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Supplement

¹³C Breath Tests: Visions and Realities¹

Research and Development, Meretek Diagnostics, Inc. and Departments of Pediatrics and Medicine, Baylor College of Medicine, Houston, TX 77030

Breath tests have been used in research laboratories for over 25 y. Originally, the tests were based on the use of ¹⁴C, rather than on the nonradioactive isotope, ¹³C. When ¹³C became widely available at a reasonable cost, research groups in the United States and Europe developed methodologies to measure ¹³C abundance in samples of CO₂. The tests used a variety of substrates and measured pancreatic function, fat absorption, bacterial overgrowth and P₄₅₀ mixed-function oxidase. Thus far, the only test to be approved by the Food and Drug Administration is the ¹³C-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.

KEY WORDS: • H. pylori • carbon-13 • ¹³CO₂ • diagnostic test • noninvasive