A rapid, one step test for the qualitative detection of Calprotectin,
transferrin, human hemoglobin and Haptoglobin-Hemoglobin in human
feces.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Calprotectin/Transferrin/FOB/Hb-Hp Combo Rapid Test is a rapid
chromatographic immunoassay for the qualitative detection of Calprotectin,
transferrin, human hemoglobin and Haptoglobin-Hemoglobin in human
fecal specimens as an aid for the diagnosis of bleeding 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
Colorectal cancer is cancer that occurs in the colon or rectum, and affects
both men and women of all racial and ethnic groups, and is most often
found in people aged 50 years or older. For men, colorectal cancer is the
third most common cancer after prostate and lung cancers. For women,
colorectal cancer is the third most common cancer after breast and lung
cancers.7
Fecal occult blood should be an important indicator in the diagnostic
evaluation of patients with suspected gastrointestinal bleeding of any
etiology, not just as an indication of colorectal cancer. The presence of
human hemoglobin in feces is inadequate as a screening test for stomach
cancer (upper gastrointestinal disorders), because of human hemoglobin
derived from the upper digestive tract is broken down in the intestinal tract
(the antigenicity is lost).8
Detection of fecal transferrin, which is more stable in stool than hemoglobin,
provides an alternative way of diagnosing the disease in the upper
digestive tract.8
Blood in the stool may be the only symptom of cancer, but not all blood in
the stool is caused by cancer. Other conditions that can cause blood in the
stool include: Haemorrhoids, Anal fissures, Colon polyps, Peptic ulcers,
Ulcerative colitis. Gastroesophageal reflux disease (GERD). Crohn's
disease, use of non-steroidal anti-inflammatory drugs (NSAIDs).9
The hemoglobin-haptoglobin complex has a higher survival rate within the
digestive tract than hemoglobin, thus the dual blood protein detection
meaningfully increases the sensitivity of Occult Blood detection, including
bleeding from upper digestive tract.10
【PRINCIPLE】
The Calprotectin/Transferrin/FOB/Hb-Hp Combo Rapid Test (Feces) is a
qualitative, lateral flow immunoassay for the detection of calprotectin,
human hemoglobin transferrin and Haptoglobin-Hemoglobin in feces.
For Calprotectin/Transferrin/FOB/Hb-Hp test
The membrane is precoated with anti-Calprotectin/anti-transferrin/anti
hemoglobin/anti-haptoglobin antibody on the test line region of the test.
During testing, the specimen reacts with the particle coated with anti
Calprotectin/anti-transferrin/anti-hemoglobin/anti-haptoglobin antibody. The
mixture migrates upward on the membrane chromatographically by
capillary action to react with anti-Calprotectin/anti-transferrin/anti
hemoglobin/anti-haptoglobin 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 calprotectin test contains anti-Calprotectin antibody particles and anti
Calprotectin antibody coated on the membrane.
The Transferrin test contains anti-transferrin antibody particles anti
transferrin coated on the membrane.
The FOB test contains anti-hemoglobin antibody particles and anti
hemoglobin antibody, anti-transferrin coated on the membrane.
The Hb-Hp test contains anti-hemoglobin, anti-haptoglobin coated on the
membrane.
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after the expiration date printed on the package. Do not
reuse the test.
• The test should remain in the sealed pouch until use.DO NOT FREZEE
• 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 may adversely affect results.
• Keep the test upright while testing. Do not move or turn the test upside
down.
【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 label.
The test must remain in the sealed pouch until use. DO NOT FREEZE. Do
not use beyond the expiration date.
Note: It is suggested to use the test within one hour after removing it from
the foil pouch.
【SPECIMEN COLLECTION AND PREPARATION】
• Specimens should not be collected during or within three days of a
menstrual period, or if the patient suffers from bleeding hemorrhoids or
blood in the urine.
• Alcohol, aspirin and other medications taken in excess may cause
gastrointestinal irritation resulting in occult bleeding. Such substances
should be discontinued at least 48 hours prior to testing.
• No dietary restrictions are necessary before using the test.
【MATERIALS】
Materials Provided
Test Cups (with dilution buffer)
Package Insert
Materials Required But Not Provided
Specimen Collection Container
Timer
【DIRECTIONS FOR USE】
Allow the test, specimen to reach room temperature (15-30 °C) prior
to testing.
1. Wash your hands with soap and rinse with clean water.
2. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 g) in a clean, dry specimen
collection container. 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.
3. Bring the pouch to room temperature before opening it. Remove the
test 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. Do not take too many
samples, otherwise the solution will not run properly.
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 on a clean and level surface, press the cup body from the
top to the bottom and start the timer.
NOTE: Keep the test upright while testing. Do not move or turn the test
upside down.
9. Read results at 5 minutes. Do not read results after 10 minutes.