Qualitative Real-Time Polymerase Chain Reaction
Lavender (EDTA) or pink (K2EDTA).
Transport 1 mL whole blood. (Min: 0.5 mL)
Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 week
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.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
|Component Test Code*||Component Chart Name||LOINC|
|2004964||Malaria Speciation PCR, P. falciparum||41447-4|
|2004966||Malaria Speciation PCR, P. knowlesi||47085-6|
|2004968||Malaria Speciation PCR, P. vivax||41450-8|
|2004970||Malaria Speciation PCR, P. malariae||41448-2|
|2004972||Malaria Speciation PCR, P. ovale||41449-0|
- Plasmodium falciparum
- Plasmodium knowlesi
- Plasmodium malariae
- Plasmodium ovale
- Plasmodium vivax