The gold standard diagnosis for malaria is the microscopic visualization of blood smears to identify Plasmodium parasites, although it is an expert-dependent technique and could trigger diagnostic errors. Artificial intelligence (AI) tools based on digital image analysis were postulated as a suitable supportive alternative for automated malaria diagnosis. A diagnostic evaluation of the iMAGING AI-based system was conducted in the reference laboratory of the International Health Unit Drassanes-Vall d'Hebron in Barcelona, Spain. iMAGING is an automated device for the diagnosis of malaria by using artificial intelligence image analysis tools and a robotized microscope. A total of 54 Giemsa-stained thick blood smear samples from travelers and migrants coming from endemic areas were employed and analyzed to determine the presence/absence of Plasmodium parasites. AI diagnostic results were compared with expert light microscopy gold standard method results. The AI system shows 81.25% sensitivity and 92.11% specificity when compared with the conventional light microscopy gold standard method. Overall, 48/54 (88.89%) samples were correctly identified [13/16 (81.25%) as positives and 35/38 (92.11%) as negatives]. The mean time of the AI system to determine a positive malaria diagnosis was 3 min and 48 s, with an average of 7.38 FoV analyzed per sample. Statistical analyses showed the Kappa Index = 0.721, demonstrating a satisfactory correlation between the gold standard diagnostic method and iMAGING results. The AI system demonstrated reliable results for malaria diagnosis in a reference laboratory in Barcelona. Validation in malaria-endemic regions will be the next step to evaluate its potential in resource-poor settings.
Keywords: Plasmodium; artificial intelligence; automated diagnosis; infectious diseases; malaria; point-of-care; tropical medicine.