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HelpTest ID: LEIS Leishmaniasis (Visceral) Antibody, Serum
Reporting Name
Leishmaniasis (Visceral) Ab, SUseful For
Aiding 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 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 (L 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 L donovani is an alternative noninvasive sensitive (95%-100%) method for the diagnosis of active, visceral leishmaniasis.
Interpretation
Negative:
Negative results indicate the absence of antibodies to members of the Leishmania donovoni complex. Repeat testing in 2 to 3 weeks if clinically indicated. Immunocompromised patients frequently have low or undetectable antibodies to Leishmania species.
Positive:
Positive results indicate the presence of antibodies to members of the L donovoni complex, the causative agents of visceral leishmaniasis. 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 have been reported.
Report Available
Same day/1 to 4 daysDay(s) Performed
Tuesday, Thursday
Clinical Reference
1. Sundar S, Sahu M, Mehta H, et al. Noninvasive management of Indian visceral leishmaniasis: clinical application of diagnosis of K39 antigen strip testing at a kala-azar referral unit. Clin Infect Dis. 2002;35(5):581-586
2. 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
SerumSpecimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.2 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| 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.
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