Malaria Detection and Speciation, Qualitative by Real-Time PCR

2004963
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Example Reports
Detected
Not Detected
Ordering Recommendation

Not a first-line test for malaria screening. Refer to Parasites Smear (Giemsa Stain), Blood (0049025) or Malaria, Rapid Screen and Giemsa Stain (2001547) for screening and diagnosing acute disease.

Mnemonic
MALARIAPCR
Methodology

Qualitative Real-Time Polymerase Chain Reaction

Performed

Sun-Sat

Reported

1-3 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA) or pink (K2EDTA).

Specimen Preparation

Transport 1 mL whole blood. (Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 week

Reference Interval
Interpretive Data

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.

Note
Hotline History
N/A
CPT Codes

87798

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Components
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
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Plasmodium falciparum
  • Plasmodium knowlesi
  • Plasmodium malariae
  • Plasmodium ovale
  • Plasmodium vivax
Malaria Detection and Speciation, Qualitative by Real-Time PCR