粪便高敏定量免疫化学试验和定性隐血试验对结直肠癌和进展期腺瘤的筛查价值比较

Comparative study of hypersensitive quantitative fecal immunochemical test and qualitative fecal occult blood test for colorectal cancer and advanced adenoma

目的比较高敏定量粪便免疫化学试验(hs-qFIT)和定性粪便隐血试验(FOBT)对结直肠癌和进展期腺瘤的筛查价值。方法连续纳入2020年4月至2021年4月在山东大学齐鲁医院行结肠镜检查的50~75岁的结直肠癌中高危人群,所有研究对象在结肠镜检查前完成hs-qFIT、胶体金法和免疫-化学双联法检测。通过灵敏度和特异度等指标比较hs-qFIT和2种定性FOBT检出结直肠癌和进展期腺瘤的效能。结果共纳入910例研究对象,男451例,女459例,年龄(59.6±6.4)岁。包括结直肠癌22例(2.4%)、进展期腺瘤61例(6.7%)、非进展期腺瘤276例(30.3%)、非腺瘤性息肉194例(21.3%)、其他病变85例(9.3%)和无异常272例(29.9%)。hs-qFIT检测结直肠癌的截断值从200 ng/ml降至10 ng/ml时,灵敏度从72.7%(95%CI:49.6%~88.4%)升至100%(95%CI:81.5%~100%),胶体金法和免疫-化学双联法检出结直肠癌的灵敏度均为63.6%(95%CI:40.8%~82.0%),低于hs-qFIT在10 ng/ml截断值时检出结直肠癌的灵敏度(P=0.008)。hs-qFIT检出结直肠癌的稳定性高于胶体金法(P=0.016)和免疫-化学双联法(P=0.031)。hs-qFIT在10 ng/ml时检出进展期腺瘤的灵敏度为52.5%(95%CI:39.4%~65.2%),高于胶体金法的13.1%(95%CI:6.2%~24.8%)(P<0.001)和免疫-化学双联法的6.6%(95%CI:2.1%~16.7%)(P<0.001)。结论hs-qFIT检出结直肠癌的灵敏度高于定性FOBT,且稳定性更高;使用更低浓度的截断值可提高检出进展期腺瘤的灵敏度。

Objective 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.Methods 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.Results 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%CI:49.6%-88.4%)to 100%(95%CI: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%CI:40.8%-82.0%)(P=0.008).The detection stability of hs-qFIT for colorectal cancer was higher than colloidal gold method(P=0.016)and chemical-immunization method(P=0.031).The sensitivity for detecting advanced adenoma of hs-qFIT at 10 ng/ml was 52.5%(95%CI:39.4%-65.2%),which was significantly higher than that of colloidal gold method(13.1%,95%CI:6.2%-24.8%,P<0.001)and chemical-immunization method(6.6%,95%CI:2.1%-16.7%,P<0.001).Conclusions 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.