Evaluation of Automated Molecular Testing Rollout for Tuberculosis Diagnosis Using Routinely Collected Surveillance Data - Uganda, 2012-2015.

In 2012, Uganda introduced the use of GeneXpert MTB/RIF (Cepheid, Sunnyvale CA), a sensitive, automated, real-time polymerase chain reaction-based platform for tuberculosis (TB) diagnosis, for programmatic use among children, adults with presumptive human immunodeficiency virus (HIV)-associated TB, and symptomatic persons at risk for rifampicin (RIF)-resistant TB. The effect of using the platform's Xpert MTB/RIF assay on TB care and control was assessed using routinely collected programmatic data; in addition, a retrospective review of district quarterly summaries using abstracted TB register data from purposively selected facilities in the capital city of Kampala was conducted. Case notification rates were calculated and nonparametric statistical methods were used for analysis. No statistically significant differences were observed in case notification rates before and after the Xpert MTB/RIF assay became available, although four of 10 districts demonstrated a statistically significant difference in bacteriologically confirmed TB. Once the GeneXpert MTB/RIF platform is established and refined, a more comprehensive evaluation should be conducted.

Beyond diagnostic connectivity: Leveraging digital health technology for the real-time collection and provision of high-quality actionable data on infectious diseases in Uganda.

Automated data transmission from diagnostic instrument networks to a central database at the Ministries of Health has the potential of providing real-time quality data not only on diagnostic instrument performance, but also continuous disease surveillance and patient care. We aimed at sharing how a locally developed novel diagnostic connectivity solution channels actionable data from diagnostic instruments to the national dashboards for disease control in Uganda between May 2022 and May 2023. The diagnostic connectivity solution was successfully configured on a selected network of multiplexing diagnostic instruments at 260 sites in Uganda, providing a layered access of data. Of these, 909,674 test results were automatically collected from 269 "GeneXpert" machines, 5597 test results from 28 "Truenat" and >12,000 were from 3 digital x-ray devices to different stakeholder levels to ensure optimal use of data for their intended purpose. The government and relevant stakeholders are empowered with usable and actionable data from the diagnostic instruments. The successful implementation of the diagnostic connectivity solution depended on some key operational strategies namely; sustained internet connectivity and short message services, stakeholder engagement, a strong in-country laboratory coordination network, human resource capacity building, establishing a network for the diagnostic instruments, and integration with existing health data collection tools. Poor bandwidth at some locations was a major hindrance for the successful implementation of the connectivity solution. Maintaining stakeholder engagement at the clinical level is key for sustaining diagnostic data connectivity. The locally developed diagnostic connectivity solution as a digital health technology offers the chance to collect high-quality data on a number of parameters for disease control, including error analysis, thereby strengthening the quality of data from the networked diagnostic sites to relevant stakeholders.

Evaluation of Xpert ® MTB/XDR test for susceptibility testing of Mycobacterium tuberculosis to first and second-line drugs in Uganda.

Background: Drug-Resistant Tuberculosis (DR-TB) is one of the key challenges toward TB control. There is an urgent need for rapid and accurate drug susceptibility tests (DST) for the most commonly used 1 st and 2 nd line TB drugs. Design and Methods: In a blinded, laboratory-based cross-sectional study, we set out to validate the performance of the Xpert ® MTB/XDR test for DST of M. tuberculosis . Sputum samples or culture isolates collected between January 2020 and December 2021 from patients with rifampicin resistance -TB and/or with higher suspicion index for isoniazid (INH) resistance and/or 2 nd line fluoroquinolones (FQ) and injectable agents (IAs) were tested using the Xpert ® MTB/XDR test from 11/September 2021 to 26/May /2022. Diagnostic accuracy and factors for laboratory uptake of Xpert ® MTB/XDR test were compared to MGIT960 and the Hain Genotype® MTBDR plus and MDRsl assays (LPA) as reference DST methods. Results: A total of 100 stored sputum samples were included in this study. Of the samples tested using MGIT960, 65/99 (65.6%) were resistant to INH, 5/100 (5.0%) resistant to FQ and none were resistant to IAs. The sensitivity and specificity, n (%; 95%Confidence Interval, CI) of Xpert ® MTB/XDR test for; INH were 58 (89.2; 79.1-95.5) and 30 (88.2; 72.5-96.6), FQ; 4 (80.0; 28.3-99.4) and 95 (100; 96.2-100), respectively. The specificity for AIs was 100 (100; 96.3-100). Using LPA as a reference standard, a total of 52/98 (53.1%) were resistant to INH, 3/100 (3.0%) to FQ, and none to IA. The sensitivity and specificity, n (%; 95%CI) of Xpert ® MTB/XDR test compared to LPA for; INH was 50 (96.1; 86.7-99.5) and 34 (74.0; 58.8-85.7) and FQ 3 (100; 29.2-100) and 96 (99.0; 94.3-99.9) respectively. The specificity of IAs was 96 (100; 96.2-100). The factors for laboratory uptake and roll-out included; no training needed for technicians with previous Xpert-ultra experience and one day for those without, recording and reporting needs were not different from those of Xpert ultra, the error rate was 4/100 (4%), no uninterpretable results reported, test turn-around-time was 1hr/45 minutes and workflow similar to that of the Xpert-ultra test. Conclusion: There is high sensitivity and specificity of Xpert ® MTB/XDR test for isoniazid, fluoroquinolones, and Injectable agents. There are acceptable Xpert ® MTB/XDR test attributes for test uptake and roll-out.