Keul-o-test
Legionella Cassette
Urinary Cassette Test
KGST208
INTENDED USE
The Keul-o-test Legionella test is an in vitro qualitative immunochromatographic assay for the rapid detection of legionella pneumophilia antigens in human urine specimen. The test results are intended to aid in the diagnosis of legionella pneumophila infection and to monitor the effectiveness of therapeutic treatment.
PRINCIPLES OF THE PROCEDURE
The Keul-o-test Legionella test is a rapid, diagnostic assay that can detect the presence of this organism directly from a urine specimen. This test is comprised of colloidal gold particle-labeled anti-Legionella antibodies dried in a binding zone and immobilized antibodies in a capture zone. In this one step procedure, several drops of urine specimen is added to a cassette test. Within minutes, the test result is read. A positive result is indicated by a colored band at the test zone.
MATERIALS PROVIDED
- Instructions.
- Disposable Dropper.
- Keul-o-test Legionella test device.
STORAGE OF KIT COMPONENTS
All kit components should be stored in a cool, dry place at room temperature of 4 to 25°C.
SPECIMEN COLLECTION AND HANDLING
Specimens should be urine samples. Samples that will not be tested within 72 hours should be refrigerated at 2 to 8°C.
For long-term storage of specimens, -20°C or colder is recommended. Repeated freezing and thawing of specimens is not recommended and may cause erroneous results. Do not store specimens in self-defrosting freezers.
SPECIMEN PREPARATION
Bring all reagents, including test device, to room temperature (15-30°C) before use..
TEST PROCEDURE
- Remove the test disk from the foil pouch, and place it on a flat, dry surface.
- Holding the sample dropper above the test disk, squeeze 3 drops of specimen into the sample well (Figure 1).
- As the test begins to work, you will see purple color move across the Result Window in the center of the test disk.
- Interpret test results at 10 to 15 minutes. Do not interpret after 30 minutes.
INTERPRETATION OF TEST
- As the test kit begins to work, a color band will appear at the left section of the Result Window to show that the test is working properly. This band is the Control Line.
- The right section of the Result Window indicates the test results. If another color band appears at the right section of the result window, this band is the Test Line.
POSITIVE RESULT: TWO COLOR BANDS
The presence of two color bands ("T" band and "C" band) within the result window regardless of which band appears first indicates a positive result (Figure 2). Note: Generally, the higher the analyte level in the specimen, the stronger the "T" band color will be. When the specimen analyte level is close to but still within the sensitivity limit of the test, the color of the "T" band will be very faint.
NEGATIVE RESULT: ONE COLOR BAND
The presence of only one purple color band within the result window indicates a negative result (Figure 3).
Invalid result:
After performing the test and no purple color band is visible within the result window, this result is considered invalid. Some causes of invalid results are: not following the directions correctly or the test is beyond the expiration date. It is recommended that the specimen be re-tested using a new test kit (Figure 4).
LIMITATIONS
The test is for qualitative detection of legionella pneumophila serogroup I antigen in Urine sample and dose not indicate the quantity of the antigens. The test is for in vitro diagnostic use only. The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
EXPECTED VALUES
Keul-o-test Legionella detects the presence of legionella pneumophila serogroup I antigens in urine specimens. Expected values for any given population should be determined for each laboratory. The positivity rate of any given laboratory may vary depending on geographic location, season, and living environment
PERFORMANCE CHARACHTERISTICS
Sensitivity and Specificity
The Keul-o-test Legionella test can detect Legionella pneumophila ATCC strain 33152 at about 3000 CFU/mL. Urine samples from urine tract infection with Klebsiella pneumonia, Enterobacter and E. Coli all showed negative results
Reproducibility
Reproducibility of Keul-o-test Legionella test was determined using negative, low positive, and high positive controls. These samples were tested in replicates of 10 in a blind study by 3 operator working independently in the same laboratory. The agreement of the expected result was 100%.
REFERENCES
Stout J.E. and Yu V.L., 1977 Legionellosis, N. Engl. J. Med. 337: 682-687
Kohler R.B. et al., 1984 Onset and duration of urinary antigen excretion in legionnaires' disease. J. Clin. Microbiol. 20: 605-607
Bibb W.F. et al., 1984 Detection of soluble Legionella pneumophila antigens in serum and urine specimens by enzymen-linked immunosorbent assay with monoclonal and polyclonal antibodies. J. Clin Microbiol. 20: 478-482
