BinaxNOW® Legionella Urinary Antigen Tests
Binax NOW® Legionella Urinary Antigen Test. 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. FDA Cleared and CLIA Classifed as Moderately Complex. (FDA 510K#: K070522)
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.
- 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.
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
Order No. 852-000
CLIA: Moderately Complex/Non-Waived
CPT Code*: 87449 - Ag detect nos eia mult
National Average Reimbursement 2019: $13.32
*All CPT codes are supplied for information purposes only and represent no statement; promise or guarantee by CLIAwaived Inc. that these codes will be appropriate or that reimbursement will be made. It is the responsibility of the service provider to confirm the appropriate coding required by their local Medicare carriers, fiscal intermediaries and commercial payors.