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iFOBT Study Project in Taiwan
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items are considered.
1. Basic performance of system (lowest & upper detectable range, linearity, reproducibility, prozone, carry-over)
2. Epidemiological study
 A. group of patients = 50 years old or older, at least 20 true positives (colon cancer patients) & 200 true negatives
 B. randomly pick 300-500 people from screening program and send all people to endoscopic examination to find PPV & NPV
    with various setting of cut-off value.
Choice of group must be same as your screening program to define proper cut-off value.

Item 1 can be done at any hospital.
Item 2-A might be done with support from cancer hospital because we need samples from actual cancer patients
Item 2-B can be done with voluntary patients who are willing to confirm his/her status. test cost for endoscopy can be considered

 expecting PPV to be around 5-8% (15-24 true positives) with 300 people, but we should not take a risk of having less PPV so that we would claim for 400 people to ensure 20 true positives.