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DIAGMAL completes training and starts recruitment for the evaluation of an innovative diagnostic platform for malaria
The DIAGMAL project aims to evaluate the diagnostic performance of an innovative molecular platform for the sensitive diagnosis of malaria. This platform circumvents complex and contamination-prone DNA extractions (as amplification is performed directly on a blood sample) and use cumbersome read-out systems (detection of amplification products is by a dipstick). It comes as a battery-operated (solar power) and mobile telephone-controlled miniaturised PCR platform.
After a period of protocol preparation (protocol recently published on Pan African Clinical Trials Registry; Trial ID=19396 and on the ISRCTN trial registry under Trial ID = ISRCTN133343) and training of study staff at AMREF in Molecular Biology techniques, the DIAGMAL started recruitment in five African countries (Burkina Faso, Ethiopia, Kenya, Namibia and Sudan), each with its own malaria epidemiology and diagnostic challenges. The first patient was recruited on 8 November 2021 at Nanoro (Clinical Research Unit of Nanoro), in Burkina Faso and as of 1 September 2022, the study sites in Burkina Faso and Sudan have recruited 75% of the sample size and Kenya, Ethiopia and Namibia have reached 50% recruitment. The first findings of the diagnostic evaluation will be discussed at the upcoming annual project meeting in October 2022. The project also includes a health economy component to identify the incremental costs and benefits of introducing and routinely using the new diagnostic platform compared to routine diagnostic practises for malaria in place in the five different study localities.