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Babesia microti DNA, Real-Time PCR
Test Code37314
CPT Codes
87469
Preferred Specimen
0.7 mL whole blood collected in an EDTA (lavender-top) or
1 tick (in 70% ethanol) submitted in a sterile, leak-proof container
1 tick (in 70% ethanol) submitted in a sterile, leak-proof container
Minimum Volume
0.5 mL
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Whole blood
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
Tick
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
Tick
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Lithium heparin (green-top) tube • Sodium heparin (green-top) tube
Methodology
Real-Time Polymerase Chain Reaction
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Mon-Sat; Report available; 1-3 days
Limitations
Individuals infected with malaria may falsely test positive.
Clinical Significance
This test is intended for the qualitative detection of Babesia microti DNA in whole blood or ticks. Babesia microti is a protozoan parasite that infects red blood cells and causes Babesiosis. Transmission to humans occurs primarily through the bite of an infected Ixodes scapularis or Ixodes pacificus tick, occasionally through transfusion of contaminated blood products, and rarely through organ transplantation or from an infected mother to her baby during pregnancy or delivery.
Clinical diagnosis of human babesiosis can be difficult, especially in the early stages. Symptoms are nonspecific and typically include fever, chills, headache, myalgia, and anorexia. Hepatomegaly and splenomegaly may also be present. Severe disease most commonly occurs in elderly and/or immunocompromised patients and is associated with higher levels of parasitemia (≥4 percent), nausea, vomiting, and diarrhea.
Symptoms typically appear one to four weeks after infection via tick bite but may appear after a longer incubation period for infections from a contaminated blood product. Babesia parasitemia may persist in asymptomatic hosts for months or years, leading to concerns about the safety of blood products since there are currently no licensed tests for donor screening.
Laboratory evaluation for Babesia microti infection includes examination of thin blood smears for the presence of parasites within red blood cells, serological assays for antibody detection in serum, and molecular identification of Babesia microti DNA in whole blood or ticks. The Babesia microti DNA, Real-Time PCR assay is rapid, sensitive and does not detect DNA sequences from the closely related canine pathogen Babesia gibsoni.
A Babesia microti PCR result should be considered in the context of clinical observations, patient history, and epidemiological data when making a final diagnosis and patient management decisions. A negative result means that Babesia microti DNA was not present in the specimen above the limit of detection but does not exclude the possibility of infection.
Clinical diagnosis of human babesiosis can be difficult, especially in the early stages. Symptoms are nonspecific and typically include fever, chills, headache, myalgia, and anorexia. Hepatomegaly and splenomegaly may also be present. Severe disease most commonly occurs in elderly and/or immunocompromised patients and is associated with higher levels of parasitemia (≥4 percent), nausea, vomiting, and diarrhea.
Symptoms typically appear one to four weeks after infection via tick bite but may appear after a longer incubation period for infections from a contaminated blood product. Babesia parasitemia may persist in asymptomatic hosts for months or years, leading to concerns about the safety of blood products since there are currently no licensed tests for donor screening.
Laboratory evaluation for Babesia microti infection includes examination of thin blood smears for the presence of parasites within red blood cells, serological assays for antibody detection in serum, and molecular identification of Babesia microti DNA in whole blood or ticks. The Babesia microti DNA, Real-Time PCR assay is rapid, sensitive and does not detect DNA sequences from the closely related canine pathogen Babesia gibsoni.
A Babesia microti PCR result should be considered in the context of clinical observations, patient history, and epidemiological data when making a final diagnosis and patient management decisions. A negative result means that Babesia microti DNA was not present in the specimen above the limit of detection but does not exclude the possibility of infection.
