Streptococcus pneumoniae and Legionella pneumophila Combo Rapid
Test, Infectious Disease Test Kit
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Urine |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
A rapid test for the qualitative detection of S. pneumoniae antigen
and Legionella pneumophila antigen in human urine specimen.
For professional in vitro diagnostic use only.
INTENDED USE
The S. pneumoniae and L. pneumophila Combo Rapid Test Cassette
(Urine) is a rapid chromatographic immunoassay for the qualitative
detection of Streptococcus pneumoniae antigen and Legionella
pneumophila antigen in human urine specimen.
SUMMARY
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, 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.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.
Legionellosis is a serious pneumonia caused by bacteria of the
genus Legionella assigned to the family Legionellaceae. This family now includes 48
species and over 60 serogroups. Approximately 20 species are implicated in
human disease.
The overwhelming majority of Legionella infections are caused by
Legionella pneumophila. Legionnaires' disease is the major clinical
manifestation of Legionella infection although extra-pulmonary infection and
non-pneumonic disease like Pontiac fever occur. Legionella pneumophila is
responsible for approximately 90% of infections, and of these, over 80% are due to
a single
serogroup, serogroup 1.6 Legionnaires' disease (LD) is not contagious. The disease is
transmitted by aerosol, and there is no evidence for direct person-to-person
transmission.
Person at risk are those whose immune system is compromised,
including transplant recipients, the elderly, cigarette smokers, or those
showing chronic obstructive pulmonary disease or chronic renal disease.
PRINCIPLE
The S. pneumoniae Rapid Test Cassette (Urine) is a qualitative,
membrane based immunoassay for the detection of Streptococcus
pneumoniae in urine specimen. During testing, Sreptococcus
pneumoiae (S. pneumoniae) antigens, if present in the specimen
react with S.pneumoniae antibody-conjugate in the reagent area. The
conjugate-antigens complex thus formed will bind with
Anti-S.pneumoniae antibodies coated on the membrane in case of a
positive result.
This would result in a dark red colored line in T line region in
case of a positive result. In case of negative result, no
conjugates would bind at Anti-S. pneumoniae coated in T line region
and no line would form in T line region of the test membrane. The
intensity of the lines will vary depending upon the amount of
antigen present in the sample. A line in Control region should
appear in all correctly performed cases. Absence of C line
indicates an invalid test result.
The L. pneumophila Rapid Test Cassette (Urine) is a qualitative,
membrane based immunoassay for the detection of Legionella
pneumophila antigen in urine specimen. During testing, Legionella
pneumophila antigen, if present in the specimen react with
Legionella pneumophila antibody-conjugate in the reagent area. The
conjugate-antigens complex thus formed will bind with
Anti-Legionella pneumophila antibodies coated on the membrane in
case of a positive result.
This would result in a dark red colored line in T line region in
case of a positive result. In case of negative result, no
conjugates would bind at Anti- Legionella pneumophila coated in T
line region and no line would form in T line region of the test
membrane. The intensity of the lines will vary depending upon the
amount of antigen present in the sample. A line in Control region
should appear in all correctly performed cases. Absence of C
line indicates an invalid test result.
SPECIMEN COLLECTION AND PREPARATION
The S. pneumoniae and L. pneumophila Combo Rapid Test Cassette
(Urine) can be performed using urine. Urine specimens should be
collected in standard containers. The sample can be stored at room
temperature (15-30°C) if assayed within 24 hours of collection.
Alternatively, specimens may be stored at 2-8°C for up to 14 days
or at -10°C to -20°C for longer periods before testing.
When necessary, urine specimens should be shipped in leak-proof
containers at 2-8°C or frozen. Allow all specimens to equilibrate
to room temperature before testing.
DIRECTIONS FOR 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 (S) 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
antigen and/or Legionella pneumophila antigen 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 antigen
and/or Legionella pneumophila antigen 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 or Legionella pneumophila
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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| ILEG-102 | Legionella pneumophila Rapid Test Cassette | Urine | 25 T |
| ISP-102 | Streptococcus pneumoniae Antigen Rapid Test Cassette | Urine | 10T |
| ISLC-125 | Streptococcus pneumoniae and Legionella pneumophila Combo Rapid
Test Cassette | Urine | 10T |
