Reaching the 100 by 2027 target for universal access to rapid diagnostic tests for tuberculosis in Africa: in-sight but out of reach

Abstract Although WHO recommended rapid molecular diagnostic tools for TB over a decade ago, only about one-third of diagnostic sites in high burden countries have access to them. We sought to understand the barriers and facilitators to reaching universal access to WHO-recommended rapid diagnostics (WRDs) in a selection of African countries. Data for 24 African countries were sourced from the WHO Global TB database to evaluate the proportion of notified people with TB tested with a WRD between 2021 and 2023, and to assess access to WRDs as defined in the WHO Diagnostic Standard. Additionally, TB program staff from six countries were surveyed to identify key factors influencing the implementation of WRD-based diagnostic algorithms. Across the 24 countries, 61% of people with TB were tested with a WRD in 2023. Only in 7 countries was this proportion above 80%, with 8 countries reporting below the global average of 48%. This proportion increased by just 6% between 2021 and 2023, with downward trends observed in 7 countries. Predominant health system barriers included supply chain disruptions, inadequate funding, staffing shortages and weak sample transportation systems. Facilitators included policy and strategic planning, expansion and optimisation of molecular diagnostic capacity, and integrated sample transport networks. Only 7 of the 24 African countries analysed are on track to meet the target for universal access to WRDs by 2027. Persisting health system barriers pose a threat to diagnostic networks and limit the effective use of WRDs. Strategic planning to address these barriers is needed to optimise the use of WRDs and maximise their impact on the TB care cascade. Competing Interest Statement The authors have declared no competing interest. Funding Statement This work was supported by the Gates Foundation (INV-038883). The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the Gates Foundation. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This analysis used programme and publicly available deidentified data that could not be traced back to individual patients. Furthermore, the responses shared by the country stakeholders did not identify individual patient data. Therefore, ethical approval was not required in accordance with local and international guidelines for secondary data analysis. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable Data Availability All data supporting our findings are contained within this manuscript. Datasets used for the quantitative analysis are open access and available from the WHO Global TB website. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.