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Licensed Unlicensed Requires Authentication Published by De Gruyter November 18, 2017

An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer

  • Josep M. Auge EMAIL logo , Cristina Rodriguez , Oihana Espanyol , Liseth Rivero , Silvia Sandalinas , Jaume Grau , Wladimiro Jimenez and Antoni Castells

Abstract

Background:

An evaluation of SENTiFIT® 270 (Sentinel Diagnostics, Italy; Sysmex, Spain) analyser for the quantitation of faecal haemoglobin (f-Hb) was performed.

Methods:

The analytical imprecision, linearity, carry over and f-Hb stability were determined. Evaluation of the diagnostic accuracy was performed on 487 patients.

Results:

Within-run and between-run imprecision ranged 1.7%–5.1% and 3.8%–6.2%, respectively. Linearity studies revealed a mean recovery of 101.1% (standard deviation, 6.7%) for all dilutions. No carry over was detected below 7650 μg Hb/g faeces. Decay of f-Hb in refrigerated samples ranged 0.2%–0.5% per day. f-Hb in patients with advanced colorectal neoplasia (ACRN) (colorectal cancer [CRC] plus advanced adenoma [AA]) were significantly higher than from those with a normal colonoscopy. Sensitivity for ACRN at f-Hb cutoffs from 10 to 60 μg Hb/g faeces ranged from 28.9% (95% confidence interval [CI], 21.7%–37.2%) to 46.5% (95% CI, 38.1%–55%), the specificity ranged from 85% (95% CI, 82.3%–87.3%) to 93.2% (95% CI, 91.2%–94.8%), positive predictive values for detecting CRC and AA ranged from 11.6% (95% CI, 7.6%–17.2%) to 20.6% (95% CI, 13.3%–30.3%) and from 34.7% (95% CI, 28.1%–42%) to 42.3% (95% CI, 32.4%–52.7%), respectively, and the negative predictive value for ACRN ranged from 90.2% (95% CI, 87.9%–92.2%) to 88.4% (95% CI, 86%–90.4%). Using two samples per patient sensitivity increased with a slight decrease in specificity.

Conclusions:

The analytical and clinical performances of SENTiFIT assay demonstrate a specific and accurate test for detecting ACRN in symptomatic patients and those undergoing surveillance.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Brenner H, Haug U, Hundt S. Sex differences in performance of fecal occult blood testing. Am J Gastroenterol 2010;105:2457–64.10.1038/ajg.2010.301Search in Google Scholar PubMed

2. Hol L, Wilschut JA, van Ballegooijen M, van Vuuren AJ, van d V, Reijerink JC, et al. Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer 2009;100:1103–10.10.1038/sj.bjc.6604961Search in Google Scholar PubMed PubMed Central

3. Parra-Blanco A, Gimeno-Garcia AZ, Quintero E, Nicolas D, Moreno SG, Jimenez A, et al. Diagnostic accuracy of immunochemical versus guaiac faecal occult blood tests for colorectal cancer screening. J Gastroenterol 2010;45:703–12.10.1007/s00535-010-0214-8Search in Google Scholar PubMed

4. Fraser CG, Halloran SP, Allison JE, Young GP. Making colorectal cancer screening fitter for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT). Clin Chem Lab Med 2013;51:2065–7.10.1515/cclm-2013-0408Search in Google Scholar PubMed

5. Auge JM, Fraser CG, Rodriguez C, Roset A, Lopez-Ceron M, Grau J, et al. Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients. Clin Chem Lab Med 2016;54:125–32.10.1515/cclm-2015-0388Search in Google Scholar PubMed

6. Cubiella J, Salve M, Diaz-Ondina M, Vega P, Alves MT, Iglesias F, et al. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis 2014;16:O273–82.10.1111/codi.12569Search in Google Scholar PubMed

7. Godber IM, Todd LM, Fraser CG, MacDonald LR, Younes HB. Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms. Clin Chem Lab Med 2016;54:595–602.10.1515/cclm-2015-0617Search in Google Scholar PubMed

8. McDonald PJ, Digby J, Innes C, Strachan JA, Carey FA, Steele RJ, et al. Low faecal haemoglobin concentration potentially rules out significant colorectal disease. Colorectal Dis 2013;15:e151–9.10.1111/codi.12087Search in Google Scholar PubMed

9. Mowat C, Digby J, Strachan JA, Wilson R, Carey FA, Fraser CG, et al. Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms. Gut 2016;65:1463–9.10.1136/gutjnl-2015-309579Search in Google Scholar PubMed PubMed Central

10. Rodriguez-Alonso L, Rodriguez-Moranta F, Ruiz-Cerulla A, Lobaton T, Arajol C, Binefa G, et al. An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test. Dig Liver Dis 2015;47:797–804.10.1016/j.dld.2015.05.004Search in Google Scholar PubMed

11. Widlak MM, Thomas CL, Thomas MG, Tomkins C, Smith S, O’Connell N, et al. Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients. Aliment Pharmacol Ther 2017;45:354–63.10.1111/apt.13865Search in Google Scholar PubMed

12. Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JC, et al. Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut 2010;59:62–8.10.1136/gut.2009.177089Search in Google Scholar PubMed

13. Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, et al. Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol 2010;105:2017–25.10.1038/ajg.2010.179Search in Google Scholar PubMed

14. van Rossum LG, van Rijn AF, van Oijen MG, Fockens P, Laheij RJ, Verbeek AL, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. Int J Cancer 2009;125:746–50.10.1002/ijc.24458Search in Google Scholar PubMed

15. van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology 2008;135:82–90.10.1053/j.gastro.2008.03.040Search in Google Scholar PubMed

16. Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: A targeted, updated systematic review for the US Preventive Services Task Force. Ann Intern Med 2008;149:638–58.10.7326/0003-4819-149-9-200811040-00245Search in Google Scholar PubMed

17. Phalguni A, Seaman H, Routh K, Halloran S, Simpson S. Tests detecting biomarkers for screening of colorectal cancer: What is on the horizon? GMS Health Technol Assess 2015;11:1–14.Search in Google Scholar

18. Carroll M, Piggott C, Pearson S, Seaman H, Halloran S. Evaluation of quantitative faecal immunochemical tests for haemoglobin. Guildford, UK: Guildford Medical Device Evaluation Centre (GMEC), 2014.10.1136/gutjnl-2014-307263.279Search in Google Scholar

19. Fraser CG, Allison JE, Halloran SP, Young GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst 2012;104:810–4.10.1093/jnci/djs190Search in Google Scholar PubMed

20. Fraser CG, Allison JE, Young GP, Halloran SP, Seaman H. A standard for faecal immunochemical tests for haemoglobin evaluation reporting (FITTER). Ann Clin Biochem 2014;51:301–2.10.1177/0004563213514392Search in Google Scholar PubMed

21. Rapi S, Rubeca T, Fraser CG. How to improve the performances of fecal immunological tests (FIT): need for standardization of the sampling and pre-analytical phases and revision of the procedures for comparison of methods. Int J Biol Markers 2015;30:e127–31.10.5301/jbm.5000093Search in Google Scholar PubMed

22. 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:e269–74.10.5301/jbm.5000150Search in Google Scholar

23. Chiang TH, Chuang SL, Chen SL, Chiu HM, Yen AM, Chiu SY, et al. Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. Gastroenterology 2014;147:1317–26.10.1053/j.gastro.2014.08.043Search in Google Scholar

24. Haeckel R. Recommendations for the application of statistical methods in the comparison of methods of clinical chemical analysis. J Clin Chem Clin Biochem 1982;20:107–10.Search in Google Scholar

25. Hassan C, Quintero E, Dumonceau JM, Regula J, Brandao C, Chaussade S, et al. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013;45:842–51.10.1055/s-0033-1344548Search in Google Scholar

26. Sobin L, Gospodarowicz M, Wittekind C. TNM classification of malignant tumours. 7th ed. New York: Wiley-Blackwell, 2009.10.1002/9780471420194.tnmc26.pub2Search in Google Scholar

27. Castiglione G, Zappa M, Grazzini G, Rubeca T, Turco P, Sani C, et al. Screening for colorectal cancer by faecal occult blood test: comparison of immunochemical tests. J Med Screen 2000;7:35–7.10.1136/jms.7.1.35Search in Google Scholar

28. Grazzini G, Visioli CB, Zorzi M, Ciatto S, Banovich F, Bonanomi AG, et al. Immunochemical faecal occult blood test: Number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening? Br J Cancer 2009;100:259–65.10.1038/sj.bjc.6604864Search in Google Scholar

29. Allison JE, Tekawa IS, Ransom LJ, Adrain AL. A comparison of fecal occult-blood tests for colorectal-cancer screening. N Engl J Med 1996;334:155–9.10.1056/NEJM199601183340304Search in Google Scholar

30. Auge JM, Rodriguez C, Pellise M, Bernal A, Grau J, Castells A, et al. Analytical and clinical performance of Kroma iT, a compact fully-automated immunochemistry analyzer for fecal occult hemoglobin. Anticancer Res 2013;33:5633–7.Search in Google Scholar

31. Petrelli N, Michalek AM, Freedman A, Baroni M, Mink I, Rodriguez-Bigas M. Immunochemical versus guaiac occult blood stool tests: results of a community-based screening program. Surg Oncol 1994;3:27–36.10.1016/0960-7404(94)90021-3Search in Google Scholar

32. Robinson MH, Pye G, Thomas WM, Hardcastle JD, Mangham CM. Haemoccult screening for colorectal cancer: the effect of dietary restriction on compliance. Eur J Surg Oncol 1994;20:545–8.Search in Google Scholar

33. St John DJ, Young GP, Alexeyeff MA, Deacon MC, Cuthbertson AM, Macrae FA, et al. Evaluation of new occult blood tests for detection of colorectal neoplasia. Gastroenterology 1993;104:1661–8.10.1016/0016-5085(93)90643-QSearch in Google Scholar

34. Grobbee EJ, van der Vlugt M, van Vuuren AJ, Stroobants AK, Mundt MW, Spijker WJ, et al. A randomised comparison of two faecal immunochemical tests in population-based colorectal cancer screening. Gut 2017;66:1975–82. [Epub ahead of print].10.1136/gutjnl-2016-311819Search in Google Scholar PubMed

35. Passamonti B, Malaspina M, Fraser CG, Tintori B, Carlani A, D’Angelo V, et al. A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer. Gut 2016. doi: 10.1136/gutjnl-2016-312716. [Epub ahead of print].10.1136/gutjnl-2016-312716Search in Google Scholar PubMed

Received: 2017-7-11
Accepted: 2017-10-9
Published Online: 2017-11-18
Published in Print: 2018-3-28

©2018 Walter de Gruyter GmbH, Berlin/Boston

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