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preLekára.sk / Journals / Clinical Biochemistry and Metabolism / 2021 - 1

Kvantitativní stanovení hemoglobinu ve stolici -
preanalytické a analytické aspekty

Česká verzia

Authors: P. Kocna
Authors place of work: Ústav lékařské biochemie a laboratorní diagnostiky, 1. Lékařské fakulty Karlovy University, a Všeobecné fakultní nemocnice, Praha
Published in the journal: Klin. Biochem. Metab., 29, 2021, No. 1, p. 4-10

Summary

Preanalytical and analytical aspects of the quantitative method for the determination of haemoglobin in stool are essential for the evaluation of the test, the positivity of which is an indication for colonoscopy in the screening of colorectal tumors. The quality requirements for laboratory analysis require, according to standard ISO 15189, that variability be assessed at all stages of the test process. The pre-analytical aspect is the collection and transport of the sample including the collection cassette (amount of stool, volume and composition of the extraction buffer), stool consistency, stability of the sample (time and temperature of transport). The analytical aspect is mainly the variability of immunochemical technology, different antibodies, buffers, standards and calibration of analysers. Harmonization and standardization of hemoglobin determination in stool samples is the topic of the IFCC Working Group for Faecal Immunochemical Testing (WG-FIT).

Keywords:

colorectal cancer – screening – determination of occult bleeding – immunochemical detection of hemoglobin in stool – analytical and preanalytical variability

Zdroje
  1. Young, G. P., Rabeneck, L., Winawer, S. J. The Global Paradigm Shift in Screening for Colorectal Cancer. Gastroenterology, 2019, 156(4), s. 843-851.
  2. Kocna, P. Stanovení hemoglobinu ve stolici - změny od ledna 2020, Bulletin FONS, 2019; č. 4, s. 25.
  3. Farrugia, A., Widlak, M., Evans, C. et al. Faecal immunochemical testing (FIT) in symptomatic patients: what are we missing? Frontline Gastroenterol., 2020, 11, s. 28-33.
  4. van Melle, M., Yep Manzano, S. I. S., Wilson, H., Hamilton, W., Walter, F. M., Bailey, S. E. R. Faecal immunochemical test to triage patients with abdominal symptoms for suspected colorectal cancer in primary care: review of international use and guidelines. Fam. Pract., 2020, 37(5), s. 606-615.
  5. Grobbee, E. J., Schreuders, E. H., Hansen, B. E. et al.  Association Between Concentrations of Hemoglobin Determined by Fecal  Immunochemi-cal Tests and Long-term Development of Advanced Colorectal Neoplasia. Gastroenterology, 2017, 153(5), s. 1251-1259.
  6. Senore, C., Zappa, M., Campari, C. et al. Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy. Gut, 2020, 69(3), s. 523-530.
  7. Fraser, C. G., Benton, S. C. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations. Clin. Chem. Lab. Med., 2019, 57(5), s. 611-616.
  8. O‘Driscoll, S., Piggott, C., Bruce, H., Benton, S. C. An evaluation of ten external quality assu-rance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin. Clin. Chem. Lab. Med., 2020, 59(2), s. 307-313.
  9. Rapi, S., Berardi, M., Cellai, F. et al. Effects of fecal sampling on preanalytical and analytical phases in quantitative fecal immunochemical tests for hemoglobin. Int. J Biol. Markers., 2017, 32(3), e261-e266.
  10. Padoan, A., D‘Incà, R., Scapellato, M. L. et al. Improving IBD diagnosis and monitoring by understanding preanalytical, analytical and biological fecal calprotectin variability. Clin. Chem. Lab. Med., 2018, 56(11), s. 1926-1935.
  11. Benton, S. C., Symonds, E., Djedovic, N. et al. Faecal Immunochemical Tests for Haemoglobin: Analytical Challenges and Potential Solutions. Clin. Chim. Acta, 2021 - submitted manuscript.
  12. Rapi, S., Rubeca, T., Fraser, C. G. 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(1), e127-131.
  13. Fraser, C. G., Allison, J. E., Halloran, S. P. et al. Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer ScreeningCommittee WEO.: A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl. Cancer Inst., 2012, 104, s. 810–814.
  14. Kocna, P., Zima, T. Stanovisko ke stanovení hemoglobinu ve stolici kvantitativní analýzou. Klin. Biochem. Metab., 2015, 23(2), s. 78-81.
  15. Kocna, P., Zima, T. Doporučení České společnosti klinické biochemie ke správnému používání metody stanovení okultního krvácení ve stolici. Tempus medicorum., 2015, 24(10), s. 30-31.
  16. Amitay, E. L., Gies, A., Weigl, K., Brenner, H. Fecal Immunochemical Tests for Colorectal Cancer Screening: Is Fecal Sampling from Multiple Sites Necessary? Cancers (Basel), 2019, 11(3), s. 400
  17. Gies, A., Gruner, L. F., Schrotz-King, P., Brenner, H. Effect of Imperfect Compliance With Instructions for Fecal Sample Collection on Diagnostic Performance of 9 Fecal Immunochemical Tests. Clin. Gastroenterol. Hepatol., 2019, 17(9), s. 1829-1839.
  18. Piggott, C., John, C., Bruce, H., Benton, S. C. Does the mass of sample loaded affect faecal haemoglobin concentration using the faecal immunochemical test?  Ann. Clin. Biochem., 2018, 55(6), s. 702-705.
  19. Thom, C. S., Dickson, C. F., Gell, D. A., Weiss, M. J. Hemoglobin variants: biochemical properties and clinical correlates. Cold Spring Harb. Perspect. Med., 2013, 3(3), a011858.
  20. Carroll, M. R., John, C., Mantio, D. et al. An assessment of the effect of haemoglobin variants on detection by faecal immunochemical tests. Ann. Clin. Biochem., 2018, 55(6), s. 706-709.
  21. Takashima, Y., Shimada, T., Yokozawa, T. Clinical benefit of measuring both haemoglobin and transferrin concentrations in faeces: demonstration during a large-scale colorectal cancer screening trial in Japan. Diagnosis (Berl). 2015, 2(1), s. 53-59.
  22. Grazzini, G., Ventura, L., Rubeca, T. et al. Impact of a new sampling buffer on faecal haemoglobin stability in a colorectal cancer screening programme by the faecal immunochemical test. Eur. J Cancer Prev., 2017, 26(4), s. 285-291.
  23. Symonds, E. L., Cole, S. R., Bastin, D. et al. Effect of sample storage temperature and buffer formulation on faecal immunochemical test haemoglobin measurements. J Med. Screen., 2017, 24(4), s. 176-181.
  24. Niedermaier, T., Weigl, K., Gies, A. et al. Accuracy of a fecal immunochemical test according to outside temperature and travel time. Clin. Epidemiol., 2018, 10, s. 1203-1213.
  25. Catomeris, P., Baxter, N. N., Boss, S. C. et al. Effect of Temperature and Time on Fecal Hemoglobin Stability in 5 Fecal Immunochemical Test Methods and One Guaiac Method. Arch. Pathol. Lab. Med., 2018, 142(1), s. 75-82.
  26. Gies, A., Cuk, K., Schrotz-King, P., Brenner, H. Direct comparison of ten quantitative fecal immuno-chemical tests for hemoglobin stability in colorectal cancer screening. Clin. Transl. Gastroenterol., 2018, 9(7), e168.
  27. Doubeni, C. A., Jensen, C. D., Fedewa, S. A. et al. Fecal Immunochemical Test (FIT) for Colon Cancer Screening: Variable Performance with Ambient Temperature. J Am. Board. Fam. Med., 2016, 29(6), s. 672-681.
  28. Piggott, C., Carroll, M. R. R., John, C. et al. Analytical evaluation of four faecal immunochemi-stry tests for haemoglobin. Clin Chem Lab Med., 2020, 59(1), s. 173-178.
  29. Gies, A., Cuk, K., Schrotz-King, P., Brenner, H. Direct Comparison of Diagnostic Performance of 9 Quantitative Fecal Immunochemical Tests for Colorectal Cancer Screening. Gastroenterology, 2018, 154(1), s. 93-104.
  30. Toes-Zoutendijk, E., van Leerdam, M. E., Dekker, E. et al. Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels. Gastroenterology, 2017, 152(4), s. 767-775.
  31. Lansdorp-Vogelaar, I. Optimal FIT Screening for Men and Women in Case of Limited Colonoscopy Capacity: A Cost-Effectiveness Analysis. WEO CRC Screening Committee, FIT for Screening, Barcelona, October 2019.
  32. de Klerk, C. M., Wieten, E., Lansdorp-Vogelaar, I. et al. Performance of two faecal immunochemical tests for the detection of advanced neoplasia at different positivity thresholds: a cross-sectional study of the Dutch national colorectal cancer screening programme. Lancet Gastroenterol. Hepatol., 2019, 4(2), s. 111-118.
  33. Haug, U. Update on CRC screening in Germany. WEO Colorectal Cancer Screening Committee, Barcelona, October 2019
  34. Závěrečná zpráva k vyhodnocení cyklu EHK FOB1/20 - Okultní krvácení. [cit. 2021-02-03]. Dostupný na www: <https://www.sekk.cz/eqa/2020/FOB120_Info.htm>
  35. Halloran, S. P., Launoy, G., Zappa, M. International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition-Faecal occult blood testing. Endoscopy, 2012, 44, Suppl 3, s. 65-87.
  36. von Karsa, L., Patnick, J., Segnan, N. et al. European Colorectal Cancer Screening Guidelines Working Group. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy, 2013, 45(1), s. 51-69.
  37. Kocna, P. Kvantitativní analýza hemoglobinu ve stolici - význam pro screening kolorektálního karcinomu. Onkologická revue, 2017, 6, s. 6-11.
  38. Fraser, C. G. Assuring the quality of examinations using faecal immunochemical tests for haemoglobin (FIT). Clin. Chem. Lab. Med., 2021, 59(2), s. 245-247.
  39. Miike, A., Ogawa, Z., Sakurabayashi, I. The development of an artificial stool usable for the surveillance of faecal haemoglobin testing. Ann. Clin. Biochem., 2018, 55(3), s. 394-399.
  40. Yasui, R., Yamada, M., Takehara, S. et al. Novel artificial stool material for external quality assurance (EQA) on a fecal immunochemical test for hemoglobin (FIT): The confirmed utility of stable hemoglobin and an internal standard material. Clin. Chim. Acta., 2018, 483, s. 76-81.
  41. Halloran, S. P. Intelligent Use of the Fecal Immunochemical Test in Population-Based Screening. Ann. Intern. Med., 2018, 169(7), s. 496-49.
  42. Kuipers, E. J., Spaander, M. C. Personalized screening for colorectal cancer. Nat. Rev. Gastroenterol. Hepatol., 2018, 15(7), s. 391-392.
  43. Arana-Arri, E., Idigoras, I., Uranga, B. et al. Population-based colorectal cancer screening programmes using a faecal immunochemical test: should faecal haemoglobin cut-offs differ by age and sex? BMC Cancer, 2017, 17(1), s. 577.
  44. Brenner, H., Qian, J., Werner, S. Variation of diagnostic performance of fecal immunochemical testing for hemoglobin by sex and age: results from a large screening cohort. Clin. Epidemiol., 2018, 10, s. 381-389.
  45. Selby, K., Jensen, C. D., Lee, J. K. et al. Influence of Varying Quantitative Fecal Immunochemi-cal Test Positivity Thresholds on Colorectal Cancer Detection: A Community-Based Cohort Study. Ann. Intern. Med., 2018, 169(7), s. 439-447.
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