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Disease/health condition -
Cancer
Faecal immunochemical test (FIT)
Assay format
Latex agglutination immuneturbidimetry
Information History
First added in 2019
Changed in 2020
Purpose type
Screening
Purpose
To screen for colorectal cancer.
Specimen types
Stool
WHO prequalified or recommended products
N/A
GMDN
54529
Faecal occult blood IVD, kit, agglutination
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin) using an agglutination method.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W0102039013
FECAL OCCULT BLOOD (IC)
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
Colorectal Cancer Screening IARC Handbooks of Cancer Prevention Volume 17, 2019. https://publications.iarc.who.int/Book-And-Report-Series/Iarc-Handbooks-Of-Cancer-Prevention/Colorectal-Cancer-Screening-2019
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended addition of the faecal immunochemical test (FIT) to the EDL, noting the strong evidence that it clinically supports diagnosis, resulting in reduced mortality from colorectal cancer. SAGE further recommended that a systematic review of studies comparing FIT with guaiac faecal occult blood test (gFOBT) be undertaken. Recommended test purpose: screening of colorectal cancer.
Given the strong evidence from randomized clinical trials (RCT) of the benefits of guaiac faecal occult blood test (gFOBT) in screening programmes, and the emerging evidence of the benefits of faecal immunochemical test (FIT) over gFOBT, SAGE IVD considered that the evidence is strong enough to include FIT on the EDL.
The evidence for the impact on mortality of faecal immunochemical testing (FIT) in colon cancer screening programmes is derived from observational studies (8) and not randomized clinical trials (RCT). Primary studies of the accuracy of FIT as compared to guaiac faecal occult blood test (gFOBT) indicate equivalent or better accuracy, although no systematic review of these studies has been published.
World Health Organization. (2019). The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (including the second WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/329527