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Licensed Unlicensed Requires Authentication Published by De Gruyter March 14, 2022

Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA

  • Shane O’Driscoll ORCID logo EMAIL logo , Carolyn Piggott ORCID logo and Sally C. Benton ORCID logo



The National Institute for Health and Care Excellence recommends faecal calprotectin (f-cal) to help differentiate inflammatory bowel diseases from irritable bowel syndrome. Faecal samples for calprotectin have historically been collected at home by patients into screw-top pots and sent to laboratories where calprotectin is extracted and analysed. Faecal haemoglobin (f-Hb) samples are collected at home into specific collection devices containing stabilising buffer. We evaluated the OC-FCa method for f-cal, developed by Eiken Chemical Co., Ltd. (Japan) that uses the same collection device and analyser as f-Hb.


OC-FCa was assessed for limit of blank (LOB), limit of detection (LOD), limit of quantification (LOQ), within and between-run imprecision, linearity, prozone, recovery and carryover. A method comparison against the BÜHLMANN fCAL® turbo (BÜHLMANN Laboratories AG, Switzerland) was performed using patient samples and EQA.


The LOB was 3 µg calprotectin/g faeces (µg/g), LOD 8 μg/g and LOQ 20 μg/g. Within and between-run imprecision was <5%; linearity was good (R2 > 0.99); prozone was appropriately detected; recovery was 99.6%; no observed carryover. OC-FCa showed a strong positive bias compared with BÜHLMANN fCAL® turbo (Z=−5.3587, p < 0.001). When categorised using our local pathway, which interprets calprotectin concentrations and need for further investigation, Cohen’s Kappa demonstrates substantial agreement at <50 μg/g (κ=0.80) and >150 μg/g (κ=0.63) and fair agreement (κ=0.22) in the borderline category 50–150 μg/g.


The OC-FCa method performed well in the evaluation. With the lack of standardisation for f-cal a clinical study is required to evaluate the positive bias and establish suitable cut-off levels.

Corresponding author: Shane O’Driscoll, NHS Bowel Cancer Screening Programme Southern Hub, Royal Surrey County Hospital, Guildford, UK, E-mail:


We would like to thank Eiken Chemical Co., Ltd., Tokyo, Japan and Mast Diagnostics Division, Bootle, Merseyside, UK for supplying the analysers and consumables, and UK NEQAS for providing materials for assessment.

  1. Research funding: None declared.

  2. Author contribution: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review.


1. National Institute for Health and Care Excellence. Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. DG 11. London: NICE; 2013. [Online]. Available from: [Accessed 16 August 2021].Search in Google Scholar

2. BÜHLMANN Laboratories, Switzerland. BÜHLMANN Instruction for use CALEX® Cap, 2020. Available from: [Accessed 09 Mar 2022].Search in Google Scholar

3. Eiken Chemical, Co., Ltd. OC-auto sampling bottle 3, 2020. [Online]. Available from: [Accessed 16 Dec 2021].Search in Google Scholar

4. Armbruster, DA, Pry, T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev 2008;29:S49–52.Search in Google Scholar

5. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods, 3rd ed. EP05-A3 Wayne, PA: Clinical and Laboratory Standards Institute; 2014.Search in Google Scholar

6. Broughton, PMG, Buttolph, MA, Gowenlock, AH, Neill, DW, Skentelbery, RG. Recommended scheme for the evaluation of instruments for automatic analysis in the clinical biochemistry laboratory. J Clin Pathol 1969;22:278–84, in Google Scholar PubMed PubMed Central

7. Turvill, J, Rook, L, Rawle, M, Rook, L, Rawle, M, Robins, G, Smale, S, Kant, P, et al.. Validation of a care pathway for the use of faecal calprotectin in monitoring patients with Crohn’s disease. Frontline Gastroenterol 2017;8:183–8, in Google Scholar PubMed PubMed Central

8. Landis, JR, Koch, GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159–74, in Google Scholar

9. Oyaert, M, Boel, A, Jacobs, J, Van den Bremt, S, De Sloovere, M, Vanpoucke, H, et al.. Analytical performance and diagnostic accuracy of six different faecal calprotectin assays in inflammatory bowel disease. Clin Chem Lab Med 2017;55:1564–73, in Google Scholar PubMed

10. Whitehead, SJ, French, J, Brookes, MJ, Ford, C, Gama, R. Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits. Ann Clin Biochem 2013;50:53–61, in Google Scholar PubMed

11. Haisma, S-M, van Rheenen, PF, Wagenmakers, L, Muller Kobold, A. Calprotectin instability may lead to undertreatment in children with IBD. Arch Dis Child 2020;105:996–8, in Google Scholar PubMed PubMed Central

12. 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. Clin Chem Lab Med 2020;59:307–13, in Google Scholar PubMed

13. Maclean, W, Singh, R, Mackenzie, P, White, D, Benton, S, Stebbing, J, et al.. The two-week rule colorectal cancer pathway: an update on recent practice, the unsustainable burden on diagnostics and the role of faecal immunochemical testing. Ann R Coll Surg Engl 2020;102:308–11. in Google Scholar PubMed PubMed Central

14. Hiraoka, S, Takashima, S, Inokuchi, T, Nakarai, A, Takahara, M, Harada, K, et al.. The novel latex agglutination turbidimetric immunoassay system for simultaneous measurements of calprotectin and hemoglobin in feces. Intest Res 2019;17:202–9, in Google Scholar PubMed PubMed Central

Received: 2021-11-04
Accepted: 2022-02-27
Published Online: 2022-03-14
Published in Print: 2022-05-25

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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