Test Catalog

Test Id : SLEG

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Legionella pneumophila (Legionnaires Disease), Antibody, Serum

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Overview

Test Catalog

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

Evaluating possible legionellosis (Legionnaires disease, Pontiac fever, extrapulmonary legionella infection caused by Legionella pneumophila)

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Legionella Pneumophila Ab, S

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

LDA (Legionnaires' Disease Antibody)

Legionnaire's Disease

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

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

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. The minimum volume is sufficient for one attempt at testing.

0.4 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Heat-inactivated specimen 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

Evaluating possible legionellosis (Legionnaires disease, Pontiac fever, extrapulmonary legionella infection caused by Legionella pneumophila)

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

Legionella pneumophila may cause pulmonary disease in normal and immunocompetent individuals. The disease may occur sporadically in the form of community acquired pneumonia or as an epidemic. Pneumonia (often referred to as Legionnaires disease) occurs more frequently in individuals who are severely immunosuppressed; however, a milder form of the illness, Pontiac fever, is more prevalent in normal hosts. Extrapulmonary infection with L pneumophila is rare. Legionnaires disease, Pontiac fever, and extrapulmonary infection have been collectively referred to as legionellosis.

 

Approximately 85% of the documented cases of legionellosis have been caused by L pneumophila. Serogroups 1 and 6 of L pneumophila, by themselves, account for up to 75% of cases of legionellosis.

 

The definitive diagnosis of L pneumophila is made by isolation of the organism on specialized culture medium (buffered charcoal yeast extract agar) or detection by a nucleic acid amplification test. In the absence of invasive procedures (eg, bronchial alveolar lavage), evaluation of patient urine samples for L pneumophila serotype 1 antigen may be useful. Testing for antibodies to L pneumophila may be helpful to establish prior exposure or infection, however, does not differentiate between acute and past infection.

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

A negative result indicates that IgG, IgA, and IgM antibodies to Legionella pneumophila serogroups 1-6 were not detected. Negative results do not exclude Legionella infection. It may require 4 to 8 weeks to develop a detectable antibody response; serum specimens taken early in the course of infection may not yet have significant antibody titers. Furthermore, antibody levels can fall to undetectable levels within a month of infection, early antibiotic therapy may suppress antibody response, and some individuals may not develop antibodies above detectable limits.

 

Some culture-positive cases of Legionella do not develop Legionella antibody.

 

Positive results are suggestive of Legionella infection. A positive result only indicates immunologic exposure at some point in time. It does not distinguish between previous or current infection. The level of antibody response may not be used to determine active infection. Other laboratory procedures or additional clinical information are necessary to establish a diagnosis.

 

Specimens with equivocal results are retested prior to reporting. Repeat testing on a second specimen should be considered in patients with equivocal results, if clinically indicated.

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

A diagnosis should not be made based on positive Legionella antibody results alone. Test results for Legionella antibodies should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures.

 

A positive result suggests infection with one or more of the groups 1-6 species; however, it is not possible to distinguish between species with the results of this enzyme-linked immunosorbent assay test alone.

 

Use of serogroups 1-6 for assessing antibody responses to different Legionella species and serogroups has not been established.

 

Cross-reactivity may occur in sera with infections due to other Legionella species.

 

Positive results may be due to cross-reactivity with an antibody generated as a result of non-Legionella infection. Serologic cross-reactions have been reported with Pseudomonas aeruginosa, several Rickettsia species, Coxiella burnetii, enteric gram-negative rods, Bacteroides species, Haemophilus species, Citrobacter freundii, and Campylobacter jejuni. Additionally, some reports indicate that a number of apparently healthy individuals may carry antibodies to legionellae; however, a positive result, along with clinical signs and symptoms may indicate possible Legionella infection. Additional testing to directly detect the organism, either through culture or nucleic acid amplification tests, is recommended to make a diagnosis of current infection.

 

The assay performance characteristics have not been established for matrices other than sera.

 

Although the conjugate is designed to detect human IgG, IgM, and IgA, it is not possible to determine which antibody is present with this assay.

 

The use of hemolytic, lipemic, bacterially contaminated, or heat-inactivated specimens should be avoided as erroneous results may occur.

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

1. Koneman EW, Allen SD, Janda WM, eds. Color Atlas and Textbook of Diagnostic Microbiology. 5th ed. Lippincott-Raven Publishers; 1997

2. Edelstein PH, Roy CR. Legionnaires' disease and Pontiac fever. In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020

Method Description
Describes how the test is performed and provides a method-specific reference

The Legionella kit is designed to detect IgG-, IgA-, and IgM-class antibodies to Legionella pneumophila in human sera. The test procedure involves 3 incubation steps:

1. Test sera (properly diluted) are incubated in multiwells coated with an inactivated, solubilized cocktail of L pneumophila groups 1-6 bacteria (antigen). Legionella specific IgG, IgM, or IgA antibodies in the specimen will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.

2. Peroxidase-conjugated goat-antihuman IgG, IgA, and IgM is added to the wells and the plate is incubated. The conjugate will react with antibody immobilized on the solid phase in step 1. The wells are washed to remove unreacted conjugate.

3. The multiwells containing immobilized peroxidase conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After an incubation period, the reaction is stopped, and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the test specimen.(Package insert: L. pneumophila IgG/IgM/IgA Test System. Zeus Scientific; Revision 12/19/2017)

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.

Wednesday

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.

1 to 7 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 account representative. 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 modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

86713

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
SLEG Legionella Pneumophila Ab, S 7947-5
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.
SLEG Legionella Pneumophila Ab, S 7947-5

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