A rapid, one step test for the qualitative detection of Calprotectin and
Lactoferrin in human fecal specimen.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Calprotectin and Lactoferrin Combo Rapid Test(Feces) is a rapid
chromatographic immunoassay for the qualitative detection of calprotectin
and lactoferrin in human fecal specimen which might be useful for 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
Lactoferrin is one of the components of the immune system of the body; it
has antimicrobial activity (bacteriocide, fungicide) and is part of the innate
defense, mainly at mucosas.7 In particular, lactoferrin provides anti-bacterial
activity to human infants.8,9
Human lactoferrin, a neutrophil derived glycoprotein, can be measured in
feces and whole gut lavage as an indicator of intestinal inflammation in both
IBD and infectious gastroenteritis. Recent studies have shown fecal
lactoferrin (FL) as a sensitive biomarker for pediatric IBD. In addition, this
biomarker can serve as an aid for guiding the diagnostic and therapeutic
process for both pediatric and adult IBD.
【PRINCIPLE】
The Calprotectin Rapid Test(Feces) is a qualitative, lateral flow
immunoassay for the detection of calprotectin in human fecal specimen. The
membrane is pre-coated 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 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.
The Lactoferrin Rapid Test(Feces) is a qualitative, lateral flow
immunoassay for the detection of lactoferrin in human fecal specimen. The
membrane is pre-coated with anti-lactoferrin antibody on the test line region
of the test. During testing, lactoferrin, if present in the specimen reacts with
anti-lactoferrin antibody conjugated with colored particle. The mixture
migrates upward on the membrane by capillary action to react with anti
lactoferrin 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, anti-Lactoferrin
antibody particles, anti-Calprotectin antibody coated on the membrane and
anti-lactoferrin 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 ,TRANSPORT 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 and
Lactoferrin Combo Rapid Test.
• Bring the necessary reagents and fecal 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 Collection Container
• Timer
• Droppers
【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 (1-2 mL or 1-2 g) 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:
• For Solid Specimens:
Unscrew the cap of the test cup,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.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2
drops of the liquid specimen (approximately 80 µL) into the test cup
containing the dilution buffer.
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.
