This document is a clinical trial report on the efficacy of the Parasight P1 device for malaria diagnosis. The study was a collaborative effort between the National Institute of Malaria Research (ICMR) in India and Parasight Ltd. in Israel. The trial aimed to evaluate the device's sensitivity and specificity in diagnosing malaria compared to PCR and microscopy. The study involved 431 patients, with 364 valid samples analyzed. The Parasight P1 device showed high sensitivity and specificity, particularly in low parasitemia cases, but did not support mixed infection reporting. The report discusses the methodology, results, limitations, and future work for the device.
documents/EFTA01090053.pdf
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