Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease

Sloovere, Maxime M W De; Smet, Dieter De; Baert, Filip; Debrabandere, Johan; Vanpoucke, Hilde

doi:10.1515/cclm-2016-0796

Cited by 29 publications

(27 citation statements)

References 22 publications

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“…However, it is a semi-quantitative assay with a limited measurement range ( 21 ). In agreement with recent literature, the fully automated FC analysis methods turn out to be the future in routine laboratory work, as they unite short turnaround times, single sample investigation, easy as well as fast handling, a high measuring range and cost-effectiveness ( 12 , 20 , 22 ).…”

Section: Discussionsupporting

confidence: 82%

Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting

et al. 2017

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IntroductionFaecal calprotectin (FC) is a routinely used marker for identifying and monitoring children with inflammatory bowel disease (IBD). This non-invasive test is useful for screening children with gastrointestinal symptoms to avoid unnecessary invasive procedures. In this study, we validated for the first time the performance of a fully automated particle-enhanced turbidimetric immunoassay (PETIA) on the VITROS® 5600 analyzer for measurement of FC in symptomatic children and adolescents.Materials and methodsFor performance validation of the PETIA (fCAL® turbo, Bühlmann Laboratories, Switzerland) on the VITROS® 5600 analyzer (Ortho Clinical Diagnostics, USA) limit of quantitation (LoQ), linearity, precision data and calibration curve stability were defined. Additionally, 95 faecal samples were measured using the PETIA, an enzyme-linked immunosorbent assay (ELISA; fCAL®, Bühlmann Laboratories, Switzerland) and a semi-quantitative lateral flow assay (Quantum Blue Reader®, Bühlmann Laboratories, Switzerland) for agreement evaluation.ResultsThe LoQ for calprotectin using PETIA on the VITROS® 5600 analyzer was 21 µg/g. The linearity range was 20 - 2100 µg/g and the precision study showed a total coefficient of variation (CV) between 2.3% and 8.9%. The calibration curve was stable for 4 weeks. Using the clinical samples quantifiable by PETIA, ELISA and the semi-quantitative lateral flow assay, Passing-Bablok regression analysis and Bland-Altman plots showed good agreement.ConclusionsDue to good performance characteristics and agreement with established methods, the fully automated PETIA on the routine chemistry analyzer VITROS® 5600 is a new analytical option for the rapid determination of FC.

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Section: Discussionsupporting

confidence: 82%

Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting

et al. 2017

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“…Four assays (PhiCal, EK-CAL, Quantum-Blue and EliA) with five or more studies each could be considered in the comparison (online supplementary 8 for 2×2 data). Nineteen studies contributed data 10 24–41. Five studies10 25 31 39 40 contributed data to two different assays.…”

Section: Resultsmentioning

confidence: 99%

“…All reported 2×2 data (online supplementary 9) for the clinical questions IBD versus IBS, IBD versus non-IBD and organic versus non-organic disease were considered in the meta-analysis investigating the effects of the different clinical questions on summary estimates of test accuracy under the assumption that the test is generic. Twenty-eight studies were included at the common threshold of 50 µg/g 10 24–50. A total of 10 studies30 32 34 36 37 43 45–48 contributed information to more than one category.…”

Section: Resultsmentioning

confidence: 99%

Faecal calprotectin to detect inflammatory bowel disease: a systematic review and exploratory meta-analysis of test accuracy

et al. 2019

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ObjectiveTest accuracy of faecal calprotectin (FC) testing in primary care is inconclusive. We aimed to assess the test accuracy of FC testing in primary care and compare it to secondary care estimates for the detection of inflammatory bowel disease (IBD).MethodsSystematic review and meta-analysis of test accuracy using a bivariate random effects model. We searched MEDLINE, EMBASE, Cochrane Library and Web of Science until 31 May 2017 and included studies from auto alerts up until 31 January 2018. Eligible studies measured FC levels in stool samples to detect IBD in adult patients with chronic (at least 6–8 weeks) abdominal symptoms in primary or secondary care. Risk of bias and applicability were assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 criteria. We followed the protocol registered as PROSPERO CRD 42012003287.Results38 out of 2168 studies were eligible including five from primary care. Comparison of test accuracy by setting was precluded by extensive heterogeneity. Overall, summary estimates of sensitivity and specificity were not recorded. At a threshold of 50 µg/g, sensitivity from separate meta-analysis of four assay types ranged from 0.85 (95% CI 0.75 to 0.92) to 0.94 (95% CI 0.75 to 0.90) and specificity from 0.67 (95% CI 0.56 to 0.76) to 0.88 (95% CI 0.77 to 0.94). Across three different definitions of disease, sensitivity ranged from 0.80 (95% CI 0.76 to 0.84) to 0.97 (95% CI 0.91 to 0.99) and specificity from 0.67 (95% CI 0.58 to 0.75) to 0.76 (95% CI 0.66 to 0.84). Sensitivity appears to be lower in primary care and is further reduced at a revised threshold of 100 µg/g.ConclusionsConclusive estimates of sensitivity and specificity of FC testing in primary care for the detection of IBD are still missing. There is insufficient evidence in the published literature to support the decision to introduce FC testing in primary care. Studies evaluating FC testing in an appropriate primary care setting are needed.

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“…There are no generally accepted calibrators for calprotectin, for either blood or faeces. Method comparisons show that there are clear calibration differences between F‐calprotectin assays from different manufacturers . These differences make it difficult to interpret test results, as the physician must be aware of the calibration of the method used, to correctly evaluate the test results.…”

Section: Introductionmentioning

confidence: 99%

“…Health Science Reports published by Wiley Periodicals, Inc. different manufacturers. 16 These differences make it difficult to interpret test results, as the physician must be aware of the calibration of the method used, to correctly evaluate the test results. If this is not considered, there is a risk that the results are misinterpreted and the patients get the wrong treatment.…”

Section: Introductionmentioning

confidence: 99%

Extraction, isolation, and concentration of calprotectin antigen (S100A8/S100A9) from granulocytes

Nilsen

Haugen

Larsson

2018

Health Science Reports

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Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease

Abstract: In conclusion, the newly developed stool extraction device protocols showed acceptable and comparable performance to the stool weight method. Overall, the automated Liaison® Calprotectin and fCAL™ turbo assay showed good analytical and diagnostic performance for detection of IBD.

Cited by 29 publications

References 22 publications

Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting

Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting

Faecal calprotectin to detect inflammatory bowel disease: a systematic review and exploratory meta-analysis of test accuracy

Extraction, isolation, and concentration of calprotectin antigen (S100A8/S100A9) from granulocytes

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