Legio/S. Pneumo Rapid Test

Product information

The Legio/S. Pneumo is a lateral flow, rapid immunochromatographic test for the qualitative detection of Legionella pneumophila and Streptococcus pneumoniae antigens in human urine.

Advantages of Legio/S. Pneumo test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Legionella bacterium is a gram-negative bacillus associated with Pontiac fever and Legionnaires’ disease leading to the infection of the upper respiratory tracts causing pulmonary disease of pneumonia. In many cases high fever has been reported. An estimated 25,000 to 10,000 cases involving Legionella pneumophila infections occur in the USA annually.

About 5 % to 30 % of people with Legionnaires’ disease die. Extra pulmonary infections may be spread through the bloodstream or the lymph system infecting heart, brain, kidney, liver and/or spleen. Common methods for the detection of Legionella pneumophila are culture, direct fluorescent antibody, indirect fluorescent antibody enzyme immunoassays and polymerase chain reaction.

Streptococcus pneumoniae is a gram-positive bacterium first isolated by Pasteur in 1881 from the saliva of a patient with rabies. The chemical structure and antigenicity of the pneumococcal capsular polysaccharide and its association with virulence and role in human disease were explained over the period of 1915 to 1945. The bacteria are lancet-shaped anaerobic organisms spreading by direct person-to person contact via respiratory droplets and causing serious disease in humans:

The 10 most common serotypes are estimated to account for about 62% of invasive disease worldwide. Streptococcus pneumoniae colonize upper respiratory tract tissues causing severe pneumonia and mild/acute earache/otitis. Pneumococci cause 13 to 19% of all cases of bacterial meningitis in the United States. One-fourth of patients with pneumococcal meningitis also have pneumonia.

The clinical symptoms are generally similar to other forms of purulent bacterial meningitis and include headache, lethargy, vomiting, irritability, fever, nuchal rigidity, cranial signs, seizures and coma. The case-fatality of pneumococcal meningitis is about 30% but can as high as 80% among elderly persons.

Bacterial pneumonia accounts of 12-16% of invasive pneumococcal disease among children 2 years of age and younger and S. pneumoniae has become the leading cause of bacterial meningitis among children younger than 5 years of age in the United States. Antibiotic treatment is efficient even if more penicillin-resistant trains have been identified. Several vaccines are available with variable efficiency depending on patient age or patients developing some chronic illness or immunodeficiency. Nevertheless, vaccines have demonstrated to provide protection against pneumococcal pneumonia.

Legio/S. Pneumo is a lateral flow, rapid immunochromatographic test for the qualitative detection of Legionella pneumophila and Streptococcus pneumoniae antigens in human urine. The test device consists of a plastic housing containing two different sticks for the detection of Legionella and Streptococcus. A colored anti-Legionella or Streptococcus monoclonal antibody colloidal gold conjugate is placed at the left end of the membrane. Few drops of urine sample are dispensed into each well (▷) of the reaction device. As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the Legionella and Streptococcus antigen (when present in the sample) forming an antibody antigen complex.

This complex binds to the polyclonal anti- Legionella or Streptococcus antibody in the positive reaction zone producing a rose-pink colored band. In absence of Legionella or Streptococcus, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device, past the positive reaction zone and control zone. Unbound conjugate binds to the reagent in the control zone producing a rose-pink colored band demonstrating that the reagents are functioning correctly.

Test procedure

Positive controls (optional)

1. Remove the test device from the pouch.
2. Add 5 drops (200μL) of positive control to the sample well (▷) on the reaction device.
3. Read the results of the test 10 minutes after adding the sample to the device.
4. Do not interpret the result after 15 minutes.

 Samples

1. Bring all reagents at room temperature.
2. Remove the reaction device from its protective wrapper by tearing along the split.
3. Label device with the patient ‘s name or control number.
4. Fill the pipette with urine and by holding it vertically, dispense drop-wise into sample well. Add 5 drops (200μL), without air bubble of urine in the sample well (▷).
5. Read the results after 10 minutes.
6. Do not interpret the result after 15 minutes.

Interpretation of the results

Negative result: Only one colored band appears in the control zone. No band is visible in the test window.

Positive result: In addition to the control band, a clearly distinguishable band also appears in the test window.

Invalid result: If there is no distinct colored band visible the control zone, the test is inconclusive for the corresponding parameter. In this case, it is recommended that the test be repeated.