Evaluation and implementation of the BÜHLMANN fCAL® turbo assay and CALEX® extraction tubes on the Abbott Alinity C
The BÜHLMANN fCAL® turbo method demonstrates acceptable performance on the Alinity C using intra and inter-assay imprecision. Correlation of the two methods using patient samples did not meet the acceptance criteria. Discrepancy would be expected when comparing BÜHLMANN fCAL® method to the Alegria® due to different methodologies. In addition the sample type has great variability as calprotectin in not evenly distributed throughout the stool sample and it is not possible to ‘pick’ the exact same location for comparison3. Results obtained from EQA regression analysis showed satisfactory assay performance. Due to the higher number of Alinity C users in the EQA scheme the decision was taken to move to the BÜHLMANN fCAL® method to improve performance monitoring.
Evaluation of the BÜHLMANN fCAL® TURBO Assay on the Beckman Coulter AU5822 Automated Chemistry Analyser
The fCAL TURBO evaluation was successful and employed into routine use in February 2024, without amendment to interpretation thresholds. This is a more robust assay, with an increased measuring range (20 to 2000 ug/g on TURBO vs 10 – 600 ug/g on ELISA), improved accuracy (based on EQA results) and precision. The higher upper reportable limit on the fCAL TURBO assay (without the need for sample dilution) was in particular recognised as a significant improvement by the Gastroenterology team for monitoring and tailoring treatment of patients with known IBD.
Evaluation of the BÜHLMANN fCAL® turbo assay on the Abbott Architect C8000
The CALEX® cap extraction devices and fCAL turbo® method on the Abbott Architect C8000 analyser, demonstrate good comparability with other established methods, with no significant interference with other chemistries and have led to improved workflow for faecal calprotectin analysis
EVALUATION OF THE WORKFLOW IMPACT FOLLOWING THE INTRODUCTION OF A TURBIDIMETRIC METHOD FOR CALPROTECTIN MEASUREMENT FROM FECES
The fecal marker calprotectin derived from neutrophilic granulocytes is increasingly used in the diagnosis and monitoring of patients suffering from chronic inflammatory bowel diseases. The increasing amount of this analysis is a challenge in the routine laboratory and urgently ask for enhanced automation.
Cerutti F. et al. (2018) GERMAN CONGRESS FOR LABORATORY MEDICINE (DGKL)
Verification and implementation of faecal calprotectin using the BÜHLMANN fCAL® turbo assay
Here we demonstrate the BÜHLMANN fCAL® turbo assay on the Abbott ARCHITECT platform is fit for purpose and we have recently received UKAS accreditation for this assay. Close collaboration with our Gastroenterology team has enabled us to provide a new IBS local pathway for primary care to follow.
The way to total automation of calprotectin measurement in faeces with Bühlmann fCAL® turbo
The preparation of stool specimens for Calprotectin determination with CALEX® and the analysis with the new fCAL turbo on the Cobas® c501 module (Roche Diagnostics) is practically a fully automated testing procedure.
Evaluation of the BÜHLMANN fCAL Turbo Calprotectin Method on the Roche Cobas 6000 (c501)
The BÜHLMANN fCAL™ turbo method demonstrates acceptable performance. The positive bias at higher concentrations is accounted for in local guidelines. A commutable reference material for calprotectin is required to define analytical accuracy in the future.
BÜHLMANN fCAL® turbo Faecal Calprotectin Assay on Abbott Architect C8000
The fCAL turbo is very adaptable and suited for rapid analysis on the Abbott Architect C8000 Clinical Chemistry Analyser with no interference to any of the other chemistries.
Analytical Performance of a Fecal CALPROTECIN (fCAL) PETIA Test
The new latex turbidimetric procedure for determining calprotectin is an attractive alternative to ELISA allowing random access and full automation of fecal calprotectin quantitation. Moreover, it represents an accurate and precise method to determine calprotectin levels in fecal extracts in a measuring range from 15 to 10’000 µg/g.
Publications
Evaluation of the BÜHLMANN fCAL Turbo Faecal Calprotectin Assay on the Abbott Architect C8000. Comparison to the Phadia EliA and the IBDoc® home test kit
fCAL turbo is very adaptable to the Abbott Architect C8000 analyser. The CALEX ® cap extraction devices are easy to use and practical. Inter-assay variability demonstrated, and recommends users to participate in the UK NEQAS Scheme . No interference to any of the other chemistries.
Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease
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.