Malaria Detection and Speciation, Qualitative by Real-Time PCR

This qualitative test is intended only for the speciation of suspected malaria infections. It is not intended to monitor treatment or to be used on repeat specimens for evaluation of parasitic clearance. A positive result may still be obtained in the absence of visible parasites.

Detection of asymptomatic parasitemia in individuals from malaria-endemic areas is possible. Therefore, this test should only be used in conjunction with patient travel history and symptoms consistent with malaria. Only circulating parasites within the blood will be detected in this assay. Latent phase hypnozoites of Plasmodium ovale and Plasmodium vivax may not be detected.

Mixed infections (eg, multiple Plasmodium spp. present) may not be accurately identified if parasitemia is significantly higher for one of the Plasmodium spp.

This test will not detect other blood-borne parasites such as Babesia spp. and Trypanosomes, which may have similar clinical presentation. A negative result on this assay does not rule out the presence of PCR inhibitors in the patient specimen or assay-specific nucleic acid in concentrations below the level of detection by the assay.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.