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Calprotectin Rapid Test CE Marking


Product Number: RAPG-CAL-001

Pack size

10 tests

Product Description

The Biopanda Calprotectin Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Calprotectin in human faeces specimen which might be useful for the diagnosis of inflammatory gastrointestinal disorders.

Inflammatory bowel disease is a group of inflammatory conditions of the small intestine and colon. Major types of IBD include Crohn’s disease and Ulcerative Colitis.
Calprotectin is a protein biomarker present in the faeces when intestinal inflammation occurs. Faecal calprotectin testing helps to improve patient care. It prevents the need for unnecessary endoscopy procedures on many patients by screening out those with Irritable Bowel Syndrome (IBS).

Principle

The Biopanda Calprotectin Rapid Test is a qualitative, lateral flow immunoassay for the detection of Calprotectin in human feces specimens. 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 a Calprotectin antibody. The mixture migrates laterally along the membrane chromatographically by capillary action to react with anti-Calprotectin antibody on the membrane and generates a coloured line. The presence of this coloured line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Test Attributes

  • Faecal samples may be used for testing
  • Results available in only 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of Inflammatory Bowel Disease

Test Procedure

  1. Collect sufficient quantity of faeces (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.
  2. For solid specimens:
    Unscrew the cap of the specimen collection tube,then randomly stab the specimen collection applicator into the faecal specimen in at least 3 different sites to collect approximately 50 mg of faeces (equivalent to 1/4 of a pea). Do not scoop the faecal specimen.
    For liquid specimens:
    Hold the dropper vertically, aspirate faecal specimens, and then transfer 2 drops (approximately 80 μl) into the specimen collection tube containing the extraction buffer.
  3. Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube to stand for 2 minutes.
  4. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
  5. Hold the specimen collection tube upright and open the cap of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 μl) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
  6. Read results at 5 minutes after dispensing the specimen. Do not read results after 10 minutes.

  7. Note: If the specimen does not migrate (due to 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.


Performance Characteristics

  • Relative sensitivity: 97.8%
  • Relative specificity: 99.0%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.



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