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HelpTest Code MISC2MAYOLEIS Leishmaniasis (Visceral) Antibody, Serum
Reporting Name
Leishmaniasis (Visceral) Ab, SUseful For
Aid in the diagnosis of active visceral leishmaniasis
This test should not be used as the sole criteria for diagnosis.
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen 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.
Day(s) Performed
Tuesday, Thursday
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 |
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.
Method Description
Immunochromatographic strip assay for the qualitative detection of antibodies to the Leishmania donovani complex in serum. The test strip membrane is coated on the bottom with a band of recombinant K39 antigen and on the top with immobilized antiprotein A antibody to detect IgG. A protein A-gold conjugate is used as the detection reagent. For this test, 20 mcL of serum is added to the test strip. The appearance of both a control and test band is considered a positive result.(Carvalho SF, Lemos EM, Corey R, Dietze R. Performance of recombinant K39 antigen in the diagnosis of Brazilian visceral leishmaniasis. Am J Trop Med Hyg. 2003;68[3]:321-324; package insert: Kalazar Detect Rapid Test for Visceral Leishmaniasis. InBios International, Inc; 12/15/2025)
Report Available
Same day/1 to 4 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
Method Name
Immunochromatographic Strip Assay
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.