Fecal Calprotectin

Non-invasive quantification of organic bowel mucosa

inflammation with superior performance, specificity and sensitivity

Figure: ROC analysis of the ability of the Buhlmann Calprotectin (monoclonal) ELISA, PhiCal Calprotectin
(polyclonal) ELISA, and a Lactoferrin ELISA to discriminate between patients with Crohn's Disease and
IBS. Comparison performed with 401 patients having organic (n=129) and non-organic (n=272) intestinal disease.
Area under the curve results: Buhlmann ELISA 0.94, PhiCAL ELISA 0.86 and Lactoferrin 0.85. With a cut-off of 50
ug/g, Buhlmann ELISA PPV was 87.8% and NPV was 93%. Adapted from M.Manz, et al. (unpublished).

Differentiate IBD from IBS

Fecal calprotectin is a reliable surrogate marker to quantitatively differentiate organic inflammation
(IBD) from functional symptoms (IBS)

Relapse Prediction
Calprotectin has been shown in numerous publications to be a good predictor of IBD relapse with
levels < 150μg/g indicating IBD remission and low risk of relapse

Therapeutic Monitoring
Quantifying low calprotectin levels after treatment can indicate response of endoscopic disease
activity and can also aid in optimizing treatment and compliance

Fecal Calprotectin
Calprotectin is a heterodimeric protein belonging to
the S100 family and accounts for up to 60% of cytosolic
protein in neutrophil granulocytes and macrophages.
Calprotectin plays a central role in neutrophil defenses -
it is an immunomodulatory protein which binds to
calcium and zinc, is antimicrobial, inhibits
metalloproteinases, induces apoptosis and activates
TLR4 amongst other roles in regulating inflammatory
reaction. Under conditions of mucosal inflammation,
calprotectin is released into the gastrointestinal lumen
and serves as a useful biomarker for accurately
identifying intestinal inflammation.
Inflammatory Bowel Disease (IBD)
IBD is a chronic disease with forms involving the lower
bowel parts or the entire GI tract, causing symptoms
like abdominal pain, diarrhea, fever and weight loss. An
estimated two million people in North America suffer
from IBD seemingly caused by an overactive mucosal
immune system. Crohn’s Disease and Ulcerative
Colitis are the major groups of inflammatory conditions
that make up IBD and are incurable, serious and
chronic organic diseases of the intestinal tract. The
symptoms are distressing, embarrassing and even
debilitating.
Irritable Bowel Syndrome (IBS)
IBS is a non-organic functional disorder. It expresses
similar symptoms to IBD such as cramping, bloating,
diarrhea, and constipation. An estimated thirty million
people in North America are affected by IBS symptoms,
resulting in over 3.5 million physician visits annually and
accounting for roughly 30% of visits to
gastroenterologists.
Fecal Calprotectin
Differentiating IBD from IBS
Both organic Inflammatory Bowel Diseases (IBD) and
non-organic functional disorders like Irritable
Bowel Syndrome (IBS) exhibit very similar symptoms. A
considerable issue in clinical gastroenterology is to
differentially diagnose patients with IBD from functional
disorders like IBS. Calprotectin is considered a reliable
indicator of inflammation in several diseases and has
been shown in numerous studies to be significantly
elevated in cases of IBD. In cases of IBS, calprotectin
levels do not become elevated therefore the distinction
in fecal levels allows calprotectin to be a useful
biomarker for distinguishing between two syndromes
whose clinical manifestations are very similar.
Management of IBD
Measurement of fecal calprotectin levels
provides physicians with valuable information for timely
decision making on whether to send IBD patients for
colonoscopy or rather to treat them for IBS symptoms.
Traditionally IBD activity has been assessed through
clinical symptoms but, it has been reported that these
recognized activity indexes are subjective and do not
correlate as consistently as fecal calprotectin levels with
histologic inflammation.
Fecal calprotectin has been demonstrated to be a
reliable biomarker of mucosal inflammation in several
organic IBD pathologies and may function as a valuable
alternative to relying on clinical symptoms, the use of
complex imaging procedures or performing endoscopy
and biopsy. Because of the biomarkers' ability to
quantify disease activity, many research studies
conclude that monitoring fecal calprotectin levels can
be useful for chronicling disease activity in IBD.
Calprotectin also has the ability to detect inflammation
prior to the appearance of clinical symptoms.
The clinical course of most patients treated for IBD is
marked by periods of remission with intermittent
relapses characterized by increased intestinal
inflammation. Thus, monitoring levels of fecal
calprotectin can play an essential role in determining
the effectiveness of therapy and is a good predictor of
potential relapse. It provides physicians with a valuable
tool, not only for differentiating IBD from IBS cases but
also allowing them to monitor and predict treatment
outcomes, enabling better management of IBD flares.
Page 2 of 4 · Version 1
 Fecal Calprotectin
ALPCO is pleased to offer the Bühlmann Calprotectin ELISA and Quantum Blue® Calprotectin rapid
tests for quantitative determination of human calprotectin in stool samples. The unique monoclonal
antibody sandwich format of these assays offers superior specificity, sensitivity and performance.
- All calprotectin assays and equipment are Health Canada licensed for IVD use. Not available for purchase in the US -

Calprotectin ELISA
This automatable ELISA method provides two options for detection ranges and comes in a single plate (1x
96 wells) format or a larger two plate (2 x 96 wells) format.

Standard Dynamic Range (10 - 600µg/g) – optimal range for differentiating IBD from IBS
Extended Dynamic Range (30 - 1800µg/g) – advantageous in monitoring mucosal inflammation and disease activity in
individuals with IBD

 Ready to use reagents  Established cut-off of 50µg/g

 Total assay time of 75 minutes  Single plate 01-EK-CAL
 Includes high and low controls  Dual plate 01-EK-CAL02

Quantum Blue Calprotectin Rapid Tests

These assays provide quantifiable, easy to use, and rapid results utilizing lateral flow technology. Tests are
available in two detection ranges and are recommended for use with the Quantum Blue reader.
®
Quantum Blue Reader
This innovative reader detects the optical density of appearing bands
on the calprotectin assay cartridges thus providing an accurate and
quantifiable digital result in µg/g. Use of the reader reduces the risk of
subjectivity and misinterpretation incurred by results read visually.

 Easy to use single button operation

 Small, lightweight and portable
 Confocal sensor provides unmatched sensitivity
 Connects to computer via USB for data transfer
 Compatible with bar codes reader or portable printer
 Order code 02-BI-POCTS-ABS
®
Quantum Blue Calprotectin Assay
Lateral flow cartridges for detection in the 30 - 300µg/g range.

 Optimal for patient screening and determination of organic inflammation versus non-organic functional disorder
 Ideal for screening patients prior to requiring colonoscopy for further diagnostic confirmation of IBD
 Results in 12 minutes
 Order code 01-LF-CAL25
®
Quantum Blue Calprotectin High Range Assay
Lateral flow cartridges for detection in the 100 - 1800µg/g range.

 Fewer dilution steps when analyzing specimens where high levels of calprotectin are anticipated
 Ideal quantitative tool to support the monitoring and follow-up of IBD patients during treatment
 Results in 15 minutes
 Order code 01-LF-CHR25

Page 3 of 4 · Version 1

Sample Collection Devices
EasySampler Stool Collection Kit
The user-friendly, hygienic and disposable EasySampler has been
specifically designed for attachment to North American toilets and
helps prevent contamination of the stool by water and dirt, decreasing
the risk of test errors.
58-EZSAMPLER
Sample Preparation Devices
Calprotectin is very stable in stool samples but accurate sample
extraction is a key element to achieving valid quantitative results with
the calprotectin assays. As an alternative to weighing samples,
ALPCO offers two kit options for sample extraction.
Smart Prep Fecal Sample Extraction Kit
Appropriate for all sample consistencies including more liquid stool
samples.
02-B-CAL-RD
® Diagnosis of Organic Bowel Disease in
The Schebo Quick Prep Fecal Sample Extraction Kit
Preferred method for solid stool samples.
02-B-CAL-SO50
Fecal Calprotectin
Recently Published Validations
 Burri E, Beglinger C. Faecal calprotectin - a
useful tool in the management of
inflammatory bowel disease.Swiss Med Wkly.
2012 Apr 5. PMID: 22481443
 Sydora, M., Sydora, B. Fedorak, R.
Validation of a point-of-care desk top device
to quantitate fecal calprotectin and distinguish
inflammatory bowel disease from irritable
bowel syndrome. J Crohn’s and Colitis. J
Crohns Colitis. 2012 Mar;6(2):207-14. Epub
2011 Sep PMID: 722325175
 Wassell J, Wallage M, Brewer E. Evaluation
of the Quantum Blue(R) rapid test for faecal
calprotectin. Ann Clin Biochem 2011 Sep 19.
PMID 21930735
 Jensen MD, Kjeldsen J, Nathan T. Fecal
calprotectin is equally sensitive in Crohn's
disease affecting the small bowel and colon.
Scand J Gastroenterol. 2011 Jun;46(6):694-
700. Epub 2011 Apr 1. PMID:21456899
 Dolci A, Panteghini M, Comparative study of
a new quantitative rapid test with an
established ELISA method for faecal
calprotectin.Clin Chim Acta. 2012 Jan 18;413-
(1-2):350-1 PMID:21982915.
 Manz M, Burri E, Rothen C, Tchanguizi N,
Niederberger C, Rossi L, Beglinger C,
Lehmann FS. Value of fecal calprotectin in
the evaluation of patients with abdominal
discomfort: an observational study. BMC
Gastroenterol. 2012 Jan 10;12(1):5.
PMID:22233279
 Kok L, Elias SG, Witteman BJ, Goedhard JG,
Muris JW, Moons KG, de Wit NJ. Diagnostic
Accuracy of Point-of-Care Fecal Calprotectin
and Immunochemical Occult Blood Tests for
Primary Care: The Cost-Effectiveness of a
Decision Rule for Abdominal Complaints in
Primary Care (CEDAR) Study. Clin Chem.
2012 Mar 9. PMID: 22407858
 Kolho KL, Turner D, Veereman-Wauters G,
Sladek M, de Ridder L, Shaoul R,
Paerregaard A, Dias JA, Koletzko S, Nuti F,
Bujanover Y, Staiano A, Bochenek K, Finnby
L, Levine A, Veres G. Rapid Test For Fecal
Calprotectin Levels In Children With Crohn'S
Disease. J Pediatr Gastroenterol Nutr. 2012
Mar 8. PMID: 22411269
Page 4 of 4 · Version 1