Transforming access to diagnostics: how to turn good intentions into action?

The Lancet Commission on diagnostics¹ highlights how 35–62% of the populations in low-income and middle-income countries (LMICs) do not have access to the diagnostic resources essential for six common medical conditions, with most unmet needs at community level. The Commission suggests that an evidence-based essential diagnostics list (EDL) and technological advances will help accelerate access to diagnostics in the context of the synergistic global health priorities of universal health coverage, COVID-19, antimicrobial resistance (AMR), and global health security. Could these proposals and the Commission's other recommendations be an impetus to finally unlock equitable access to diagnostics globally? And what is needed to revolutionise the application of diagnostics in Africa?

Technology innovation and uptake through EDL are justifiably at the heart of the Commission's proposed strategy. The EDL is an aspirational list of validated diagnostic tools for settings with and without access to a laboratory.² On its own, the overarching guidance of the EDL will not suffice to enable an effective implementation of diagnostics. Additional operational instruments that define tier-specific diagnostic testing menus are needed, and they already exist in some sub-Saharan African countries.3, 4, 5, 6, 7, 8 Importantly, these complementary plans, guidance, and strategies factor in practical considerations in terms of regulations, infrastructures, finances, human resources, and other supporting systems and operationalise national EDL.

The scarcity of locally relevant disease burden data in parts of the world where EDL implementation is most needed is an obstacle to progress and means diagnostics could be prioritised on the basis of information that may or may not reflect reality. Beyond limiting some of the Commission's conclusions, these gaps in health data compromise rational investments in diagnostics. Programmes are warranted that use an approach similar to The Fleming Fund supported Global Research on Antimicrobial Resistance (GRAM), Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP), and Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA) initiatives,9, 10, 11 which are working to improve the usability of existing AMR datasets in LMICs. Analysing larger volumes of in-country data can help define disease burden estimates in relation to local epidemiology and increase the local relevance of diagnostic selection. But generating, curating, and using local health data must be a priority, given their crucial importance for assessing the impact of diagnostic strategies.

Digital technologies and other innovations are proposed by the Commission to resolve diagnostic gaps for underserved populations. But to address pervasive infrastructure needs in LMICs, the information and communications technology power sector has to be mobilised to expedite power connections, availability of off-grid renewable energy, and affordable tariffs. The African Union's Digital Transformation Strategy for Africa¹² offers a suitable framework to establish such partnerships. Training based on digital technology further requires delivery through robust nationally or regionally owned competency-based qualification, registration, and licensing systems, such as done by the College of Pathologists of East, Central and Southern Africa.¹³

Corruption is rightly identified by the Commission as an impediment to progress. Yet corruption extends beyond the procurement examples provided to include falsified diagnostics, power play within circles of monopolised decision making, polarised resources, and corporate interests in the global health industry.¹⁴ Independent watchdog systems that are deliberately designed to reduce corruption¹⁵ in large international diagnostics partnerships are essential, especially in the context of the quick mobilisation of large amounts of funding to address health emergencies such as COVID-19.¹⁶

© 2021 Joseph Ndung'u/FIND

The emphasis in the Commission on access to diagnostics at the primary care level and the adoption of new point-of-care (POC) tests and hand-held imaging devices is commendable. But the skewed interest towards POC technology leaves important challenges such as AMR largely unaddressed. In the absence of reliable POC diagnostics, the expansion of culture and susceptibility testing to and below secondary care levels should become an unambiguous recommendation, in line with the practice in most health systems in high-income countries.

The concept of an integrated diagnostic network is advanced by the Commission to reach beyond the constraints of conventional laboratory and clinical facilities. Nevertheless, we caution against creating parallel oversight mechanisms for testing services in community settings. We recommend a reframing of roles, responsibilities, and accountability mechanisms for diagnostic services at in-country operational, coordination, and governance levels. Laboratory workers will need to adopt more supervisory functions, including quality assurance, result reading, interpretation, and reporting, and be part of diagnostic activities in community settings. Existing leadership and governance structures for laboratory and cure-and-care services will need to be consolidated to adequately coordinate the implementation of pathology and laboratory medicine and diagnostic imaging strategies in community sites, including the compliance to quality and safety standards and the reporting and case notification for surveillance. Thus, the Commission's suggested development of dedicated national diagnostics strategies and governance structures might create or exacerbate the disconnect between diagnostic services and the overall health programme.

An international Diagnostic Alliance is proposed by the Commission. Nevertheless, achieving representation of LMIC stakeholders could be challenging. The Commission itself, despite greater than usual practice representation, includes only ten of 32 authors with an LMIC affiliation. Leveraging existing systems might be easiest either by integrating diagnostic policy making into national and international health policy bodies in ways that enable bottom-up inclusion or by working with entities with the necessary political weight, legal traction, and context-specific expertise, such as the Africa Collaborative Initiative to Advance Diagnostics (AFCAD), which was launched by the Africa Centres for Disease Control and Prevention (Africa CDC) and its partners in 2018.¹⁷ AFCAD promotes local manufacturing to improve independent access to diagnostics and in support of addressing Africa originated and defined health priorities.¹⁸

The Lancet Commission on diagnostics offers potentially transformative recommendations for diagnostic access. Achieving change will, however, require promoting partnerships that are more inclusive of local and regional stakeholders, equity-minded decision making in global health programmes addressing diagnostics, and result-oriented interventions.