title: Fecal immunochemical test accuracy in average-risk colorectal cancer screening.
abstract: OBJECTIVE
  To assess the fecal immunochemical test (FIT) accuracy for colorectal cancer (CRC) and advanced neoplasia (AN) detection in CRC screening.
  
  
  METHODS
  We performed a multicentric, prospective, double blind study of diagnostic tests on asymptomatic average-risk individuals submitted to screening colonoscopy. Two stool samples were collected and the fecal hemoglobin concentration was determined in the first sample (FIT1) and the highest level of both samples (FITmax) using the OC-sensor™. Areas under the curve (AUC) for CRC and AN were calculated. The best FIT1 and FITmax cut-off values for CRC were determined. At this threshold, number needed to scope (NNS) to detect a CRC and an AN and the cost per lesion detected were calculated.
  
  
  RESULTS
  About 779 individuals were included. An AN was found in 97 (12.5%) individuals: a CRC in 5 (0.6%) and an advanced adenoma (≥ 10 mm, villous histology or high grade dysplasia) in 92 (11.9%) subjects. For CRC diagnosis, FIT1 AUC was 0.96 (95%CI: 0.95-0.98) and FITmax AUC was 0.95 (95%CI: 0.93-0.97). For AN, FIT1 and FITmax AUC were similar (0.72, 95%CI: 0.66-0.78 vs 0.73, 95%CI: 0.68-0.79, respectively, P = 0.34). Depending on the number of determinations and the positivity threshold cut-off used sensitivity for AN detection ranged between 28% and 42% and specificity between 91% and 97%. At the best cut-off point for CRC detection (115 ng/mL), the NNS to detect a CRC were 10.2 and 15.8; and the cost per CRC was 1814€ and 2985€ on FIT1 and FITmax strategies respectively. At this threshold the sensitivity, NNS and cost per AN detected were 30%, 1.76, and 306€, in FIT1 strategy, and 36%, 2.26€ and 426€, in FITmax strategy, respectively.
  
  
  CONCLUSIONS
  Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Vicent
authors.initials: V
authors.lastname: Hernandez
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Cubiella
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: M Carmen
authors.initials: MC
authors.lastname: Gonzalez-Mao
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Iglesias
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Concepción
authors.initials: C
authors.lastname: Rivera
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: M Begoña
authors.initials: MB
authors.lastname: Iglesias
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Lucía
authors.initials: L
authors.lastname: Cid
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Ines
authors.initials: I
authors.lastname: Castro
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Luisa
authors.initials: L
authors.lastname: de Castro
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Vega
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Jose Antonio
authors.initials: JA
authors.lastname: Hermo
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Macenlle
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Martínez-Turnes
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Martínez-Ares
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Pamela
authors.initials: P
authors.lastname: Estevez
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Estela
authors.initials: E
authors.lastname: Cid
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: M Carmen
authors.initials: MC
authors.lastname: Vidal
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Angeles
authors.initials: A
authors.lastname: López-Martínez
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Hijona
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Herreros-Villanueva
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Bujanda
authors.affiliation: Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.
authors.forename: Jose Ignacio
authors.initials: JI
authors.lastname: Rodriguez-Prada
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D014408:Biomarkers, Tumor / Q000032:analysis*; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000191:economics / Q000378:metabolism* / Q000473:pathology; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000191:economics / Q000379:methods*; D005243:Feces / Q000737:chemistry*; D017048:Health Care Costs; D006801:Humans; D007150:Immunohistochemistry / Q000191:economics; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012372:ROC Curve; D013030:Spain
chemical_list: D014408:Biomarkers, Tumor
keywords: Adenoma; Colorectal neoplasms; Cost-benefit analysis; Early detection of cancer; Occult blood; Sensitivity and specificity