INTRODUCTION

The Legionella Urinary Antigen Rapid Test is a lateral flow immunoassay intended for the in vitro rapid qualitative detection of legionella pneumophilia antigens in human urine specimens to aid in the diagnosis of legionella pneumophila infection and to monitor the effectiveness of therapeutic treatment by their healthcare providers.

INTENDED USE

Legionella pneumophila serogroup I is gram-negative bacillus. It is now recognized to be the common cause of community-acquired and nosocomial pneumonia. Infections caused by this bacterium include the pulmonary disease of pneumonia. The infections may spread through the blood circulation or the lymph system to heart, brain, kidney, liver and spleen. In addition, gastrointestinal symptoms are prominent in Legionella pneumonia. Legionellaire’s disease can be acquired by the inhalation of aerosols associated with air handing systems, respiratory therapy equipment and whirlpool baths. The elderly are seen as most susceptible to the infection, although children and neonates are also affected. About 5% to 39% of people with legionnaires’ disease die. Legionella pneumophila serogroup I antigen has been detected in urine during acuate phase of the disease. It presents an opportunity for rapid detection of the bacterium with non-invasive method. Rapid diagnosis and early initiation of appropriate antimicrobial therapy can significantly reduce the mortality associated with Legionella pneumonia.