rapid test kit,
infectious disease diagnostic tests
Legionella pneumophila Rapid Test Cassette(Urine) is an in vitro diagnostic test based on immunochromatographic assay. It is designed for detection of soluble antigen from Legionella pneumophila serogroup 1 in human urine specimen.
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. The name Legionella pneumophila was derived from the dramatic outbreak at the 1976 American Legion Convention in Philadelphia. Legionella pneumophila is responsible for approximately 90% of infections, and of these, over 80% are due to a single serogroup, serogroup 1. 2 Legionella bacteria are small faintly staining Gram-negative rods with polar flagella. Legionella bacteria have a widespread distribution in both natural and manmade aquatic habitats. They are readily found in fresh water, cooling towers and potable water systems. The organisms can survive in a wide range of conditions, and temperature is a critical determinant for Legionella proliferation. Nosocomial infection is particularly associated with colonization of hospital hot water system by Legionella.
The incubation period of Legionnaires' disease after being exposed to the bacteria is from two to ten days. Most patients who are admitted to the hospital develop high fever often higher than 39.5°C (103°F). Cough can be the first sign of a lung infection. Other common symptoms include headaches, muscle aches, chest pain, and shortness of breath. Gastrointestinal symptoms are common.
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.
Diagnosis of legionellosis can be difficult because signs and symptoms are nonspecific and do not distinguish L. pneumophila infections from other common causes of pneumonia. L. pneumophila infections are considered to be fairly common but they are probably underdiagnosed and under-reported. The underdiagnosis of legionellosis can in part be attributed to the need for rapid, specific and sensitive diagnostic testing methods.
The Legionella pneumophila Rapid Test Cassette (Urine) detects soluble antigen from L .pneumophila serogroup 1 in urine.
How to use?
Allow the test, specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Open the pouch and remove the device. Once opened, run the test immediately.
2. Swirl urine gently to mix before testing.
3. Add 4 drops of swirled urine sample( Approx. 100 μL) to the sample well.
4. Wait for the color line to appear. Read the results at 15 minutes, do not interpret the results after 20 minutes.
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Legionella pneumophila was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Legionella pneumophila 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 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.
||Legionella pneumophila Rapid Test Cassette