Gastroenterology Today Winter 2022

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ADVERTORIAL FEATURE WORKING TOWARDS QUALITY STANDARDISATION FOR FAECAL IMMUNOCHEMICAL TESTING Alpha Laboratories recently held a FIT user group meeting that was attended by some of the leading laboratories who utilise the HM-JACKarc technology for their faecal immunochemical testing service. Key speakers discussed their challenges and contributions towards standardisation and quality in FIT testing. So far, work has been completed to establish the current status of four automated FIT systems (5): HM-JACKarc (Minaris Medical Co. Ltd, Japan): OC-Sensor PLEDIA (Eiken Chemical Co. Ltd, Japan); SENTiFIT 270 (Sentinel Diagnostics, Italy), NS-Prime (Alfresa Pharma, Japan); data show that all analysers met manufacturers’ claims. GASTROENTEROLOGY TODAY - WINTER 2022 6 FIT Quality Assurance Carolyn Piggott, FIBMS, Research Scientist, Bowel Cancer Screening Programme (BCSP), Southern Hub, Guildford Carolyn Piggott presented on the factors that contribute towards the pre-analytical and laboratory challenges faced in FIT testing. The major contributors are the differences in faecal samples, inconsistent sampling by participants and haemoglobin (Hb) stability in faeces. In addition to sample variability, there is no FIT assay standardisation. Different reagents are used between each manufacturer and there is no primary reference materials of methodologies. The lack of standardisation or harmonisation of FIT means that variations are observed in f-Hb results generated on different systems. Carolyn mentioned a range of approaches to tackle these challenges. One development is that manufacturers have developed new buffers focused on improved sample stability. Also projects are being undertaken at BCSP Guildford, which include evaluation of the available EQA (1), third party internal QC (2) and the effect of Hb-variants (3). In addition, they are working in conjunction with the IFCC FIT Working group, established in 2017, to formally address the challenges (representatives from other manufacturers, clinical scientists, and representatives from EQA companies) according to the references below(4): Terms of Reference • To attempt to standardise analysis of haemoglobin in faecal samples by immunochemistry (FIT) • To identify all sources of pre-analytical variation and standardise if possible • To establish external quality assurance and third-party internal quality control programmes • To determine impact of assay interference of Hb variants and other factors Additionally, EQA programmes investigated types and imprecision of EQAS available worldwide. 13 manufacturers of EQA were identified and 11 agreed to take part, to either provide: faecal-like material loaded by participants (UK NEQAS and HECTEF, Japan), faecal-like material loaded by EQA provider (WEQAS and CEQAL, Canada), or aqueous material loaded directly onto the analysers in cups (CRB, Italy, ESFEQA, Germany, Labquality, Finland, SEKK, Czech Republic, SEQC, Spain, SKML, Netherlands). Results showed that faecal-like matrices have larger coefficient of variant (CVs), and liquid materials have smaller CVs. Carolyn also reported on the evaluation of QC material from each FIT manufacturer, measured on the other three analysers, and the CVs were overall
ADVERTORIAL FEATURE Current Status and Future Plans for the UK NEQAS for Faecal Haemoglobin Finlay MacKenzie, Director of Birmingham Quality, an NHS Department within University Hospitals Birmingham Finlay defined External Quality Assessment as a retrospective assessment of quality – ‘EQA is an independent assessment of quality and is an essential component of an accredited laboratory’s governance system and assesses the performance of in-vitro diagnostic examination procedures.’ Part of the role of EQA is to assess the stability of diagnostic tests over time, this includes the Alpha Laboratories’ HM-JACKarc system, in comparison to other faecal haemoglobin (f-Hb) detection systems that are available. EQA aims to send representative patient samples to a network of national laboratories. Finlay shared his observations on the variations associated with differing f-Hb cut-offs between the National Screening Hubs and how critical it is to ensure homogeneity of a specimen for true representation. He shared his concerns about the large differences in numerical data between FIT testing methodologies, although this is not limited to f-Hb testing, as it also affects most other clinical chemistry tests, so it is a wider problem. Furthermore, the stability of samples may affect the uniformity of assessments as he expanded on the fact that biological samples may not respond in the same way all the time due to: • Tolerance limits • Manufacturing systems • Presence of antibodies Lastly, adapting to the clamour for ‘sanitisation’ by both patients and laboratories is also a challenge. Having a pre-filled cartridge assumes that the sample was taken correctly, and you have to take on trust that it was an accurate representative sample of the whole, real, stool. Overall, EQA aims to evaluate the entirety of the process and not just the relatively simple, well controlled parts, like the analysis itself. That said, all EQA providers aim to send easy-to-use materials to laboratories, in order to provide a sample type that is representative of what the laboratory routinely receives. Find out more about support for your FIT service at www.faecal-immunochemical-test.co.uk References 1. O’Driscoll S, Piggott C, Bruce H, Benton SC. An evaluation of ten external quality assurance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin. Clinical chemistry and laboratory medicine. 2020;59(2):307-13. 2. Piggott C, Shugaa Z, Benton SC. Independent internal quality control (IQC) for faecal immunochemical tests (FIT) for haemoglobin: use of FIT manufacturers’ IQC for other FIT systems. Clinical chemistry and laboratory medicine. 2020. 3. Carroll MR, John C, Mantio D, Djedovic NK, Benton SC. An assessment of the effect of haemoglobin variants on detection by faecal immunochemical tests. Annals of clinical biochemistry. 2018;55(6):706-9. 4. Benton SC, Symonds E, Djedovic N, Jones S, Deprez L, Kocna P, et al. Faecal immunochemical tests for haemoglobin: Analytical challenges and potential solutions. Clinica chimica acta; international journal of clinical chemistry. 2021;517:60-5. 5. Piggott C, Carroll MRR, John C, O’Driscoll S, Benton SC. Analytical evaluation of four faecal immunochemistry tests for haemoglobin. Clinical chemistry and laboratory medicine. 2020;59(1):173- 6. Benton SC, Piggott C, Zahoor Z, O’Driscoll S, Fraser CG, D’Souza N, et al. A comparison of the faecal haemoglobin concentrations and diagnostic accuracy in patients suspected with colorectal cancer and serious bowel disease as reported on four different faecal immunochemical test systems. Clinical chemistry and laboratory medicine. 2022;60(8):1278-86. GASTROENTEROLOGY TODAY - WINTER 2022 7
Page 1 and 2: Volume 32 No. 4 Winter 2022 18 Week
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