Test Catalog

Test Id : LAGU

Legionella Antigen, Random, Urine

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

An adjunct to culture for the detection of past or current Legionnaires disease (Legionella pneumophila serogroup 1)

 

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

Immunochromatographic Membrane Assay

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 Ag, U

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

Legionella pneumophila

Legionellosis

Legionnaires' Disease

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering Guidance

This assay has been verified using urine specimens only. For serum specimens, order SLEG / Legionella pneumophila (Legionnaires Disease), Antibody, Serum.

 

Other specimen types (eg, plasma or body fluids) that may contain Legionella antigen have not been verified for testing.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Urine Tubes, 10 mL (T068)

Container/Tube: Plastic, 10-mL urine tube

Specimen Volume: 0.5 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

3. Excessively bloody or very turbid specimens containing protein, cells, or particulates will be canceled. They can inhibit the function of the test.

4. Centrifuging to remove particulates is not approved.

5. Specimens with any dyes or unnatural color are not acceptable and will be canceled.

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Infectious Disease Serology Test Request (T916)

-Microbiology Test Request (T732)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.25 mL

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

Gross hemolysis Reject
Turbid Dyes/unnaturally colored 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
Urine Refrigerated (preferred) 7 days
Frozen 14 days
Ambient 24 hours

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

An adjunct to culture for the detection of past or current Legionnaires disease (Legionella pneumophila serogroup 1)

 

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

Legionnaires disease, named after the outbreak in 1976 at the American Legion convention in Philadelphia, is caused by Legionella pneumophila and is an acute febrile respiratory illness ranging in severity from mild illness to fatal pneumonia. Since that time, it has been recognized that the disease occurs in both epidemic and endemic forms, and that sporadic cases are not readily differentiated from other respiratory infections by clinical symptoms. It is estimated that about 25,000 to 100,000 Legionella infections occur annually. Known risk factors include immunosuppression, cigarette smoking, alcohol consumption, and concomitant pulmonary disease. The resulting mortality rate, which ranges up to 40% in untreated immunocompetent patients, can be lowered if the disease can be rapidly diagnosed and appropriate antimicrobial therapy instituted early. L pneumophila is estimated to be responsible for 80% to 85% of reported cases of Legionella infections with the majority of cases being caused by L pneumophila serogroup 1 alone.

 

A variety of laboratory techniques (culture, direct fluorescent antibody, DNA probes, immunoassay, antigen detection), using a variety of specimen types (respiratory specimens, serum, urine), have been used to help diagnose Legionella pneumonia. Respiratory specimens are preferred. Unfortunately, one of the presenting signs of Legionnaires disease is the relative lack of productive sputum. This necessitates the use of invasive procedures to obtain adequate specimens (eg, bronchial washing, transtracheal aspirate, lung biopsy) in many patients. Serology may also be used but is often retrospective in nature.

 

It was shown as early as 1979 that a specific soluble antigen was present in the urine of patients with Legionnaires disease.(1) The presence of Legionella antigen in urine makes this an ideal specimen for collection, transport, and subsequent detection in early, as well as later, stages of the disease. The antigen may be detectable in the urine as early as 3 days after onset of symptoms.

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

Positive

Positive for Legionella pneumophila serogroup 1 antigen in urine, suggesting current or past infection. Culture is recommended to confirm infection.

 

Negative

Negative for L pneumophila serogroup 1 antigen in urine, suggesting no recent or current infection. Infection with Legionella cannot be ruled out because:

-Other serogroups (other than serogroup 1, which is detected by this assay) and other Legionella species (other than L pneumophila) can cause disease

-Antigen may not be present in urine in early infection

-The level of antigen may be below the detection limit of the test

 

Legionella culture is recommended for cases of suspected Legionella pneumonia due to organisms other than L pneumophila serogroup 1.

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

The diagnosis of Legionnaires disease cannot be based on clinical or radiological evidence alone. There is no single satisfactory laboratory test for Legionnaires disease. Culture results, serology, and antigen detection methods should all be used in conjunction with clinical findings for diagnosis.

 

The Legionella pneumophila serogroup 1 will not detect infections caused by other serogroups, Legionella micdadei or Legionella longbeachae. Culture is recommended for suspected pneumonia to detect causative agents other than L pneumophila serogroup 1, and to confirm infection.

 

Excretion of Legionella antigen in urine may vary among patients, depending on their underlying illness or treatment. Some individuals have been shown to excrete antigen for extended periods of time (up to 1 year after acute infection) and positivity may, therefore, indicate previous infection rather than current infection. Early treatment with appropriate antibiotics may decrease antigen excretion in some individuals, and the use of diuretics may affect the ability of the test to detect antigen. Consequently, patient history (eg, a history of a recent respiratory illness compatible with Legionnaires disease) must be considered when evaluating results.

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

1. Berdal BP, Farshy CE, Feele JC: Detection of Legionella pneumophila antigen in urine by enzyme-linked immuno-specific assay. J Clin Microbiol. 1979 Dec;9(5):575-578

2. Fraser DW, Tsai TR, Orenstein W, et al: Legionnaires' disease: description of an epidemic of pneumonia. N Engl J Med. 1977 Dec 1;297(22):1189-1197

3. Stout JE, Yu VL: Legionellosis. N Engl J Med. 1997 Sept 4;337(10):682-687

4. 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; 2020:2807-2817

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

The BINAXNOW Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 soluble antigen in human urine. Rabbit anti-L pneumophila serogroup 1 antibody (the patient line) is adsorbed onto nitrocellulose membrane. Goat-anti-rabbit IgG (the control line) is adsorbed onto the same membrane as a second stripe. Rabbit anti-L pneumophila serogroup 1 antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and the striped membrane are combined to construct the test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, book-shaped test device.

 

To perform the test, a swab is dipped into the urine specimen, removed, and then inserted into the test device. Reagent A is added from a dropper bottle. The device is then closed, bringing the specimen into contact with the test strip. L pneumophila serogroup 1 urinary antigen captured by immobilized anti-L pneumophila serogroup 1 antibody reacts to bind conjugated antibody. Immobilized goat-anti-rabbit IgG also captures visualizing conjugate, forming the control line. A positive test result is visually read in 15 minutes or less depending on the concentration of antigen present in the urine specimen. A negative result, read in 15 minutes, indicates that L pneumophila serogroup 1 antigen was not detected in the urine specimen.

 

The test is interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive result will include the detection of both a patient and a control line, while a negative assay will produce only the control line. Failure of the control line to appear, whether the patient line is present or not, indicates an invalid assay.(Package insert: BinaxNow Legionella Urinary Antigen Card. Abbott Diagnostics Scarborough Inc; IN852050 Rev.12, 01/2021)

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.

Monday through Friday

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.

Same day/1 day

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 Regional Manager. 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 cleared, approved, or is exempt by the US 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
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.

87899

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
LAGU Legionella Ag, U 32781-7
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.
81268 Legionella Ag, U 32781-7

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