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Fio's Deki Reader Meets Field Evaluation Objective for Rapid Malaria Detection

A field evaluation recently published in Malaria Journal demonstrated consistent interpretation of rapid diagnostic tests (RDTs) for multiple disease strains between Fio Corporation's Deki Reader™ and laboratory experts. The field evaluation analyzed results from 1,807 cases tested with an RDT for the two species of malaria responsible for most infections worldwide.

Widespread use of RDTs in low-resource settings is regarded as a pivotal strategy in malaria control and elimination efforts, particularly after the World Health Organization recommended parasitological confirmation of all malaria cases to reduce inappropriate use of anti-malarial drugs.

"Large-scale implementation of rapid diagnostic testing in malaria programs frequently results in poor diagnosis because operators often have limited expertise," said Dr. Sócrates Herrera, director of the Caucaseco Scientific Research Center in Colombia. "This trial demonstrated that even when using RDTs with multiple antigens, the Deki Reader's automated interpretation can be trusted to deliver high-level accuracy."

Fio Corporation conducted the field evaluation in collaboration with the Caucaseco Scientific Research Center, 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 U.S. National Institutes of Health.

The field evaluation analyzed results from cases tested with an RDT capable of detecting Plasmodium falciparum and Plasmodium vivax species of malaria at seven health facilities in malaria-endemic areas of Colombia. Seven study technicians, all trained laboratory microbiologists with rapid diagnostic testing experience, used Deki Readers to process the RDTs according to manufacturer recommendations; the Deki Readers 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. The study technicians then immediately inserted the RDTs into the Deki Reader to obtain an objective interpretation of the test.

Researchers concluded that the diagnostic performance of the Deki Reader was comparable to the visual interpretation of the RDTs. They further suggested that large-scale implementation of rapid diagnostic testing in malaria programs would greatly benefit from the standardized, automated interpretation and near real-time reporting of test results provided by the Deki Reader.

The Deki Reader is a key component of the Fionet™ platform, which enables expert-level rapid diagnostic testing, while integrating data capture into clinical workflow to give stakeholders a window into the point of care.

The results of this field evaluation in Colombia follow validation of the Deki Reader's automated RDT interpretation from a previous field evaluation in Tanzania testing for a single species of malaria. Published in Malaria Journal in 2013, those results similarly demonstrated that the Deki Reader's objective RDT analysis was comparable to visual interpretation by laboratory technicians.

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