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.

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.

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

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 Lateral Flow 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. Antigen capture lateral flow immunoassays for urine samples were developed as asimpler, less invasive way to detect and diagnose Legionella infection. Lateral flow assays are accurate, rapid, relatively easy to perform, and require no specialized training or equipment.

The IVD Legionella Urinary Antigen Detection Lateral Flow test is performed in twosteps:

  • The sample is diluted using the provided buffer and then added to the sample window on the test device.
  • The diluted sample is added to the sample window of the test device and incubated for 15 minutes.
    • The diluted sample resolubilizes the anti-Legionella conjugate contained in the test device.
    • The diluted sample and resolubilized conjugate flow across the nitrocellulose membrane and interact with the test line area and the control line area. If Legionella antigens are present in the sample, they are captured by the anti-Legionella antibodies in the conjugate and at the test line area.
    • The diluted sample and resolubilized conjugate continue to flow across the membrane and form a line in the control line area.
    • A sample that is positive for Legionella will result in a visible line in the test and control line area; this indicates that detectable amounts of Legionella antigen are present in the sample. If no line forms in the test line area, this indicates either that the sample is negative for Legionella antigen or that the sample contains Legionella antigen below detectable levels.

Each test kit contains 20 tests and has up to a 12 month shelf life. Test kits should be stored between 2-30 ˚C. Please contact us for pricing and availability.