Colocare self-test versus Hemoccult II Sensa for fecal occult blood testing.

OBJECTIVES

To compare the efficacy of ColoCARE Self-Test pads against Hemooccult II SENSA, a traditional guaiac-based card test, in the screening for colorectal neoplasia.

METHODS

Prospective crossover analysis of 102 high-risk patients for screening of colorectal neoplasia with fecal occult blood testing, using ColoCARE Self-Test pads and Hemoccult II SENSA cards.

RESULTS

Sixty-eight of the 102 patients (67%) had colorectal lesions diagnosed at colonoscopy. Of this group, 55 patients (81%) had either a polyp or cancer diagnosed at colonoscopy, with 13 of these 55 patients having polyps > or = 1 cm. ColoCARE detected 21% of all lesions, compared with 72% for Hemoccult II SENSA. ColoCARE detected only 16% of cases involving either a cancer or a polyp, and 24% of cases involving either a cancer or polyp > or = 1 cm in size. This compares with 75% and 95%, respectively, for Hemoccult II SENSA. Significantly more patients preferred ColoCARE (84%) to Hemoccult II SENSA (5%) (p < 0.00001), and patients found it easier to use ColoCARE (p < 0.01). However, 33% of patients did not feel comfortable interpreting the ColoCARE results, and 29% found it difficult to interpret the color change.

CONCLUSION

These results indicate that patients may prefer the simplicity and convenience of ColoCARE; however, the test is not sensitive for the detection of colorectal neoplasia. Furthermore, patients do not feel comfortable interpreting ColoCARE results and prefer to have fecal occult blood testing interpreted by medical personnel.