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This kit is used for qualitative detection of calprotectin and hemoglobin in human stool sample, and it’s suitable for auxiliary diagnosis of inflammatory bowel disease and gastrointestinal bleeding. This kit only provides detection results of calprotectin and hemoglobin in stool sample, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
Methodology:
Colloidal GoldTesting time:
10-15 minutesStorage temperature ::
2℃-30℃Specimen::
Human stoolValid Time ::
24 monthAccurancy:
96.65%Specification:
25 test/boxDiagnostic Kit for Calprotectin/Fecal Occult Blood (Colloidal Gold)
1.SUMMARY
Calprotectin is a calcium and zinc binding protein with a molecular weight of 36 kDa, which belongs to neutrophil granulocyte. It’s extensively distributed in human body and has expression in histiocyte and body fluid. However,contents at different sites vary a lot, and the content’s the highest in neutrophil and monocyte. Content of calprotectin in stool sample of patients with inflammatory bowel disease is higher, which concentration is closely associated with leucocyte concentration in stool. In comparison with other systemic inflammatory markers,calprotectin level is not affected by reasons other than inflammatory bowel disease, it’s of high specificity and extremely stable, which can be stored for 7 days at room temperature. It can be used as a noninvasive marker of inflammatory bowel disease.
Fecal occult blood refers to small amount of bleeding of alimentary tract that cannot be verified with naked eye and microscope, red blood cells are destroyed by digestion, and there’s no abnormal change in appearance of stool. Most fecal occult blood tests of patients with gastrointestinal bleeding and peptic ulcer shows intermittent positivity. Diarrhea, rectal polyp and hemorrhoidal bleeding may also lead to relatively large number of erythrocytes in stool and positivity of fecal occult blood test. Fecal occult blood detection is an item of stool routine, it’s of important reference value to diagnosis and differential diagnosis of gastrointestinal bleeding, and it’s often used as a screening indicator for diagnosis of gastrointestinal bleeding.
2.PRODUCTS INFORMATION
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♦ Name:Diagnostic Kit for Calprotectin/Fecal Occult Blood ♦ Model Number: CAL/FOB ♦ Methodology: Colloidal Gold ♦ accurancy: 99% ♦ Certificate: CE/ISO13485 ♦ Shelf time : 24 months ♦ after sale service: online technical support ♦ Packing: 25tests/kit,30boxes/ctn ♦ OEM/ODM service :Avaliable ♦ Storage:2'C-30'C |
3.FEATURE
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♦ Speciments are easy to collect: Human Stool ♦ Easy to carry, Rapid test in 15 mins, Cost effective . ♦ Highly Accuracy rate ♦ Application:simple operation ,suitable for bedside,outpatient,ICU ,outdoor and so on .
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4.TEST PROCEDURE
♦ Use sample collection tube to collect, mix well and dilute the sample. Use sampling stick to take about 30mg of stool. Then, transfer the stool to a sample collection tube containing sample diluent, tighten by rotating, and shake sufficiently.
♦ If stool of patient with diarrhea is loose, use disposable pipette to draw the sample, add 3 drops (about 100μL) of sample-to-sample collection tube, and shake the sample and sample diluent sufficiently.
♦ Take the test device out of the aluminum foil bag, place it on a horizontal worktable flat, and make a proper mark. Discard the first two drops of diluted sample. Then, vertically, and slowly add 3 drops (about 100μL) of bubble-free diluted sample to the center of sample hole of the test device and start timing.
♦ The result shall be read within 10-15 minutes. Test result obtained after 15 minutes is invalid (for detail about result see Interpretation of Test Results).
4.INTERPRETATION
Diagram | Result interpretation |
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Positive: There are color stripes on test lines (T1 and T2) and control line (C) of test device at the same time within reaction time. (1) Appearance of color stripes on both test line (T1) and control line (C) of test device indicates positive calprotectin. (2) Appearance of color stripes on both test line (T2) and control line (C) of test device indicates positive hemoglobin. |
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Negative: There is one color stripe on control line of test device (C), and there’s no color stripe on test lines (T1 and T2) within reaction time. It indicates that sample doesn’t contain calprotectin and/or hemoglobin, or content of calprotectin and/or hemoglobin in sample is lower than lower limit of detection of the kit. |
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Invalid: There is no color stripe on control line (C) of test device within reaction time. Invalid result indicates that: it can be caused by incorrect operation process or deteriorated and damaged reagent. Retest shall be conducted in case of invalid result, which shall be operated strictly in accordance with the specification. If the problem still exists, please immediately stop using products of the lot number, and contact local supplier. |
5.CERTIFICATE
♦ CE certification ♦ Registered by the EU ♦ Product test certification ♦ ISO system certification |
6.FACTORY
RELATED PRODUCTS
Diagnostic Kit for Calprotectin(Colloidal Gold) Diagnostic Kit for Fecal Occult Blood (Colloidal Gold)
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