Fecal Calprotectin: A Comparison of Two Commercial Enzymoimmunoassays and Study of Fecal Extract Stability at Room Temperature

Acevedo, Delia; Salvador, Maria Pilar; Girbés, Javier; Estáñ, Nuria

doi:10.14740/jocmr3275e

Cited by 18 publications

(14 citation statements)

References 36 publications

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“…This underlines the necessity of kit-specific cut-off values. A similar conclusion must be drawn from similar studies demonstrating highly different cut-off values [17,18,22]…”

Section: Discussionsupporting

confidence: 58%

Head to head comparison of two commercial fecal calprotectin kits as predictor of Mayo endoscopic sub-score and mucosal TNF expression in ulcerative colitis

Goll¹,

Heitmann²,

Moe³

et al. 2019

PLoS ONE

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BackgroundFecal calprotectin is widely used to monitor disease activity in patients with inflammatory bowel disease. Multiple commercial kits exist, however, since the analyses are not standardized, these kits cannot be used interchangeably. We aimed to perform a technical evaluation of two kits (Calpro from Calprolab, Norway and Calprest from Eurospital, Italy) and perform a tuning for detection of clinically relevant disease states in ulcerative colitis.Materials and methodsFor tuning against different clinical states a total of 116 patients with ulcerative colitis were recruited (67 of which were part of an earlier publication). For the technical evaluation an additional series of 80 random samples from the hospital lab were included. Technical evaluation was done by correlation and limits of agreement analysis; cut-off levels were explored by ROC analysis against clinically relevant actual states.ResultsThe technical evaluation revealed good correlation between assays, however a non-linear difference was found: At values below 200 mg/kg, no significant bias was found; in the interval 200–1000 mg/kg the Calprest assay measured on average 30% lower than Calpro; and at higher values Calprest measured 60% higher values than Calpro. Both assays predicted Mayo endoscopic score (MES) 0 (cutoff 28: sensitivity 0.38; specificity 0.82 for Calprest; cutoff 28: sensitivity 0.50; specificity 0.77 for Calpro), and MES 2–3 (cutoff 148: sensitivity 0.72; specificity 0.80 for Calprest; cutoff 208: sensitivity 0.64; specificity 0.80 for Calpro), but did not predict normalization of mucosal TNF transcript per se. A combination of calprotectin and MES predicted mucosal TNF transcript values reasonably well (Calpro: sensitivity 0.85, specificity 0.58; Calprest: sensitivity 0.85, specificity 0.61).ConclusionThe Calpro and Calprest assays correlated well, but subtle differences were found, underlining the need for kit-specific cut-off values. Both kits were most precise in predicting active inflammation (MES 2–3), but less so for prediction of mucosal healing (MES 0) and normalization of mucosal TNF gene expression.

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“…This underlines the necessity of kit-specific cut-off values. A similar conclusion must be drawn from similar studies demonstrating highly different cut-off values [17,18,22]…”

Section: Discussionsupporting

confidence: 58%

Head to head comparison of two commercial fecal calprotectin kits as predictor of Mayo endoscopic sub-score and mucosal TNF expression in ulcerative colitis

Goll¹,

Heitmann²,

Moe³

et al. 2019

PLoS ONE

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“…A Swedish group observed a decline in calprotectin when stool samples were stored at room temperature for 7 days but claimed that the concentration remained unchanged in the first 3 days after collection 4. A Spanish group claimed that calprotectin remained stable in stool extracts stored at room temperature for 4 days,5 as opposed to our finding that extraction does not prevent a decline.…”

Section: Discussioncontrasting

confidence: 68%

Calprotectin instability may lead to undertreatment in children with IBD

et al. 2019

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BackgroundTreatment decisions in children with inflammatory bowel disease (IBD) are increasingly based on longitudinal tracking of faecal calprotectin concentrations, but there is little known about the stability of this protein in stool.MethodsWe stored aliquots of homogenised stool at room temperature and at 4°C, and measured the calprotectin concentration for 6 consecutive days with three different assays. In addition, we assessed calprotectin stability in assay-specific extraction buffers kept at room temperature.ResultsAfter 6 days of storage at room temperature, mean percentage change from baseline calprotectin concentrations in stool and extraction buffer was 35% and 46%, respectively. The stability of calprotectin was significantly better preserved in samples stored at 4°C (p=0.0066 and 0.0011, respectively).ConclusionsCalprotectin is not stable at room temperature. Children with IBD and their caretakers may be falsely reassured by low calprotectin values. The best advisable standard for preanalytical calprotectin handling is refrigeration of the stool sample until delivery at the hospital laboratory.

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“…S100 proteins are remarkably resistant to degradation by fecal bacteria, making them suitable markers for gut wall inflammation. 9 …”

mentioning

confidence: 99%

Clinical Performance of a Novel LIAISON Fecal Calprotectin Assay for Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

Campbell

Zierold

Rode

et al. 2020

Journal of Clinical Gastroenterology

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Goal: The goal of this study was to assess the clinical performance of an investigational in vitro fecal calprotectin immunoassay for differentiating inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS). Background: Fecal calprotectin is a stool biomarker that can assist in the detection of intestinal inflammation and is utilized to identify individuals who have a higher chance of having IBD and who require further invasive tests. Current assays exhibit variable performance. Materials and Methods: This study was a multicenter, cross-sectional analysis of prospectively collected stool samples from patients 4 years of age or older who presented with gastrointestinal (GI) symptoms and underwent colonoscopy for diagnostic confirmation. IBD was diagnosed based on clinical, endoscopic, and histologic findings. IBS was diagnosed based on Rome III Criteria and negative colonoscopy. Stool samples were extracted and tested on the DiaSorin LIAISON XL using the LIAISON Calprotectin Assay. Results: A total of 240 patients (67% female) were included in the study. In total, 102 patients had IBD (54% ulcerative colitis), 67 had IBS, and 71 had other GI disorders. Median fecal calprotectin levels were significantly higher in patients with IBD [522 μg/g; 95% confidence interval (CI): 354-970 μg/g] compared with IBS (34.5 μg/g; 95% CI: 19.7-44.2 μg/g, P <0.001) and other GI disorders (28.6 μg/g; 95% CI: 18.7-40.3 μg/g, P <0.001). Receiver operating characteristic curve analysis indicated a fecal calprotectin cutoff of 94 μg/g for distinguishing IBD from other GI disorders with an area under the curve of 0.964 (sensitivity=92.2%, specificity=88.4%). Conclusion: The automated LIAISON Calprotectin assay brings efficient calprotectin testing to the laboratory with a time to the first result of 35 minutes and is a sensitive marker for distinguishing IBD from IBS with a cutoff of ∼100 μg/g.

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Fecal Calprotectin: A Comparison of Two Commercial Enzymoimmunoassays and Study of Fecal Extract Stability at Room Temperature

Cited by 18 publications

References 36 publications

Head to head comparison of two commercial fecal calprotectin kits as predictor of Mayo endoscopic sub-score and mucosal TNF expression in ulcerative colitis

Head to head comparison of two commercial fecal calprotectin kits as predictor of Mayo endoscopic sub-score and mucosal TNF expression in ulcerative colitis

Calprotectin instability may lead to undertreatment in children with IBD

Clinical Performance of a Novel LIAISON Fecal Calprotectin Assay for Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

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