Interpretive Data

LIMITATIONS:

1. This test is qualitative in nature. No quantitative interpretation should be made with respect the intensity of the positive Test Line when reporting results.
2. TRU Legionella cannot be used as the sole means of determining Legionella pneumophilia infection. Test results must be used in conjunction with information available from clinical evaluation of the patient and other diagnostic procedures.
3. Over-incubation of tests may lead to an increase in false-positive results. Conversely, incubation of periods less than those defined in the above procedure can result in an increase in false-negative results. Always follow the incubation times defined in the procedure.
4. Both viable and non-viable Legionella pneumophilia serogroup 1 organisms will be detected. The appearance of a positive test depends on the antigen load in the specimen; therefore a positive test may not always correlate with culture results.
5. The antibodies used in this test may not detect all antigenic variants or new strains of Legionella pneumophilia serogroup 1.
6. A negative test results does not exclude infection with Legionella pneumophilia serogroup 1 nor does it rule out other microbial causes of respiratory infection or disease caused by serogroups of Legionella pneumophilia other than serogroup 1.
7. A positive test does not rule out co infection with other microbes.
8. This test is intended only for use with urine specimens.
9. A positive result implies the presence of antigen to Legionella pneumophilia serotype 1, however, all test results should be viewed in light of other clinical data by the clinician.
10. This assay is not intended for monitoring therapy.
11. Performance characteristics have not been established for patients under the age of 21.