title: New immunochemical fecal occult blood test with two-consecutive stool sample testing is a cost-effective approach for colon cancer screening: results of a prospective multicenter study in Chinese patients.
abstract: The purpose of the study is to evaluate a new immunochemical fecal occult blood test method (Hemosure IFOBT), and compare it to the Guaiac-based chemical method (CFOBT) for colorectal cancer detection. A hypothetical sequential method (SFOBT), in which IFOBT was used only as a confirmatory test for CFOBT, was also evaluated. A total of 324 patients were recruited from 5 major hospitals in Beijing, China. For each patient, 3 consecutive stool samples were collected for simultaneous CFOBT and IFOBT tests, followed by colonoscopic examination. We compared the sensitivity and specificity of the 3 methods (CFOBT, IFOBT and SFOBT) in two settings, with the first 2 consecutive samples versus all 3 samples. Although the sensitivity for the detection of cancer and large (>20 mm) or multiple adenoma was similar for all 3 methods in the three-sample setting, in the two-sample setting IFOBT had higher sensitivity than SFOBT for detecting cancer (87.8% vs. 75.5%, respectively, p < 0.05) and large (>20 mm) or multiple adenomas (65.4% vs. 42.3%, respectively, p < 0.05). The IFOBT also had a higher specificity than the CFOBT (89.2% vs. 75.5%, respectively, p < 0.01) in "normal" individuals defined by colonoscopy in the three-sample setting. Comparing two-sample setting to the three-sample setting, both CFOBT and SFOBT showed significant loss of sensitivity for the detection of cancer as well as adenoma, whereas the sensitivity for IFOBT did not change significantly. Overall, IFOBT with two-sample testing showed compatible sensitivity and specificity to the three-sample testing, and had a lower relative cost per cancer detected than the three-sample testing. In conclusion, the new Hemosure IFOBT with two consecutive stool samples appears to be the most cost-effective approach for colon cancer screening.
authors.affiliation: Department of Gastroenterology, Beijing Army General Hospital, People's Republic of China. lishirong@263.sina.com
authors.forename: Shirong
authors.initials: S
authors.lastname: Li
authors.forename: Huahong
authors.initials: H
authors.lastname: Wang
authors.forename: Jichun
authors.initials: J
authors.lastname: Hu
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.forename: Yulan
authors.initials: Y
authors.lastname: Liu
authors.forename: Zitao
authors.initials: Z
authors.lastname: Wu
authors.forename: Yue
authors.initials: Y
authors.lastname: Zheng
authors.forename: Honghua
authors.initials: H
authors.lastname: Wang
authors.forename: Kai
authors.initials: K
authors.lastname: Wu
authors.forename: Hui
authors.initials: H
authors.lastname: Ye
authors.forename: Jianyu
authors.initials: J
authors.lastname: Rao
mesh_terms: D000236:Adenoma / Q000175:diagnosis / Q000191:economics; D000328:Adult; D000368:Aged; D002681:China / Q000453:epidemiology; D003110:Colonic Neoplasms / Q000175:diagnosis* / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control; D003113:Colonoscopy; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000191:economics* / Q000379:methods*; D008875:Middle Aged; D009780:Occult Blood; D012680:Sensitivity and Specificity