Accuracy of fecal occult blood screening for colorectal neoplasia. A prospective study using Hemoccult and HemoQuant tests

JAMA. 1993 Mar 10;269(10):1262-7.


Objectives: To define the validity of fecal blood as a marker for colorectal neoplasia in the screening setting and to compare yields by Hemoccult and HemoQuant fecal occult blood screening tests.

Design: A multicenter masked comparison of fecal blood test results against structural colorectal evaluations and longitudinal follow-up, serving as criterion standards, in nonreferred subjects at risk for colorectal neoplasia.

Setting: Communities, primary care centers, referral centers.

Participants: Two groups: (1) 1217 patients aged at least 18 years undergoing routine structural surveillance evaluations following curative resection of a colorectal tumor and (2) 12312 relatives of colorectal cancer patients aged at least 50 years.

Interventions: Blinded Hemoccult II and HemoQuant testing on three mailed-in stool samples per subject.

Main outcome measure: Sensitivity of fecal blood tests for colorectal neoplasia.

Results: In the postresection group, surveillance evaluations revealed 46 malignant colorectal neoplasms and 402 polyps. At matched specificity, sensitivity of either test for cancer was 26% (95% confidence interval, 13% to 39%). Hemoccult was positive in 21% of intraluminal recurrences, 33% of all new primary tumors, and 29% of Dukes A or B cancers; HemoQuant was elevated in 24%, 28%, and 29%, respectively. Sensitivity for polyps 1.0 cm or larger was 13% by Hemoccult and 11% by HemoQuant. In the group of relatives, estimated sensitivity for cancer at 1 to 3 years of follow-up was 25% to 33% by Hemoccult, not significantly different from the 29% to 43% by HemoQuant.

Conclusions: Based on our observations in the screening setting, fecal blood appears to be a poor marker for colorectal neoplasia. Most cancers and the vast majority of polyps will be missed. Hemoccult and HemoQuant are similarly insensitive.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Colorectal Neoplasms / epidemiology
  • Colorectal Neoplasms / prevention & control*
  • Humans
  • Mass Screening / methods
  • Middle Aged
  • Occult Blood*
  • Prospective Studies
  • Reagent Kits, Diagnostic
  • Risk Factors
  • Sensitivity and Specificity


  • Reagent Kits, Diagnostic