Legionella Pneumophila Rapid Test

Product information

The Legionella Pneumophila Rapid Test is a lateral flow, rapid immunochromatographic test for the qualitative detection of Legionella pneumophila antigens in urine.

Advantages of Legionella Pneumophila test

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

General information

The Legionella Pneumophila Rapid Test is a rapid qualitative assay for the detection of Legionella pneumophila antigens in urine. This bacterium is a gram-negative bacillus is 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.

The method employs a unique combination of polyclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify Legionella antigens in the test samples. As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the bacterial antigens if present in sample forming an antibody-antigen complex.

This complex binds to the capture antibody in the test zone and produces a pink-rose color band when antigen if present. In the absence of Legionella antigens, there is no line in the test zone. The reaction mixture continues flowing through the absorbent device past the test zone and control zone. Unbound conjugate binds to the reagents in the control zone,
producing a pink-rose color 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 (”SAMPLE”) 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. Allow specimen and Legionella Rapid Test to come to room temperature prior to testing.
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 (”SAMPLE”).
5. Read the results after 10 minutes
6. Do not interpret the result after 15 minutes.

Interpretation of the results

Negative result: One colored band appears in the control zone. No apparent band in the test zone.

Positive result: In addition to the control band a clearly distinguishable band also appears in the test zone indicating a positive result.

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.