Test ID: LEPTO
Leptospira Antibody, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
As an aid in the diagnosis of leptospirosis
Method Name A short description of the method used to perform the test
Indirect Hemagglutination
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Leptospirosis Antibody
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Leptospirosis is a zoonotic disease of worldwide prevalence. Although wild mammals are the primary natural reservoir of pathogenic strains, domestic animals represent a major source of human infection. Most often, transmission is indirect-by human contact with soil, food, or water contaminated by urine from an infected animal.
The clinical manifestations of leptospirosis are variable, ranging from a mild infection with fever, chills, headache, conjunctivitis, myalgia, and gastrointestinal symptoms to icteric disease with severe kidney and liver involvement.
Leptospira organisms may be found in the blood at the onset of disease and may persist for approximately 1 week. The organisms also may be found in the urine after week one of the disease. They may persist in the urine for 2 to 3 months; however, shedding may be intermittent and the numbers of organisms present may be low. Urine must be cultured immediately because the organisms cannot survive in acidic urine for more than a few hours.
Leptospirosis is accompanied by a brisk antibody response.
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
Interpretation Provides information to assist in interpretation of the test results
Both IgM and IgG classes of antibody are produced in response to any of 16 leptospira serovars that produce infection. IgM antibody is first detectable within 1 to 2 weeks after onset of illness and peaks at 2 to 4 weeks.
Titers of 1:50 are considered borderline and follow-up specimens should be drawn for isolation of live leptospires (ie, culture) and repeat serology.
Titers > or =1:100 represent recent or active infection.
The overall sensitivity of the assay is 100% and the specificity is 97% when compared to CDC reagents.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Serologic results must be correlated with the clinical picture.
Sera drawn too close to onset of symptoms may precede the initial IgM antibody response.
Acute titers may be delayed or substantially decreased by early and intensive antibiotic treatment.
The assay detects antibody to the genus Leptospira but will not determine which serovar is associated with the infection.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Sulzer CR, Glosser JW, Rogers F, et al: Evaluation of an indirect hemagglutination test for the diagnosis of human leptospirosis. J Clin Microbiol 1975;2:218-221
2. Sulzer CR, Jones WL: Leptospirosis. Methods in laboratory diagnosis (revised edition). United States Deptartment of Health Education and Welfare, Centers for Disease Control, Publication No. 79:8275;1978
3. Tappero JW, Ashford DA, Perkins BA: Leptospirosis. In Principles and Practice of Infectious Diseases. 5th edition. Edited by GL Mandell, JE Bennet, R Dolin. New York, Churchill Livingstone, 1999
4. Weyant RS, Bragg SL, Kaufmann AF: Leptospira and leptonema. In Manual of Clinical Microbiology. 7th edition. Edited by PR Murray, EF Baron, MA Pfaller, et al. Washington, DC, ASM Press, 1999;739-745
Method Description Describes how the test is performed and provides a method-specific reference
The assay is an indirect hemagglutination procedure. This indirect hemagglutination test uses human type "O" erythrocytes that have been coated (sensitized) with genus-specific leptospiral antigens derived from Leptospira biflexa strain Patoc 1. When a positive patient serum is incubated with these coated cells, the antigen-antibody reaction causes agglutination of the cells. The antibody titer is measured by testing serial dilutions of positive sera and recording the highest serum dilution that produces the agglutination reaction. Control cells (unsensitized erythrocytes) are also tested to screen for nonspecific reactivity. Both IgG and IgM class antibodies are detected in the assay, but are not distinguished. (Sulzer CR, Glosser JW, Rogers F, et al: Evaluation of an indirect hemagglutination test for the diagnosis of human leptospirosis. J Clin Microbiol 1975;2:218-221)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday, Friday; 9 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86720
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 9697 | Leptospira Ab, S | 23196-9 |
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