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The HeartsbreathTM test is a non-invasive breath test for breath biomarkers that predict the probability of grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. It employs a breath collection apparatus (BCA) for collection of volatile organic compounds in breath onto a sorbent trap, as well as for the collection of a separate sample of room air. Analysis of the organic compounds in breath and room air is performed by gas chromatography and mass spectroscopy, which are laboratory tests. The Food & Drug Administration approved the Heartsbreath test for clinical use as a Humanitarian Device exemption. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=h030004
Publications
Phillips M, Boehmer JP, Cataneo RN et al.The American Journal of Cardiology (2004); 94: 1593-1594.(PDF document) Heart Allograft Rejection: Detection with Breath Alkanes in Low Levels (the HARDBALL study). Phillips M, Boehmer JP, Cataneo RN et al.The Journal of Heart and Lung Transplantation (2004); 23: 701-8(PDF document) Heart Allograft Rejection: Detection with Breath Alkanes in Low Levels (the HARDBALL study). Phillips M, Boehmer JP, Cataneo RN, Cheema T, Eisen HJ, Fallon JT, Fisher PE, Gass A, Greenberg J, Kobashigawa J, Mancini D, Rayburn B and Zucker MJJournal of the American College of Cardiology (2002); 1(40): 12-13 |
on Australia's Channel 7 (may require downloading Quicktime 7) ![]() |