Streptococcus pneumoniae is the leading cause of community-acquired pneumonia (CAP) and, according to a recent study, may be the most important agent in CAP of unknown etiology.^1,2 The easy-to-use, rapid, urine-based test allows for identification and focused treatment within 4 hours, meeting Hospital Quality Initiative guidelines (Health and Human Services). Rapid identification can lead to focused treatment decisions, improved patient outcomes and lower overall health care costs.

Intended Use

The BinaxNOW^® Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic assay for the qualitative detection of S. pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. In conjunction with culture and other methods, it is intended to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.

Product Details

• Availability – Global
• CLIA Status – Moderate Complexity
• Sample type - Urine or CSF
• Time for test results – 15 minutes
• Urine Sensitivity/Specificity – 86% / 94%**
• CSF Sensitivity/Specificity – 97% / 99%

BinaxNOW Streptococcus pneumoniae
Testing Procedure

Bring patient sample(s) and/or liquid control(s) to room temperature, then swirl gently to mix. 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 3 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 Streptococcus pneumoniae

Streptococcus pneumoniae is the leading cause of community-acquired pneumonia. Pneumococcal pneumonia has a mortality rate as high as 30%, depending on bacteremia, age, and underlying diseases.^1,3 When not properly diagnosed and treated, S. pneumoniae infection can lead to bacteremia, meningitis, pericarditis, empyema, purpura fulminans, endocarditis, and/or arthritis.^4,5

Pneumococcal meningitis, a condition that frequently leads to permanent brain damage or death, can occur as a complication of other pneumococcal infection or may arise spontaneously without any preceding illness.⁶ Progression from mild illness to coma can occur within hours, making immediate diagnosis and antimicrobial treatment critical.

References

1. Plouffe, J., S. Moore, R. Davis, R. Facklam. Serotypes of Streptococcus pneumoniae blood culture isolates from adults in Franklin County, Ohio. J. Clin. Microbiology 1994; 32:1606-1607.
2. A. Ruiz-Gonzalez, MD, M. Falguera, MD, A. Nogues, MD, M. Rubio-Caballeroa, MD. Is Streptococcus pneumoniae the leading cause of pneumonia of unknown etiology? A microbiologic study of lung aspirates in consecutive patients with community-acquired pneumonia. Am. J. of Med. 1999; 106:385-390.
3. Holmberg, H., A. Krook, A. Sjogren. Determination of antibodies to pneumococcal C polysaccharide in patients with community-acquired pneumonia. J. Clin. Microbiology 1985; 22:808-814.
4. Johnston, Jr., R. Pathogenesis of pneumococcal pneumonia. Rev. of Infect. Diseases 1991; 13(Suppl 6):S509-S517.
5. Robbins, J.B., R. Austrian, C.J. Lee, S.C. Rastogi, G. Schiffman, J. Henrichsen, P.H. Makela, C.V. Broome, R.R. Facklam, R.H. Tiesjema, J.C. Parke, Jr. Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups. J. Infect. Diseases 1983; 148:1136-1159.
6. Wiselka, Martin. Specialists view on pneumococcal meningitis. www.eclipse.co.uk/meningitis.information/text/medic-guide/pm.htm.

** Retrospective data. See package insert for complete performance information.