Streptococcus Pneumoniae Antigen Rapid Test Cassette , Rapid Urine Test

Streptococcus Pneumoniae Antigen Rapid Test Cassette , Rapid Urine Test

Applications:

The S. pneumoniae Antigen Rapid Test Cassette (urine) is a rapid chromatographic
immunoassay for the qualitative detection of Streptococcus pneumoniae antigens in
human urine specimen.

Description:

Streptococcus pneumoniae, or pneumococcus, is a Gram-positive, alpha-hemolytic
(under aerobic conditions) or beta-hemolytic (under anaerobic conditions), facultative
anaerobic member of the genus Streptococcus,1 As a significant human pathogenic
bacterium S. pneumoniae was recognized as a major cause of pneumonia in the late
19th century, and is the subject of many humoral immunity studies. S.
pneumoniae resides asymptomatically in healthy carriers typically colonizing the
respiratory tract, sinuses, and nasal cavity. However, in susceptible individuals
with weaker immune systems, such as the elderly and young children, the bacterium
may become pathogenic and spread to other locations to cause disease. It spreads by
direct person-to-person contact via respiratory droplets and by autoinoculation in
persons carrying the bacteria in their upper respiratory tract.2 It can be a cause
of neonatal infections.3 S. pneumoniae is the main cause of community acquired
pneumonia and meningitis in children and the elderly,4 and of septicemia in those
infected with HIV. The organism also causes many types of pneumococcal
infections other than pneumonia. These invasive pneumococcal diseases include
bronchitis, rhinitis, otitis media, conjunctivitis, meningitis, sepsis, osteomyelitis, septic
arthritis, endocarditis, peritonitis, pericarditis, cellulitis, and brain abscess.⁵

How to use?

Allow the test, specimen and/or controls to reach room temperature (15-30°C)
prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results
will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
3. Absorb the urine specimen with a dropper, add 3 full drops (approx.120ul) specimen
into the sample well of test cassette vertically.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret
the result after 20 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
POSITIVE: * Two lines appear. One colored line should be in the control line
region (C) and the other colored line should be in the test line region (T). A positive
result indicates that S. pneumoniae antigens are present in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the
concentration of S. pneumoniae antigens present in the specimen. Therefore, any
shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T). A negative result indicates that S. pneumoniae
antigen is not present in the specimen, or is present below the detectable level of the
test.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect
procedural techniques are the most likely reasons for control line failure. Review the
procedure and repeat the test with a new test. If the problem persists, discontinue using
the test kit immediately and contact your local distributor.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the
control region (C) is an internal procedural control. It confirms sufficient specimen
volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive
and negative controls be tested as a good laboratory practice to confirm the test
procedure and to verify proper test performance.