6 LEADING EDGE - 2022-1 NHS Lanarkshire, to the east of Glasgow, is the third largest NHS Health Board in Scotland. It serves 655,000 people at the Hairmyres, Wishaw and Monklands Hospitals. Faecal calprotectin testing for the diagnosis and monitoring of inflammatory bowel diseases is conducted at the Monklands Hospital. Jacqui McGuire and Neil Syme, Consultant Clinical Biochemists from the Biochemistry Department at Monklands explain how their testing has evolved over recent years. “We perform around 400 faecal calprotectin tests a month across NHS Lanarkshire. Initially, when we first introduced the assay we used the BÜHLMANN fCAL® ELISA and CALEX extraction device, running the assays on a Dynex DS2 ELISA processor. As the volume of tests increased we switched to the BÜHLMANN fCAL® turbo assay on our Roche platform, in the spring of 2021. Since we were already using the CALEX® extraction method, this transferred to the turbo assays, retaining consistency and benefiting from the much easier work flow with the turbo method. Challenges of the Pandemic With the onset of COVID we were faced with a number of challenges to our testing processes. With concern regarding the risk of infection from stool samples, we didn’t have adequate access to bio-safety cabinets to handle our patient samples for the extraction process. The only way we could continue the service was if the patients could take their own samples directly in the CALEX devices. So, we implemented a process to outsource the calprotectin pre-analytical sample collection and preparation to the patients at home. We don’t offer faecal calprotectin in a primary care setting, so samples tend to just be from secondary care for monitoring purposes. We had discussions with the clinical team and recognised that the CALEX direct sample collection process is really very similar to that for the faecal immunochemical test (FIT) sample pickers used for bowel cancer screening and symptomatic testing. Since patients currently do this themselves very successfully, there was no resistance to rolling out a similar format for calprotectin testing. CALEX Stability The only real issue we had was the stability of the CALEX tubes when stored at ambient temperature, because the clinic doesn’t have enough capacity to store them in the fridge. When the process was initially established, the information we had was that the CALEX was stable at ambient for 3 months. So, we add an expiry date label to the tubes when they are issued to the clinic, so that this can be monitored on their return. The clinic are dispensing the CALEX devices and a specific instructions for use (IFU) document is supplied to the patients when a test is required. In the main this is by post but if the patient is coming into clinic for a face to face appointment, then they are being issued with the CALEX then. We ask for the patient demographic label to be applied to the tube when it is sent out and we re-label with a barcode when they are returned. Going forward this will be replaced by an ordercoms label when that is implemented. Once the sample has been collected the patients drop the CALEX back at their GP and it is brought to Wishaw Hospital to be sorted and separated from all the other samples, before being sent across to the Monklands Hospital. The CALEX tubes are checked for the ambient expiry date, and the level of buffer in the tubes, stored in the fridge and batches of tests are then run two to three times a week. Outsourcing Calprotectin Stool Pre-analytics to the Patient’s Home Jacqui McGuire and Neil Syme, Consultant Clinical Biochemists, Department of Biochemistry, Monklands Hospital
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