A comparison of the accuracy of two bowel cancer test kits in healthy people.

The study is an open study designed to determine the clinical specificity of the bowel cancer screening tests QuickVue(R) faecal immunochemical test (FIT) and to compare this to Hemoccult II(R) Sensa(R). A new immunochemical, faecal occult blood test (FOBT) QuickVue(R)FIT has recently been developed, that incorporates features that may result in improved population participation. These features relate to sampling process itself where a specimen is taken by inserting into the stool a small grooved probe instead of the more traditional spatula sampling; therefore the QuickVue(R) FIT device uses a stool sampling procedure where a small probe is inserted into the stool surface at multiple points and then transferred to a plastic container containing a stabilization solution which is then sealed. The test is then activated and a stable test result is generated which is concealed from the participant. The Hemoccult II(R) Sensa(R) device is a guaiac (chemical) test, which employs a direct stick-based faecal sampling method to collect a sample from a stool captured by defaecating onto a stool collection sheet held above toilet bowel water. The faecal sample is then smeared onto a collection card by the patient using a small wooden spatula, allowed to dry and sent to the developing laboratory using postal system approved packaging. Therefore one significant difference between these devices is that the Hemoccult II(R) Sensa(R) uses a stick-based stool sampling method while the QuickVue(R) FIT uses a probe sampling method. While there are other inherent differences between the sampling methodologies used in the QuickVue(R) FIT and the Hemoccult II(R) Sensa(R) test devices, a study based on a direct, per-stool comparison is practical. To complete both devices a total period of approximately 6 days, depending on bowel habit, is expected. This study commenced enrolment 7 July 2009. Enrolment is expected to be completed in June/July 2010. These tests are undertaken simultaneously using the same stool sample; i.e. the participant will use both the FOBT QuickVue(R) FIT and the Hemoccult II(R) Sensa(R) device on the same sample of stool on three different occasions. All participants use the Hemoccult II(R) Sensa(R) device first followed by the QuickVue(R) FIT This is a single procedure. Participants only receive the tests on one occasion.