A rapid, one step test for the qualitative detection of Calprotectin in human fecal
specimen.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Calprotectin Rapid Test (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of Calprotectin in human fecal specimen as an aid in the
diagnosis of inflammatory gastrointestinal disorders.
【SUMMARY】
Calprotectin is a 24 kDa dimer of calcium binding proteins S100A8 and S100A9. 1 The
complex accounts for up to 60% of the soluble protein content of the neutrophil
cytosol. 2 Calprotectin becomes available in the intestinal lumen via leukocyte
shedding,3 active secretion,2 cell disturbance, and cell death.3 This results in elevated
faecal calprotectin levels, which can be detected in the stool. 3 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. 5 Calprotectin is useful as a marker, as it is resistant to enzymatic
degradation, and can be easily measured in faeces. 6
【PRINCIPLE】
The Calprotectin Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of Calprotectin in human fecal specimen. The membrane is precoated with
anti-Calprotectin antibody on the test line region of the test. During testing, the
specimen reacts with the particle coated with Calprotectin antibody. The mixture
migrates upward on the membrane chromatographically by capillary action to react
with anti-Calprotectin antibody on the membrane and generate a colored line. The
presence of this colored line in the test line region indicates a positive result, while its
absence indicates a negative result. To serve as a procedural control, a colored line
will always appear in the control line region, indicating that the proper volume of
specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-Calprotectin antibody particles and anti-Calprotectin antibody
coated on the membrane.
【PRECAUTIONS】
• For professional in vitro diagnostic use only. Do not use after the expiration date.
• The test should remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout all procedures and follow
the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature can adversely affect results.
【STORAGE AND STABILITY】
The kit can be stored at room temperature or refrigerated (2-30 °C). The test is stable
through the expiration date printed on the sealed pouch. The test must remain in the
sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
•The fecal specimen must be collected in clean, dry, waterproof container containing
no detergents, preservatives or transport media.
•No dietary restrictions are necessary before using the Calprotectin Rapid Test.
•Bring the necessary reagents and feces specimen to room temperature before use.
•If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials Provided
• Test Cups (with dilution buffer)
• Package Insert
Materials Required But Not Provided
• Specimen Containers
• Timer
• Centrifuge • Pipette
【DIRECTIONS FOR USE】
Before performing the test, allow the test specimen and cup to reach room
temperature (15-30°C), stool samples must be collected following the
instruction below.
1. Wash hands with soap and rinse with clear water.
2. To collect fecal specimens:
Collect sufficient quantity of feces (1-2g) in a clean, dry specimen collection
container to obtain maximum antigens (if present). 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.
3. Bring the pouch to room temperature before opening it. Remove the test cup 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. To process fecal specimens:
Unscrew the cap of the specimen collection tube , then randomly stab the
specimen collection applicator into the fecal specimen in 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.
5. Insert the specimen collection applicator back into the test cup and tighten the cap.
6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction
for 2 minutes.
7. Remove the plastic limit strip of the test cup.
8. Put the test cup on a clean and level surface, press the cup body from the top to
the bottom and start the timer.
NOTE: Keep the test cup upright during the test developing. Do not move or turn
the test cup upside down.
9. Read results at 5 minutes. Do not read results after 10 minutes.