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pISSN 2950-9114 eISSN 2950-9122
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Original Article

Lab Med Qual Assur 2021; 43(4): 190-198

Published online December 31, 2021


Copyright © Korean Association of External Quality Assessment Service.

Evaluation of the Cut-Off Value of Fecal Immunochemical Test for Colorectal Cancer Screening during Health Checkups

Hye-Ran Park , Eun-Hee Nah , Jong-Seon Lee , and Seon Cho

Health Promotion Research Institute, Korea Association of Health Promotion, Seoul, Korea

Correspondence to:Eun-Hee Nah
Health Promotion Research Institute, Korea Association of Health Promotion, 372 Hwagok-ro, Gangseo-gu, Seoul 07572, Korea
Tel +82-2-2600-0107
E-mail cellonah@hanmail.net

Received: July 15, 2021; Revised: August 19, 2021; Accepted: August 20, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: The fecal immunochemical test (FIT) is recommended as the first choice for mass colorectal cancer (CRC) screening in the community. The cut-off value can be adjusted according to the target population and colonoscopy resources. We aimed to compare and determine the optimal cut-off value for CRC screening to strike a balance between FIT performance and colonoscopy burden.
Methods: This cross-sectional retrospective study consecutively selected subjects who underwent health checkups including FIT and colonoscopy at 16 health-promotion centers in Korea between 2018 and 2019. FIT was performed using an OC-SENSOR PLEDIA (Eiken Chemical Co., Japan). We assessed the test performance in detecting CRC and measured the burden of colonoscopy with different cut-off values of 22 (FIT 22) ng/mL, 50 (FIT 50) ng/mL, and 100 (FIT 100) ng/mL.
Results: Among the 90,323 participants, CRC was found in 485 patients (0.54%). From FIT 22 and, FIT 50 to FIT 100, the positivity rate decreased from 4.7% and, 3.6% to 3.1%, and AUC were 0.79, 0.77, and 0.76, respectively. The sensitivity/specificity of FIT 22, FIT 50, and FIT 100 for CRC were 61.9%/95.6%, 57.3%/96.7%, and 54.0%/97.1%, respectively, and their positive predictive value/negative predictive value were 7.0%/99.8%, 8.7%/99.8%, and 9.3%/99.8%, respectively. The number of colonoscopies needed to detect one CRC for FIT 22, FIT 50, and FIT 100 were 14.3, 11.6, and 10.8, respectively.
Conclusions: This study presents cut-off values for CRC screening to strike a balance between FIT performance and colonoscopy burden, which could provide information for the cut-off of FIT for CRC in a national cancer screening program.

Keywords: Colorectal neoplasms, Fecal immunochemical test, Colonoscopy, Colonoscopy burden, Cut-off value

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