NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
The rapid and accurate detection and species identification of Plasmodium
Detection of Babesia, trypanosomes, and some species of microfilariae
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Malaria is potentially a life-threatening disease and testing for this infection should be performed as rapidly as possible. Therefore, this test should not be used as a primary screening test for malaria, except for clients in the immediate Rochester, Minnesota area when the specimen can be delivered within several hours of collection. Laboratories that are unable to deliver a specimen within this time frame should provide an initial screen for malaria and other blood parasites in their laboratory prior to sending a specimen to Mayo Medical Laboratories. This test is useful for confirmation of a presumptive malaria diagnosis and determination of infecting Plasmodium species.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Blood and slides are required.
Specimen Type: Blood
Container/Tube: Lavender top (EDTA)
Specimen Volume: 1 mL
1. Invert several times to mix blood.
2. Do not transfer blood to other containers. Send specimen in original tube.
Specimen Stability Information: Refrigerated
Specimen Type: Blood films
Container/Tube: Clean, grease-free slides in plastic slide container
Specimen Volume: 2 thin blood films and 2 thick blood films
1. Ideally, blood films should be made from fingerstick or drops of blood from needle following venipuncture. However, EDTA anticoagulated blood is also acceptable.
2. Prepare thin blood films as follows:
a. Prepare a thin film with a "feathered edge" which is no more than a single cell thick.
b. Allow the film to thoroughly air dry and then fix by briefly immersing in either absolute or 95% methyl alcohol.
c. Allow to air dry after fixation.
3. Prepare thick blood films as follows:
a. Place a large drop of blood (approximately the size of a dime and preferably from a fingerstick) on a slide.
b. Using a corner of a second slide, spread the drop in a circular motion while applying firm pressure to literally scratch the blood onto the carrier slide. This technique allows the blood to dry quickly and adhere well to the slide. Use approximately 20 circular sweeps with the second slide. The drop of blood should be about the size of a quarter when finished.
c. Do not fix. Air dry thoroughly (approximately 45 minutes) before placing in transport container.
Specimen Stability Information: Refrigerated (preferred)/ Ambient
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Blood: 0.5 mL/Slides: NA
Mild reject; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Malaria is a major tropical disease infecting approximately 500 million people and causing 1.5 to 2.7 million deaths annually. Ninety percent of the deaths occur in sub-Saharan Africa and most of these occur in children <5 years old; it is the leading cause of mortality in this age group. This disease is also widespread in Central and South America, Hispaniola, the Indian subcontinent, the Middle East, Oceania, and Southeast Asia. In the United States, individuals at risk include travelers to, and visitors from endemic areas.
Malaria parasites undergo a life cycle which includes sexual mating of gametocytes in mosquitoes and asexual replication in the erythrocytes of humans who have been infected by the bites of mosquitoes. Infected erythrocytes rupture producing anemia and initiating the release of cytokines including tumor necrosis factor.
Malaria "pigment" and sluggish cerebral blood flow cause cerebral edema. Pulmonary and renal failures are dire consequences of malaria due to Plasmodium falciparum which can be a life-threatening infection. It is crucial to suspect malaria in any febrile patient who has been in an endemic area and to distinguish Plasmodium falciparum from other species since Plasmodium falciparum can cause life-threatening infections and is resistant to many commonly used antimalarial agents such as chloroquine.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
If positive, organism identified
A positive smear indicates infection with the identified species of Plasmodium or with Babesia.
Species identification can indicate the appropriate antimalarial therapy.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
For most sensitive detection of Plasmodium, thick smears must be examined.
Any exam which does not include a thick smear cannot be considered adequate.
On rare occasions, LightCycler PCR may be used to confirm difficult smears.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Hoffman SL: Diagnosis, treatment, and prevention of malaria. Med Clin North Am 1992;76:1327-1355
Method Description Describes how the test is performed and provides a method-specific reference
The thin blood film is fixed in methyl alcohol and stained with a Giemsa stain. The thick films are not fixed and are directly stained with Giemsa stain. The thick films are used for screening. When the thick film is positive, the thin films are used for species identification. (Mayo Clinic Parasitology Laboratory Procedure Manual, 1995, pp 52-58)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Continuously
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test uses a standard method. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
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