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Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cristian Vladescu
Internal reviewers: Antonio Migliore, Pernilla Östlund, Frida Mowafi, Daniela d’Angela, Jesus Gonzalez
iFOBTs are around 10-fold more expensive than gFOBT. In an evaluation of three automated analytical iFOB methods in the UK {5}, investments made by a laboratory for use of FIT, include:
-Analytical platforms (automated analysers): The number of analysers required will depend on the laboratory workload; number required in the evaluation for a 5,000 sample per day workload will be 1 for HemSp/MagStream HT; 5 for OC-Sensor/DIANA, and 15 SentiFOB and 1 chemistry analyser for FOB Gold/SENTiFOB. All analysers required routine prentative maintance visits (part of the service contract, annualy, but depend on the workload). All analysers required a 13 amp power suplly and purified water to wash the cuvettes (OC-Sensor/DIANA) or for preparation of wash solutions (all three) and system solution (SentiFOB). All three have RS 232-C serial interface ports.
-Sample collection devices: for OC-Sensor the faecal sample was collected into the OC-Auto sampling bottle 3; for Hem-SP/MagStream HT (MagStream Hem-Sp®) the faecal sample was collected into the NEW HEMTUBE; for the FOB Gold the faecal sample was collected into the FOB Gold tube.
- Refrigerated storage space
- Clinical waste disposal. iFOBT sample collection tubes required disposal in rigid bins to contain any liquid, which required different procedure and more manual handling.
- End of life disposal: end of life disposal of the products may have financial and/or environmental costs, depending on the regulations in place (e.g. Waste Electrical and Electronic Equipment regulation in the UK).
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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.