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Test ID: LEIS Leishmaniasis (Visceral) Antibody, Serum

Reporting Name

Leishmaniasis (Visceral) Ab, S

Useful For

Aid in the diagnosis of active visceral leishmaniasis

This test should not be used as the sole criteria for diagnosis.

Clinical Information

Visceral leishmaniasis (kala azar) is most commonly caused by Leishmania donovani, Leishmania chagasi, or Leishmania infantum (L donovani complex). Transmission of Leishmania species occurs via the bite of sandflies. Infection with these intracellular protozoa typically leads to a disseminated infection that primarily affects the reticuloendothelial system (liver, spleen, bone marrow). Clinical symptoms include fever, weight loss, and splenomegaly; pancytopenia and hypergammaglobulinemia are also 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 of visceral leishmaniasis requires 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 L donovani is an alternative noninvasive method for the diagnosis of active, visceral leishmaniasis.

Interpretation

Negative:

No antibodies to members of the Leishmania donovoni complex detected. Repeat testing in 2 to 3 weeks if clinically indicated. Immunocompromised patients frequently have low or undetectable antibodies to Leishmania species.

 

Positive:

Antibodies to members of the L donovoni complex detected. Results should not be used as the sole criterion for diagnosis or treatment of visceral leishmaniasis and should not be used to diagnose other forms of leishmaniasis. False-positive reactions due to malaria infection may occur.

Report Available

Same day/1 to 4 days

Day(s) Performed

Tuesday, Thursday

Clinical Reference

Aronson NE, Copeland NK, Magill AJ. Leishmania species: visceral (Kala-Azar), cutaneous, and mucosal leishmaniasis. In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:3321-3339

Method Name

Immunochromatographic Strip Assay

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.2 mL Serum

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

Serum: 0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 14 days
  Frozen  14 days

Reference Values

Negative

Reference values apply to all ages.

Test Classification

This test has been cleared, approved, or is exempt by the US 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LEIS Leishmaniasis (Visceral) Ab, S 7958-2

 

Result ID Test Result Name Result LOINC Value
86219 Leishmaniasis (Visceral) Ab, S 7958-2

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

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