A rapid test for the qualitative detection of Legionella pneumophila antigen in urine specimen CE certified
Legionella pneumophila Rapid Test Cassette(Urine) is an in vitro diagnostic test based on
immunochromatographic assay. It is designed for detection of
soluble antigen from Legionella pneumophila serogroup 1 in human urine specimen.
Legionellosis is a serious pneumonia caused by bacteria of the
genus Legionella assigned to the family Legionellaceae. This family
now includes 48 species and over 60 serogroups. Approximately 20
species are implicated in human disease. The overwhelming majority
of Legionella infections are caused by Legionella pneumophila. Legionnaires' disease is the major clinical manifestation of Legionella infection although extra-pulmonary infection and non-pneumonic
disease like Pontiac fever occur. The name Legionella pneumophila
was derived from the dramatic outbreak at the 1976 American Legion
Convention in Philadelphia.
Legionella pneumophila is responsible for approximately 90% of infections, and of these,
over 80% are due to a single serogroup, serogroup 1. Legionella bacteria are small faintly staining Gram-negative rods with polar
flagella. Legionella bacteria have a widespread distribution in both natural and
manmade aquatic habitats. They are readily found in fresh water,
cooling towers and potable water systems. The organisms can survive
in a wide range of conditions, and temperature is a critical
determinant for Legionella proliferation. Nosocomial infection is particularly associated
with colonization of hospital hot water system by Legionella.
The incubation period of Legionnaires' disease after being exposed
to the bacteria is from two to ten days. Most patients who are
admitted to the hospital develop high fever often higher than
39.5°C (103°F). Cough can be the first sign of a lung infection.
Other common symptoms include headaches, muscle aches, chest pain,
and shortness of breath. Gastrointestinal symptoms are common.
Legionnaires' disease (LD) is not contagious. The disease is
transmitted by aerosol, and there is no evidence for direct
person-to-person transmission. Person at risk are those whose
immune system is compromised, including transplant recipients, the
elderly, cigarette smokers, or those showing chronic obstructive
pulmonary disease or chronic renal disease.
Diagnosis of legionellosis can be difficult because signs and
symptoms are nonspecific and do not distinguish L. pneumophila infections from other common causes of pneumonia. L. pneumophila infections are considered to be fairly common but they are
probably underdiagnosed and under-reported. The underdiagnosis of
legionellosis can in part be attributed to the need for rapid,
specific and sensitive diagnostic testing methods.
The Legionella pneumophila Rapid Test Cassette (Urine) detects soluble antigen from L
.pneumophila serogroup 1 in urine.
How to use?
Allow kit components, in unopened packaging, and specimens to reach
room temperature (15-30°C) before performing a test.
- Open the pouch and remove the device. Once opened, run the test
- Swirl urine gently to mix before testing.
- Add 4 drops of swirled urine sample( Approx. 100 μL) to the sample
Wait for the color line to appear. Read the results at 15 minutes , do not interpret the results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line
region (C) and another apparent colored line should be in the test
line region (T). A positive result indicates that Legionella
pneumophila was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary
depending on the concentration of Legionella pneumophila present in
the specimen. Therefore, any shade of color in the test line region
(T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T). A negative result indicates
that Legionella pneumophila antigen is not present in the specimen,
or is present below the detectable level of the test.
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
This is a ready-to-use membrane test based on colloidal gold
particles. This test allows detection of Legionella pneumophila LPS in urine samples. The test sensitivity and specificity come
from monoclonal and polyclonal anti-Legionella antibodies. mouse
anti-Legionella antibodies are conjugated to colloidal gold
particles and dried on a conjugate absorbent pad. Each strip is
sensitized with goat anti-Legionella antibodies at the T-line
region and with a control antibody at the C-line region when the
urine sample migrates, conjugate is rehydrated and migrates along
with the sample. If L. pneumophila urinary antigens are present in
the sample, a complex between the anti-L. pneumophila conjugates
and the L. pneumophila antigens is formed that will be caught by
the specific anti- L. pneumophila reagent coated on the stick.
Results appear in 15 minutes in the form of a red line that
develops on the strip.
In accordance with Good Laboratory Practices, we recommend to check
the test’s performance regularly according to the laboratory’s
Positive and Negative Controls can be run as a quality control to
demonstrate a positive or negative reaction in order to ensure that
test reagents are working and the test is correctly performed.
Positive and negative controls must be used as a urine sample.