aKey Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Key Laboratory of Molecular Biology in Medical Sciences, Cancer Institute, The Second Affiliated Hospital, Zhejiang University School of Medicine bJiashan Institute of Cancer Prevention and Treatment, Zhejiang Province, China.
Eur J Cancer Prev. 2014 Jan;23(1):27-34. doi: 10.1097/CEJ.0b013e328364f229.
The aim of this study was to evaluate the performance of qualitative and quantitative fecal immunochemical tests (FITs) in population screening for colorectal neoplasm. A total of 9000 participants aged between 40 and 74 years were enrolled in this study. Each participant received two stool sampling tubes and was asked to simultaneously submit two stool samples from the same bowel movement. The stool samples of each participant were tested using an immunogold labeling FIT dipstick (qualitative FIT) and an automated fecal blood analyzer (quantitative FIT). Colonoscopy was performed for those who test positive in either FIT. The positive predictive values and population detection rates of the FITs for predicting colorectal neoplasm were compared. A total of 6494 (72.16%) participants simultaneously submitted two stool samples. The diagnostic consistency for a positive result between quantitative and qualitative FITs was poor (κ=0.278, 95% confidence interval=0.223-0.333). The positive predictive values of the quantitative FIT were significantly higher than those of the qualitative FIT for predicting large (≥1 cm) adenomas (23 cases, 14.29% and 16 cases, 6.72%, P=0.013) and colorectal cancer (10 cases, 6.21% and 5 cases, 2.10%, P=0.034); however, the population detection rate for advanced neoplasm of the quantitative FIT was not significantly different from that of the qualitative FIT. Quantitative FIT is superior to qualitative FIT in predicting advanced colorectal neoplasm during colorectal cancer screening. Further studies are needed to elucidate the causes of the predictive superiority.
本研究旨在评估定性和定量粪便免疫化学检测(FIT)在结直肠肿瘤人群筛查中的性能。共有 9000 名年龄在 40 至 74 岁之间的参与者参加了这项研究。每位参与者都收到了两个粪便采样管,并被要求同时提交来自同一粪便的两份粪便样本。每位参与者的粪便样本均使用免疫胶体金标记 FIT 试纸条(定性 FIT)和自动粪便血液分析仪(定量 FIT)进行检测。对于 FIT 检测阳性的患者进行结肠镜检查。比较了 FIT 检测预测结直肠肿瘤的阳性预测值和人群检出率。共有 6494 名(72.16%)参与者同时提交了两份粪便样本。定量和定性 FIT 检测阳性结果的诊断一致性较差(κ=0.278,95%置信区间=0.223-0.333)。定量 FIT 预测大(≥1cm)腺瘤(23 例,14.29%和 16 例,6.72%,P=0.013)和结直肠癌(10 例,6.21%和 5 例,2.10%,P=0.034)的阳性预测值显著高于定性 FIT;然而,定量 FIT 检测晚期结直肠肿瘤的人群检出率与定性 FIT 无显著差异。定量 FIT 在预测结直肠癌筛查中晚期结直肠肿瘤方面优于定性 FIT。需要进一步的研究来阐明预测优势的原因。