Result card
|
English
No adaptation help available for this domain
|
Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cristian Vladescu
Internal reviewers: Antonio Migliore, Pernilla Östlund, Frida Mowafi, Daniela d’Angela, Jesus Gonzalez
FITs /iFOBTs are a class of faecal occult blood tests and one out of few different screening options for colorectal cancer (CRC). The aim of population-based screening for CRC is to reduce mortality through both, prevention (by the removal of adenomas) and earlier diagnosis of CRC.
Overall, the advantages of FIT in contrast to gFOBT are: specificity for human Hb, reducing the number of false positive results and no dietetic restrictions are necessary; increased sensitivity to human Hb; automated analysis and the possibility to set cut-off limits (the latter applies only to quantitative FIT tests).
According to the EU Guidelines for quality assurance in CRC screening and diagnosis (2010) {6}:
-“iFOBT have improved test characteristics than gFOBT, and they are currently the test of choice for population CRC screening. In different settings, individual device characteristics like ease of use by participant and laboratory, suitability for transport, sampling reproducibility and sample stability are important and should be all taken into account when selecting the iFOBT most appropriate for CRC screening programme (Level of evidence II, Grade of recommendation A);
-Maximum period between collection and analysis is significantly shorter than for gFOBT (14-21 days), and screening programmes should adopt the conditions and period of storage described in manufacturers. Instructions for use should be appropriate for local conditions which might expose samples to high temperatures for long period of time (Level of evidence III, Grade of recommendation A);
-The potential for dietary interference is significantly less for iFOBT. With the qualification that a diet peculiar to a particular country or culture may not have been tested or reported, dietary restriction is not indicated for programmes using either gFOBT or iFOBT (Level of evidence II, Strength of recommendation D)“.
1. Young GP, St John DJ, Winawer SJ, Rozen P. Choice of fecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organization) and OMED (World Organization for Digestive Endoscopy) report. The American journal of gastroenterology. 2002;97(10):2499-507. eng.
13. Exact Sciences Corp. Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer. [Internet]. 2013, April 18 [cited 2013 Aug 9]. Available from: http://investor.exactsciences.com/releasedetail.cfm?ReleaseID=757341.
14. ClinicalTrials.gov. Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C) [Internet]. U.S. National Institutes of Health; 2013, Jun 18 [cited 2013 Aug 9]. Available from: http://prsinfo.clinicaltrial.gov/ct2/show/record/NCT01397747?id=NCT01397747&rank=1).
17. Epigenomics AG. Epigenomics AG submits the fourth module and completes its PMA submission to the FDA for Epi proColon®. [Internet]. Epigenomics AG,; 2013, Jan 7 [cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.
18. ClinicalTrials.gov. Head to Head Study Epi proColon and FIT. [Internet]. U.S. National Institutes of Health; 2013 [updated 2013, Feb 6; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.
19. Epigenomics AG. Results of Comparative Study between Epigenomics Epi proColon® and FIT to be Presented at Digestive Disease Week. [Internet]. Epigenomics AG,; 2013, Mar 15 [updated 2011; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.