Legionellosis is more prevalent than you might think.
Legionella pneumophila is one of the leading causes of
bacterial pneumonia. The BinaxNOW® Legionella
Urinary Antigen Test is one of the most widely recognized rapid
urine tests in the world due to its sensitivity, specificity and
ease of use.
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 (Legion-naires’ disease) caused by
L. pneumophila serogroup 1 in conjunction with culture and
other methods.
This product is FDA-Cleared and CE Marked.
Product Details
- Availability – Global
- CLIA Status – Moderate
Complexity
- Sample type - Urine
- Time for test results – 15
minutes
- Sensitivity – 95%*
- Specificity – 95%*
BinaxNOW® Legionella Testing Procedure
Bring patient sample(s) and/or liquid control(s)
to room temperature. Remove device from its pouch just before use
and lay flat.
Dip a Binax swab into the urine
sample to be tested, completely covering the swab head.
If the swab drips, touch swab to side of urine
container to remove excess liquid.
There are two holes on the inner right panel of
the device. Insert swab into the BOTTOM hole (swab
well). Firmly push upwards so that the swab tip is fully visible in
the top hole. DO NOT REMOVE SWAB.
Hold Reagent A vial vertically, ½ to 1 inch
above the device. Slowly add 2 free-falling drops
of Reagent A to the BOTTOM
hole.
Immediately peel adhesive liner from the right
edge of the test device. Close and securely seal the device. Read
result in window 15 minutes after closing the device. Results read
beyond 15 minutes may be inaccurate. However, some positive
patients may produce a visible sample line in less than 15
minutes.
For full instructions for use, see package insert.
About Legionella
Legionnaires' Disease, named after the outbreak in 1976 at the
American Legion convention in Philadelphia, is caused by
Legionella pneumophila and is characterized as an acute
febrile respiratory illness ranging in severity from mild illness
to fatal pneumonia.1 The disease occurs in both epidemic
and endemic forms and sporadic cases are not easily differentiated
from other respiratory infections by clinical symptoms.
Methods for the laboratory detection of pneumonia caused by
L. pneuomophila require a respiratory specimen.
Unfortunately, one of the presenting signs of patients with
Legionnaires' Disease is the relative lack of productive
sputum.2,3 In many cases, this necessitates the use of
an invasive procedure to obtain a respiratory specimen.
BinaxNOW Legionella allows for the early diagnosis of
L. pneumophila serogroup 1 infection through detection of
a specific soluble antigen present in the urine of patients with
Legionnaires' Disease.4-8
References
- Fraser DW, Tsai TR, Orensein W, et al and The Field
Investigation Team. Legionnaires' disease: description of an
epidemic of pneumonia. N Engl J Med. 1977;297:1189-1197.
- Stout JE, Yu VL. Legionellosis. N Engl J Med.
1997;337:682-687.
- Edelstein PH. Legionnaire's disease. Clin Infect Dis.
1993;16:741-749.
- Berdal BP, Farshy CE, Feeley JC. Detection of Legionella
pneumophila antigen in urine by enzyme-linked immunospecific
assay. J Clin Microbiol. 1979;9:575-578.
- Tilton RC. Legionnaires' disease antigen detected by
enzyme-linked immunosorbent assay. Ann Intern Med.
1979;90:697-698.
- Kohler RB, Zimmerman SE, Wilson E, et al. Rapid
radioimmunoassay diagnosis of Legionnaires' Disease. Ann Intern
Med. 1981;94:601-605.
- Bibb WF, Arnow PM, Thacker L, McKinney RM. Detection of soluble
Legionella pneumophila antigens in serum and urine
specimens by enzyme-linked immunosorbent assay with monoclonal and
polyclonal antibodies. J Clin Microbiol. 1984;20:478-482.
- Tang PW, Toma S. Broad-spectrum enzyme-linked immunosorbent
assay for detection of Legionella soluble antigens. J Clin
Microbiol. 1986;24:556-558.
* Retrospective data. See package insert for complete performance
information.