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 Full Title Evaluation of two rapid diagnostic test quality assurance methods in 
peripheral health facilities, rural Tanzania.
 Short Title RDT-QA Project
 Project Leader Irene Masanja
 Description Prompt, reliable diagnosis of malaria is essential to improving case management and monitoring trends in malaria control. Clinical diagnosis alone is not specific, and results in inappropriate use of antimalarial drugs. Increasing drug resistance to inexpensive antimalarial drugs and the higher cost of alternative medications has led to an increased focus on malaria diagnosis. Rapid diagnostic tests (RDTs) were developed to improve the quality of malaria diagnosis in resource-limited settings.

Initial field trials of HRP2-based RDTs showed sensitivity and specificity of over 90% for P. falciparum malaria at parasite densities of >200 parasites/µL.6, 7 However, recent product testing by the World Health Organization (WHO) found that just 6 of the 41 RDTs tested were able to achieve >90% Plasmodium falciparum detection rates at parasite densities of 200 parasites/µL and that few of these products had been developed for large-scale production.

The Tanzanian Ministry of Health and Social Welfare through National Malaria Control Program (NMCP) is expanding malaria diagnostic capacity to reduce inappropriate use of the first-line antimalarial. In 2009, the NMCP introduced RDTs in Iringa, Kagera and Coastal Regions. This study seeks to monitor RDT performance in selected health facilities in two districts in Iringa (Mufindi and Iringa Rural) using two QA methods – the first based on reference microscopy, the second based on detection of parasite DNA by real time quantitative polymerase chain reaction (RT-PCR) on dried blood spots (DBS). The aims are to:

1.  Monitor sensitivity and specificity of RDTs in routine field use;

2.  Evaluate cost of each method;

3.  Evaluate timeliness of each method and

4.  Assess health workers acceptability of the two mRDT Quality Assurance methods.
 Collaborators Meredith McMorrow         Center for Disease Control & Prevention (CDC)

Patrick Kachur                Center for Disease Control & Prevention (CDC)

Peter McElroy                 President's Malaria Initiative (PMI)

Salim Abdulla                  Ifakara Health Institute (IHI)                 

 Source of funding President's Malaria Initiative (PMI)
 Start Date October 2009                   End Date         August 2011
     

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