Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test, Infectious Disease Test Kit
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.
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.
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.
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.
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|Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette