Zhou R C, Wang P Z, Ma M J, Meng F Y, Li Y Y, Zhang Y, Yang X Y, Li Y Q, Zuo X L
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan 250012, China.
Zhonghua Yi Xue Za Zhi. 2022 Dec 13;102(46):3667-3672. doi: 10.3760/cma.j.cn112137-20220330-00663.
To evaluate the screening performance of hypersensitive quantitative fecal immunochemical test (hs-qFIT) and qualitative fecal occult blood test (FOBT) for colorectal cancer and advanced adenoma. Consecutive participants scheduled to undergo colonoscopy from April 2020 to April 2021 in Qilu Hospital of Shandong University were included in the study. All the participants were 50-75 years old and at moderate to high risk for colorectal cancer. Participants completed hs-qFIT and two kinds of qualitative FOBTs (colloidal gold method and chemical-immunization method) before colonoscopy. The sensitivities and specificities of hs-qFIT and two qualitative FOBTs for colorectal cancer and advanced adenoma were compared. A total of 910 participants were enrolled in the study, including 451 males and 459 females, aged (59.6±6.4) years. There were 22 cases (2.4%) of colorectal cancer, 61 cases (6.7%) of advanced adenoma, 276 cases (30.3%) of non-advanced adenoma, 194 cases (21.3%) of non-adenomatous polyp, 85 cases (9.3%) of other colorectal lesion and 272 cases (29.9%) of non-colorectal lesion. The sensitivities of hs-qFIT for detecting colorectal cancer increased from 72.7% (95%: 49.6%-88.4%) to 100% (95%: 81.5%-100%) with cut-off value decreasing from 200 ng/ml to 10 ng/ml, and the sensitivities of both colloidal gold method and chemical-immunization method were 63.6% (95%: 40.8%-82.0%) (=0.008). The detection stability of hs-qFIT for colorectal cancer was higher than colloidal gold method (=0.016) and chemical-immunization method (=0.031). The sensitivity for detecting advanced adenoma of hs-qFIT at 10 ng/ml was 52.5% (95%: 39.4%-65.2%), which was significantly higher than that of colloidal gold method (13.1%, 95%: 6.2%-24.8%, <0.001) and chemical-immunization method (6.6%, 95%: 2.1%-16.7%, <0.001). The sensitivity and detection stability of hs-qFIT for detecting colorectal cancer was higher than qualitative FOBT. Moreover, the sensitivity for detecting advanced adenoma can be further improved using a lower cut-off value.
评估高敏定量粪便免疫化学检测（hs-qFIT）和定性粪便潜血试验（FOBT）对结直肠癌和进展期腺瘤的筛查性能。纳入2020年4月至2021年4月在山东大学齐鲁医院计划接受结肠镜检查的连续参与者。所有参与者年龄在50 - 75岁之间，患结直肠癌的风险为中到高。参与者在结肠镜检查前完成hs-qFIT和两种定性FOBT（胶体金法和化学免疫法）。比较hs-qFIT和两种定性FOBT对结直肠癌和进展期腺瘤的敏感性和特异性。本研究共纳入910名参与者，其中男性451名，女性459名，年龄（59.6±6.4）岁。有22例（2.4%）结直肠癌，61例（6.7%）进展期腺瘤，276例（30.3%）非进展期腺瘤，194例（21.3%）非腺瘤性息肉，85例（9.3%）其他结直肠病变和272例（29.9%）非结直肠病变。hs-qFIT检测结直肠癌的敏感性随着临界值从200 ng/ml降至10 ng/ml从72.7%（95%：49.6% - 88.4%）增至100%（95%：81.5% - 100%），胶体金法和化学免疫法的敏感性均为63.6%（95%：40.8% - 82.0%）（P = 0.008）。hs-qFIT检测结直肠癌的稳定性高于胶体金法（P = 0.016）和化学免疫法（P = 0.031）。hs-qFIT在10 ng/ml时检测进展期腺瘤的敏感性为52.5%（95%：39.4% - 65.2%），显著高于胶体金法（13.1%，95%：6.2% - 24.8%，P < 0.001）和化学免疫法（6.6%，95%：2.1% - 16.7%，P < 0.001）。hs-qFIT检测结直肠癌的敏感性和稳定性高于定性FOBT。此外，使用更低的临界值可进一步提高检测进展期腺瘤的敏感性。
