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 costeffective approach for colon cancer screening. ' 2006 Wiley-Liss, Inc.

Effect of Verification Bias on the Sensitivity of Fecal Occult Blood Testing: a Meta-Analysis

“…The studies that evaluated the standard guaiac-based FOBT that did not correct for verification bias are listed in Table 1. [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50] In the last study, the data was presented in two separate publications. These 19 studies included 713 subjects with colorectal cancer and 4181 controls.…”

“…Both control-and cancersubjects underwent a confirmatory test, usually a colonoscopy though some of the older studies also utilized barium enema and sigmoidoscopy, particularly if FOBT negative. Most studies included subjects who submitted 3 stool specimens [31][32][33][34]36,37,39,41,44,[46][47][48][49][50] while some studies included subjects who only submitted one specimen 35,42,43 or the number was not specified. 38,40,45 Almost all of the studies reported that the specimens were collected at home while one study did not specify the location.…”

“…38,40,45 Almost all of the studies reported that the specimens were collected at home while one study did not specify the location. 38 The studies listed in Table 1 recruited subjects by two methods: inclusion of patients undergoing colonoscopy for a variety of indications (e.g., FOBT positivity, GI symptoms, colon cancer screening, polyp surveillance) [31][32][33][34][35][36][37][38][39]41,[44][45][46][47] or selection of a group of known colorectal cancer patients and controls undergoing colonoscopy. 40,42,43,[48][49][50] Both of these methods contain potential verification bias as not all of the FOBT negative patients in the population underwent a confirmatory test.…”

Evaluación de dos estrategias de cribado de cáncer colorrectal: test inmunológico versus test bioquímico. Cataluña, 2008-2010

“…Respecto a los estudios que han evaluado el coste-efectividad de ambos tests, dos concluyeron que el inmunológico era, como mínimo, igual de efectivo que el guayaco pero más barato 27,28 . En otro estudio, la utilización del test inmunológico durante 20 años en un cribado bienal aumentaba 59 euros más que el guayaco por individuo y la media de la esperanza de vida en 0,0198 años, lo que corresponde a un incremento de la ratio coste-efectividad de 2.980 euros por año de vida salvada 29 .…”

Transferrin Dipstick as a Potential Novel Test for Colon Cancer Screening: A Comparative Study With Immuno Fecal Occult Blood Test

“…Fecal occult blood test, especially IFOBT, is a wellaccepted effective screening method for colorectal cancers (12)(13)(14). The main detection target in IFOBT is fecal hemoglobin.…”