Visceral Leishmaniasis Lateral Flow Assay !!! NOTE: The contents are valid only for: 01/27/2026 !!!
| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SS02052 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1-3 Days |
| Recommended Uses: | Qualitative detection of antibodies to members of L. donovani in a human serum specimen to aid in the presumptive diagnosis of Visceral Leishmaniasis. |
| Pre-approval: | No |
| Contraindications: | Post-mortem testing Testing <14 days since infection |
| Additional Tests Performed: |
|
| Preparation for Collection: | None |
| Specimen Requirements: | Minimum of 0.5 mL human serum |
| Collection Instructions: | Routine blood draw Remove serum from the clot of red cells as soon as possible to avoid hemolysis. |
| Collection Kit/Container: |
|
| Requisition Form: |
|
| Required Information: | Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier, date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label which is required to have a minimum of two identifiers. |
| Rejection Criteria: | Specimens stored longer than 3 days at 2-8°C are unacceptable for testing. Hemolyzed specimens are unacceptable for testing. |
| Specimen Handling: | Specimens should be stored at 2-8°C , transported with a frozen cool pack, and should be received at the lab within 48 hours of collection. If specimens will not be tested for 3 or more days, they should be frozen at -20°C until ready for shipment and shipped on dry ice. |
| Packaging Requirements: | |
| Courier Information: | Not eligible for fee exempt courier |
| Specimen Receiving Hours: | Monday-Friday 6:00 AM - 4:30 PM, Saturday 6:30 AM - 12:30 PM |
| Results Include: | Positive, Negative, or Inconclusive |
| Limitations: | Should not be used as the sole criterion for the diagnosis of Visceral Leishmaniasis. False results may occur. Serum samples containing glycerol or other viscous materials will decrease sensitivity of the assay. Persons with advanced HIV infection or other immunocompromising diseases frequently have low or undetectable anti-Leishmanial antibodies. |
| Additional Tests Recommended: | |
| Additional Comments: | |
| Methodology: | Lateral Flow Immunochromatographic Assay for the qualitative detection of human antibodies specific to antigens from members of L. donovoni post infection. |
| Includes: | |
| Regulatory Compliance: | |
| CPT Code: | 86717 |
| Price: | $45.00 |
| Fee Exempt Eligible: | Yes, for submitters in the Midwest region |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |