title: Automated immunochemical quantitation of haemoglobin in faeces collected on cards for screening for colorectal cancer.
abstract: BACKGROUND
  Simple card collection systems are becoming available for faecal immunochemical tests (FITs) as well as guaiac faecal occult blood tests (gFOBTs). FITs are now obtainable that allow quantitation of haemoglobin, so that the analytical detection limit can be set to give a positivity rate that is manageable in terms of the available colonoscopy. A combination of a card collection device and an automated FIT analytical system could be advantageous.
  
  
  METHODS
  The quantitation of haemoglobin in samples collected on cards with a new analytical system and the relationship between faecal haemoglobin concentration and pathology were investigated in a cohort of gFOBT-positive individuals.
  
  
  RESULTS
  All groups had large ranges of haemoglobin concentration and there was overlap between the groups. Median haemoglobin concentrations in participants with normal findings on colonoscopy (167), diverticular disease (43), hyperplastic polyps (41), low risk adenoma (63), higher risk adenoma (35) and cancer (27) were 13.5, 15.6, 16.8, 15.2, 65.6 and 168.9 ng/ml haemoglobin, respectively. Those with diverticular disease, hyperplastic polyps and low risk adenoma were not significantly different from the normal group (p>0.2), but those with higher risk adenoma had significantly higher concentrations (p<0.001), as did those with cancer (p<0.001). Receiver operating characteristic analysis demonstrates that the cut-off concentration can be set to give appropriate clinical characteristics; optimum sensitivity and specificity are achieved at 26.7 ng/ml.
  
  
  CONCLUSIONS
  The haemoglobin in faeces on simple FIT card collection devices can be immunoturbidimetrically analysed quantitatively, and the concentration relates to the presence or absence of significant neoplastic disease.
authors.affiliation: Scottish Bowel Screening Centre Laboratory, Kings Cross, Dundee DD3 8EA, UK. callum.fraser@nhs.net
authors.forename: C G
authors.initials: CG
authors.lastname: Fraser
authors.forename: C M
authors.initials: CM
authors.lastname: Mathew
authors.forename: K
authors.initials: K
authors.lastname: McKay
authors.forename: F A
authors.initials: FA
authors.lastname: Carey
authors.forename: R J C
authors.initials: RJ
authors.lastname: Steele
mesh_terms: D000236:Adenoma / Q000175:diagnosis; D000368:Aged; D003111:Colonic Polyps / Q000175:diagnosis; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D003937:Diagnosis, Differential; D004241:Diverticulum, Colon / Q000175:diagnosis; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009780:Occult Blood; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods
chemical_list: D006454:Hemoglobins