Legionella Test is a rapid qualitative immunochromatographic test intended for professional in vitro diagnostics. It enables the detection of the soluble antigen of Legionella pneumophila serogroup 1 in a urine sample.

Legionella pneumophila is a bacterium associated with Legionnaires’ disease, a severe form of pneumonia. Symptoms of infection may include high fever, cough, headache, muscle aches, chest pain, and shortness of breath. The test can aid in the diagnosis of infections caused by Legionella pneumophila serogroup 1.

The test provides a result as early as 15 minutes after sample application. The result is presented qualitatively—in the form of test lines. The result should not be interpreted after 20 minutes.

This product is intended for professional use. This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Sample type: urine
• Quick and easy test procedure
• Specificity: >99.9%, sensitivity: 97.6%, accuracy: 99.1%
• High-quality product
• Fast results in just 15 minutes!
• Single-use packaging
• Product intended for professional use

Package Contents

• 1 test cassette with a dropper in a foil pouch
• 1 user manual

Application

• Rapid diagnosis of Legionella pneumophila infection: The test enables the qualitative detection of Legionella pneumophila serogroup 1 antigen in a urine sample.
• Support for the diagnosis of legionellosis: The test result can support the diagnosis of infection with Legionella pneumophila, which is associated with Legionnaires’ disease.
• Diagnosis of patients with symptoms of pneumonia: The test can be used in patients with symptoms such as high fever, cough, headache, muscle aches, chest pain, or shortness of breath.
• Urine sample testing: The product allows for the detection of Legionella pneumophila serogroup 1 antigen in an easily collected sample.
• Support for medical decision-making: The test result can assist healthcare professionals in making further diagnostic or therapeutic decisions.
• Professional use: This product is intended for professional in vitro diagnostics and should be used in accordance with the instructions for use.

Product identification and responsible entities

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