Legionellosis is a community-acquired or hospital-acquired respiratory infection caused by the Legionellapneumophilia bacteria. Severe cases of legionellosis take the form of Legionnaire’s Disease, a potentially deadly strain of pneumonia.

Read more about the transfer, diagnosis, and treatment of legionellosis on our Articles page.

Symptoms of the disease range from mild to severe and can include non-productive cough, fever, gastrointestinal problems, and respiratory failure. Elderly populations and young children and infants are most susceptible to Legionella infection. Other risk factors include cigarette smoking and immunosuppression. If left untreated in people with compromised immune systems, Legionella infection has up to a 25% mortality rate. Early diagnosis and use of antimicrobial therapies can significantly reduce this mortality rate.

Approximately 80% of patients infected with Legionella secrete soluble Legionella antigen in their urine, making urine samples a prime channel through which to detect the disease. The IVD Legionella Urinary Antigen Detection Microwell ELISA test kit provides accurate, reliable detection of Legionella antigens in human urine samples.

Traditional detection of Legionella infection required a respiratory specimen, such as sputum, bronchial washings, transtracheal aspirate, or lung biopsy. Since the cough associated with legionellosis typically does not produce sputum, these latter three, more invasive specimen samples were often the norm. In addition to being invasive, traditional methods of detecting Legionella infection also required experienced technicians, who have historically been difficult and costly to find and train. The enzyme-linked immunosorbent assay (ELISA) for urine samples were developed as a simpler, less invasive way to detect and diagnose Legionella infection. ELISA assays are accurate, relatively easy to perform, and require no specialized training.

The IVD Legionella Urinary Antigen Detection Microwell ELISA test is performed in four steps (three incubation periods and a stop solution):

  • The first incubation: In this step, antibodies attached to the kit microwells capture Legionella-specific antigens present in the urine sample; a washing step removes any unbound samples.
  • The second incubation: This step adds an anti-Legionella antibody conjugated to horseradish peroxidase, which “sandwiches” any antigen bound to the microwells; a washing step removes any unbound conjugate.
  • The third incubation: This step adds a chromogen, which turns blue in the presence of the enzyme complex and peroxide.
  • The addition of a stop solution: This ends the chemical reaction and turns the blue to yellow in the presence of Legionella antigen. If no antigen is captured, or if there is an insufficient antigen level, the solution will remain colorless.

Each test kit contains 96 wells and has a shelf life of up to 12 months. Test kits should be stored between 2-8˚C. Please contact us for pricing and availability.