|Values are valid only on day of printing.|
As an adjunct to culture for the presumptive diagnosis of past or current Legionnaires disease (Legionella pneumophila serogroup 1)
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.
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.
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 / 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.
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