两种粪便DNA检测和粪便免疫化学检测在检测结直肠肿瘤中的比较:一项多中心诊断研究。

Peng Jin, Peng You, Jingyuan Fang, Qian Kang, Fang Gu, Yunlong Cai, Huihong Zhai, Bangmao Wang, Yanqing Li, Junfeng Xu, Jiheng Wang, Yuqi He, Yang Wang, Min Dai, Jianqiu Sheng
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引用次数: 6

摘要

背景:粪便潜血检查是目前应用最广泛的大肠癌无创筛查方法。粪便DNA检测是近年来发展起来的。然而,在同一人群中对这些测试进行的直接比较分析仍然很少。方法:共有2,842名访问门诊诊所或癌症筛查中心的参与者被纳入研究。对2240名参与者进行粪便DNA测试i (KRAS、BMP3、NDRG4和血红蛋白免疫化学测试)、粪便DNA测试ii (SDC2和SFRP2测试)和粪便免疫化学测试(FIT),并以结肠镜检查为金标准。42名和302名参与者分别患有结直肠癌和晚期腺瘤(AA)。结果:粪便DNA检测- i、-II和FIT对结直肠癌的敏感性分别为90.5%、92.9%和81.0%。对晚期肿瘤的敏感性(AN;大便DNA测试i、-II和FIT分别为34.9%、42.2%和25.9%。结肠镜检查阴性的患者,粪便DNA测试i、-II和FIT的特异性分别为91.4%、93.3%和96.8%。当通过改变阈值调整FIT的特异性以匹配粪便DNA检测时,三种检测结直肠癌的灵敏度无显著差异。对于AN, FIT的敏感性高于DNA test-I,在相同特异性下与DNA test-II相似。结论:在本研究中,两种粪便DNA检测与FIT相比在检测结直肠癌或AN方面没有明显优势。影响:我们的研究结果不支持广泛使用粪便DNA测试代替FIT。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Performance of Two Stool DNA Tests and a Fecal Immunochemical Test in Detecting Colorectal Neoplasm: A Multicenter Diagnostic Study.

Background: The most widely used noninvasive screening tests for colorectal cancer are fecal occult blood tests. Stool DNA test was developed in recent years. However, direct comparative analyses of these tests within the same population are still sparse.

Methods: A total of 2,842 participants who visited outpatient clinics or cancer screening centers were enrolled. Stool DNA test-I (KRAS, BMP3, NDRG4, and hemoglobin immunochemical tests), stool DNA test-II (SDC2 and SFRP2 tests), and fecal immunochemical test (FIT) alone were performed and colonoscopy was used as the gold standard among 2,240 participants. Forty-two and 302 participants had colorectal cancer and advanced adenomas (AA), respectively.

Results: The sensitivity for colorectal cancer of stool DNA test-I, -II, and FIT was 90.5%, 92.9%, and 81.0%, respectively. The sensitivity for advanced neoplasm (AN; colorectal cancer plus AA) of stool DNA test-I, -II, and FIT was 34.9%, 42.2%, and 25.9%, respectively. The specificity of stool DNA test-I, -II, and FIT was 91.4%, 93.3%, and 96.8%, respectively, among those with negative results on colonoscopy. When the specificity of FIT was adjusted to match that of stool DNA tests by changing the threshold, no significant difference was seen in the sensitivities among the three tests for detecting colorectal cancer. For AN, the sensitivity of FIT was higher than DNA test-I and similar to DNA test-II under the same specificities.

Conclusions: There was no significant advantage of the two stool DNA tests compared with FIT in detecting colorectal cancer or AN in this study.

Impact: Our findings do not support extensive use of stool DNA tests instead of FIT.

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