Legionellosis is a severe inflammation of the lungs caused by bacteria of the genus Legionella in the family Legionellaceae. The vast majority of Legionella infections are caused by Legionella pneumophila. Legionella pneumophila is responsible for approximately 90% of infections and of these, more than 80% are caused by a single serogroup, serogroup 1. Legionella bacteria are widely distributed in natural and man-made aquatic habitats. They are readily found in freshwater, cooling towers and drinking water systems.
The Lomina Legionella pneumophila Test is an in vitro diagnostic test based on the principle of immunochromatography. It is designed to detect soluble Legionella pneumophila serogroup 1 antigen in a human urine sample.
Legionellosis is a severe inflammation of the lungs caused by bacteria of the genus Legionella in the family Legionellaceae. The vast majority of Legionella infections are caused by Legionella pneumophila. Legionella pneumophila is responsible for approximately 90% of infections and of these, more than 80% are caused by a single serogroup, serogroup 1. Legionella bacteria are widely distributed in natural and man-made aquatic habitats. They are readily found in freshwater, cooling towers and drinking water systems. These organisms can survive in a wide range of conditions and temperature is a critical factor in the spread of Legionella. Nosocomial infection is mainly associated with colonisation of hospital hot water systems by Legionella. The incubation period of the disease after contact with the bacteria is two to ten days. Most patients who are admitted to the hospital develop a high fever, often greater than 103°F (39.5°C). The first sign of a lung infection may be a cough. Other common symptoms include headache, muscle aches, chest pain, and shortness of breath. Gastrointestinal symptoms are common. Legionellosis is not contagious. The disease is transmitted by aerosol and there is no evidence of direct human-to-human transmission. Persons at risk are those whose immune systems are compromised, including transplant recipients, the elderly, cigarette smokers, or persons with chronic obstructive pulmonary disease or chronic kidney disease.
The test is developed and tested from a human urine sample.
Test duration: 15 min
Disease category: Infectious disease
Sensitivity: 97.6% (95%CI: 87.1%~99.9%)
Specificity: >99.9% (95%CI: 95.7%~100%)
Accuracy: 99.1% (95%CI*: 95.0%~100%)
The Lomina Legionella pneumophila Test is a membrane test based on the reaction of colloidal gold particles. This test allows the detection of Legionella pneumophila in urine samples. The sensitivity and specificity of the test is based on monoclonal and polyclonal anti-Legionella antibodies. Mouse anti-Legionella antibodies are conjugated to colloidal gold particles and dried on a conjugated absorbent pad. Each strip is sensitized with goat anti-Legionella antibody in the T test region and antibody in the C line control region, when the urine sample migrates, the conjugate is rehydrated and migrates with the sample. If L. pneumophila antigens are present in the urine sample, a complex will form between the anti-L. pneumophila conjugates and the L. pneumophila antigens, which will be captured by a specific anti-L. pneumophila reagent applied to the membrane. The results will appear within 15 minutes in the form of a red ring that forms on the test strip.
A single coloured line appears in the control area (C). No coloured line appears in the test area (T).
Two coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area (T). The intensity of the colour in the test area (T) will vary depending on the concentration of antibodies present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.
The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.