transfer
from Truenat instruments to the LabXpert DS. Nonetheless,
internet routers should be made available in areas with poor
network connectivity to boost data transfer.
Inability to retrieve data Retrieving previous information was also problematic, as
not all tests done prior to configurations automatically
uploaded to the LabXpert DS server, aecting reporting.
We initially thought that these machines would not work. However,
we have found out that the use of Truenat sites at referral centers
has reduced driving distances (by Hub riders), thus reducing the
fuel consumption and motorcycle breakdown. Patients are now
able to get results on the same day compared to the waiting that
they had to endure during the time they were doing microscopy
and then referring samples to Wakiso HCIV Hub for GeneXpert
testing. I am very excited about it.
Mr. Kaketo Alex | District Laboratory Focal Person, Wakiso District
Early Experience in Implementation of Truenat MTB Plus and MTB-RIF Dx Testing in Uganda
Looking Ahead
The NTRL and NTP are continuing to monitor the performance of Truenat at
facilities including as part of active case finding activities to inform decision
making around possible scale-up of the technology. The NTRL plans to
collect additional evidence around acceptability, cost-eectiveness, and other
benefits of decentralized use of Truenat compared to more centralized use of
other rapid molecular tests.
National Tuberculosis Reference Laboratory
Abdunoor Nyombi
Joel Kabugo
Joanita Namutebi
Ocung Guido
Niringiiyimana Benjamini
Julius Tumwine
Fredrick Kangave
Denis Oola
Kenneth Musisi
Moses Joloba
National Tuberculosis & Leprosy Control Program
Vincent Kamara
Raymond Byaruhanga
Stavia Turyahabwe
Path/IDDS Uganda Team
Thomas Ssemakadde
Derrick Mimbe
Photos courtesy of Infectious Disease Detection and
Surveillance (IDDS) Project and Makerere University Joint
AIDS Program (MJAP)
Acknowledgments
Disclaimer: The findings in this publication are those of the authors and do not necessarily represent the views of the U.S.
Agency for International Development or the U.S. Government.
For more information on the introducing New Tools Project, visit:
https://www.stoptb.org/accelerate-tb-innovations/introducing-new-tools-project