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Which Fecal Immunochemical Test Should I Choose?

Objectives: To summarize the fecal immunochemical tests (FITs) available in the United States, the 2014 pathology proficiency testing (PT) program FIT results, and the literature related to the test characteristics of FITs available in the United States to detect advanced adenomatous polyps (AAP) an...

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Autores principales: Daly, Jeanette M., Xu, Yinghui, Levy, Barcey T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5932727/
https://www.ncbi.nlm.nih.gov/pubmed/28447866
http://dx.doi.org/10.1177/2150131917705206
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author Daly, Jeanette M.
Xu, Yinghui
Levy, Barcey T.
author_facet Daly, Jeanette M.
Xu, Yinghui
Levy, Barcey T.
author_sort Daly, Jeanette M.
collection PubMed
description Objectives: To summarize the fecal immunochemical tests (FITs) available in the United States, the 2014 pathology proficiency testing (PT) program FIT results, and the literature related to the test characteristics of FITs available in the United States to detect advanced adenomatous polyps (AAP) and/or colorectal cancer (CRC). Methods: Detailed review of the Food and Drug Administration’s Clinical Laboratory Improvement Amendments (CLIA) database of fecal occult blood tests, the 2014 FIT PT program results, and the literature related to FIT accuracy. Results: A search of the CLIA database identified 65 FITs, with 26 FITs available for purchase in the United States. Thirteen of these FITs were evaluated on a regular basis by PT programs, with an overall sensitivity of 99.1% and specificity of 99.2% for samples spiked with hemoglobin. Automated FITs had better sensitivity and specificity than CLIA-waived FITs for detection of AAP and CRC in human studies using colonoscopy as the gold standard. Conclusion: Although many FITs are available in the United States, few have been tested in proficiency testing programs. Even fewer have data in humans on sensitivity and specificity for AAP or CRC. Our review indicates that automated FITs have the best test characteristics for AAP and CRC.
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spelling pubmed-59327272018-05-07 Which Fecal Immunochemical Test Should I Choose? Daly, Jeanette M. Xu, Yinghui Levy, Barcey T. J Prim Care Community Health Original Research Objectives: To summarize the fecal immunochemical tests (FITs) available in the United States, the 2014 pathology proficiency testing (PT) program FIT results, and the literature related to the test characteristics of FITs available in the United States to detect advanced adenomatous polyps (AAP) and/or colorectal cancer (CRC). Methods: Detailed review of the Food and Drug Administration’s Clinical Laboratory Improvement Amendments (CLIA) database of fecal occult blood tests, the 2014 FIT PT program results, and the literature related to FIT accuracy. Results: A search of the CLIA database identified 65 FITs, with 26 FITs available for purchase in the United States. Thirteen of these FITs were evaluated on a regular basis by PT programs, with an overall sensitivity of 99.1% and specificity of 99.2% for samples spiked with hemoglobin. Automated FITs had better sensitivity and specificity than CLIA-waived FITs for detection of AAP and CRC in human studies using colonoscopy as the gold standard. Conclusion: Although many FITs are available in the United States, few have been tested in proficiency testing programs. Even fewer have data in humans on sensitivity and specificity for AAP or CRC. Our review indicates that automated FITs have the best test characteristics for AAP and CRC. SAGE Publications 2017-04-27 2017-10 /pmc/articles/PMC5932727/ /pubmed/28447866 http://dx.doi.org/10.1177/2150131917705206 Text en © The Author(s) 2017 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research
Daly, Jeanette M.
Xu, Yinghui
Levy, Barcey T.
Which Fecal Immunochemical Test Should I Choose?
title Which Fecal Immunochemical Test Should I Choose?
title_full Which Fecal Immunochemical Test Should I Choose?
title_fullStr Which Fecal Immunochemical Test Should I Choose?
title_full_unstemmed Which Fecal Immunochemical Test Should I Choose?
title_short Which Fecal Immunochemical Test Should I Choose?
title_sort which fecal immunochemical test should i choose?
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5932727/
https://www.ncbi.nlm.nih.gov/pubmed/28447866
http://dx.doi.org/10.1177/2150131917705206
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