13C breath tests: visions and realities.

Breath tests have been used in research laboratories for over 25 y. Originally, the tests were based on the use of (14)C, rather than on the nonradioactive isotope, (13)C. When (13)C became widely available at a reasonable cost, research groups in the United States and Europe developed methodologies to measure (13)C abundance in samples of CO(2). The tests used a variety of substrates and measured pancreatic function, fat absorption, bacterial overgrowth and P(450) mixed-function oxidase. Thus far, the only test to be approved by the Food and Drug Administration is the (13)C-urea breath test. This manuscript describes the process by which approval is gained, and indicates the steps necessary for other tests to receive Food and Drug Administration approval.