Abstract / Summary
Malaria remains a significant global public health threat, particularly in sub-Saharan Africa, including Tanzania, where Plasmodium falciparum is the most prevalent causative species. Malaria rapid diagnostic tests (mRDTs) are useful tools for simple, fast and effective diagnosis in settings where good-quality microscopy cannot be maintained. These mRDTs need to be of acceptable quality and performance standards to ensure their reliability. This study aimed to evaluate the quality and performance of mRDTs circulating in the Tanzania Mainland market. A descriptive cross-sectional survey was conducted from July to December 2020 across ten regions of Tanzania mainland as part of the post-marketing surveillance (PMS) activities conducted by the Tanzania Medicines and Medical Devices Authority (TMDA) in collaboration with the Global Fund. Regions were selected based on their location, population density, malaria prevalence and climatic conditions. Samples were collected from hospitals, health centres, dispensaries, Medical Stores Department (MSD) warehouses, pharmacies/outlets and laboratories. Only registered samples were subjected to product information review (PIR) and laboratory testing for quality and performance, focusing on the assessment of specificity and sensitivity for Plasmodium falciparum –specific histidine-rich protein 2 (HRP2), pan-specific Plasmodium lactate dehydrogenase (pLDH), and pan-specific Plasmodium aldolase. A total of 334 mRDT samples were collected during the survey, representing six brands. Of these, 326 (97.6%) were registered by TMDA and included in the final analysis, while eight (2.4%) unregistered samples were excluded. The majority (183; 56.1%) were collected during Phase I and 143 (43.9%) during Phase II. CareStart was the most common brand, accounting for 88.9% (290/326) of registered samples, followed by SD Bioline (8.6%) and other brands (2.5%). Product information review (PIR) showed 100% compliance with TMDA and ISO guidelines. Laboratory testing confirmed that all registered samples met acceptable quality criteria, achieving 100% pass rates for sensitivity and specificity for HRP2, pLDH, and Plasmodium aldolase antigens. This study demonstrates that all registered mRDTs circulating in the Tanzania Mainland market during the study period met the required quality and performance standards, supporting their reliability for malaria diagnosis. However, the identification of unregistered mRDTs (2.4%) in the market is a cause for concern and highlights the need for strengthened regulatory enforcement. Continuous post-marketing surveillance and enhanced stakeholder awareness are essential to maintain the quality of mRDTs and safeguard public health as Tanzania moves towards malaria elimination.