Barcey T Levy, Yinghui Xu, Jeanette M Daly, Richard M Hoffman, Jeffrey D Dawson, Navkiran K Shokar, Marc J Zuckerman, Jennifer Molokwu, Daniel S Reuland, Seth D Crockett
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(ClinicalTrials.gov: NCT03264898).</p><p><strong>Setting: </strong>Three U.S. academic medical centers and affiliated endoscopy units.</p><p><strong>Participants: </strong>Patients aged 50 to 85 years undergoing screening or surveillance colonoscopy.</p><p><strong>Intervention: </strong>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).</p><p><strong>Measurements: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Limitation: </strong>The study did not assess the programmatic sensitivity of annual FIT.</p><p><strong>Conclusion: </strong>Although considered a single class, FITs have varying test performance for detecting ACN and should not be considered interchangeable.</p><p><strong>Primary funding source: </strong>National Institutes of Health.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":null,"pages":null},"PeriodicalIF":19.6000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Performance of Common Fecal Immunochemical Tests : A Cross-Sectional Study.\",\"authors\":\"Barcey T Levy, Yinghui Xu, Jeanette M Daly, Richard M Hoffman, Jeffrey D Dawson, Navkiran K Shokar, Marc J Zuckerman, Jennifer Molokwu, Daniel S Reuland, Seth D Crockett\",\"doi\":\"10.7326/M24-0080\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Despite widespread use of fecal immunochemical tests (FITs) for colorectal cancer (CRC) screening, data to guide test selection are limited.</p><p><strong>Objective: </strong>To compare the performance characteristics of 5 commonly used FITs, using colonoscopy as the reference standard.</p><p><strong>Design: </strong>Cross-sectional study. 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引用次数: 0
摘要
背景：尽管粪便免疫化学检验（FIT）被广泛用于结直肠癌（CRC）筛查，但用于指导检验选择的数据却很有限：以结肠镜检查为参考标准，比较 5 种常用粪便免疫化学检验的性能特点：设计：横断面研究。(设计：横断面研究（ClinicalTrials.gov：NCT03264898）：三家美国学术医疗中心及附属内镜室：干预措施：干预措施：参与者在结肠镜检查前完成 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，以制造商规定的阳性阈值 >100 ng/mL）：主要结果是 5 种 FIT 检测晚期结直肠肿瘤（ACN）（定义为晚期息肉或 CRC）的性能（灵敏度和特异性）。比较了阳性率、阳性预测值和阴性预测值以及无效检验率。使用多变量模型确定影响灵敏度的因素：共有 3761 名参与者登记，平均年龄为 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。有 320 名参与者患有 ACN（8.5%），其中 9 人患有 CRC（0.2%）。不同 FIT 的检测阳性率相差 4 倍（3.9% 到 16.4%）。无价值的 FIT 比率从 0.2% 到 2.5% 不等。ACN 的灵敏度从 10.1% 到 36.7% 不等，特异性从 85.5% 到 96.6% 不等。除 Hemosure iFOB 和 QuickVue iFOB 外，其他 FIT 之间的灵敏度差异均有显著的统计学差异，特异性差异均有显著的统计学差异。除 FIT 品牌外，ACN 的远端位置也与较高的 FIT 敏感性有关：局限性：该研究没有评估年度 FIT 的项目敏感性：结论：尽管FIT被认为是一个单一的类别，但其检测ACN的测试性能各不相同，因此不应被认为是可以互换的：主要资金来源：美国国立卫生研究院。
Comparative Performance of Common Fecal Immunochemical Tests : A Cross-Sectional Study.
Background: Despite widespread use of fecal immunochemical tests (FITs) for colorectal cancer (CRC) screening, data to guide test selection are limited.
Objective: To compare the performance characteristics of 5 commonly used FITs, using colonoscopy as the reference standard.
Setting: Three U.S. academic medical centers and affiliated endoscopy units.
Participants: Patients aged 50 to 85 years undergoing screening or surveillance colonoscopy.
Intervention: 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).
Measurements: 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.
Results: 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.
Limitation: The study did not assess the programmatic sensitivity of annual FIT.
Conclusion: Although considered a single class, FITs have varying test performance for detecting ACN and should not be considered interchangeable.
Primary funding source: National Institutes of Health.
期刊介绍：
Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.
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