Human Legionella Urinary Antigen ELISA Kit

Sample

Urine Sample 100 μL

Species Reactivity

Human

Detection Method

sELISA

Intended Use

The Urinary Antigen test is intended as an adjunct to culture for the presumptive detection of past or current Legionnaires' disease by qualitative detection of Legionella pneumophilia antigen in human urine.

Contents of Kit

1. ELISA Microplate
2. Enzyme Conjugate
3. Positive Control
4. Negative Control
5. Chromogen
6. Wash Concentrate (20×)
7. Stop Solution

Storage

• Reagents, strips and bottled components should be stored at 2 - 8°C.
• Squeeze bottle containing diluted wash buffer may be stored at room temperature (15 - 25°C).

Performance Characteristics

Specificity: 95%
Sensitivity: 100%

General Description

Legionella pneumophilia was first isolated and characterized in 1976 after a major outbreak of pneumonia at an American Legion convention in Philadelphia, Pennsylvania; thus the name "Legionnaires' Disease". Traditional laboratory methods for the detection of pneumonia caused by Legionella pneumophilia infection requires an adequate respiratory specimen (e.g. sputum, bronchial washings, transtracheal aspirate, lung biopsy) or paired serum specimens (acute and convalescent) for accurate diagnosis. Accurate diagnosis of Legionella pneumophilia using these methods depends upon proper specimen collection and the level of technical expertise available. Patient compliance in obtaining the specimens can be poor, and serological methods are retrospective in nature. Approximately 80% of Legionella pneumonia patients excrete soluble Legionella antigen in their urine. This presents the opportunity for rapid detection of Legionella Urine Antigen (LUA) in a urine specimen. Urine is the preferred specimen for collection, transport, and detection in all phases of the disease. Specific soluble Legionella antigen is present in the urine of patients with Legionnaires' disease.