Fecal Immunochemical Test Positivity Thresholds: An International Survey of Population-Based Screening Programs: An International Survey of Population-Based Screening Programs
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| Titel: | Fecal Immunochemical Test Positivity Thresholds: An International Survey of Population-Based Screening Programs: An International Survey of Population-Based Screening Programs |
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| Autoren: | Young, Graeme P., Benton, Sally C., Bresalier, Robert S., Chiu, Han-Mo, Dekker, Evelien, Fraser, Callum, Frasa, Marieke A. M., Halloran, Stephen P., Hoffmeister, Michael, Parry, Susan, Selby, Kevin, Senore, Carlo, Singh, Harminder, Symonds, Erin L. |
| Quelle: | Dig Dis Sci Digestive diseases and sciences, vol. 70, no. 5, pp. 1637-1645 |
| Verlagsinformationen: | Springer Science and Business Media LLC, 2024. |
| Publikationsjahr: | 2024 |
| Schlagwörter: | Non-invasive screening tests, Population screening, Humans, Colorectal Neoplasms/diagnosis, Hemoglobins/analysis, Feces/chemistry, Occult Blood, Early Detection of Cancer/methods, Mass Screening/methods, Immunochemistry, Colorectal cancer, Positivity threshold, Quantitative fecal immunochemical test, Screening program outcomes, Review |
| Beschreibung: | The fecal immunochemical test for hemoglobin (FIT) is now a widely used non-invasive test in population-based organized screening programs for colorectal neoplasia. The positivity thresholds of tests currently in use are based on the fecal hemoglobin concentration (f-Hb), but the rationale for the adopted thresholds are not well documented. To understand current global usage of FIT in screening programs we conducted an international survey of the brands of FIT used, the f-Hb positivity threshold applied and the rationale for the choice.All members of the World Endoscopy Organization CRC Screening Committee were invited to complete an eight-element initial electronic survey exploring the key aims. Responses were obtained from 63 individuals, representing 38 specific locations in 28 countries. A follow-up survey on technical issues was offered to the 38 locations, with replies from 17 sites in 13 countries.In-use quantitative FIT were provided by four main manufacturers; Minaris Medical (2 countries), Eiken Chemical Company/Polymedco (21), Alfresa Pharma (2) and Sentinel Diagnostics (4). Of the 38 screening sites, 15 used the threshold of 20 µg hemoglobin/g feces, while thresholds ranged between 8.5 and 120 ug/g in the remainder. Seven explanations were given for adopted FIT thresholds; maximizing the sensitivity for colorectal neoplasia (n = 23) was the most common followed by the availability of colonoscopy resources (n = 18). Predictive value, specificity, and cost effectiveness were less frequently reported as the rationale. Nine sites found it necessary to change the threshold that they had initially selected.This international survey has documented the wide range of FIT positivity thresholds that are in current use. Quantitative FITs enable programs to achieve the desired program outcomes within available resource constraints by adjusting the positivity threshold. This supports the need for enabling positivity threshold adjustment of emerging new screening tests based on novel predictive biomarkers, rather than providing inflexible test endpoints. |
| Publikationsart: | Article Other literature type Review |
| Dateibeschreibung: | application/pdf |
| Sprache: | English |
| ISSN: | 1573-2568 0163-2116 |
| DOI: | 10.1007/s10620-024-08664-7 |
| Zugangs-URL: | https://pubmed.ncbi.nlm.nih.gov/39528850 https://pure.amsterdamumc.nl/en/publications/b1518393-dec7-4f81-8a53-72433ecb9655 https://doi.org/10.1007/s10620-024-08664-7 http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_FDEB25637DAC8 https://serval.unil.ch/notice/serval:BIB_FDEB25637DAC https://serval.unil.ch/resource/serval:BIB_FDEB25637DAC.P001/REF.pdf |
| Rights: | CC BY NC CC BY URL: http://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (http://creativecommons.org/licenses/by-nc/4.0/) . |
| Dokumentencode: | edsair.doi.dedup.....6c81a4b0e1679b80131f61e47dca418b |
| Datenbank: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstract: | The fecal immunochemical test for hemoglobin (FIT) is now a widely used non-invasive test in population-based organized screening programs for colorectal neoplasia. The positivity thresholds of tests currently in use are based on the fecal hemoglobin concentration (f-Hb), but the rationale for the adopted thresholds are not well documented. To understand current global usage of FIT in screening programs we conducted an international survey of the brands of FIT used, the f-Hb positivity threshold applied and the rationale for the choice.All members of the World Endoscopy Organization CRC Screening Committee were invited to complete an eight-element initial electronic survey exploring the key aims. Responses were obtained from 63 individuals, representing 38 specific locations in 28 countries. A follow-up survey on technical issues was offered to the 38 locations, with replies from 17 sites in 13 countries.In-use quantitative FIT were provided by four main manufacturers; Minaris Medical (2 countries), Eiken Chemical Company/Polymedco (21), Alfresa Pharma (2) and Sentinel Diagnostics (4). Of the 38 screening sites, 15 used the threshold of 20 µg hemoglobin/g feces, while thresholds ranged between 8.5 and 120 ug/g in the remainder. Seven explanations were given for adopted FIT thresholds; maximizing the sensitivity for colorectal neoplasia (n = 23) was the most common followed by the availability of colonoscopy resources (n = 18). Predictive value, specificity, and cost effectiveness were less frequently reported as the rationale. Nine sites found it necessary to change the threshold that they had initially selected.This international survey has documented the wide range of FIT positivity thresholds that are in current use. Quantitative FITs enable programs to achieve the desired program outcomes within available resource constraints by adjusting the positivity threshold. This supports the need for enabling positivity threshold adjustment of emerging new screening tests based on novel predictive biomarkers, rather than providing inflexible test endpoints. |
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| ISSN: | 15732568 01632116 |
| DOI: | 10.1007/s10620-024-08664-7 |