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

1. 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.
2. Stout JE, Yu VL. Legionellosis. N Engl J Med. 1997;337:682-687.
3. Edelstein PH. Legionnaire's disease. Clin Infect Dis. 1993;16:741-749.
4. 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.
5. Tilton RC. Legionnaires' disease antigen detected by enzyme-linked immunosorbent assay. Ann Intern Med. 1979;90:697-698.
6. Kohler RB, Zimmerman SE, Wilson E, et al. Rapid radioimmunoassay diagnosis of Legionnaires' Disease. Ann Intern Med. 1981;94:601-605.
7. 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.
8. 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.