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2009 Program and Abstracts: Experience with An Alternate Wipe Guaiac Fecal Occult Blood Test in a National Bowel Screening Program
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Experience with An Alternate Wipe Guaiac Fecal Occult Blood Test in a National Bowel Screening Program
Paula Mcdonald*, Linda Colford, Audrey Irvine, Margaret Kenicer, Robert J. Steele, Callum G. Fraser
Scottish Bowel Screening Programme, Dundee, United Kingdom

Background: The format of the traditional guaiac fecal occult blood test [gFOBT], particularly the collection technique, might lead to difficulties for some potential participants, particularly the visually impaired and those with poor manual dexterity. Methods: Four tests with different fecal collection approaches were investigated. Moreover, a focus group informed the decision to investigate further a wipe test. Randomly selected fecal samples [100] were tested with EZ-Wipe [three wipes for each] and hema-screen gFOBT [all six windows], both obtained from Immunostics Inc, Ocean, NJ 07712. This wipe test was then made available in the Scottish Bowel Screening Programme as from June 2007. SOPs were generated for the Centre staff to respond to requests for the wipe test.Results: Identical results were attained with both gFOBT techniques: the analytical detection limit found for the wipe test was 0.6 mg hemoglobin/g feces. To the end of August 2008, 334 requests were made for the wipe test. Overall, 433 wipe test packs were issued: this number includes replacement and follow-up packs. 236 wipe kit sets were analysed in the Centre Laboratory to the end of August 2008: 17 were positive, 118 negative, 71 weak positive, and 30 spoiled. Expressed as percentages, these are 7.2, 50.0, 30.1, and 12.7% respectively. The comparison, although not absolutely direct, is with gFOBT and the relevant percentages for this test were: 0.4, 90.7, 7.6 and 1.3%. With the wipe test, participants can be referred for colonoscopy either on first finding that all three wipes are positive or on finding that at least one of the three tests in each of two successfully completed wipe test sets are positive. The total number of participants referred through these routes was 33. The colonoscopy outcomes were requested from the appropriate NHS Boards. To the end of September 2008, outcome data were available on 26 participants: 6 declined colonoscopy, 1 was judged unsuitable, 1 was already in follow-up, 2 did not attend, 7 had normal colonoscopy, 3 had low risk adenoma, 2 had a metaplastic polyp, 3 had diverticular disease, and 1 had a high risk adenoma. No participant had cancer. Conclusions: The analytical performance of the wipe test was satisfactory. However, a high percentage of participants were invited for colonoscopy. Moreover, a large number of participants spoiled the test and required a further set of tests. In addition, a high percentage referred declined colonoscopy and the pick up of significant neoplasia was small. The clinical performance characteristics of the wipe test are such that it cannot be recommended as a screening test for bowel cancer.


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