Diagnosing IBS
Accuracy of three different fecal calprotectin tests in the diagnosis of inflammatory bowel disease
In conclusion, fecal calprotectin tests are useful for distinguishing IBD from IBS or “other colitis” (in the descending order of performance): Quantum Blue® Calprotectin, EliA™ Calprotectin, and RIDASCREEN® Calprotectin.
Concept for a rapid point-of-care calprotectin diagnostic test for diagnosis and disease activity monitoring in patients with inflammatory bowel disease: expert clinical opinion
As a sensitive biomarker of mucosal inflammation, fecal calprotectin could be used in a rapid point-of-care test to monitor disease activity in patients with IBD, and help reduce unnecessary specialist referrals and subsequent endoscopic investigations, which can be both uncomfortable and painful for the patient, and time-consuming and costly for health services.
Rogler et al. (2013) Journal of Crohn’s and Colitis. Vol. 7, pp. 670-7
Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome
Our results confirm the effective use of fecal calprotectin levels in differentiating non-inflammatory from active inflammatory intestinal diseases. The desk top Bühlmann Quantum Blue Reader® exhibits a fast, non-invasive, and reliable way of identifying an inflammatory intestinal disease.
Sydora MJ et al. (2012) Journal of Crohn’s and Colitis. Vol. 6, pp. 207-14
Diagnostic Accuracy of Point-of-Care Fecal Calprotectin and Immunochemical Occult Blood Tests for Diagnosis of Organic Bowel Disease in Primary Care: The Cost-Effectiveness of a Decision Rule for Abdominal Complaints in Primary Care (CEDAR) Study
Diagnostic accuracy of the tests alone or combined was insufficient when all adenomas were considered OBD. When only adenomas >1 cm were considered OBD, all tests could rule out OBD to a reasonable extent, particularly the combined POC tests. The tests were less useful for inclusion of OBD.
Evaluation of the Quantum Blue® rapid test for faecal calprotectin
The Quantum Blue method was a suitable screening test for excluding inflammatory bowel disease. It may be of value to laboratories wishing to offer calprotectin but who do not have sufficient numbers to warrant ELISA methodology or in ‘one stop’ gastrointestinal clinics where an immediate result is required.
Point of Care
Therapeutic Drug Monitoring of Adalimumab: a comparative study of a new point-of-care quantitative test with three established ELISA assays
The need for therapeutic drug monitoring (TDM) in the treatment of inflammatory bowel disease (IBD) patients under biologics, namely adalimumab (ADA), is unquestionable. Several ELISA-based methodologies are already available in the market. A new point-of-care device (POC-ADA) was recently launched for monitoring serum ADA levels. The aim of this study was to validate the first point of care for TDM of serum ADA levels available in the market by comparing it with three well- established methods.
Alfonso J., et al. (2018) Poster from United European Gastroenterology Week
Concept for a rapid point-of-care calprotectin diagnostic test for diagnosis and disease activity monitoring in patients with inflammatory bowel disease: expert clinical opinion
As a sensitive biomarker of mucosal inflammation, fecal calprotectin could be used in a rapid point-of-care test to monitor disease activity in patients with IBD, and help reduce unnecessary specialist referrals and subsequent endoscopic investigations, which can be both uncomfortable and painful for the patient, and time-consuming and costly for health services.
Rogler et al. (2013) Journal of Crohn’s and Colitis. Vol. 7, pp. 670-7
Evaluation of the Quantum Blue® rapid test for faecal calprotectin
The Quantum Blue method was a suitable screening test for excluding inflammatory bowel disease. It may be of value to laboratories wishing to offer calprotectin but who do not have sufficient numbers to warrant ELISA methodology or in ‘one stop’ gastrointestinal clinics where an immediate result is required.
Validation of Two Calprotectin Rapid Tests in Daily Routine
Quantum Blue provided high diagnostic accuracy and was less time consuming in clinical routine than quantification of fecal calprotectin by ELISA. This makes these tests excellent candidates for the use in clinical routine. The routine application of ELISA techniques for the quantification of fecal calprotectin levels is a valid option in laboratories or clinical departments with high quantities of samples to allow prompt follow up for patient management.
Schulz et al. (2016) Clinical Laboratory. Vol 62, no. 7, pp. 1249-1254
Faecal calprotectin: comparative study of the Quantum Blue rapid test and an established ELISA method
We may conclude that the point-of-care test can serve as a reliable alternative to the time consuming ELISA in the differential diagnosis between functional and organic bowel disease. Furthermore, it seems to be reliable in the follow-up of inflammatory bowel disease patients.
Coorevits et al. (2013) Clinical Chemistry and Laboratory Medicine. Vol. 51, pp. 825-31
A New Rapid Quantitative Test for Fecal Calprotectin Predicts Endoscopic Activity in Ulcerative Colitis
FC determine by QPOCT was an accurate surrogate marker of “endoscopic remissions” in UC and presented a good correlation with the FC-ELISA test.
Ortega et al. (2013) Inflammatory Bowel Disease. Vol. 0 pp. 1-9
A new rapid test for fecal calprotectin predicts endoscopic remission and postoperative recurrence in Crohn's disease
FC determined by rapid quantitative test predicts “endoscopic remission” and endoscopic postoperative recurrence in CD patients.
Lobatón et al. (2013) Journal of Crohn’s & Colitis. Vol. 12 pp. 641-51
Diagnostic Value of Fecal Calprotectin Point of Care Testing in the Paediatric Practice
Fecal calprotectin point of care testing is a useful screening tool to detect children with intestinal inflammation and to identify those requiring further endoscopic assessment. It is simple and has a good diagnostic performance comparable to the time-consuming ELISA assay.
Fecal calprotectin determination in preterm neonates: evaluation of two methods
FC values found in this preliminary cohort of preterm neonates have been similar to those reported in the literature. The finding of a good correlation between the two techniques suggests the potential clinical usefulness of Quantum Blue at this age group (after validation).
Gonçalves et al. (2011) Paediatric Research. Vol. 70, pp. 475
The Quantum Blue® Rapid Test for point of care quantitation of fecal calprotectin in paediatric patients.
Qualitatively, the Quantum Blue® and ELISA results showed a very good diagnostic discrimination of IBD versus IBS in paediatric patients. This fast (within minutes) new test thus offers an accurate and useful tool in clinical settings and plans are being made to use it routinely in the paediatric department of the Hospital.
Fecal Occult Blood and Fecal Calprotectin as Point-of-Care Markers of Intestinal Morbidity in Ugandan Children with Schistosoma mansoni Infection
Due to its lower-cost which makes its scale-up of use affordable, FOB could be immediately adopted as a monitoring tool for PC campaigns for efficacy evaluation before and after treatment.
Point-of-care and home faecal calprotectin tests for monitoring treatment response in inflflammatory bowel disease
Faecal Calprotectin is a Cost-Effective Method of Assessing Activity of Inflammatory Bowel Disease
FC can be used in the majority of patients to guide management without the need for further tests. In this observational study a management decision was made based on the FC result in 76% of patients. It has reduced the use of expensive and invasive investigations and delivered a cost benefit to our service saving £11646 in 1 year. We recommend FC as a cost efficient test to assess disease activity in IBD.
Instrument Comparison & Product Assessment
The usefulness of Faecal Calprotectin in assessing inflammatory bowel disease activity
FC levels measured by ELISA and QPOCT showed very close correlation in both UC (r = 0.874, p = 0.000) and CD (r = 0.908, p = 0.000)…. both calprotectin assays could predict MH with high sensitivity (> 81%) and specificity (100%) in UC patients. Therefore, FC may be a useful alternative to repeated endoscopies. In addition, QPOCT can be used more conveniently than ELISA to assess FC in clinical practice.
Woon Lee et al. (2018) The Korean Journal of Internal Medicine
Accuracy of three different fecal calprotectin tests in the diagnosis of inflammatory bowel disease
In conclusion, fecal calprotectin tests are useful for distinguishing IBD from IBS or “other colitis” (in the descending order of performance): Quantum Blue® Calprotectin, EliA™ Calprotectin, and RIDASCREEN® Calprotectin.
Validation of Two Calprotectin Rapid Tests in Daily Routine
Both POCTs, Quantum Blue and PreventID®, provide high diagnostic accuracy and were less time consuming in clinical routine than quantification of fecal calprotectin by ELISA. This makes these tests excellent candidates for the use in clinical routine. The routine application of ELISA techniques for the quantification of fecal calprotectin levels is a valid option in laboratories or clinical departments with high quantities of samples to allow prompt follow up for patient management.
Schulz et al. (2016) Clinical Laboratory. Vol 62, no. 7, pp. 1249-1254
Faecal calprotectin: comparative study of the Quantum Blue rapid test and an established ELISA method
We may conclude that the point-of-care test can serve as a reliable alternative to the time consuming ELISA in the differential diagnosis between functional and organic bowel disease. Furthermore, it seems to be reliable in the follow-up of inflammatory bowel disease patients.
Coorevits et al. (2013) Clinical Chemistry and Laboratory Medicine. Vol. 51, pp. 825-31
Comparison of two immunoassays for measurement of faecal calprotectin in detection of Inflammatory Bowel Disease: (pre)-analytical and diagnostic performance characteristics
The Thermo Fisher device is not reliable for extraction of faecal calprotectin. The performance characteristics of the EliA Calprotectin assay are statistically equivalent to the Bühlmann POCT.
Oyaert et al. (2013) Clinical Chemistry and Laboratory Medicine
Comparison of six different calprotectin assays for the assessment of inflammatory bowel disease
All calprotectin assays showed comparable clinical performance for diagnosis of IBD. For follow up, performance was acceptable, except for mild Crohn’s disease. Because of the large quantitative differences, further efforts are needed to standardize calprotectin assays.
Labaere et at. (2013) United European Gastroenterology Journal. Vol. 2, no. 1, pp. 30-30
Evaluation of Prevent ID and Quantum Blue rapid tests for fecal calprotectin
The Quantum Blue calprotectin rapid test demonstrated better analytical performance than the Prevent ID CalDetect in reducing the number of colonoscopies. Furthermore, the former test has the advantage of using a point of care reader for quantitative measurement and for establishing an optimal cut-off level.
Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome
Our results confirm the effective use of fecal calprotectin levels in differentiating non-inflammatory from active inflammatory intestinal diseases. The desk top Bühlmann Quantum Blue Reader® exhibits a fast, non-invasive, and reliable way of identifying an inflammatory intestinal disease.
Sydora et al. (2012) Journal of Crohn’s and Colitis. Vol. 6, pp. 207-14
Fecal calprotectin: assessment of a rapid test
The new rapid test is useful as a screening test for excluding GI inflammation when the cut-off of 15 microg/g is used. With fecal calprotectin concentrations >15 microg/g, the rapid test should be supplemented by quantitative measurement.
Comparative study of a new quantitative rapid test with an established ELISA method for faecal calprotectin
Results of this preliminary study suggest that Quantum Blue POCT may be highly recommended as a replacement for the cumbersome ELISA method, making faecal calprotectin determination rapid, effective, and suitable for any laboratory setting.
Monitoring & TDM
First successful comparison of Quantum Blue® rapid TDM assay standardization with WHO international standard for infliximab
High Correlation of the Quantum Blue® rapid assay with HPLC tandem mass spectrometry for infliximab therapeutic drug monitoring
Accuracy of a New Rapid Test Assay for Monitoring Adalimumab Levels
Therapeutic Drug Monitoring as a Predictive Marker of Mucosal Healing in Crohn’s Disease Patients Treated with Anti-TNF: A Prospective Multicenter Study
Quantum Blue® Anti-Adalimumab: Development and evaluation of a point of care rapid test for measuring anti-adalimumab antibodies in human serum
Quantum Blue® Anti-Infliximab: Development and evaluation of a point of care rapid test for measuring anti-infliximab antibodies in human serum
Patient-near Adalimumab trough-level testing by a novel quantitative rapid test: The Quantum Blue Adalimumab assay
Therapeutic drug monitoring (TDM) has become standard clinical practice and overwhelming clinical evidence indicates that dose-optimization improve clinical outcome by decreasing the risk for anti-drug-antibodies and improves the efficacy of the drug itself. Watanabe et al. (Clin Gastroenterol Hepatol, in press) recently demonstrated that increasing trough-levels were closely associated with endoscopic response and mucosal healing. However, this has been hampered by the high cost of and the absence of a near patient testing.
Lindsjø I., et al (2018) Poster from United European Gastroenterology Week
Therapeutic Drug Monitoring of Adalimumab: a comparative study of a new point-of-care quantitative test with three established ELISA assays
The need for therapeutic drug monitoring (TDM) in the treatment of inflammatory bowel disease (IBD) patients under biologics, namely adalimumab (ADA), is unquestionable. Several ELISA-based methodologies are already available in the market. A new point-of-care device (POC-ADA) was recently launched for monitoring serum ADA levels. The aim of this study was to validate the first point of care for TDM of serum ADA levels available in the market by comparing it with three well- established methods.
Afonso J., et al. (2018) Poster from United European Gastroenterology Week
Rapid fecal calprotectin test for prediction of mucosal inflammation in ulcerative colitis and Crohn disease: a prospective cohort study
FC levels increased dynamically even with mild signs of intestinal inflammation. The rapid Quantum Blue® test presents a potential alternative to the time‑consuming ELISA, because its diagnostic accuracy is not influenced by disease location. It may be useful in the hospital setting, providing faster diagnosis and allowing cost reduction by lowering the number of endoscopic procedures.
Moniuszko et al. (2017). Polish Archive of Internal Medicine. Vol. 127, no. 5, pp 312-318
Agreement between Home-Based Measurement of Stool Calprotectin and ELISA Results for Monitoring Inflammatory Bowel Disease Activity
Measurements of fecal levels of calprotectin made with home-based lateral flow method were in agreement with measurements made by Quantum Blue and ELISA, as long as concentrations were <500 μg/g. For patients with concentrations of fecal calprotectin above this level, findings from IBDoc should be confirmed by another method. (Netherlands Trial Registration Number: NTR5133).
Heida et al. (2017) Clinical Gastroenterology and Hepatology. Vol. 15, no 11, pp. 1742-1749
The Utility of Fecal Calprotectin in the Real-World Clinical Care of Patients with Inflammatory Bowel Disease
FCAL is a useful marker of disease activity and a valuable tool in managing persons with IBD in clinical practice. Clinicians have to be cautious in interpreting FCAL results in small bowel CD.
Abej et al. (2016) Canadian Journal of Gastroenterology and Hepatology
Faecal calprotectin correlates well with extent of active endoscopic inflammation in patients with ulcerative colitis
FC is reasonably accurate in predicting active disease location. This may be improved by adding clinical markers such as rectal bleeding and PMS. Pending larger studies validation, FC may be useful to direct topical vs systemic therapy in UC.
Chayut et al. (2016) Inflammatory Bowel Diseases. Congress abstract, P351
Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn’s disease patients on maintenance treatment with adalimumab
In CD patients on ADA maintenance therapy, FC levels measured with a rapid test allow relapse over the following months to be predicted with high accuracy. Low FC levels exclude relapse within at least 4 months after testing, whereas high levels are associated with relapse in three out of every four patients.
Rapid fecal calprotectin testing predicts mucosal healing better than C-reactive protein and serum tumor necrosis factor α in patients with ulcerative colitis
Rapid calprotectin testing is a better predictor of mucosal healing than serum biomarkers and it could improve the management of ulcerative colitis patients by decreasing the need for invasive investigations.
Voiosu et al. (2015) Romanian Journal of Internal Medicine. Vol. 53, no. 4
Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study
Fecal calprotectin and SIBDQ have good diagnostic accuracy in detecting mucosal inflammatory changes in IBD patients in clinical remission. Combining simple, non-invasive tests such as the SIBDQ and FC levels appears to be a practical method for monitoring disease activity in these patients, possibly reducing the need for repeat endoscopic examinations.
Voiosu et al. (2014) Journal of Gastrointestinal and Liver Disease. Vol. 23, no. 3, pp. 273-8
Concept for a rapid point-of-care calprotectin diagnostic test for diagnosis and disease activity monitoring in patients with inflammatory bowel disease: expert clinical opinion
As a sensitive biomarker of mucosal inflammation, fecal calprotectin could be used in a rapid point-of-care test to monitor disease activity in patients with IBD, and help reduce unnecessary specialist referrals and subsequent endoscopic investigations, which can be both uncomfortable and painful for the patient, and time-consuming and costly for health services.
Rogler et al. (2013) Journal of Crohn’s and Colitis. Vol. 7, pp. 670-7
Therapeutic Drug Monitoring of Infliximab and Mucosal Healing in Inflammatory Bowel Disease: A Prospective Study
Therapeutic drug monitoring of IFX strongly predicts the likelihood of achieving MH following IFX dose intensification in both CD and UC.
Paul et al. (2013) Inflammatory Bowe Disease. Vol 19, pp. 2568-76
A New Rapid Quantitative Test for Fecal Calprotectin Predicts Endoscopic Activity in Ulcerative Colitis
FC determine by QPOCT was an accurate surrogate marker of “endoscopic remissions” in UC and presented a good correlation with the FC-ELISA test.
Ortega et al. (2013) Inflammatory Bowel Disease. Vol. 0 pp. 1-9
Monoclonal antibody testing for fecal calprotectin is superior to polyclonal testing of fecal calprotectin and lactoferrin to identify organic intestinal disease in patients with abdominal discomfort
Monoclonal testing of calprotectin is superior to both polyclonal calprotectin testing and fecal lactoferrin in identifying symptomatic patients with organic intestinal disease.
A new rapid test for fecal calprotectin predicts endoscopic remission and postoperative recurrence in Crohn's disease
FC determined by rapid quantitative test predicts “endoscopic remission” and endoscopic postoperative recurrence in CD patients.
Lobatón et al. (2013) Journal of Crohn’s & Colitis. Vol. 12 pp. 641-51
A new rapid test for fecal calprotectin (FC) predicts mucosa healing in Crohn’s Disease (CD)
Fecal calprotectin predict MH more accurately than CRP and the rest of biomarkers. The good correlation between ELISA and this quantitative rapid test enables us to use the rapid one in order to take fast and adequate decisions.
A new rapid test for fecal calprotectin (FC) predicts mucosa healing in ulcerative colitis (UC)
Fecal calprotectin is an accurate biomarker of endoscopic activity/mucosa healing. A 250 µg/g cut-off of FC offers a high sensitivity and specificity to predict MH. The good correlation between ELISA and the new rapid quantitative test enables us to use in in order to take fast and adequate decisions.
Paediatrics
Fecal calprotectin levels in pediatric cow's milk protein allergy
The most prevalent food allergy in younger children is cow’s milk protein allergy (CMPA), and its most common clinical manifestation is allergic colitis. This study shows a significant decrease in FC levels and clinical symptoms when a strict elimination diet is adopted. Measuring FC levels to monitor the extent of intestinal inflammation caused by the allergen is proposed
Correlation of rapid point-of-care vs send-out fecal calprotectin monitoring in pediatric inflammatory bowel disease
In pediatric IBD patients, there is better correlation of between ELISA and POC calprotectin measurements at clinically meaningful, low-range levels. Future adoption of POC calprotectin testing in the United States may have utility for guiding clinical decision making in real time.
Rodriguez et al. (2017) World Journal of Gastrointestinal Pharmacology and Therapeutics
Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease
Based on high FCal, the majority of children had treatment escalation that resulted in clinical improvement. FCal measurements were useful and reliable in decision-making and clinical care of children with IBD.
Diagnostic Value of Fecal Calprotectin Point of Care Testing in the Paediatric Practice
Fecal calprotectin point of care testing is a useful screening tool to detect children with intestinal inflammation and to identify those requiring further endoscopic assessment. It is simple and has a good diagnostic performance comparable to the time-consuming ELISA assay.
Rapid fecal calprotectin (FC) analysis: point of care testing for diagnosing early necrotizing enterocolitis
We present the first data showing that rapid assay FC levels are potentially useful in the bedside diagnosis of NEC.
Bin-Nun et al. (2015) American Journal of perinatology. Vol 32, no. 4, pp. 337-42
Fecal calprotectin is a good biomarker of mucosal healing in monitoring of children with IBD
FC is a good biomarker of mucosal healing in monitoring of children with IBD. Values below 54 μg/g enable to select 77% patients with full mucosal healing.
Rapid Test for Fecal Calprotectin Levels in Children with Crohn Disease
Using a cut-off of 100 μg/g for normal values, the percentage agreement between the 2 tests was 87%. The optimal cut-off values to guide clinical decisions in the therapy of inflammatory bowel disease have yet to be determined.
Kolho et al. (2012) Journal of Pediatric gastroenterology and nutrition. Vol. 55, no. 4, pp. 436-439
Fecal calprotectin determination in preterm neonates: evaluation of two methods
FC values found in this preliminary cohort of preterm neonates have been similar to those reported in the literature. The finding of a good correlation between the two techniques suggests the potential clinical usefulness of Quantum Blue at this age group (after validation).
Gonçalves et al. (2011) Paediatric Research. Vol. 70, pp. 475
The Quantum Blue® Rapid Test for point of care quantitation of fecal calprotectin in paediatric patients
Qualitatively, the Quantum Blue® and ELISA results showed a very good diagnostic discrimination of IBD versus IBS in paediatric patients. This fast (within minutes) new test thus offers an accurate and useful tool in clinical settings and plans are being made to use it routinely in the paediatric department of the Hospital.
Other Applications
Pregnancy does not affect fecal calprotectin concentration in healthy women
Since FC levels remained unchanged during pregnancy, it may be a useful non-invasive diagnostic tool in pregnancy for monitoring mucosal inflammation.
Bálint et al. (2017) Turkish Journal of Gastroenterology. Vol. 28, no. 3, pp. 171-5
Synovial calprotectin a potential biomarker to exclude a prosthetic joint infection
Synovial calprotectin may be a valuable biomarker in the diagnosis of a PJI, especially in the exclusion of an infection. With a lateral flow immunoassay, a relatively rapid quantitative diagnosis can be made. The measurement is cheap and is easy to use.
Wouthuyzen-Bakker (2017) The Bone and Joint Journal. Vol. 99-B, no. 5
Fecal calprotectin is associated with disease activity in patients with ankylosing spondylitis
The results indicated that fecal calprotectin levels were associated with AS disease findings and activity parameters. Calprotectin is a vital disease activity biomarker for AS and may have an important role in the pathogenesis of the disease. Multi-cantered prospective studies are needed in order to provide further insight.
Duran et al. (2016) Bosnian Journal of Basic Medical Sciences. Vol 16, no. 1, pp. 71-74
Faecal calprotectin during treatment of severe infantile colic Lactobacillus reuteri DSM 17938: A Randomized, Double-Blind, Placebo-Controlled Trial
The administration of L. reuteri DSM 17938 significantly decreases crying time and fecal calprotectin level. Colicky infants have significantly higher calprotectin levels than healthy controls. Finally, fecal calprotectin assay after probiotic treatment with L. reuteri DSM 17938 can be used to predict sustained clinical response and monitor gut health in infants.
Fecal Occult Blood and Fecal Calprotectin as Point-of-Care Markers of Intestinal Morbidity in Ugandan Children with Schistosoma mansoni Infection
Due to its lower-cost which makes its scale-up of use affordable, FOB could be immediately adopted as a monitoring tool for PC campaigns for efficacy evaluation before and after treatment.