NIHR Imperial Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College Healthcare NHS Trust London, England, United Kingdom
Madhumitha Pandiaraja, MB BChir1, Robert Perry, MBBCh2, Abisoye Akintimehin, MB BCh, BAO3, Nasro Hashi, BSc4, Mark Busbridge, MSc, PhD4, Alan Courtney, DPhil4, Peter Foulser, MBBS2, Shiva Radhakrishnan, MBBS, PhD2, Sharmili Balarajah, MB ChB2, Benjamin Mullish, MB BChir, PhD2, James Alexander, MBBS, PhD2, Julian Marchesi, PhD2, Lucy Hicks, MBBS, PhD2, Horace Williams, MBBS, PhD2 1NIHR Imperial Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College Healthcare NHS Trust, London, England, United Kingdom; 2Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, England, United Kingdom; 3Departments of Gastroenterology and Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, England, United Kingdom; 4Department of Clinical Biochemistry, Northwest London Pathology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, England, United Kingdom Introduction: Faecal calprotectin (FC) is a validated, non-invasive biomarker widely used in the diagnosis and monitoring of IBD. Faecal specimen collection, however, poses practical challenges for patients, contributing to poor return rates. This study aimed to evaluate patient perspectives on self-administered rectal swabs (RS) as an alternative to conventional faecal sampling and assess their performance in FC quantification. Methods: Adult IBD patients on biologic therapy requiring regular FC monitoring were recruited. For each participant, a conventional faecal sample produced within the preceding 24 hours, and two COPAN Floqswabs were collected: a faecal sample swab (FSS, swab dipped into stool) and a RS. A survey was distributed to gather views on RS usage. FC analysis was performed using a Bülhmann FCAL Turbo assay and Abbott Architect C8000 analyser, with protocol modifications for FC extraction from swabs. Statistical analyses were conducted using Graphpad Prism (ver10.3.1). Results: Twenty patients were included in the study (11 UC, 9 CD; 12M, 8F). The majority (89.5%, 15/17) found RS easy to use, and 84.2% (14/17) preferred it over faecal sample collection. Responses pertaining to comfort level were equivocal, with approximately half (41.2%, 7/17) finding it comfortable. The diagnostic accuracy of RS was evaluated against matched faecal samples (gold standard). Using ≥250 μg/g as the threshold for active IBD, 20% (4/20) of patients had a positive FC test from their faecal sample. FSS showed a strong correlation with FC values from the faecal samples (r = 0.78, p < 0.0001), with a sensitivity of 75% (95% CI 30.1%-98.7%) and a specificity of 87.5% (95% CI 64%-97.8%). Even though the RS had similar sensitivity (75%, 95% CI 30.1-98.7%), it had a lower specificity of 50% (95% CI 28%-72%). Pairwise comparison revealed no significant difference in FC levels from FSS and faecal samples; FC levels yielded by RS were however significantly different from the FSS (p = 0.001) and faecal samples (p = 0.006). Discussion: Overall, participant responses conveyed high levels of acceptability for rectal swabbing as a method of sample collection for FC testing. Whilst faecal swabs are comparable to conventional stool samples for quantification of FC levels, self-administered rectal swabs are less reliable. Their high sensitivity does however warrant further research into various collection and sample processing techniques, given strong patient preference for alternatives to traditional faecal sampling.
Disclosures: Madhumitha Pandiaraja indicated no relevant financial relationships. Robert Perry: Ferring Pharmaceuticals Inc – Travel reimbursement. Abisoye Akintimehin indicated no relevant financial relationships. Nasro Hashi indicated no relevant financial relationships. Mark Busbridge indicated no relevant financial relationships. Alan Courtney indicated no relevant financial relationships. Peter Foulser indicated no relevant financial relationships. Shiva Radhakrishnan: Alfasigma USA, Inc – Speaking and lecture fees. Ferring Pharmaceuticals Inc – Travel reimbursement. Pfizer – Travel reimbursement. Sharmili Balarajah: Bowel Research UK – Grant/Research Support. Dr. Falk Pharma AG – Travel reimbursement. Ferring Pharmaceuticals Inc – Travel reimbursement. Benjamin Mullish indicated no relevant financial relationships. James Alexander indicated no relevant financial relationships. Julian Marchesi: Crescent Enterprise Ltd – Advisor or Review Panel Member, Consultant. EnterBiotix Ltd – Advisor or Review Panel Member, Consultant. National Institute for Health Research Imperial Biomedical Research Centre – Grant/Research Support. UK Research and Innovation Medical Research Council – Grant/Research Support. Lucy Hicks indicated no relevant financial relationships. Horace Williams indicated no relevant financial relationships.
Madhumitha Pandiaraja, MB BChir1, Robert Perry, MBBCh2, Abisoye Akintimehin, MB BCh, BAO3, Nasro Hashi, BSc4, Mark Busbridge, MSc, PhD4, Alan Courtney, DPhil4, Peter Foulser, MBBS2, Shiva Radhakrishnan, MBBS, PhD2, Sharmili Balarajah, MB ChB2, Benjamin Mullish, MB BChir, PhD2, James Alexander, MBBS, PhD2, Julian Marchesi, PhD2, Lucy Hicks, MBBS, PhD2, Horace Williams, MBBS, PhD2. P1133 - Evaluation of Rectal Swabs as a Viable Alternative to Faecal Sampling for Calprotectin Measurement in IBD Patients, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.