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Test ID LEIS Leishmaniasis (Visceral) Antibody, Serum

Reporting Name

Leishmaniasis (Visceral) Ab, S

Useful For

Aiding in the diagnosis of active visceral leishmaniasis

 

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

Specimen Type

Serum


Specimen Required


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 Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  14 days

Reference Values

Negative

Reference values apply to all ages.

Day(s) and Time(s) Performed

Monday, Wednesday, Friday; 9 a.m.

Test Classification

This test has been cleared, approved or is exempt 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

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 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.

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;25:581-586

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

Analytic Time

Same day/1 day

Method Name

Immunochromatographic Strip Assay

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.