Identifying pathways to achieve diverse objectives of the National Essential Diagnostics List: developing an...

Access to essential in vitro diagnostics is limited in many low- and middle-income countries (LMICs). To address this, the World Health Organization introduced the Model List of Essential In Vitro Diagnostics (EDL) in 2018, encouraging member states to develop National Essential Diagnostics Lists (NEDLs). To date, five LMICs-Burkina Faso, Ethiopia, India, Nepal, and Nigeria-have developed NEDLs. However, gaps remain in the objectives of NEDL development, which may undermine their effective use. In this study, we aimed to analyze the objectives of NEDL development through a literature review, elicit potential pathways for achieving these objectives, and develop an assessment framework for defining NEDL objectives and pathways.

We analyzed the WHO EDL and NEDL documents and other relevant materials, aligning the objectives mentioned in these documents with a logic model. A provisional assessment framework was then designed and applied to examine stakeholder perspectives on NEDL objectives, which were obtained through key informant interviews in four Association of Southeast Asian Nations (ASEAN) countries-Cambodia, Indonesia, Lao PDR, and the Philippines-where NEDL initiatives are still in their early stages. Based on these findings, a revised assessment framework was developed.

The literature review yielded a provisional assessment framework comprising six domains: procurement, supply chain, laboratory equipment maintenance, quality assurance, regulatory work, and benefit packages. An analysis of stakeholder perspectives in the four ASEAN countries identified potential pathways for achieving the NEDL objectives across these six domains and other aspects. This process resulted in a new seven-domain assessment framework, incorporating key modifications to the provisional framework: "benefit packages" was replaced with "health financing", and "service delivery platform" was added as the seventh domain.

The newly developed assessment framework can support high-level officials in initiating NEDL development and promoting its effective use. It can also guide health ministries in selecting NEDL leads and technical committee members and help identify intermediary outcomes for monitoring NEDL operationalization. Although empirical evidence on NEDL outcomes remains limited owing to its early global implementation stage, this study provides valuable insights to support the future development and deployment of NEDLs and strengthen diagnostic systems in LMICs.