Profiling in vitro diagnostics that achieved WHO prequalification or emergency use listing and mapping manufacturers’ challenges through WHO specialized technical assistance

Abstract Equitable access to quality-assured in vitro diagnostics (IVDs) is essential for health security, universal health coverage, and effective responses to public health emergencies. The World Health Organization provides mechanisms, most prominently the Prequalification (PQ), for evaluating whether diagnostics meet international standards of quality, safety and performance, enabling procurement agencies to make informed selections. However, many priority diagnostics remain underrepresented. In parallel, the WHO Product Policies, Access and Manufacturing Support (PAM) Unit offers Specialized Technical Assistance (STA) to help manufacturers in aligning with international standards and progress toward WHO-quality assured status. This paper profiles IVDs that achieved WHO PQ or Emergency Use Listing and analyzes key readiness gaps identified through PAM’s STA to determine how targeted support can strengthen manufacturers’ capacity to meet PQ expectations, expand product portfolios in priority disease areas, and increase engagement from Low- and Middle-Income Countries (LMICs). Among 430 products, most are concentrated in HIV and malaria, while tuberculosis, neglected tropical diseases, and other priority conditions remain underserved. Geographic analysis shows that listed products largely originate from high-income countries, with limited participation from LMIC manufacturers despite high disease burden and growing diagnostic needs. Recurring technical challenges—including deficiencies in documentation, suboptimal performance evaluation planning, and weaknesses in quality management systems—continue to constrain PQ readiness. Strengthening early integration of quality and regulatory practices, enhancing coordination among WHO and partners, and sustaining investment in capacity-building initiatives such as STA are essential to support equitable participation in assessment pathways. These measures may help ensure that priority diagnostics are available, accessible, and aligned with global health needs.