Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use

  • P. R
  • D. C
  • Z. L
 et al. 
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Abstract

BACKGROUND: Quantified, human hemoglobin (Hb)-specific, immunochemical fecal occult blood test (IFOBT) measurements are now used for colorectal cancer (CRC) screening. The objective was to evaluate sensitivity and specificity for CRC and advanced adenomatous polyps (APs) by the fecal Hb threshold used to determine a positive test and the number of IFOBTs prepared per test, so as to determine the least number of colonoscopies required to detect a neoplasm. METHODS: Cumulative data were analyzed from a prospective cross-sectional double-blind study of 1682 consecutive, ambulatory, nonbleeding colonoscopy patients who volunteered for IFOBTs, most of above average risk, from 3 ambulatory-endoscopy centers. Fecal Hb was measured in 3 samples and analyzed by an automated instrument, and the highest result >50 ng Hb/mL of buffer was related to findings. RESULTS: Colonoscopy identified CRC in 20 patients and advanced APs in 129. Sensitivity for either was best when any of 3 tests had >50 ng Hb/mL of buffer; sensitivity was 61.1% (95% confidence interval [CI], 53.2-68.9), and specificity was 87.8% (95% CI, 86.2-89.4). Positive tests identified 100% of CRCs and 55% of advanced APs every 3.1 colonoscopies. Sensitivity of a single test at the commonly used 100-ng Hb/mL threshold was lower at 31.5% (95% CI, 24.1-39.0) (P

Author-supplied keywords

  • *cancer screening
  • *colorectal cancer/di [Diagnosis]
  • *hemoglobin/ec [Endogenous Compound]
  • *occult blood
  • Adenomatous Polyps
  • Colonic Polyps
  • Colonoscopy
  • Colorectal Neoplasms
  • Early Detection of Cancer
  • Hemoglobins
  • Humans
  • Immunohistochemistry
  • Middle Aged
  • Occult Blood
  • Predictive Value of Tests
  • Sensitivity and Specificity
  • adenomatous polyp
  • adult
  • aged
  • analysis
  • article
  • colonoscopy
  • diagnosis
  • female
  • follow up
  • human
  • immunochemistry
  • major clinical study
  • male
  • priority journal
  • sensitivity and specificity

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Authors

  • Rozen P.

  • Comaneshter D.

  • Levi Z.

  • Hazazi R.

  • Vilkin A.

  • Maoz E.

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