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25T / Kit Legionella pneumophila Rapid Test Cassette lateral flow assay

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Hangzhou AllTest Biotech CO.,LTD
City: Hangzhou
Province/State: Zhejiang
Country/Region: China
Tel: 86-571-85361863
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25T / Kit Legionella pneumophila Rapid Test Cassette lateral flow assay

Brand Name : AllTest
Model Number : cassette
Certification : CE
Place of Origin : CHINA
MOQ : 500
Supply Ability : 100 Million a year
Packaging Details : 25 tests per kit
Format : Cassette
Specimen : Urine
Kit Size : 25T/Kit
Cut-Off : See Insert
Storage : 2-30℃
Shelf Time : 24 months
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25T / Kit Legionella pneumophila Rapid Test Cassette lateral flow assay


Applications:


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.


Description:


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. 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 kit components, in unopened packaging, and specimens to reach room temperature (15-30°C) before performing a test.

  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.

Wait for the color line to appear. Read the results at 15 minutes , do not interpret the results 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 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.


【PRINCIPLE】


This is a ready-to-use membrane test based on colloidal gold particles. This test allows detection of Legionella pneumophila LPS in urine samples. The test sensitivity and specificity come from monoclonal and polyclonal anti-Legionella antibodies. mouse anti-Legionella antibodies are conjugated to colloidal gold particles and dried on a conjugate absorbent pad. Each strip is sensitized with goat anti-Legionella antibodies at the T-line region and with a control antibody at the C-line region when the urine sample migrates, conjugate is rehydrated and migrates along with the sample. If L. pneumophila urinary antigens are present in the sample, a complex between the anti-L. pneumophila conjugates and the L. pneumophila antigens is formed that will be caught by the specific anti- L. pneumophila reagent coated on the stick. Results appear in 15 minutes in the form of a red line that develops on the strip.


QUALITY CONTROL


In accordance with Good Laboratory Practices, we recommend to check the test’s performance regularly according to the laboratory’s requirements.

Positive and Negative Controls can be run as a quality control to demonstrate a positive or negative reaction in order to ensure that test reagents are working and the test is correctly performed. Positive and negative controls must be used as a urine sample.


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