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
- 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.
- 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.
- 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.
- Johnston, Jr., R. Pathogenesis of pneumococcal pneumonia. Rev.
of Infect. Diseases 1991; 13(Suppl 6):S509-S517.
- 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.
- 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.