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Calprotectin Gut Inflammation Test

$129.00 $159.00 saving $30.00
Calprotectin Gut Inflammation Test

An FDA cleared 510(k) Calprotectin Test

Calprotectin, is a cytosolic protein (inside your immune cells) derived predominantly from neutrophils, and to some extent from monocytes, and activated macrophages (cells that defend you from infections). Calprotectin is found in various bodily fluids at concentrations proportional to the degree of inflammation, including in feces at levels roughly six times higher than in the blood. Fecal calprotectin (fCAL) therefore reflects intestinal inflammation. It has been shown to be extremely useful to aid in the diagnosis of inflammatory bowel disease (IBD).

Giving Back

We are delighted to provide a portion of our proceeds to the Crohn's & Colitis Foundation, a non-profit organization dedicated to finding cures for Crohn's & Colitis and improving the quality of those living with these diseases. To learn more about the Crohn's & Colitis Foundation, please visit their website:


 Crohn's & Colitis Foundation
description

Diagnosis inflammation in the gut.

Intended for the quantitative measurement of fecal calprotectin in human stool. The test aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.

Inflammatory Bowel Disease (IBD)

Irritable Bowel

Syndrome (IBS)

Ulcerative Colitis (UC)

Crohn's Disease (CD)

The Fastest, Most Accurate
Diagnosis Tool for Gut Inflammation

Get Your Results in
as Little as 3 Days

In 3 business days from sample receipt, results will be released and available for review. No third-party labs, all done in-house at Floré Laboratories.

The Highest Level
of Accuracy

Our Calprotectin testing has a diagnostic accuracy with an AUC of 0.9333 of 1.0. Along with the highest level of precision with 93.3% sensitivity.

Differentiates Between
IBS and IBD

Based on the levels of calprotectin present, we can differentiate between IBS (normal levels) and IBD (elevated levels).

The Process

Our clinical lab will send out the needed collection materials for processing of your sample. Once you return the sample, we will take it from there.

1

Collect and Send

It takes only five minutes.

2

Analysis

Our test is a colorimetric, microtiter plate-based enzyme linked immuno-sorbent assay that uses monoclonal antibodies (mAb) highly specific to calprotectin.

3

Review Results

Results will be uploaded to our portal and available for review by you and your provider.

Frequently Asked Questions

How long does it take to get my test results?

Once Floré Laboratories receives your sample we will update the webportal and mobile app with the status and processing of your sample. Our stated turnaround time from sample receipt is 3 business days.

Where does my sample get processed?

Your sample is processed by Sun Genomics, Inc. – a wholly owned CLIA Certified CAP accredited lab called Floré Laboratories. In the laboratory, we implemented a quality management process that involves the entire testing process: pre-analytical, analytical (testing), and post-analytical (reporting) processes to ensure timely and accurate results.

What are the limitations of the test?

  • Test results should be interpreted in conjunction with information available from clinical assessment of the patient and other diagnostic procedures.
  • Fecal calprotectin results may not be clinically applicable to children less than 4 years of age.
  • Patients taking non-steroidal anti-inflammatory drugs (NSAID) may have elevated fecal calprotectin levels.
  • Patients with granulocytopenia may have false negative results due to bone marrow depression.
  • Patients with IBD fluctuate between active (inflammatory) and inactive stages of the disease. These stages must be considered when interpreting results of the fecal calprotectin assay.

How it Works

In inflammatory bowel disease, neutrophils, monocytes, and macrophages (immune cells) release Calprotectin from their cytosol (cell insides). These immune cells either release Calprotectin on the opposite side of your intestinal tract opening (lamina propria) or the immune cells migrate across the epithelial cell layer (cells lining your gut) and into your intestinal tract (gut lumen) and then release Calprotectin. As a result, this inflammatory event triggers an increase of Calprotectin in your gut. The Calprotectin is then detected in your stool through the Floré Calprotectin Test.

Differentiating Between
IBS and IBD

Intestinal inflammation is associated with inflammatory bowel disease (IBD) and with some bacterial gastrointestinal (GI) infections, but it is not associated with many other disorders that affect bowel function and cause similar symptoms. Calprotectin can be used to help distinguish between inflammatory and non-inflammatory conditions.

References

  1. Occhipinti K and Smith JW. Irritable Bowel Syndrome: A review and Update. Clin Colon Rectal Surg 25, 46-52 (2012)
  2. Pavlidis P, Chedgy FJ, Tibble JA: Diagnostic accuracy and clinical application of faecal calprotectin in adult patients presenting with gastrointestinal symptoms in primary care. Scand J Gastroenterol. 48(9):1048-54 (2013)
  3. Mindemark M, Larsson A: Ruling out IBD: estimation of the possible economic effects of pre-endoscopic screening with F-calprotectin. Clin Biochem. 45(7-8):552-5 (2012)
  4. Waugh N: Faecal calprotectin testing for differentiating amongst inflammatory and non- inflammatory bowel diseases: systematic review and economic evaluation. Health Technol Assess. 17(55):xv-xix, 1-211 (2013)
  5. Kappelman MD, et al. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 58(2), 519-25 (2013)
  6. Stange EF, et al. European evidence-based consensus on the diagnosis and management of ulcerative colitis: Definitions and diagnosis. J Crohns Colitis 2, 1-23 (2008)
  7. Van Assche et al. The second European evidence-based consensus on the diagnosis and management of Crohn's disease: Definition and diagnosis. J Crohns Colitis 4, 7-27 (2010)
  8. Tibble JA et al. Use of surrogate markers of inflammation and Rome criteria to distinguish organic from nonorganic intestinal disease. Gastroenterol 123, 450-460 (2002)
  9. Jahnsen J, et al. Measurement of calprotectin in faeces. Tidsskr Nor Legeforen 128, 743-5 (2008)
  10. Dale I et al. Distribution of a new myelomonocytic antigen (L1) in human peripheral blood leukocytes. Immunofluorescence and immunoperoxidase staining features in comparison with lysozyme and lactoferrin. Am J Clin Pathol 84, 24-34 (1985)
  1. Roseth AG et al. Assessment of disease activity in ulcerative colitis by faecal calprotectin, a novel granulocyte marker protein. Digestion 58, 176- 180 (1997)
  2. Roseth AG et al. Assessment of the neutrophil dominating protein calprotectin in feces. A methodologic study. Scand J Gastroenterol 27, 793-798 (1992)
  3. Fagerhol MK. Calprotectin, a faecal marker of organic gastrointestinal abnormality. Lancet 356, 1783-4 (2000) Konikoff MR and Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis 12(6), 524-34 (2006)
  4. Van Rheenen PF et al. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta- analysis. BMJ 341 c3369. doi: 10.1136/bmj.c3369. Review. (2010)
  5. Burri E et al. Calprotectin - a useful tool in the management of inflammatory bowel disease. Swiss Med Wkly 142:0. doi: 10.4414/smw.2012.13557 (2012)
  6. CLSI. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition. CLSI document EP17-A2. Wayne, PA: Clinical Laboratory Standards Institute (2012)
  7. CLSI. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline- Third Edition. CLSI document EP5-A3 [ISBN 1- 56238-968-8]. Wayne, PA: Clinical and Laboratory Standards Institute (2014)
  8. NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedure: A Statistical Approach Guideline. NCCLS document EP6-A [ISBN 1-56238-498-8]. Wayne, PA: Clinical and Laboratory Standards Institute (2003)
  9. CLSI. Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI document EP7-A2 [ISBN 1-5623-584]. Wayne, PA: Clinical and Laboratory Standards Institute (2005)
  10. CLSI. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition. CLSI document EP09-A3. Wayne, PA: Clinical and Laboratory Standards Institute (2013)