A rapid test for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood. For professional in vitro diagnostic use only. Sensitivity The Malaria P.f/ Pan Rapid Test Device (Whole Blood) has been tested with thin or thick microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f/ Pan Rapid Test Device (Whole Blood) is >99.9% relative to microscopy. For Pan: Relative Sensitivity: >99.9% (158/158) (97.6%100.0%)* For P.f: Relative Sensitivity: >99.9% (53/53) (93%100.0%)* Specificity The Malaria P.f/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria P.f/ Pan antigens in whole blood. The results show that the specificity of the Malaria P.f/ Pan. Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy. Relative Specificity: >99.0% (324/327)(97.3%99.8%)* Accuracy: >99.4%(535/538)(98.3%99.8%)* * 95% Confidence Interval Total Results211327538 Note: The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan-malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.