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KMID : 0985420210430040190
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Laboratory Medicine and Quality Assurance
2021 Volume.43 No. 4 p.190 ~ p.198
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Evaluation of the Cut-Off Value of Fecal Immunochemical Test for Colorectal Cancer Screening during Health Checkups
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Park Hye-Ran
Nah Eun-Hee
Lee Jong-Seon
Cho Seon
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Abstract
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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.
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KEYWORD
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Colorectal neoplasms, Fecal immunochemical test, Colonoscopy, Colonoscopy burden, Cut-off value
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