A rapid test for the qualitative detection of Giardia lamblia in
human stool samples CE certified
The Giardia Lamblia Rapid Test Cassette (Feces) is a rapid
chromatographic immunoassay for the qualitative detection of
Giardia Lamblia in human feces specimen.
Parasitary infections remain a very serious health problem
worldwide. Giardia lamblia is the most common protozoa known to be
responsible for one of the main causes of severe diarrhoea in
humans, particularly in immunodepressed people. Epidemiological
studies, in 1991, showed that infections with Giardia increased in
the United States with a prevalence of around 6% on 178,000
samples. Generally, the disease passes through a short acute phase
followed by a chronic phase. Infection by G. lamblia, in the acute
phase, is the cause of watery diarrhoea with principally the
elimination of trophozoites. The stools become normal again, during
the chronic phase, with transient emissions of cysts.
The presence of the parasite on the wall of the duodenal epithelium
is responsible for a malabsorption. The disappearance of
villosities and their atrophy lead to problems with the digestive
process at the level of the duodenum and the jejunum, followed by
weight loss and dehydration. The majority of infections remain
The diagnosis of G. lamblia is carried out under microscopy after
flotation on zinc sulphate or by direct or indirect
immunofluorescence, on non-concentrated samples displayed on a
slide. More and more ELISA methods are also now available for the
specific detection of cysts and/or trophozoïtes. Detection of this
parasite in surface or distribution water can be undertaken by PCR
Coris BioConcept has developed a rapid membrane test that can
detect Giardia lamblia in non-concentrated faecal samples within 15
minutes. The test is based on the detection of a 65-kDA
coproantigen, a glycoprotein that is present in the cysts and
trophozoites of G. lamblia.
How to use?
1.To collect fecal specimens:
Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean,
dry specimen collection container to obtain enough virus particles.
Best results will be obtained if the assay is performed within 6
hours after collection. Specimen collected may be stored for 3 days
at 2-8°C if not tested within 6 hours. For long term storage,
specimens should be kept below -20°C.
2. To process fecal specimens:
Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen at
least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
Hold the dropper vertically, aspirate fecal specimens, and then
transfer 2 drops of the liquid specimen (approximately 80 µL) into
the specimen collection tube containing the extraction buffer.
Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the
collection tube for reaction for 2 minutes.
3.Bring the pouch to room temperature before opening it. Remove the
test cassette from the foil pouch and use it as soon as possible.
Best results will be obtained if the test is performed immediately
after opening the foil pouch.
4.Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection
tube and transfer 3 full drops of the extracted specimen (approximately 120 mL) to the specimen well (S) of the test
cassette, then start the timer. Avoid trapping air bubbles in the
specimen well (S). See illustration below.
5.Read the results at 15 minutes after dispensing the specimen. Do
not read results after 20 minutes.
Note: If the specimen does not migrate (presence of particles),
centrifuge the diluted sample contained in the extraction buffer
vial. Collect 120 µL of supernatant, dispense into the specimen
well (S). Start the timer and continue from step 5 onwards in the
above instructions for use.
INTERPRETATION OF RESULTS
Negative test result: a reddish-purple line appears across the central reading window at
the Control line (C) position. No other band is present.
Positive test result: in addition to a reddish-purple band at the Control line (C), a
visible reddish-purple band appears at the Test line position (T).
Intensity of the test line may vary according to the quantity of
antigens found in the sample. Any reddish-purple line (T), even
weak, should be considered as a positive result.
Invalid test result: The absence of a Control line indicates a failure in the test
procedure. Repeat invalid tests with a new test device.
Note: during the drying process, a very faint shadow may appear at the
Test line position. It should not be regarded as a positive result.
In accordance with Good Laboratory Practices, we recommend checking
the test’s performance regularly according to the laboratory’s
requirements. For the test,dispense 100 µL of prepared control (see
CTR-1000 or C-1093 instructions for use) into the sample well of