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
etiology1,2. 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® S.
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
| Sample Type: |
Urine, CSF |
| Time to Result: |
15 minutes |
| Kit Size: |
12 or 22 tests |
| Performance data: |
Urine Sensitivity/Specificity – 86% / 94*
|
| |
CSF Sensitivity/Specificity – 97% /
99% |
| Regulatory: |
Cleared for distribution by the FDA and CE marked, |
| |
available in 11 languages |
For 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 diseases1,3. When not properly diagnosed and
treated, S. pneumoniae infection can lead to bacteremia,
meningitis, pericarditis, empyema, purpura fulminans, endocarditis,
and/or arthritis4,5 .
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 illness6. Progression from mild illness to
coma can occur within hours, making immediate diagnosis and
antimicrobial treatment critical.
For more information about pneumonia, please see the links
below:
For more information about bacterial meningitis, please see the
links below:
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.