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

Noebauer, Britta; Ramic, Lejla; Konstantin, A Artemenko; Zachbauer, Christina; Einwallner, Elisa

doi:10.11613/bm.2017.030710

Cited by 9 publications

(10 citation statements)

References 23 publications

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“…In clinical practice, the fC enzyme‐linked immunosorbent assay (ELISA) remains the most often applied method for the quantification of fC. The PETIA which was used in our study, was shown to be equal compared to ELISA in several studies 39–41 …”

Section: Discussionmentioning

confidence: 68%

The Vampire Study: Significant elevation of faecal calprotectin in healthy volunteers after 300 ml blood ingestion mimicking upper gastrointestinal bleeding

et al. 2018

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Section: Discussionmentioning

confidence: 68%

The Vampire Study: Significant elevation of faecal calprotectin in healthy volunteers after 300 ml blood ingestion mimicking upper gastrointestinal bleeding

et al. 2018

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“…One European group has previously published their validation of the fCal Turbo assay under similar conditions [ 12 ]. Our results align closely with these previously published data.…”

Section: Discussionmentioning

confidence: 99%

Validation of the newly FDA-approved Buhlmann fCal Turbo assay for measurement of fecal calprotectin in a pediatric population

Garnett

Pagaduan

Rajapakshe

et al. 2020

Practical Laboratory Medicine

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Objectives Inflammatory bowel disease (IBD) is an increasingly prevalent disorder marked by chronic intestinal inflammation. Fecal calprotectin has emerged as a useful biomarker for differential diagnostics and monitoring IBD activity. We validated the newly FDA-approved fCal Turbo fecal calprotectin assay in our pediatric hospital. Design and methods The performance of the fCal Turbo assay was assessed on the Vitros 5600 analyzer (Ortho Clinical Diagnostics, USA), including limit of quantitation, linearity, precision, and interference studies. Method comparison was performed with 20 fecal samples with the Buhlmann fCal ELISA, and reference range verification was performed with 33 fecal samples. Results The fCal Turbo assay on the Vitros 5600 was linear between 33.1 and 14,182.5 μg/g, with dilution studies extending the range to 33.1–22,000 μg/g, Reproducibility of the assay met acceptability criteria, with intra-assay CV of 0.3–3.2% and inter-assay CV of 5.2–8.9%. Interference studies identified acceptable thresholds for protein, bilirubin, and lipids. We verified a reference range of 33.1–60 μg/g in our patient population. Deming regression identified acceptable correlation with minor positive bias (2.7%) between the fCal Turbo and fCal ELISA methods. Conclusions The fCal Turbo assay performs well on the Vitros 5600 analyzer in our patient population, with the assay being easy to use in our routine chemistry workflow. We anticipate that the fCal Turbo assay will be useful as a rapid screening method for differential diagnostics and disease monitoring of IBD in our patient population.

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“…In a Chinese cohort, the following median levels of FC in healthy children were reported, according to age: 12–24 months, 96.14 μg/g; 24–36 months, 81.48 μg/g; and 36–48 months, 65.36 μg/g [ 12 ]. This non-invasive test is useful for screening children with gastrointestinal symptoms to avoid unnecessary invasive procedures [ 15 ]. Our study shows that the prevalence of intestinal mucosal integrity disturbance in this cohort of presumed healthy children aged 1–3 years was 45.5% according to FC levels.…”

Section: Discussionmentioning

confidence: 99%

Effect of Supplementation of Zinc, Glutamine, Fiber, and Prebiotics in Presumed Healthy Indonesian Children Aged 1–3 Years

Kadim

Hegar

Bardosono

et al. 2020

Pediatr Gastroenterol Hepatol Nutr

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Purpose Impaired intestinal mucosal integrity may affect the gastrointestinal function, especially in relation to nutrition, absorption, and barrier function. The purpose of this study was to measure the prevalence of impaired intestinal mucosal integrity in presumed healthy children aged 1–3 years and assess the effects of zinc, glutamine, fiber, and prebiotic supplementation in them. Methods A cross-sectional study was conducted in 200 children aged 1–3 years in Pasar Minggu, South Jakarta, Indonesia. A randomized double-blind parallel group method clinical trial was then performed to assess the effects of zinc, glutamine, fiber, and prebiotic supplementation. Results Elevated calprotectin was found in 91/200 subjects (45.5%) at the onset of the study. After 10 months, 144 subjects completed the study: 72 subjects received the trial formula, whereas the other 72 received the standard formula. A transitory decrease in fecal calprotectin (FC) was observed after 6 months in the subgroup with normal FC levels, who were fed the test formula ( p =0.012). Conclusion The prevalence of impaired intestinal mucosal integrity in this group of Indonesian children aged 1–3 years was high. Supplementation with zinc, glutamine, fiber, and prebiotics during 6 months reduced FC only in those who had low levels at baseline but not in those with impaired integrity.

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

Cited by 9 publications

References 23 publications

The Vampire Study: Significant elevation of faecal calprotectin in healthy volunteers after 300 ml blood ingestion mimicking upper gastrointestinal bleeding

The Vampire Study: Significant elevation of faecal calprotectin in healthy volunteers after 300 ml blood ingestion mimicking upper gastrointestinal bleeding

Validation of the newly FDA-approved Buhlmann fCal Turbo assay for measurement of fecal calprotectin in a pediatric population

Effect of Supplementation of Zinc, Glutamine, Fiber, and Prebiotics in Presumed Healthy Indonesian Children Aged 1–3 Years

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