Legionella Antigen, Urine
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
As an adjunct to culture for the presumptive diagnosis of past or current Legionnaires disease (Legionella pneumophila serogroup 1)
Immunochromatographic Membrane Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Legionella Ag, U
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: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 0.5 mL
1. Collect a random urine specimen.
2. No preservative.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
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.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Urine||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Legionnaire's 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. Legionella pneumophila is estimated to be responsible for 80% to 85% of reported cases of Legionella infections with the majority of cases being caused by Legionella 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 (reported as positive or negative)
Presumptive positive for Legionella pneumophila serogroup 1 antigen in urine, suggesting current or past infection. Culture is recommended to confirm infection.
Presumptive negative for Legionella 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 Legionella 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 Legionella 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.
This assay has been validated using urine specimens only. For serum specimens, see SLEG/8122 Legionella pneumophila (Legionnaires' Disease), Antibody, Serum. Other specimen types (eg, plasma or body fluids) that may contain Legionella antigen have not been tested.
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 Legionella 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 also 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 Provides recommendations for further 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
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-Legionella pneumophila serogroup 1 antibody (the patient line) is adsorbed onto nitrocellulose membrane. Goat, antirabbit IgG (the control line) is adsorbed onto the same membrane as a second stripe. Rabbit anti-Legionella 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. Legionella pneumophila serogroup 1 urinary antigen captured by immobilized anti-Legionella 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 Legionella 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 Test, Binax, Inc., Portland, ME, 1999)
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 through Friday; 12 p.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.
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 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.
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|
|81268||Legionella Ag, U||32781-7|