Leishmania Antibody (IgG)
Test Summary
Detection of Leishmania IgG provides strong support for the diagnosis of visceral leishmaniasis. Some (but not all) patients with cutaneous leishmaniasis also have detectable serum levels of Leishmania IgG. Sera from patients with Trypanosoma cruzi infection (Chagas' disease) show significant cross-reactivity in the Leishmania IgG assay.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.2 mL serum
Minimum Volume
0.1 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 7 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Grossly lipemic
Order Code
LEISH
EPIC (Premier) Code
LAB6364
Includes
N/A
CPT Code
- 86717
Billing Code
- 700000
CPT Statement
Methodology
Enzyme Immunoassay (EIA)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Reference Range
<1.00
Interpretive Criteria
This assay is intended to aid in the diagnosis of visceral leishmaniasis. Its use in diagnosing cutaneous leishmaniasis is limited, since a detectable antibody response is often absent in this form of the disease. Sera from patients with Chagas' disease (Trypanosoma cruzi infection) may be positive in this assay; thus, results should be used in conjunction with other clinical findings when considering a diagnosis of leishmaniasis.
Interpretive Criteria
| <1.00 | Negative |
| ≥1.00 | Positive |
Setup Schedule / Expected Turnaround Time
Wednesday; Report available: 1 - 8 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.2 mL serum
Minimum Volume
0.1 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Transport tube
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 7 days
- Refrigerated: 14 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Gross hemolysis • Grossly lipemic
Result Information
Methodology
Enzyme Immunoassay (EIA)
Testing Laboratory
N/A
Reference Range
<1.00
Interpretive Criteria
This assay is intended to aid in the diagnosis of visceral leishmaniasis. Its use in diagnosing cutaneous leishmaniasis is limited, since a detectable antibody response is often absent in this form of the disease. Sera from patients with Chagas' disease (Trypanosoma cruzi infection) may be positive in this assay; thus, results should be used in conjunction with other clinical findings when considering a diagnosis of leishmaniasis.
Interpretive Criteria
| <1.00 | Negative |
| ≥1.00 | Positive |
Setup Schedule / Expected Turnaround Time
Wednesday; Report available: 1 - 8 days