SUNY Downstate Health Sciences University, Brooklyn, New York, USA.
NYU Langone Health, VA New York Harbor Health Care System, New York, New York, USA.
Clin Transl Gastroenterol. 2022 Apr 1;13(4):e00464. doi: 10.14309/ctg.0000000000000464.
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.
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。