INTENED USE
Reagent for the quantitative detection of calprotection in human stool
samples.
This assay has a simple performance and multiple applications. This
product is optimised for several automated analyser. For professional in vitro diagnostic use only
CLINICAL SIGNIFICANCE
Inflammatory Bowel Disease (IBD) includes Crohn's disease, ulcerative
colitis. There is an overlap in symptoms between IBD and Irritable Bowel
Syndrome (IBS). calprotection-Turbilatex allows to rule out IBD in
patients under suspicion of IBS. Moreover, it is useful to monitor
treatment in patients with IBD.
PRINCIPLE OF THE METHOD
The assay is based on agglutination reactions. These involve in vitro
aggregation of microscopic latex particles. This aggregation consists in
the specific reaction between antigen and antibodies. Antigens contained
in the sample bind with the antibodies coated on polystyrene latex
particles. The sample is mixed with a suspension containing antibodies
against the antigen bound to latex particles. If antigen is present in the
sample, it will react with the antibodies and form an aggregate. If no
antigen is present in the sample, the mixture will maintain its clear
appearance.
STORAGE AND STABILITY
Store at 2-8ºC.
Components are stable once opened until the expiry date marked in the
label if kept at the recommended storage temperature, well closed and if
contamination is prevented during their use.
On board stability: The reagents opened and stored in the refrigerated
compartment of the analyzer are stable for 30 days.
Do not freeze. Reagent deterioration: presence of particles (R1,R2)and
turbidity (R1).
SAMPLES
Collect a sufficient amount of human stool in a clean and dry container
(no preservatives or transport media is necessary).
The raw stool samples can be stored at 2-8ºC for 7 days. If not
immediately tested, stool samples can be frozen and stored at -20ºC for a
maximum of 6 months. In this case, the sample must be totally thawed,
and brought to room temperature (15-30℃) before testing.
Stool samples must be homogenised as thoroughly as possible prior to
preparation.
Use sample collection tube, following the instructions included in the
package. Stool extract is stable at 2-8ºC for 7 days.
NOTES
The clinical diagnosis should not be based on a single test result; the
complete medical history of the patient should be taken into
consideration.
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