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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


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.

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

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.

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 coinfected with HIV and Leishmania may fail to produce antibodies.

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 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;68:321-324; package insert: Kalazar Detect Rapid Test for Visceral Leishmaniasis. InBios International, Inc; 05/01/2018)

Report Available

Same day/1 to 4 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

NY State Approved

Yes

Method Name

Immunochromatographic Strip Assay

Forms

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