Faecal Pancreatic Elastase – BÜHLMANN fPELA® turbo on cobas® c501

Dr. Jörg Oliver Thumfart, Labormedizinisches Zentrum Dr. Risch

The Medical Laboratory Center Dr. Risch is a privately owned group of routine medical laboratories with 14 competence centres across Switzerland and Liechtenstein. It was founded in 1970 by Dr. Gert Risch and is managed today by his sons, Lorenz and Martin Risch. Their core laboratories have held accreditation under ISO/IEC 17025:2017, since 1997.

Dr. Jörg Oliver Thumfart, FAMH Clinical Chemistry and Medical Microbiology is Head of Corelab at the company and has recently introduced the BÜHLMANN turbidimetric pancreatic elastase assay alongside the calprotectin assay.

“Before implementing the BÜHLMANN fPELA® turbo assay on the cobas® c501, we used a plate-based ELISA solution running on the DSX ELISA robot from Dynex. No major hurdles appeared during the transition process to the new pancreatic elastase assay provider. We started at an early phase when the new assay was not yet IVD certified. Therefore, only a limited amount of performance data was available. With the IVD CE registration of the product by BÜHLMANN in June 2020 this changed, and a comprehensive set of performance data is now available.

The BÜHLMANN fPELA® turbo offers a broader measuring range than the ELISA at the higher, normal pancreatic elastase levels, therefore many tested samples with non-pathological levels exceeded the ELISA measuring range and consequently could not be used for the quantitative method comparison.”

Read the Full Case Study from Dr. Jörg Oliver Thumfart Here