Audited Supplier
CALP-DF02
IVD Reagent
ISO
24 Months
Professional Use
Feces
Within 15 Mins
Immunochromatography
2~30ºC
Dewei
Cartons
40test/box
China
Product Description
The Calprotectin Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Calprotectin in human feces specimen which might be useful for the diagnosis of inflammatory gastrointestinal disorders.
Calprotectin is a 24 kDa dimer of calcium binding proteins S100A8 and S100A9. The complex accounts for up to 60% of the soluble protein content of the neutrophil cytosol. Calprotectin becomes available in the intestinal lumen via leukocyte shedding, active secretion, cell disturbance, and cell death. This results in elevated faecal calprotectin levels, which can be detected in the stool. Elevated faecal calprotectin levels therefore indicate migration of neutrophils into the intestinal mucosa, which occurs during intestinal inflammation.[4] Faecal calprotectin has been used to detect intestinal inflammation, and can serve as a marker for inflammatory bowel diseases. Calprotectin is useful as a marker, as it is resistant to enzymatic degradation, and can be easily measured in faeces.
• One pouch containing a rapid test cassette with desiccant.
• Specimens dilution tube with buffer
• Package insert
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
• The Calprotectin Rapid Test (Feces) is intended only for use with human fecal specimens.
• Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
• Bring specimens to room temperature prior to testing.
• Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Best results will be obtained if the assay is performed within 6 hours after collection.
2) Unscrew and remove the dilution tube applicator stick. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 4 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
3) Place the applicator stick back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed
within one hour.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2-3 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read in 15 minutes.
Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.
About Us
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
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