Diagnostic device meets malaria field evaluation objective

Fio Corporation’s Deki Reader - a mobile in vitro diagnostic device - has demonstrated consistent interpretation of rapid diagnostic tests (RDTs) for multiple malaria strains in a field evaluation. The results of the trial were published in Malaria Journal.

Rapid diagnostic testing has become a pivotal strategy in malaria control since the World Health Organization called for parasitological confirmation of all cases to reduce inappropriate use of antimalarial drugs. But as noted in the journal, “there are still obstacles to the widespread implementation of this strategy, such as reporting constraints and lack of proper quality assurance of RDT-based programs at point-of-care (POC)”.

“Large-scale implementation of rapid diagnostic testing in malaria programs frequently results in poor diagnosis because operators often have limited expertise,” explained Dr Sócrates Herrera, director of the Caucaseco Scientific Research Center in Colombia. The centre is the lead institution behind the Centro Latino Americano de Investigación en Malaria (CLAIM), one of 10 International Centers of Excellence for Malaria Research funded by the US National Institutes of Health.

Fio conducted the field evaluation in collaboration with the Caucaseco Scientific Research Center. A cohort of 1807 patients, at seven health centres in malaria-endemic areas of Colombia, was used to assess the diagnostic performance of the Deki Reader device. The field evaluation analysed results from cases tested with an RDT capable of detecting the Plasmodium falciparum and Plasmodium vivax species of malaria.

Seven study technicians, all trained laboratory microbiologists with rapid diagnostic testing experience, used Deki Readers to process the RDTs according to manufacturer recommendations. The devices provided job aids and helped the study technicians keep track of the incubation time for each RDT processed. Once the incubation period was completed, the study technicians interpreted the RDTs by visual inspection and entered results using the Deki Reader’s touch screen. They then inserted the RDTs into the Deki Reader to obtain an objective interpretation of the test.

“The diagnostic performance of the Deki Reader was comparable to visual interpretation of RDTs (without significant differences) for both malaria species,” the researchers concluded. Dr Herrera added that “even when using RDTs with multiple antigens, the Deki Reader’s automated interpretation can be trusted to deliver high-level accuracy”.

The researchers suggested that large-scale implementation of rapid diagnostic testing in malaria programs would greatly benefit from the standardised, automated interpretation and near-real-time reporting of test results provided by the Deki Reader.