Establishing Zambia's first national malaria rapid diagnostic test proficiency-testing programme: a descriptive implementation case study

Quality-assured Malaria Rapid Diagnostic Testing (mRDT) is essential for effective case management and surveillance, yet many resource-limited settings still struggle to establish national External Quality Assessment (EQA) systems. We describe the implementation and early operational performance of Zambia’s first national mRDT proficiency-testing (PT) programme, established through a structured South–South peer-learning partnership with Uganda and facilitated by the East, Central and Southern Africa Health Community (ECSA-HC). This descriptive implementation case study analysed two national PT cycles conducted in 2025. The primary unit of analysis was the participating site; Test observations were analysed separately by testing setting. Programme implementation data was abstracted from benchmarking, training, production, quality-control, distribution, submission, and corrective-action records. PT panels used dried tube specimens (DTS). We summarised participation, PT scores, diagnostic error rates, turnaround times, and panel quality-control results descriptively using Microsoft Excel. The programme expanded from 100 enrolled sites in Cycle 1 to 250 in Cycle 2. Participation was 98% (98/100) and 94% (235/250), respectively. Among participating sites, 96/98 (98.0%) in Cycle 1 and 229/235 (97.4%) in Cycle 2 achieved satisfactory performance using the predefined threshold of ≥80%. Overall error rates were 1.01% in Cycle 1 and 1.61% in Cycle 2. In Cycle 2, the error rate was 2.83% among community-based testers and 0.98% among facility-based testers. The median response turnaround time was 5 days (interquartile range [IQR], 1–8) and the median shipping turnaround time was 13 days (IQR, 7–20). Across the two cycles, 445 DTS-based panels were produced locally; quality-control assessments recorded 100% homogeneity and stability among the panels assessed. The programme also established an ISO 17043-aligned quality-management framework and trained national and sub-national personnel. Zambia established a functioning national mRDT PT programme and maintained high participation and satisfactory performance during early scale-up. The case illustrates how regional peer learning can support country-led diagnostic quality assurance. Longer-term assessment is required to determine sustainability, cost-effectiveness, and effects on patient- or programme-level outcomes.