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GASTROENTEROLOGY


of severe disease and has been proven to be a valuable marker even in those referred with rectal bleeding,6


suggesting that FIT is


suitable in both high- and low-risk patient groups.


This is further supported by recent diagnostic accuracy studies, highlighting that the negative predictive value (NPV) for CRC is over 98.9%7


for onward transport. even when using


a high threshold of 150 µg Hb/g faeces. Other possible thresholds for investigation have been recently documented in detail.8 However, ubiquitous use of FIT in the triage for further investigation of patients presenting with symptoms is still relatively novel in terms of sample collection and logistics – so, while technically FIT is a suitable test, its application must be carefully managed to ensure the issues with overburdened services are resolved and not just redistributed. The FIT cut-offs that have been published for triaging have varied between local guidance, e.g. The London Pathway involves referring only FIT-positive two week wait patients at a threshold over 10 µg Hb/g faeces for investigation and patients with a FIT more than 150 µg Hb/g faeces are prioritised for colonoscopy.9 The cut-offs published recently by the Scottish Government are shown in Figure 1, with two published pathways for use during the pandemic and then during the recovery period.10


Increased utilisation of


FIT during the pandemic has allowed more focused referral to services which are unable to operate at full capacity, while supporting prudent healthcare.


Ongoing clinical audit of these processes and analysis of outcome measures will provide more national evidence-based guidance on the use of FIT in these settings, alongside robust safety netting for FIT negative patients.


Managing remote sample collection The pandemic makes patient contact challenging, reducing the number of face-to- face consultations to minimise the spread of COVID-19. FIT offers a unique solution since the process can be managed ‘contact free’, reducing risk to patients and health workers. Faecal sample collection by patients is still novel, compared to other sample collection


These approaches make the complete process between consultation and the generation of a result ‘contact free’ and therefore reduces the risk of spreading COVID-19. With the sample collection, handling, transport, and other logistics now in place, encouraging correct use is clearly a vital consideration.


methods such as for blood tests. However, patients are often reluctant to handle faecal samples.


A solution must, therefore, have a patient- centred approach to encourage sample collection and return, while ensuring good quality samples for analysis. The answer lies in the provision of bespoke patient literature and FIT Kits as supplied by Alpha Laboratories. Trust and Health Board specific leaflets with local phone numbers, QR-codes, barcodes, and clear visuals, with non-clinical instructional text, provide much needed support to FIT pathways which, in turn, has aided the management of endoscopy waiting lists. The bespoke leaflets result in noticeable increases in return rates, and the quality of samples received by laboratories are also much improved.


GP consultations dropped by 30% between the end of March and end of May 2020,11 and primary care is the most common starting point for referral for patients with suspected CRC. With this decrease, there was concern surrounding the use of FIT and how well clinical pathways could be supported. To address this, innovative logistics strategies were required because good engagement is a key driver to motivating patients to collect and sample faeces, and return them for analysis.


Since telephone and video consultations increased sharply, it was considered that the FIT sample collection device and instructions for use could be posted out to the patient, as well as being collectable at the GP surgery. After the sample is collected by the patient, the device is either posted back to the laboratory or dropped off at the GP surgery


Derwa et al showed that patient-reported symptoms correlate poorly with mucosal inflammation. 60% of patients who were escalated for treatment did not actually have inflammation and 35% who weren’t escalated or investigated were later shown to have inflammation.


AUGUST 2021


Maximising uptake With such reliance on samples collected by patients, uptake is vital. With faecal samples, there are the associated ‘fear’ and ‘disgust’ factors which deter some patients from collecting the sample – despite the simple, easy-to-use, hygienic FIT sample collection devices.


However, bespoke instruction for use (IFU) leaflets have been hugely influential in increasing uptake and improving sample quality. Such IFU are based around core sampling requirements but adapted to suit the specific clinical pathway adopted by Trusts and Health Boards. Patients are made to feel included in the diagnostic process and are provided with tools to complete the sample collection successfully or talk to a knowledgeable professional should they have any questions. IFU have evolved over time, after initially being used in primary care, FIT is now being used in a more diverse range of patients,12 so the detail must be regularly reviewed to ensure suitability. Usability studies, consultation events, focus groups and feedback from cancer charities all contribute to the design and production of these IFU to maximise the inclusivity of the process.


Calprotectin Testing Management of IBD patients has traditionally involved ‘routine’ periodic colonoscopy to monitor the status of gut inflammation. However, the now well- established link between the concentration of faecal calprotectin (fCAL) and intestinal inflammation means this non-invasive, test provides an efficient, cost effective alternative for diagnosing and monitoring patients’ conditions.13


Thus, if the fCAL concentration


is low there should be no need to perform a colonoscopy and additional burden on the endoscopy department is reduced. With extensive expertise in calprotectin testing, Alpha Laboratories provides a range of testing solutions to suit various clinical and laboratory requirements. The Bühlmann Quantum Blue system offers a rapid lateral flow test read in a small bench top instrument that is ideal for point of care testing (PoCT). This means a fCAL test can be performed in clinic to understand the patient’s status and decisions can be made based on the real time result. Derwa et al14


showed that patient- WWW.CLINICALSERVICESJOURNAL.COM l 79





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