University of Iowa Carver College of Medicine; University of Iowa College of Public Health; and Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa (B.T.L.).
University of Iowa Carver College of Medicine, Iowa City, Iowa (Y.X., J.M.D.).
Ann Intern Med. 2024 Oct;177(10):1350-1360. doi: 10.7326/M24-0080. Epub 2024 Sep 3.
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.
尽管粪便免疫化学检测（FIT）广泛用于结直肠癌（CRC）筛查，但用于指导检测选择的数据有限。
使用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）。
美国 3 家学术医疗中心及其附属内镜单位。
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 种不同的 FIT，包括 4 种定性检测（Hemoccult ICT、Hemosure iFOB、OC-Light S FIT、QuickVue iFOB）和 1 种定量检测（OC-Auto FIT，制造商的阳性阈值为 >100ng/mL）。
主要结局是 5 种 FIT 检测高级结直肠腺瘤（ACN）的性能（敏感性和特异性），定义为高级息肉或 CRC。比较了阳性率、阳性和阴性预测值以及未评估试验的发生率。使用多变量模型确定影响敏感性的因素。
共纳入 3761 名参与者，平均年龄 62.1 岁（SD，7.8）；63.2%的参与者为女性，5.7%为黑人，86.4%为白人，28.7%为西班牙裔。320 名参与者患有 ACN（8.5%），其中 9 名患有 CRC（0.2%）。FIT 的检测阳性率差异高达 4 倍（3.9%至 16.4%）。未评估的 FIT 率范围为 0.2%至 2.5%。ACN 的敏感性为 10.1%至 36.7%，特异性为 85.5%至 96.6%。FIT 之间的敏感性差异均具有统计学意义，除了 Hemosure iFOB 和 QuickVue iFOB 之间，特异性差异也均具有统计学意义。除了 FIT 品牌外，ACN 的远端位置也与更高的 FIT 敏感性相关。
该研究未评估年度 FIT 的计划敏感性。
尽管被认为是单一类别，但 FIT 对检测 ACN 的检测性能各不相同，不应被视为可互换。
美国国立卫生研究院。
