Abstract
Objectives
Faecal immunochemical tests (FIT) for haemoglobin (Hb) are being used in the investigation of colorectal cancer. These tests use antibodies raised to the globin moiety of human Hb. Here, four automated quantitative FIT systems (HM-JACKarc, NS-Prime, OC-Sensor PLEDIA and SENTiFIT 270) are evaluated analytically to confirm whether the performance of the systems meet the manufacturers’ claims.
Methods
Assessment of the analytical performance of the FIT systems was undertaken using Hb lysates, real patient samples and external quality assessment (EQA) samples. This analytical assessment focused on detection characteristics, imprecision, linearity, prozone effect, recovery and carryover.
Results
All four methods demonstrated good analytical performance, with acceptable within- and between-run imprecision, good recovery of f-Hb and limited carryover of samples. They also all show good linearity across the range of concentrations tested. The results of EQA samples showed different variations from the target values (−52 to 45%), due to the absence of standardisation across the different methods.
Conclusions
All four systems are fit for purpose and have an analytical performance as documented by their manufacturers.
Acknowledgments
We thank FIT system suppliers (HM-JACKarc: Alpha Laboratories, Eastleigh, UK; NS-Prime: originally supplied by Alere Ltd., Chester, UK, with continuing support from Abbott, Maidenhead, UK, and Alfresa Pharma, Osaka, Japan; OC-Sensor PLEDIA: Mast Diagnostics Division, Bootle, UK; SENTiFIT 270: Sysmex UK Ltd., Milton Keynes, UK) for supplying the analysers and consumables. We also thank Berkshire and Surrey Pathology Services (Royal Surrey Foundation Trust, Guildford, UK) for supplying samples used in the assessment and the United Kingdom National External Quality Assessment Services (UK NEQAS, Birmingham, UK) for the external quality assessment (EQA) samples they provided.
Research funding: None declared.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Competing interests: None declared.
References
1. Schreuders, EH, Ruco, A, Rabeneck, L, Schoen, RE, Sung, JJ, Young, GP, et al. Colorectal cancer screening: a global overview of existing programmes. Gut 2015;10:1637–49. https://doi.org/10.1136/gutjnl-2014-309086.Search in Google Scholar PubMed
2. National Institute for Health and Care Excellence. Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care, 2017 DG30. Available at: https://www.nice.org.uk/guidance/dg30.pdf [Accessed 12 Nov 2019].Search in Google Scholar
3. Kato, J, Hiraoka, S, Nakarai, A, Takashima, S, Inokuchi, T, Ichinose, M. Fecal immunochemical test as a biomarker for inflammatory bowel diseases: can it rival fecal calprotectin?. Intest Res 2016;14:5–14. https://doi.org/10.5217/ir.2016.14.1.5.Search in Google Scholar PubMed PubMed Central
4. Hippisley-Cox, J, Coupland, C. Identifying patients with suspected colorectal cancer in primary care: derivation and validation of an algorithm. Br J Gen Pract 2012;62:e29–37. https://doi.org/10.3399/bjgp12x616346.Search in Google Scholar PubMed PubMed Central
5. Halloran, SP. Intelligent use of the fecal immunochemical test in population-based screening (editorial). Ann Int Med 2018;169:496–7. https://doi.org/10.7326/m18-2257.Search in Google Scholar PubMed
6. Koivunen, ME, Krogsrud, RL. Principles of immunochemical techniques used in clinical laboratories. Lab Med 2006;37:490–7. https://doi.org/10.1309/mv9rm1fdlwauwq3f.Search in Google Scholar
7. Carroll, MRR, Piggott, C, Pearson, S, Seaman, HE, Halloran, SP. Evaluation of quantitative faecal immunochemical tests for haemoglobin. Guildford Medical Device Evaluation Centre (GMEC); 2012. Available at: http://www.worldendo.org/wp-content/uploads/2018/07/gmec_fit_evaluation_report_update-final.pdf [Accessed 28 Feb 2020].Search in Google Scholar
8. Fraser, CG, Allison, JE, Young, GP, Halloran, SP, Seaman, HE. Improving the reporting of evaluations of faecal immunochemical tests for heamoglobin: the FITTER standard and checklist. Eur J Cancer Prev 2015;24:24–6. https://doi.org/10.1097/cej.0000000000000016.Search in Google Scholar
9. Fraser, CG, Benton, S. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations. Clin Chem Lab Med 2019;57:611–6. https://doi.org/10.1515/cclm-2018-0464.Search in Google Scholar PubMed
10. Clinical and Laboratory Standards Institute. Evaluation of detection capability for clinical laboratory measurement procedures. In: Approved guideline, 2nd ed. Wayne PA, USA: CLSI document EP17-A2; 2012.Search in Google Scholar
11. Broughton, PM, Gowenlock, AH, McCormack, JJ, Neill, DW. A revised scheme for the evaluation of automatic instruments for use in clinical chemistry. Ann Clin Biochem 1974;11:207–18. https://doi.org/10.1177/000456327401100164.Search in Google Scholar PubMed
12. Piggott, C, John, C, Bruce, H, Benton, SC. Does the mass of sample loaded affect faecal haemoglobin concentration using the faecal immunochemical test. Ann Clin Biochem 2018;55:702–5. https://doi.org/10.1177/0004563218778701.Search in Google Scholar PubMed
13. Ahn, A, Kim, J, Jin Ko, Y, et al. Perofrmance evaluation of two automated quantitative fecal occult blood tests. Lab med Online 2016;6:233–9. https://doi.org/10.3343/lmo.2016.6.4.233.Search in Google Scholar
14. Kusaka, T, Nozaki, T, Shibata, M, et al. Measurement performance evaluation of fecal occult blood analyzer OC Sensor PLEDIA. J Clin Lab Inst and Reag 2014;37:643–8.Search in Google Scholar
15. Lee, C, O’Gorman, P, Walsh, P. Immunochemical faecal occult blood tests have superior stability and analytical performance characteristics over guaiac-based tests in a controlled in vitro study. J Clin Pathol 2011;64:524–8. https://doi.org/10.1136/jcp.2010.085399.Search in Google Scholar PubMed
16. Rubeca, T, Cellai, F, Confortini, M, Fraser, CG, Rapi, S. Impact of preanalytical factors on fecal immunochemical tests: need for new strategies in comparison of methods. Int J Biol Markers 2015;30:e269–74. https://doi.org/10.5301/jbm.5000150.Search in Google Scholar PubMed
17. Benton, SC. IFCC – FIT Working Group (FIT-WG). IFCC e-news; 2017, pp. 16–7. Available at: http://www.ifcc.org/media/461890/IFCCeNewsJune2017.pdf [Accessed 6 March 2019].Search in Google Scholar
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