Legionellosis is more prevalent than you might think.
Legionella pneumophila is one of the leading causes of
bacterial nosocomial pneumonia. The BinaxNOW®
Legionella urinary antigen test is one of the
most widely recognized rapid urine test in the world due to
sensitivity, specificity and ease of use. In addition to the rapid
test there is the Binax® Legionella Urinary
Antigen EIA.
Intended
Use
The BinaxNOW® Legionella
urinary antigen test is an in vitro rapid
immunochromatographic assay for the qualitative detection of
Legionella pneumophila serogroup 1 antigen in urine
specimens from patients with symptoms of pneumonia. It is intended
to aid in the presumptive diagnosis of Legionella
infection (Legionnaires’ disease) caused by L. pneumophila
serogroup 1 in conjunction with culture and other methods.
The Binax® Legionella
Urinary Antigen EIA is intended for in
vitro diagnostic use for qualitative detection of
Legionella pneumophila serogroup 1 antigen in human urine
as an adjunct to culture for the presumptive diagnosis of past or
current Legionnaires’ disease.
Product Details
| Sample Type: |
Urine |
| Time to Result: |
15 minutes |
| Kit Size: |
12 or 22 tests |
| Performance data: |
Sensitivity/Specificity – 95% / 95%* |
| Regulatory: |
Cleared for distribution by the FDA and CE
marked, |
| |
available in 11 languages |
For instructions for use, see package
insert
| Binax®
Legionella Urinary Antigen EIA |
| Sample Type: |
Urine |
| Time to Result: |
3 hours (approx) |
| Kit Size: |
96 well test kit |
| Performance data: |
Sensitivity/Specificity – 97.7% / 100% |
| Regulatory: |
Cleared for distribution by the FDA and CE
marked, |
| |
available in 11 languages |
For instructions for use, see
package insert
About Legionella
Legionellae is the cause of Pontiac fever, a
self-limited flu-like illness, and Legionnaires' disease (LD), a
severe multisystem disease involving pneumonia1.
Legionnaires' disease can take the form of community-acquired
pneumonia, nosocomial pneumonia, and even traveller's pneumonia. An
estimated 8,000-18,000 cases of Legionnaires' disease occur in the
United States each year2. Approximately 90% of all
reported cases of Legionnaires' disease in the United States are
believed to be caused by L. pneumophila; L.
pneumophila serogroup 1 accounts for approximately 71% of all
culture-confirmed or urine antigen-confirmed cases3. The
CDC estimates that a mere 2-10% of cases are reported, partially
due to lack of testing. Populations at risk include persons over 60
years; smokers and those with chronic lung disease; and
immunocompromised individuals4.
For more information about diseases caused by
Legionella, please see the links below:
References
1. Fraser DW, Tsai
TR, Orenstein W, Parkin WE, Beecham HJ, Sharrar RG, Harris J,
Mallison GF, Martin SM, McDade JE, Shepard CC, Brachman PS. 1977.
Legionnaires' disease: description of an epidemic of pneumonia.
N. Engl. J. Med. 297:1189-1197.
2. Marston BJ, Plouffe
JF, File TM, Hackman BA, Salstrom SJ, Lipman HB, Kolczak MS,
Breiman RF. 1997.
Incidence of community-acquired pneumonia requiring hopstalization
- results of a population-based active surveillance study in
Ohio. Arch. Intern. Med. 157:1709-1718.
3. Marston BJ, Plouffe
JF, File TM, Hackman BA, Salstrom SJ, Lipman HB, Kolczak MS,
Breiman RF. 1994.
Surveillance for Legionnaires‘ disease. Risk factors for morbidity
and mortality. Arch. Intern. Med. 164:2417-2422.
4. Bartlett J and C. J.
Grace. 2003. Community-Acquired Pneumonia and Bronchitis, p. 235,
in Medical Management of Infectious Disease. CJ Grace
(ed.), Marcel Dekker, Inc., New York.
*Retrospective data.
See package insert for complete performance information.