Leading Edge 2022 Issue 2

4 LEADING EDGE - 2022-2 A Game Changer for Faecal Elastase Testing Switching to the new fPELA turbo assay for improved workflow and efficiency Kaleem Fayyaz, Blood Sciences Team Leader, Spire Manchester Hospital Spire Healthcare is a leading UK independent hospital group. It delivers high standards of care to insured, self-pay and NHS patients across 39 hospitals and 8 clinics. The laboratories at Spire Manchester Hospital provide the faecal testing services for the entire Spire group. The team there has recently switched its pancreatic elastase testing from an ELISA format to the new turbidimetric fPELA assay from BÜHLMANN. Kaleem Fayaaz, who is the blood sciences team leader at Spire Manchester, tells us about their assay transition: We test quite a large volume of samples for faecal elastase, receiving around 8-10 samples every day. These are mainly referred due to a ‘change of bowel habit’ in the clinical symptoms. The lab in Manchester performs all the testing for the entire Spire network, so all samples are referred to us. We also have a contract with an NHS Trust for all their elastase testing, so together this equates to around 3500 tests a year. However, this is increasing. Previously we were using the R-Biopharm (BioServ) ELISA method for pancreatic elastases on our Triturus analyser. This was run on Monday, Wednesday and Friday due to the requirement to batch samples for the ELISA plates and the fact that we could only get 50 samples on the carousel. Why Change? The main reason we looked to change the elastase assay format was the EQA performance. We had seen a a strong negative bias with the ELISA. We did lots of root cause analysis and had repeat samples from NEQAS, but the bias seemed to be with the method and since we were unable to resolve it this was obviously quite a concern. The second reason was the time - the ELISA method took about 3 hours depending on the number of samples within the batch. After 3 hours you didn’t know if the results would be okay because the calibrators and controls all ran at the same time. If something was wrong you would have to repeat the batch again. This was very difficult to resource and caused a delay in reporting. We did consider switching the elastase to an alternative ELISA method. However, simultaneously we were also investigating switching from the BÜHLMANN fCAL® ELISA to the BÜHLMANN fCAL turbo to be run on our Roche c501. With all the workflow benefits that would bring, it just made sense to do the same with the elastase and move straight to the BÜHLMANN fPELA turbo, when we needed to change anyway. Assay Verification The whole process of verifying the fPELA on the Roche platform was really good. All the supporting information that we needed was provided promptly and the relationship that we have with the Alpha Laboratories’ product and key account managers is really supportive. All our questions or issues were resolved quickly. Game Changer Overall, the transfer to the fPELA was really easy, simple and effective. The fact that you can get a result in 10 minutes is fantastic. This is interesting because initially we didn’t really think about this as a real benefit. But it is great in terms of the laboratory workflow and the service we are able to provide – it really is worlds apart from the ELISA method. For the staff that have been used to the ELISA method they really see the BUHLMANN fPELA as a game changer. Once we had completed the lab validation we sent out a communication to all our users, and everyone has been really pleased because the turn around time is now much quicker. The assay workflow is so much easier. It allows us to run the test daily, even over the weekend – that is how easy it is to run; it really is turbo! We went live with the fPELA in February 2022 and there really have been no issues – the calibrations and controls have always been spot on It really has been great. The extractions are done first thing in the morning by the MLAs and we run the QCs whilst everything is being prepared. The staff that do the extractions find the process much easier with the CALEX compared to the previous method, so they are delighted. When the samples are ready, the tests are loaded onto the analyser and you have results coming off within 10 minutes. So a batch of 30 samples is completed in about 20 minutes. They are authorised, and the results are out within 30 minutes. At the moment we probably only get about 5-10% of samples with requests for both calprotectin and elastase tests. However, this may be a communication issue whereby the clinical staff don’t realise that they can now request both tests from a single sample. „ The fact that you can get a result in 10 minutes is fantastic“