Evaluation of the BÜHLMANN fPELA® turbo Assay on the Beckman Coulter AU5822 Automated Chemistry Analyser
- The fPELA turbo assay evaluation was successful and employed into routine use in June 2024, without amendment to interpretation thresholds.
- Additional clinical advice has been provided with regards to the 20% positive bias with Creon, in these patients a higher threshold of >250 ug/g should be used to determine
pancreatic sufficiency. - Faeces is a heterogenous sample type which may explain some of the discrepant results seen e.g. EQA reports show 20-30% variation in results from the same method likely due to variations in sample transport, storage and extraction techniques. In addition studies quote within-person variation of up to 37%.
- The analysis of faecal elastase on-site has vastly improved the turnaround time and resulted in an overall cost-saving
H. Witham & N.J. Pullan Royal United Hospitals Bath LabMedUK25
Verification of an Automated Faecal Elastase Assay for Use in NHS Lanarkshire
The BÜHLMANN fPELA assay provides a suitable and robust alternative to the ScheBo® PE1 assay, offering advantages to the laboratory in being automated and benefiting patients served by NHS Lanarkshire, enabling the use of a single sample type, a CALEX® tube for measurement of both Fe-1 and FCal. Local implementation could improve access to the test, shorten turnaround times and reduce the environmental impact of Fe-1 measurement, by reducing both the use of disposable plastic and transportation
Verification of the BÜHLMANN Automated Elastase Assay on Abbott Alinity analysers
The BÜHLMANN fPELA® turbo assay for faecal elastase is acceptable for clinical use – it has acceptable precision and accuracy, and will reduce turnaround time and throughput in the laboratory.
Comparison of the Buhlmann Automated Elastase assay against the Schebo ELISA assay
The fPELA turbo assay on Abbott Alinity analysers is fit for use in the BCPS, with acceptable performance for patient comparison, accuracy, precision and stability over 7 days.
The fPELA assay was verified alongside the Buhlmann fCAL turbo assay, which also uses the CALEX® Cap extraction devices. This means that both calprotectin and elastase can be analysed using the same faecal extract, helping to further reduce the workload for staff.
Verification of the BÜHLMANN fPELA turbo faecal elastase assay on the Binding Site Optilite benchtop analyser
The Bühlmann fPELA turbo assay performs well on the Binding Site Optilite analyser. Faecal elastase results are commutable between with Bühlmann fPELA turbo and DiaSorin Liaison PE1 assays.
Handley S A et al. Annals of Clinical Biochemistry 2023 Jan;60(1):68-71
