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Test Code LEPDT Leptospira, IgM, Serum

Secondary ID

65183

Useful For

Aids in the diagnosis of leptospirosis

Method Name

Enzyme-Linked Immunoassay Dot (Immunodot)

Reporting Name

Leptospira, IgM, S

Specimen Type

Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.3 mL

Collection Instructions: Serum should be collected according to standard practices. Acute and convalescent specimens obtained to determine seroconversion should be collected 2 or more weeks apart.


Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 30 days
  Frozen  30 days

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

Clinical Information

Leptospirosis is a zoonotic disease of worldwide prevalence, though the majority of infections occur in warm, tropical climates. Wild mammals, typically rodents, are the primary, natural reservoir for pathogenic strains of Leptospira, however, domestic animals (eg, dogs) also represent a major source of human infection. Leptospira are Gram-negative spirochetes with at least 20 different species in the genus. Of these, at least 9 species are considered pathogenic, including the most common agent of leptospirosis, Leptospira interrogans.

 

Transmission occurs through indirect human contact (eg, via mucous membranes or abraded skin) with water, food, or soil contaminated with animal urine containing the Leptospira spirochetes. Following infection, the incubation period can range from 3 to 30 days depending on the inoculum dose and immune status of the individual.

 

The clinical manifestations of leptospirosis can vary, ranging from a mild, flu-like illness (eg, headache, malaise, fever, arthralgia, fatigue) to fulminant disease, with severe liver and kidney involvement. The latter manifestation was previously referred to as Weil disease. Leptospira organisms may be found in the blood at the onset of disease and can persist for approximately 1 week. Subsequently, spirochetes may be found in the urine and can persist for 2 to 3 months; however, shedding may be intermittent and the numbers of organisms present may be low.

 

While Leptospira can be grown in culture, this is a fastidious organism and requires immediate transport to the laboratory. Additionally, detectable growth requires prolonged incubation (1-6 weeks), limiting the utility of culture for acute diagnosis. For this reason, serologic detection for antibodies to Leptospira remains the method of choice for rapid diagnosis. IgM-class antibodies to this spirochete are detectable by day 6 of illness and remain detectable for 2 to 3 months following symptom onset.

Reference Values

Negative

Interpretation

Positive: IgM antibodies to Leptospira species detected suggesting recent infection. Antibody presence alone cannot be used to definitively diagnose acute infection, as antibodies from a prior exposure or infection may remain detectable for a prolonged period of time.

 

Borderline: Result should be interpreted with caution. Additional testing of a second, convalescent specimen is recommended. If the specimen remains borderline reactive, a second serological method should be considered if leptospirosis infection is still suspected.

 

Negative: No IgM antibodies to Leptospira detected. Since antibodies may not be present or may be present at undetectable levels during early disease, repeat testing of a convalescent sample collected in 2 to 3 weeks is recommended.

Clinical Reference

1. CDC: Leptospriosis. Accessed 12/30/16. Available at: www.cdc.gov/leptospirosis/

2. Costa F, Hagan JE, Calcagno J, et al: Global Morbidity and Mortality of Leptospirosis: A Systemic Review. PLoS Negl Trop Dis 2015 Sept;9(9) doi: 10.1371/journal.pntd.0003898

3. Package Insert: ImmunoDot Leptospira IgM, GenBio, San Diego, CA; Version 4.0

Day(s) and Time(s) Performed

Monday, Wednesday, Friday; 9 a.m.

Analytic Time

Same day/1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved 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

86720

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LEPDT Leptospira, IgM, S 23201-7

 

Result ID Test Result Name Result LOINC Value
65183 Leptospira, IgM, S 23201-7