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Test ID LBAB Babesia species, Molecular Detection, PCR, Blood

Useful For

An initial screening or confirmatory testing method for suspected babesiosis during the acute febrile stage of infection in patients from endemic areas, especially when Giemsa-stained peripheral blood smears do not reveal any organisms or the organism morphology is inconclusive.

Method Name

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)

Reporting Name

Babesia species, PCR, B

Specimen Type

Whole Blood EDTA

Container/Tube: Lavender top (EDTA)

Specimen Volume: 1 mL

Forms: If not ordering electronically, complete, print, and send a Microbiology Test Request Form (T244) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/microbiology_test_request_form.pdf).

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood EDTA Refrigerated (preferred) 7 days
  Frozen  7 days

Clinical Information

Babesiosis is an emergent zoonosis caused by an intraerythrocytic protozoan in the genus Babesia. Babesia microti is responsible for the vast majority of human cases in the United States, with "hot spots" of disease along the Northeast Coast (eg, Martha's Vineyard, Long Island, and Nantucket) and the upper Midwestern states, although the distribution of disease is spreading. In addition, a small number of cases of Babesia duncani and Babesia duncani-like human infection (WA and CA strains) have been reported along Pacific Coast states from Washington to northern California, and Babesia divergens/Babesia divergens-like strains have been isolated from humans in Missouri (MO-1 strain), Kentucky, and Washington. At this time, only Babesia microti is a nationally notifiable disease.

 

Babesia microti shares a tick vector with Borrelia burgdorferi and Anaplasma phagocytophilum, the causative agents of Lyme disease and human granulocytic anaplasmosis (HGA), respectively. Recent studies suggest that exposure to Babesia microti is quite common in areas endemic for Lyme disease and anaplasmosis, so it is prudent to consider testing for all 3 diseases concurrently. Less commonly, babesiosis may be acquired through blood transfusion, and therefore donor units are tested for this parasite in some endemic areas.

 

Most patients with babesiosis have a mild illness or are asymptomatic, but some develop a severe illness that may result in death. Patient symptoms may include fever, chills, extreme fatigue, and severe anemia. The most severe cases occur in asplenic individuals and those over 50 years of age. Rare cases of chronic parasitemia, usually in immunocompromised patients, have been described.

 

The definitive laboratory diagnosis of babesiosis rests on the demonstration of Babesia species characteristic intraerythrocytic parasites in Giemsa-stained thick and thin blood films. This method is capable of detecting (but not differentiating) human-infective Babesia species.

 

Babesia may closely resemble those of Plasmodium falciparum. The Mayo Clinic real-time PCR assay provides a rapid and sensitive alternative to blood film examination and enables the detection and differentiation of Babesia microti, Babesia duncani/Babesia duncani-like and Babesia divergens/Babesia divergens-like parasites. It does not cross-react with malaria parasites. Finally, antibody testing may be used and is useful for detection of babesiosis, but may be negative in the early phase of illness and cannot distinguish active from past infection.

Reference Values

Negative

Cautions

While this assay is designed to detect symptomatic infection with Babesia microti, Babesia duncani and Babesia divergens/MO-1, it may detect low-grade asymptomatic parasitemia in individuals in babesiosis-endemic areas. Thus, it should only be used for testing patients with a clinical history and symptoms consistent with babesiosis.

 

Inhibitory substances may cause false-negative results.

 

Inadequate specimen collection or improper storage may invalidate test results.

 

This is a qualitative assay and the results are reported either as negative or positive for targeted Babesia species DNA.

Day(s) Performed

Monday through Saturday; Varies

Report Available

Same day/1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

87798

NY State Approved

Yes