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Biomedical Science

Rapid Test for Inflammatory Bowel Disease (IBD)

Table of contents

Table of contents

Actim Calprotectin – Semi-quantitative Rapid Test for Supporting the Diagnosis of Intestinal Inflammation 

Introduction to Actim Calprotectin 

Actim® Calprotectin is a user-friendly, semi-quantitative rapid test designed for the diagnosis and monitoring of intestinal inflammation related to inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. The test detects calprotectin in stool samples – an antimicrobial and immunoregulatory protein primarily secreted by neutrophils. Mucosal damage triggers neutrophil degranulation, leading to elevated calprotectin levels in the intestine and stool. 

Calprotectin can be detected in feces for up to 7 days after being released from the mucosa. Actim Calprotectin is a valuable tool for differentiating IBD from IBS (Irritable Bowel Syndrome), which is not associated with pathological intestinal inflammation. The test is also useful for monitoring treatment response over time, after initiation of a new therapy, or following dose adjustments. 

Principle of the Test 

Actim Calprotectin is based on immunochromatography using highly specific monoclonal antibodies for the detection of fecal calprotectin. The antibodies are conjugated to blue latex particles, serving as color markers. 

The test membrane contains two calprotectin-specific antibody zones, where the latex particles will bind if calprotectin is present in the sample. When the stool suspension comes into contact with the dip area of the test stick, the stick absorbs the liquid, which then migrates upward. If calprotectin is present, it binds to the latex-conjugated antibodies. The latex complexes are carried by the liquid flow and, when bound to calprotectin, will attach to the corresponding antibody capture zones. 

Actim Calprotectin provides semi-quantitative results by indicating calprotectin concentrations within three ranges: 

  • < 50 µg/g 

  • 50–200 µg/g 

  • 200 µg/g 

Key Advantages 

  • Fast procedure: Only 15 seconds of hands-on time, with results available in 10 minutes. 

  • Hygienic sampling: Improved leak-proof sample tube ensures safe and clean stool collection, even at home. 

  • Consistent results: The integrated sampling probe automatically standardizes the amount of collected specimen, ensuring reliable and reproducible outcomes. 

  • Safe handling: Once the sample is collected, the test can be performed without reopening the tube, minimizing contamination risks. 

  • No laboratory equipment required: The kit contains all necessary materials. Sample tubes can be stored at room temperature for up to one week, allowing collection on different days if needed. 

  • Semi-quantitative results with 3 clinically relevant cut-off ranges, providing strong support for clinical decision-making. 

Clinical Significance 

  • Rapid differentiation of IBD from IBS: Helps avoid unnecessary endoscopic procedures or costly investigations when primary intestinal inflammation is absent. 

  • Treatment monitoring: Enables assessment of inflammation over time, from therapy initiation or following treatment adjustments. 

  • High reliability: When compared with quantitative ELISA methods such as Bühlmann fCAL ELISA, Actim Calprotectin demonstrates equivalent performance (see Figure 1). 

Test Procedure for Actim Calprotectin 




 

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Step 1: Open the specimen dilution buffer tube and collect a stool sample using the sampling probe attached to the screw cap. 
Step 2: Rotate the probe in different areas of the stool sample until both grooves are filled. 
Step 3: Return the probe into the tube and tighten the cap securely. 
Step 4: Shake the tube to thoroughly mix the specimen with the buffer. 
Step 5: Use the piercing device to puncture the bottom of the dilution tube, then insert the test stick into the tube until the stopper prevents further movement. 
Step 6: Gently invert the tube and immediately place it upright on the table (avoid sudden inversion; gentle inversion is essential for accurate results). Do not leave the tube upside down. 

Step 7: Read the results after 10 minutes: 

  • One blue line = fecal calprotectin < 50 µg/g 

  • Two blue lines = fecal calprotectin 50–200 µg/g 

  • Three blue lines = fecal calprotectin > 200 µg/g 

Kit Contents 

The Actim Calprotectin kit contains: 

  • 20 test sticks 

  • 20 specimen dilution buffer tubes 

  • 1 Instructions for Use (IFU) 

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