Test Order Name - Malaria Molecular Identification (Malaria Real-Time PCR)
Synonym(s) - Plasmodium for Identification, Plasmodium Species Identification
Methodology - Real-time PCR (for Plasmodium/malaria identification)
Acceptable Specimen Type(s) for Testing - Whole blood with EDTA. Also required: thick and thin blood smears (stained or unstained* with Giemsa stain) on glass microscopy slides per CCR, Title 17, Section 2505. *Note: for unstained slides, thin smears must be methanol-fixed prior to submission.
Transport / Collection Medium - Collect a 1 to 5 ml blood sample in Vacutainer® EDTA tubes prior to antiparasitic therapy, shipped on cold packs (not frozen); smears in slide transport container.
Storage and Preservation of Specimen - Store whole blood refrigerated (2 to 8°C) until transport, and submit sample within 5 days of collection; smears can be refrigerated (2 to 8°C) or stored at ambient temperature.
Minimum Volume Required - 500 microliters whole blood for malaria PCR
Additional Collection Instructions - None
Additional Required Information - Patient travel history, patient clinical history, physician's full name and contact number, onset of symptoms, county of residence.
Send Out? - No
Turnaround Time - 1 to 3 business days
Limitations / Notes / Disclaimers - This PCR test is to be used in conjunction with microscopic examination of blood smears, as it does not determine the level of malarial parasitemia. In addition, this PCR test does not test for the presence of Plasmodium knowlesi or Babesia species DNA. Whole blood negative for Plasmodium species on this assay does not rule out the possibility of infection with Plasmodium knowlesi or Babesia species. Thick and thin smear examination will be used in conjunction with this assay to detect the presence of other blood parasites. This PCR test was developed and its performance characteristics were determined by the San Francisco Public Health Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such approval is not necessary and results should not be regarded as investigational or for research.