Test Catalog

Test Id : LEIS

Leishmaniasis (Visceral) Antibody, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of active visceral leishmaniasis

 

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

Method Name
A short description of the method used to perform the test

Immunochromatographic Strip Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Leishmaniasis (Visceral) Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Kala-azar

l. donovani

Leishmania

Leishmania donovoni

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.2 mL

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of active visceral leishmaniasis

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Supportive Data

Manufacturer's reported sensitivity and specificity (for endemic areas) are 90% or more and 93% to 100% respectively (InBios Kalazar Detect Rapid Test product insert). Validation studies in the Mayo Clinic Division of Clinical Microbiology provided a sensitivity of 94% (panel of 16 known positives) and specificity of 100% (panel of 50 normal blood donors plus 16 positives for other parasitic infections).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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 Sep 1;25(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
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86717

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
LEIS Leishmaniasis (Visceral) Ab, S 7958-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
86219 Leishmaniasis (Visceral) Ab, S 7958-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports