title: A new immunological test strip device for the rapid, qualitative detection of faecal occult blood.
abstract: OBJECTIVE
  Guaiac tests for faecal occult blood are still the most commonly performed screening procedure for colorectal cancer. Because both sensitivity and specificity of faecal occult blood testing are critical to cost-effective colorectal cancer screening programs, we investigated a rapid immunological test strip device for bedside detection of faecal occult blood.
  
  
  METHODS
  Stool specimen from 100 patients were chosen for this study based on the presence (n = 50) or absence (n = 50) of faecal occult blood as measured with a human haemoglobin ELISA (cut-off level </= 10 micro g Hb/g stool). All specimens were analysed for faecal occult blood by a guaiac test (Hemocare) and an immunological test strip device (Prevent ID CC).
  
  
  RESULTS
  Sensitivity and specificity of the immunological faecal occult blood test strip device were 76 % and 92 %, compared to 30 % and 90 % for the guaiac test. Increasing the cut-off level of the haemoglobin ELISA to </= 20 micro g Hb/g stool, the corresponding sensitivity and specificity were 86 % and 83 % for the immunological test strip device and 42 % and 92 % for the guaiac faecal occult blood test, respectively. The highest positive predictive value was achieved with the immunological test strip device.
  
  
  CONCLUSIONS
  The new immunological test strip device is more sensitive than a guaiac test for the detection of faecal occult blood, whereas the specificity of both tests was comparable. However, the clinical validity of this new immunological faecal occult blood test strip device for colorectal cancer screening has to be established, yet.
authors.affiliation: Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe Universität, Frankfurt, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Trojan
authors.forename: N
authors.initials: N
authors.lastname: Povse
authors.forename: O
authors.initials: O
authors.lastname: Schröder
authors.forename: J
authors.initials: J
authors.lastname: Stein
mesh_terms: D015179:Colorectal Neoplasms / Q000175:diagnosis; D004797:Enzyme-Linked Immunosorbent Assay; D006138:Guaiac; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007118:Immunoassay; D009780:Occult Blood; D011237:Predictive Value of Tests; D011934:Reagent Strips; D012680:Sensitivity and Specificity
chemical_list: D006454:Hemoglobins; D011934:Reagent Strips; D006138:Guaiac