Head-to-head comparison of the test performance of selfadministered qualitative vs. laboratory-based quantitative fecal immunochemical tests in detecting colorectal neoplasm  

作　　者：Ming Lu Yu-Han Zhang Bin Lu Jie Cai Cheng-Cheng Liu Hong-Da Chen Min Dai 

机构地区：[1]Office of Cancer Screening,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China [2]Department of General Surgery,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China

出　　处：《Chinese Medical Journal》2021年第11期1335-1344,共10页中华医学杂志（英文版）

基　　金：by grants from the Cancer Foundation of China;the Beijing Nova Program of Science and Technology(No.Z191100001119065);the Natural Science Foundation of Beijing Municipality(No.7202169);the CAMS Innovation Fund for Medical Sciences(No.2017-I2M-1-006).

摘　　要：Background:Fecal immunochemical tests(FITs)are the most widely used non-invasive tests in colorectal cancer(CRC)screening.However,evidence about the direct comparison of the test performance of the self-administered qualitative a laboratory-based quantitative FITs in a CRC screening setting is sparse.Methods:Based on a CRC screening trial(TARGET-C),we included 3144 pre-colonoscopy fecal samples,including 24 CRCs,230 advanced adenomas,622 non-advanced adenomas,and 2268 participants without significant findings at colonoscopy.Three selfadministered qualitative FITs(Pupu tube)with positivity thresholds of 8.0,14.4,or 20.8 mg hemoglobin(Hb)/g preset by the manufacturer and one laboratory-based quantitative FIT(OC-Sensor)with a positivity threshold of 20 mg Hb/g recommended by the manufacturer were tested by trained staff in the central laboratory.The diagnostic performance of the FITs for detecting colorectal neoplasms was compared in the different scenarios using the preset and adjusted thresholds(for the quantitative FIT).Results:At the thresholds preset by the manufacturers,apart from the qualitative FIT-3,significantly higher sensitivities for detecting advanced adenoma were observed for the qualitative FIT-1(33.9%[95%CI:28.7–39.4%])and qualitative FIT-2(22.2%[95%CI:17.7–27.2%])compared to the quantitative FIT(11.7%[95%CI:8.4–15.8%]),while at a cost of significantly lower specificities.However,such difference was not observed for detecting CRC.For scenarios of adjusting the positivity thresholds of the quantitative FIT to yield comparable specificity or comparable positivity rate to the three qualitative FITs accordingly,there were no significant differences in terms of sensitivity,specificity,positive/negative predictive values and positive/negative likelihood ratios for detecting CRC or advanced adenoma between the two types of FITs,which was further evidenced in ROC analysis.Conclusions:Although the self-administered qualitative and the laboratory-based quantitative FITs had varied test performance at th

关 键 词：Fecal immunochemical test Test performance Colorectal neoplasm SCREENING 

分 类 号：R735.34[医药卫生—肿瘤]