Quantum Blue®

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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 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.

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.

Therapeutic drug monitoring of IFX strongly predicts the likelihood of achieving MH following IFX dose intensification in both CD and UC.

FC determine by QPOCT was an accurate surrogate marker of “endoscopic remissions” in UC and presented a good correlation with the FC-ELISA test.

Monoclonal testing of calprotectin is superior to both polyclonal calprotectin testing and fecal lactoferrin in identifying symptomatic patients with organic intestinal disease.

FC determined by rapid quantitative test predicts “endoscopic remission” and endoscopic postoperative recurrence in CD patients.

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.

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.

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

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.

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.

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.

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).

FC from the ileostomy output is a valuable biomarker with high sensitivity and specificity for monitoring small bowel inflammation in post operative patients with CD

Since FC levels remained unchanged during pregnancy, it may be a useful non-invasive diagnostic tool in pregnancy for monitoring mucosal inflammation.

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.

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.

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.