Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and Regenstrief Institute, Indianapolis, Indiana (T.F.I.).
Regenstrief Institute, Indianapolis, Indiana (R.N.G.).
Ann Intern Med. 2019 Mar 5;170(5):319-329. doi: 10.7326/M18-2390. Epub 2019 Feb 26.
Studies report inconsistent performance of fecal immunochemical tests (FITs) for colorectal cancer (CRC) and advanced adenomas.
To summarize performance characteristics of FITs for CRC and advanced adenomas in average-risk persons undergoing screening colonoscopy (reference standard) and to identify factors affecting these characteristics.
Ovid MEDLINE, PubMed, Embase, and the Cochrane Library from inception through October 2018; reference lists of studies and reviews.
Two reviewers independently screened records to identify published English-language prospective or retrospective observational studies that evaluated FIT sensitivity and specificity for colonoscopic findings in asymptomatic, average-risk adults.
Two authors independently extracted data and evaluated study quality.
Thirty-one studies (120 255 participants; 18 FITs) were included; all were judged to have low to moderate risk of bias. Performance characteristics depended on the threshold for a positive result. A threshold of 10 µg/g resulted in sensitivity of 0.91 (95% CI, 0.84 to 0.95) and a negative likelihood ratio of 0.10 (CI, 0.06 to 0.19) for CRC, whereas a threshold of greater than 20 µg/g resulted in specificity of 0.95 (CI, 0.94 to 0.96) and a positive likelihood ratio of 15.49 (CI, 9.82 to 22.39). For advanced adenomas, sensitivity was 0.40 (CI, 0.33 to 0.47) and the negative likelihood ratio was 0.67 (CI, 0.57 to 0.78) at 10 µg/g, and specificity was 0.95 (CI, 0.94 to 0.96) and the positive likelihood ratio was 5.86 (CI, 3.77 to 8.97) at greater than 20 µg/g. Studies had low to high heterogeneity, depending on the threshold. Although several FITs had adequate performance, sensitivity and specificity for CRC for 1 qualitative FIT were 0.90 and 0.91, respectively, at its single threshold of 10 µg/g; positive and negative likelihood ratios were 10.13 and 0.11, respectively. Comparison of 3 FITs at 3 thresholds was inconclusive: CIs overlapped, and the comparisons were across rather than within studies.
Only English-language studies were included. Incomplete reporting limited quality assessment of some evidence. Performance characteristics are for 1-time rather than serial testing.
Single-application FITs have moderate to high sensitivity and specificity for CRC, depending on the positivity threshold. Sensitivity of 1-time testing for advanced adenomas is low, regardless of the threshold.
Department of Medicine, Indiana University School of Medicine.
研究报告表明粪便免疫化学检测（FIT）在结直肠癌（CRC）和高级腺瘤中的表现不一致。
总结平均风险人群接受筛查性结肠镜检查（参考标准）时 FIT 检测 CRC 和高级腺瘤的性能特征，并确定影响这些特征的因素。
从 Ovid MEDLINE、PubMed、Embase 和 Cochrane 图书馆检索至 2018 年 10 月的数据；研究和综述的参考文献列表。
两位评审员独立筛选记录，以确定发表的评估无症状、平均风险成年人结肠镜检查结果的 FIT 敏感性和特异性的前瞻性或回顾性观察性研究。
两位作者独立提取数据并评估研究质量。
纳入 31 项研究（120 255 名参与者；18 种 FIT）；所有研究均被判定为低至中度偏倚风险。性能特征取决于阳性结果的阈值。阳性结果阈值为 10 µg/g 时，FIT 检测 CRC 的敏感性为 0.91（95%CI，0.84 至 0.95），阴性似然比为 0.10（CI，0.06 至 0.19）；阳性结果阈值大于 20 µg/g 时，FIT 检测 CRC 的特异性为 0.95（CI，0.94 至 0.96），阳性似然比为 15.49（CI，9.82 至 22.39）。高级腺瘤的敏感性为 0.40（CI，0.33 至 0.47），阴性似然比为 0.67（CI，0.57 至 0.78），阳性结果阈值为 10 µg/g；特异性为 0.95（CI，0.94 至 0.96），阳性似然比为 5.86（CI，3.77 至 8.97），阳性结果阈值大于 20 µg/g。研究存在低至高异质性，取决于阈值。尽管几种 FIT 具有较好的性能，但 1 种定性 FIT 的 CRC 检测的敏感性和特异性分别为 0.90 和 0.91，阳性结果阈值为 10 µg/g；阳性和阴性似然比分别为 10.13 和 0.11。对 3 种 FIT 在 3 个阈值的比较尚无定论：CI 重叠，且比较是在不同研究之间进行的，而非在同一研究内进行。
仅纳入了英语语言的研究。有限的报告导致对某些证据的质量评估不完整。性能特征是针对单次检测，而非连续检测。
单次应用 FIT 检测 CRC 的敏感性和特异性具有中高度，取决于阳性结果的阈值。无论阈值如何，单次检测高级腺瘤的敏感性均较低。
印第安纳大学医学院医学系。
