Quantum Blue®

QuantumBlue_publications
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.

Hui Won Jong et al. (2016) Korean Association for the Study of Intestinal Diseases. Vol 14, no. 4, pp 305-313
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.

 Kok et al. (2012) Clinical Chemistry. Vol. 58, no. 6
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.

 Wassell, et al. (2011) Annals of Clinical Biochemistry
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.

 Hui Won Jong et al. (2016) Korean Association for the Study of Intestinal Diseases. Vol 14, no. 4, pp 305-313
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.

 Hessels et al. (2012) Clinical Chemistry and Laboratory Medicine, Volume 50, Issue 6, Pages 1079–1082
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.

Vestergaard et al. (2008) Scand J Clin Lab Invest.
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.

Dolci et al. (2011) Clinic Chimica Acta, Volume 413
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.

 Ferreiro-Iglesias et al. (2015) Scandinavian Journal of Gastroenterology. Vol. 51, no. 4, pp. 442-447
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.

 Burri et al. (2013) Clinica Chimica Acta. Vol 416, pp 41-41
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 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.

 Ortega et al. (2012) European Crohn’s and Colitis Organisation. Presentation Poster, 2012 Congress Barcelona
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.

Ortega et al. (2012) European Crohn’s and Colitis Organisation. Presentation Poster, 2012 Congress Barcelona
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.

 El-Matary, et al. (2017) Frontiers in Paediatrics
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.

 Shentova et al. (2016) Merit Research Journal of Medicine and Medical Sciences. Vol. 4, no. 3, pp 169
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.

 Szczepański et al. (2014) Postępy Nauk Medycznych
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.

 Fellay et al. (2010) UEGW 18th United European Gastroenterology Week, Barcelona. Synopsis of talk, item number P0633, pp. 248
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.

 Savino et al. (2015) Paediatrics
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.

 Bustinduy, et al. (2013) PLOS Neglected Tropical Diseases
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.

 Wassell, et al. (2011) Annals of Clinical Biochemistry
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.

 Shentova et al. (2016) Merit Research Journal of Medicine and Medical Sciences. Vol. 4, no. 3, pp 169
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.

 Fellay et al. (2010) UEGW 18th United European Gastroenterology Week, Barcelona. Synopsis of talk, item number P0633, pp. 248
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.

Bustinduy, et al. (2013) PLOS Neglected Tropical Diseases 
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.

Dhanda et al. Poster at ECCO