Analytical evaluation of eight qualitative FIT for haemoglobin products, for professional use in the UK

Carolyn Piggott; Cerin John; Shane O’Driscoll; Sally C. Benton

doi:10.1515/cclm-2024-0502

Article

Analytical evaluation of eight qualitative FIT for haemoglobin products, for professional use in the UK

Carolyn Piggott , Cerin John , Shane O’Driscoll and Sally C. Benton

Published/Copyright: October 9, 2024

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 3

Abstract

Objectives

Qualitative faecal immunochemical tests for haemoglobin (FIT), for triaging for colorectal cancer investigations, are available for professional use. The aim was to evaluate these lateral flow tests. No previous analytical evaluations have been published.

Methods

Analytical sensitivity (AS) was assessed using samples spanning manufacturers’ quoted AS, concurrently with the quantitative OC-SENSOR PLEDIA, using Hb-spiked samples in manufacturers’ buffer (n≥5; ≤9–99 ng Hb/mL buffer), Hb-spiked feces (n=6; <2–34 µg Hb/g feces) and natural feces (n=17; <2–82 μg/g); concentrations for 50 %/100 % Hb-detected were compared with quoted AS. Compatibility with two external quality assessment schemes (EQAS) (n=9; 3–96 μg/g) and prozone compared with manufacturers limits (n=9; 2,500–10,000,000 ng/mL) were tested. Ease-of-use by five healthcare personnel was assessed.

Results

Seven products showed lower AS (ng/mL) than manufacturers quoted using Hb-spiked aqueous samples compared with OC-SENSOR, one was equivocal; six manufacturers quoted AS in µg/g, five showed lower AS using Hb-spiked feces. Results were similar but less consistent for natural feces. Result lines for low concentrations can be faint and open to interpretation. Results were consistent with manufacturers quoted prozone limits. Results were consistent for seven products for two EQAS. The ease-of-use was 68.5–85.6 %; products with lower scores could be improved with better instructions and sample bottles.

Conclusions

AS was lower for seven products (aqueous samples) and five products (aqueous/faecal samples) and prozone consistent with manufacturers expected concentrations, compared with OC-SENSOR. EQAS results were mostly consistent with expected results; products can be used by healthcare professionals, though some manufacturer improvements could be made.

Keywords: FIT faecal haemoglobin; qualitative; lateral flow test; point of care testing

Corresponding author: Carolyn Piggott, NHS Bowel Cancer Screening Programme – Southern Hub, Royal Surrey County Hospital, 20 Priestley Road, Surrey Research Park, GU2 7YS, Guildford, UK, E-mail: carolyn.piggott@nhs.net

Acknowledgments

We would like to thank: Medix Biochemica (Espoo, Finland), Pro-lab Diagnostics (Bromborough, UK), Biohit Healthcare (Ellesmere Port, UK), Alpha Laboratories (Eastleigh, UK), BHR Biosynex (Nuneaton, UK), Cambridge Life Sciences Ltd (Ely, UK), Nal Von Minden (Ticehurst, UK) for supplying the qualitative FIT products; Mast Diagnostics Division (Bottle, UK) for supplying the OC-SENSOR PLEDIA products; WEQAS (Cardiff, UK), UK NEQAS (Birmingham, UK) for supplying EQAS samples; Berkshire and Surrey Pathology Servies (BSPS) for supplying faecal and blood samples.

Research ethics: Not applicable.
Informed consent: Not applicable.
Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Use of Large Language Models, AI and Machine Learning Tools: None declared.
Conflict of interest: The authors state no conflict of interest.
Research funding: None declared.
Data availability: Not applicable.

References

1. Schreuders, EH, Ruco, A, Rabeneck, L, Schoen, RE, Sung, JJY, Young, GP, et al.. Colorectal cancer screening: a global overview of existing programmes. Gut 2015;64:1637–49. https://doi.org/10.1136/gutjnl-2014-309086.Search in Google Scholar PubMed

2. Chiu, H-M, Chen, SL-S, Yen, AM-F, Chiu, SY-H, Fann, JC-Y, Lee, Y-C, et al.. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer 2015;121:3221–9. https://doi.org/10.1002/cncr.29462.Search in Google Scholar PubMed PubMed Central

3. Young, GP, Rabeneck, L, Winawer, SJ. The global paradigm shift in screening for colorectal cancer. Gastroenterol 2019;156:843–51.e2. https://doi.org/10.1053/j.gastro.2019.02.006.Search in Google Scholar PubMed

4. National Institute for Health and Care Excellence. Suspected cancer: recognition and referral. In: NICE guideline (NG12). London: National Institute for Health and Care Excellence; 2017.Search in Google Scholar

5. Pin Vieito, N, Puga, M, Fernandez-de-Castro, D, Cubiella, J. Faecal immunochemical test outside colorectal cancer screening? World J Gastroenterol 2021;27:6415–29. https://doi.org/10.3748/wjg.v27.i38.6415.Search in Google Scholar PubMed PubMed Central

6. Piggott, C, Carroll, MRR, John, C, O’Driscoll, S, Benton, SC. Analytical evaluation of four faecal immunochemistry tests for haemoglobin. Clin Chem Lab Med 2020;59:173–8. https://doi.org/10.1515/cclm-2020-0251.Search in Google Scholar PubMed

7. O’Driscoll, S, Carroll, M, Maclean, W, Piggott, C, Jourdan, I, Benton, SC. Assessment of the analytical performance of point-of-care faecal immunochemical tests for haemoglobin. Ann Clin Biochem 2021;58:181–9. https://doi.org/10.1177/0004563220986595.Search in Google Scholar PubMed

8. Hoepffner, N, Shastri, YM, Hanisch, E, Rosch, W, Mossner, J, Caspary, WF, et al.. Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study. Aliment Pharmacol Ther 2006;23:145–54. https://doi.org/10.1111/j.1365-2036.2006.02702.x.Search in Google Scholar PubMed

9. Hundt, S, Haug, U, Brenner, H. Comparative evaluation of immunochemical fecal occult blood tests for colorectal adenoma detection. Ann Intern Med 2009;150:162–9. https://doi.org/10.7326/0003-4819-150-3-200902030-00005.Search in Google Scholar PubMed

10. Tao, S, Seiler, CM, Ronellenfitsch, U, Brenner, H. Comparative evaluation of nine faecal immunochemical tests for the detection of colorectal cancer. Acta Oncol 2013;52:1667–75. https://doi.org/10.3109/0284186x.2013.789141.Search in Google Scholar

11. Elias, SG, Kok, L, de Wit, NJ, Witteman, BJM, Goedhard, JG, Romberg-Camps, MJL, et al.. Is there an added value of faecal calprotectin and haemoglobin in the diagnostic work-up for primary care patients suspected of significant colorectal disease? A cross-sectional diagnostic study. BMC Med 2016;14:141–52. https://doi.org/10.1186/s12916-016-0684-5.Search in Google Scholar PubMed PubMed Central

12. Högberg, C, Gunnarsson, U, Cronberg, O, Thulesius, H, Lilja, M, Jansson, S. Qualitative faecal immunochemical tests (FITs) for diagnosing colorectal cancer in patients with histories of rectal bleeding in primary care: a cohort study. Int J Colorectal Dis 2020;35:2035–40. https://doi.org/10.1007/s00384-020-03672-1.Search in Google Scholar PubMed PubMed Central

13. Högberg, C, Gunnarsson, U, Jansson, S, Thulesius, H, Cronberg, O, Lilja, M. Diagnosing colorectal cancer in primary care: cohort study in Sweden of qualitative faecal immunochemical tests, haemoglobin levels, and platelet counts. Br J Gen Pract 2020;70:e843–51. https://doi.org/10.3399/bjgp20x713465.Search in Google Scholar PubMed PubMed Central

14. Fraser, CG, Benton, SC. Faecal haemoglobin examinations have come of age, but further maturation seems desirable. Ann Clin Biochem 2022;59:97–100. https://doi.org/10.1177/00045632211063459.Search in Google Scholar PubMed

15. Levy, BT, Daly, JM, Xu, Y, Crockett, SD, Hoffman, RM, Dawson, JD, et al.. Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol. Contemp Clin Trials 2021;106:106430. https://doi.org/10.1016/j.cct.2021.106430.Search in Google Scholar PubMed PubMed Central

16. Clinical and Laboratory Standards Institute. User protocol for evaluation of qualitative test performance; Approved guideline, 2nd ed. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.Search in Google Scholar

17. Meklin, J, SyrjÄnen, K, Eskelinen, M. Fecal occult blood tests in colorectal cancer screening: systematic review and meta-analysis of traditional and new-generation fecal immunochemical tests. Anticancer Res 2020;40:3591–604. https://doi.org/10.21873/anticanres.14349.Search in Google Scholar PubMed

18. 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. Clin Chem Lab Med 2022;60:1278–86. https://doi.org/10.1515/cclm-2021-1248.Search in Google Scholar PubMed

Received: 2024-04-22

Accepted: 2024-09-06

Published Online: 2024-10-09

Published in Print: 2025-02-25

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Articles in the same Issue

https://doi.org/10.1515/cclm-2024-0502

Keywords for this article

FIT faecal haemoglobin; qualitative; lateral flow test; point of care testing