For more information please visit: www.alphalabs.co.uk/CALEX-pack Stability within CALEX Once the sample is in the CALEX it is stable at ambient for 7 days, giving sufficient time for the return of the sample by the patient to the laboratory. This reduces the variable degradation seen in the untreated stool samples, enablingmore consistent reporting. If the lab doesn’t want to test the CALEX immediately upon receipt, if stored at 2-8C, it is stable for 15 days. Using the CALEX gives more consistent results and the flexibility for laboratories to follow practices that best suit their work load. Consistent Results The result obtained from the patient using the CALEX, compared to sending in a stool sample into the lab for extraction will be different. This has long been the case with use of the IBDoc® calprotectin home test, for IBD positive patients, compared to the lab result. The calprotectin results are generally higher with the patient prepared sample compared to the lab prepared sample. This is to be expected with the CALEX as well, as was shown in the article from H. Bruce et al2. This highlights the impact of the immediate stabilisation of the calprotectin in the buffer compared to the variable degradation of the calprotectin in a stool pot whilst in transit to the lab. However, the general interpretation doesn’t alter greatly as is shown in the table below from the same publication: Compliance and Acceptance Compliance, or more accurately the cost of non-compliance, is another big consideration when considering the introduction of patient calprotectin extraction kits. Lanarkshire NHS introduced CALEX to patients during COVID because of a lack of access to extraction hoods for sample preparation within the laboratory. They conducted an audit that we reported in the 2022 Leading Edge issue 13 and they found a 95% compliance: Of the samples that were returned to the laboratory, 94% Analysis of CALEX Tubes Returned July-Dec 2021 94% Samples analysed 3% Unlabelled 2% Low fluid level 1% Other 95% Return rate were able to be analysed, (3% were unlabelled, 2% had low fluid level and 1% were spoiled). Considering this was using a trial kit and process, these results are extremely encouraging. Giving the CALEX to patients to prepare and send back to the laboratory worked well for the laboratory and a subsequent survey by Dr A Hart that was published at UKMedLab 20234 confirmed that there was a high level of acceptance around using the CALEX and that patients found it easy to use: Patients also seemed confident that they had prepared the CALEX correctly and where they had previous experience of using the stool pot, actually preferred using the CALEX. There are a large number of hospitals looking to implement the CALEX to patients process to gain efficiencies. Having a ready to use, UKCA marked, standardised patient pack available with clear instructions will make this significantly easier than laboratories having to prepare kits themselves. References: 1. Lasson et al. (Journal of Crohns & Colitis 2014): The Intra-Individual Variability of Faecal Calprotectin: A Prospective Study In Patients With Active Ulcerative Colitis 2. H. Bruce et al2 (Annuals of Clinical Biochemistry 2023): Comparison of faecal calprotectin using two collection & extraction strategies for the BUHLMANN CALEX cap 3. Jacqui McGuire et al: Outsourcing Calprotectin stool pre-analytics to the patients home 4. Dr A Hart, UKMedLab 2023: Evaluating the service user experience of CALEX® cap devices as a faecal sample collection method for calprotectin testing: a local audit www.alphalabs.co.uk © 2024 Copyright Alpha Laboratories Ltd. 3
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