Test ID LEIS Leishmaniasis (Visceral) Antibody, Serum
Useful For
Diagnosis of active visceral leishmaniasis
Method Name
Immunochromatographic Strip Assay
Reporting Name
Leishmaniasis (Visceral) Ab, SSpecimen Type
SerumContainer/Tube:
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.2 mL
Specimen Minimum Volume
0.1 mL
Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Serum | Refrigerated (preferred) | 14 days |
Frozen | 14 days |
Clinical Information
Visceral leishmaniasis (kala azar) is a disseminated intracellular protozoal infection that targets primarily the reticuloendothelial system (liver, spleen, bone marrow) and is caused by Leishmania donovani, Leishmania chagasi, or Leishmania infantum (Leishmania donovani complex).
Transmission is by the bite of sandflies. Clinical symptoms include fever, weight loss, and splenomegaly; pancytopenia and hypergammaglobulinemia are often present. Most (90%) new cases each year arise in rural areas of India, Nepal, Bangladesh, Sudan, and Brazil but the disease has a worldwide distribution, including the Middle East.
Definitive diagnosis has required the microscopic documentation of characteristic intracellular amastigotes in stained smears from culture of aspirates of tissue (spleen, lymph node) or bone marrow. The detection of serum antibodies to the recombinant K39 antigen of Leishmania donovani is an alternative noninvasive sensitive (95%-100%) method for the diagnosis of active, visceral leishmaniasis.
Reference Values
Negative
Cautions
This test indicates only the presence of antibodies and should not be used as the sole criteria for diagnosis.
False-positive results may occur in patients with malaria or in the presence of rheumatoid factor.
Specimens containing glycerol or other viscous materials may interfere with the test.
Patients co-infected with HIV and Leishmania may fail to produce antibodies.
Day(s) Performed
Monday, Wednesday, Friday; 9 a.m.
Report Available
Same day/1 dayPerforming Laboratory

Test Classification
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86717