Development, validation and evaluation of a rapid…

Background: Molecular tools are very sensitive and specific and could be an alternative for the diagnosisof malaria. The complexity and need for expensive equipment may hamper implementationand, therefore, simplifications to current protocols are warranted. Methods: A PCR detecting the different Plasmodium species and differentiating between Plasmodiumfalciparum and Plasmodium vivax was developed and combined with a nucleic acid lateralflow immuno-assay (PCR-NALFIA) for amplicon detection. The assay was thoroughlyevaluated for the analytical sensitivity and specificity in the laboratory, the robustness andreproducibility in a ring trial and accuracy and predictive value in a field trial. Results: The analytical sensitivity and specificity were 0.978 (95% CI: 0.932-0.994) and 0.980 (95%CI: 0.924-0.997), respectively, and were slightly less sensitive for the detection of P

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Development, validation and evaluation of a rapid…