Handley, SA and Dote, N and Wanandy, T and Prentice, L, Verification of the Buhlmann fPELA turbo faecal elastase assay on the Binding Site Optilite benchtop analyser, Annals of Clinical Biochemistry, 60, (1) pp. 68-71. ISSN 1758-1001 (2022) [Refereed Article]
Background: Pancreatic elastase-1 (PE1) can be measured to assess exocrine activity of the pancreas. A semi-automated particle-enhanced, open-channel turbidimetric immunoassay has been introduced by Bühlmann (fPELA turbo, Bühlmann Laboratories AG, Schoenenbuch, Switzerland). Published evaluation data is lacking. We therefore verified performance of the assay on the Binding Site Optilite benchtop analyser and undertook a sample comparison with the DiaSorin PE1 assay on the Liaison.
Methods: Accuracy, imprecision, lower limit of quantitation (LLoQ) and linearity of the Bühlmann fPELA turbo assay on the Binding Site Optilite analyser was ascertained. Comparison with the DiaSorin Liaison PE1 assay was also undertaken. Difference between assays was evaluated using the Wilcoxon signed-rank test and method comparison was undertaken using Spearmans rank correlation (rs), BlandAltman and PassingBablok regression analyses.
Results: The fPELA turbo assay was linear between 5 and 2500 μg/g. The LLoQ was 5 µg/g. Intra- and inter-assay imprecision was <6%. There was a good agreement (rs = 0.92) and no significant bias (5.8 µg/g, P = 0.29) present between the Bühlmann fPELA turbo and DiaSorin PE1 assays.
Conclusions: 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.
|Item Type:||Refereed Article|
|Keywords:||elastase, pancreatic insufficiency, immunoassay|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Clinical sciences|
|Research Field:||Pathology (excl. oral pathology)|
|Objective Group:||Other health|
|Objective Field:||Other health not elsewhere classified|
|UTAS Author:||Handley, SA (Dr Simon Handley)|
|UTAS Author:||Dote, N (Mr Nikko Dote)|
|UTAS Author:||Wanandy, T (Mr Troy Wanandy)|
|UTAS Author:||Prentice, L (Dr Louise Prentice)|
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