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粪便 DNA 检测在结直肠癌筛查中的应用概述

A Practical Overview of the Stool DNA Test for Colorectal Cancer Screening.

机构信息

SUNY Downstate Health Sciences University, Brooklyn, New York, USA.

NYU Langone Health, VA New York Harbor Health Care System, New York, New York, USA.

出版信息

Clin Transl Gastroenterol. 2022 Apr 1;13(4):e00464. doi: 10.14309/ctg.0000000000000464.

Abstract

The multitarget stool DNA test with fecal immunochemical test (sDNA-FIT) is recommended by all major US guidelines as an option for colorectal cancer screening. It is approved by the Food and Drug Administration for use in average-risk individuals aged 45 years and older. The sDNA-FIT tests for 11 biomarkers, including point mutations in KRAS, aberrant methylation in NDRG4 and BMP3, and human hemoglobin. Patients collect a stool sample at home, send it to the manufacturer's laboratory within 1 day, and the result is reported in approximately 2 weeks. Compared with FIT, sDNA-FIT has higher sensitivity but lower specificity for colorectal cancer, which translates to a higher false-positive rate. A unique feature of sDNA-FIT is the manufacturer's comprehensive patient navigation system, which operates 24 hours a day and provides active outreach for patient education and reminders in the first month after a test is ordered. Retesting is recommended every 1-3 years, although the optimal testing interval has not yet been determined empirically. The cost of sDNA-FIT is $681 without insurance, but Medicare and most private insurers cover it with no copay or deductible.

摘要

多靶点粪便 DNA 检测结合粪便免疫化学试验(sDNA-FIT)被所有美国主要指南推荐作为结直肠癌筛查的一种选择。它已获得美国食品和药物管理局批准,可用于年龄在 45 岁及以上的一般风险人群。sDNA-FIT 检测 11 种生物标志物,包括 KRAS 点突变、NDRG4 和 BMP3 异常甲基化以及人血红蛋白。患者在家中采集粪便样本,在 1 天内将其送到制造商的实验室,大约 2 周后报告结果。与 FIT 相比,sDNA-FIT 对结直肠癌的敏感性更高,但特异性更低,这意味着假阳性率更高。sDNA-FIT 的一个独特特点是制造商的综合患者导航系统,该系统每天 24 小时运行,在检测后第一个月提供积极的患者教育和提醒。建议每 1-3 年进行一次复查,尽管尚未通过经验确定最佳检测间隔。sDNA-FIT 的费用为 681 美元,没有保险,但医疗保险和大多数私人保险公司都承保,无需自付额或免赔额。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac47/9038502/9e99584600c4/ct9-13-e00464-g001.jpg

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