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Test ID LEIS Leishmaniasis (Visceral) Antibody, Serum

Useful For

Diagnosis of active visceral leishmaniasis

Method Name

Immunochromatographic Strip Assay

Reporting Name

Leishmaniasis (Visceral) Ab, S

Specimen Type

Serum

Container/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 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

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

NY State Approved

Yes