尽管粪便免疫化学检测（FIT）广泛用于结直肠癌（CRC）筛查，但指导检测选择的数据有限。以结肠镜检查作为参考标准，比较 5 种常用 FIT 的性能特征。横断面研究。 （ClinicalTrials.gov：NCT03264898）。三个美国学术医疗中心和附属内窥镜检查单位。年龄在 50 至 85 岁之间接受筛查或监测结肠镜检查的患者。参与者在结肠镜检查前完成了 5 项不同的 FIT，包括 4 项定性测试（Hemocult ICT、Hemosure iFOB、 OC-Light S FIT、QuickVue iFOB）和 1 项定量测试（OC-Auto FIT，在制造商设定的阳性阈值 >100 ng/mL 下运行）。主要结果是每个测试的测试性能（灵敏度和特异性）晚期结直肠肿瘤 (ACN) 的 5 个 FIT，定义为晚期息肉或 CRC。比较阳性率、阳性和阴性预测值以及无法评估的测试率。使用多变量模型来确定影响敏感性的因素。总共纳入了 3761 名参与者，平均年龄为 62.1 岁（SD，7.8）； 63.2% 的参与者是女性，5.7% 是黑人，86.4% 是白人，28.7% 是西班牙裔。有 320 名参与者患有 ACN (8.5%)，其中 9 名参与者患有 CRC (0.2%)。 FIT 的测试阳性率相差 4 倍（3.9% 至 16.4%）。无法估价的 FIT 税率范围为 0.2% 至 2.5%。 ACN 的敏感性从 10.1% 到 36.7% 不等，特异性从 85.5% 到 96.6% 不等。除 Hemosure iFOB 和 QuickVue iFOB 之间外，FIT 之间的敏感性差异均存在统计学显着差异，并且特异性差异彼此之间均存在统计学显着差异。除了 FIT 品牌之外，ACN 的远端位置也与较高的 FIT 敏感性相关。该研究没有评估年度 FIT 的程序敏感性。尽管被视为单一类别，但 FIT 在检测 ACN 方面具有不同的测试性能，不应被视为可互换.国立卫生研究院。

Despite widespread use of fecal immunochemical tests (FITs) for colorectal cancer (CRC) screening, data to guide test selection are limited.To compare the performance characteristics of 5 commonly used FITs, using colonoscopy as the reference standard.Cross-sectional study. (ClinicalTrials.gov: NCT03264898).Three U.S. academic medical centers and affiliated endoscopy units.Patients aged 50 to 85 years undergoing screening or surveillance colonoscopy.Participants completed 5 different FITs before their colonoscopy, including 4 qualitative tests (Hemoccult ICT, Hemosure iFOB, OC-Light S FIT, QuickVue iFOB) and 1 quantitative test (OC-Auto FIT, which was run at the manufacturer's threshold for positivity of >100 ng/mL).The primary outcome was test performance (sensitivity and specificity) for each of the 5 FITs for advanced colorectal neoplasia (ACN), defined as advanced polyps or CRC. Positivity rates, positive and negative predictive values, and rates of unevaluable tests were compared. Multivariable models were used to identify factors affecting sensitivity.A total of 3761 participants were enrolled, with a mean age of 62.1 years (SD, 7.8); 63.2% of participants were female, 5.7% were Black, 86.4% were White, and 28.7% were Hispanic. There were 320 participants with ACN (8.5%), including 9 with CRC (0.2%). The test positivity rate varied 4-fold (3.9% to 16.4%) across FITs. Rates of unevaluable FITs ranged from 0.2% to 2.5%. The sensitivity for ACN varied from 10.1% to 36.7%, and specificity varied from 85.5% to 96.6%. Differences in sensitivity between FITs were all statistically significantly different except between Hemosure iFOB and QuickVue iFOB, and specificity differences were all statistically significantly different from one another. In addition to FIT brand, distal location of ACN was also associated with higher FIT sensitivity.The study did not assess the programmatic sensitivity of annual FIT.Although considered a single class, FITs have varying test performance for detecting ACN and should not be considered interchangeable.National Institutes of Health.