Actim® Calprotectin

A rapid test for the diagnosis and monitoring of intestinal inflammation.

Overview

A user-friendly rapid test for the diagnosis and monitoring of intestinal inflammation

Actim® Calprotectin is an easy-to-use rapid test for the diagnosis and monitoring of intestinal inflammation associated with inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis. The test detects fecal calprotectin, which is a stable and sensitive indicator of IBD.

The prevalence of IBD is rapidly increasing across the world. Actim Calprotectin can quickly distinguish IBD from non-inflammatory conditions, such as irritable bowel syndrome (IBS), all while avoiding uncomfortable and invasive examinations. Actim Calprotectin is also useful for monitoring the evolution of the disease over time and evaluating patients’ treatment responses.

The Actim Calprotectin test is user-friendly for both patients and healthcare professionals, offering a hygienic and convenient way to detect the level of the presence of calprotectin in feces. The test can be done simply on the spot, and it gives semiquantitative and visually interpretable results in just 10 minutes.

Actim Calprotectin in a nutshell

  • Actim Calprotectin has been developed for a reliable and immediate diagnosis of intestinal inflammation based on calprotectin – a sensitive indicator for inflammatory bowel disease (IBD).
  • The test provides semiquantitative results, with the three following ranges of concentration of calprotectin detected in feces:
    <50, 50–200, and >200 μg/g.
  • Actim Calprotectin offers an exceptionally hygienic and convenient sample collection process.
  • This easy to use and one-step dipstick test gives results on the spot in just 10 minutes.
  • No laboratory equipment is required to perform the test.
  • The test kit contains all the materials needed to perform the test and it can be conveniently stored at room temperature.

How it works

How Actim Calprotectin works

Actim Calprotectin is a rapid immunological dipstick test that is based on highly specific monoclonal antibodies that detect fecal calprotectin. The test kit contains all the materials needed for at-home sampling, and the one-step test protocol requires only 15 seconds of hands-on time. The results can be read from the test strip in just 10 minutes, with the number of blue lines indicating the concentration level of calprotectin found in feces.

Actim Calprotectin gives semiquantitative results by reporting calprotectin concentration in three ranges: <50, 50–200, and >200 μg/g. This helps to distinguish between patients without mucosal damage, those with an irritable bowel, and those with an active inflammation.

The innovative leak-proof sample tube allows an exceptionally hygienic sample collection – even at home. The sampling device automatically adjusts the amount of sample, ensuring that test results are always consistent and reliable. The test can be carried out without opening the tube cap. This guarantees a convenient and user-friendly testing. Once the sample collection is done, the sample tube can be stored at room temperature for up to one week, which enables taking multiple samples on different days and sending all of them for testing at once.

About calprotectin:

  • Fecal calprotectin is a sensitive marker of intestinal inflammation.
  • It is an immunomodulatory and antimicrobial protein that is primarily secreted by neutrophils. Mucosal damage causes neutrophil degranulation, which leads to elevated levels of calprotectin concentration in the bowel and feces.
  • Calprotectin is an extremely stable protein that can be found in feces even after 7 days of secretion from the mucosal membrane.

FIGURE 1. Actim Calprotectin test results have been shown to be comparable to a quantitative ELISA-based calprotectin assay.

How it helps

How Actim Calprotectin helps

Fecal calprotectin is an important biomarker for IBD, including Crohn’s disease and ulcerative colitis. Calprotectin levels are low in feces of healthy individuals, while IBD patients have elevated fecal calprotectin concentrations due to leakage from damaged mucosa. Actim Calprotectin test is a useful tool to distinguish IBD from IBS, which does not involve pathological damage to the bowel.

Key benefits of Actim Calprotectin include:

  • The quick diagnosis of IBD, helping to avoid unnecessary, invasive and costly examinations.
  • The timely establishment of an appropriate treatment plan, preventing the disease from evolving.
  • The monitoring of the treatment response over time, either following the initiation of a new medication or after a dose adjustment.
  • An innovative design for an exceptionally hygienic sample handling.

Optimized treatment is essential for the appropriate management of IBD, and can remarkably improve patients’ wellbeing and quality of life.

How to use it

How to use Actim Calprotectin

Actim Calprotectin kit contains all the materials needed to perform the test, and it can conveniently be stored at room temperature (2–30 °C).

Collect sample

Open the Specimen Dilution Buffer tube and take some feces using the sampling stick attached to the screw cap.

Twist the stick in different places in the feces sample.

Put the sampling stick back into the tube by pushing the stick trough the cone and close the cap tightly.

Shake the tube to suspend the specimen in the buffer.

Perforation

Use the sharp tip of the perforating device (dipstick) to puncture the perforation area in the bottom of the buffer tube then push the device into the tube until the stopper prevents it going further

Activate the test

Slowly invert the tube once and immediately place the tube on the table in an upright position.

It is important that the inverting movement is not too abrupt, a peaceful inversion is vital for the correct performance of the test. Also, the tube must not remain upside down.

Interpret results

A test result can be read in 10 minutes after test activation. In addition to the blue control line: 

  • One blue line = fecal calprotectin concentration < 50 µg/g
  • Two blue lines = fecal calprotectin concentration 50–200 µg/g
  • Three blue lines = fecal calprotectin concentration > 200 µg/g

How to order it

How to order Actim Calprotectin

Actim Calprotectin test kits contains 20 tests and the following items:

  • Dipsticks in perforating device
  • Specimen Dilution Buffer tubes
  • Test instructions for use

Separate instructions for sampling are available online.

Ordering information

  • Actim Calprotectin 20 test kit | product code 35032ETAC
  • Actim Calprotectin Controls | product code 35000ETAC

Actim® Calprotectin Controls are intended to be used with the Actim® Calprotectin test for external quality control. The controls may also be used to demonstrate negative results and weak and strong positive results.

Materials

MDSAP 13485 and ISO 13485 can be found here.

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Combine with Actim® CRP

To support identification of intestinal inflammation in two different ways, combine Actim Calprotectin with Actim CRP to measure serum CRP, a systemic marker of inflammation.

Actim CRP