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Exhaled breath analysis of volatile organic compounds for disease diagnosis is considered the new frontier in clinical diagnosis. Exhaled breath biomarkers of many diseases including various cancers have been identified. Exhaled breath analysis is most suitable as a preliminary screening method due to the simplicity of the process and the abundance of constituents of diagnostic value present in exhaled breath. However, the progress of exhaled breath analysis is hindered due to several limitations. Lack of a standard sampling method is a major shortcoming and has been identified as a main cause of inconsistencies found in initial clinical studies. Cost and complexity of analytical instruments used for analysis of volatile organic compounds further limit the viability of breath analysis as a rapid and low cost clinical screening method. To address these shortcomings, the overall objective of this project is to develop technologies/devices necessary to transform exploratory clinical studies into clinical diagnostic tests are consistent and repeatable while providing an analysis platform that is cost effective and easily useable by a clinical care providers at the point of patient care (i.e. in the doctors office or in the patient care facility).The Smart breath sampling device is an exhaled breath sample collection apparatus for repeatable sample collection. The device controls factors known to negatively influence the volatile organic compounds levels during sample collection. Sampling protocols are developed for repeatable and reproducible sample collection using this device.At the heart of this novel point of care breath analysis device is a polymer core intrinsic optical waveguide sensor. When coupled with a novel, separation method known as the Heat Stripping Absorption, the polymer core intrinsic optical sensor can provide analytical performance comparable to gas chromatography mass spectrometry. The sensor technology has high selectivity for identification various species and high sensitivity for quantification of volatile organic compounds in a complex sample such exhaled breath. Perhaps most important, the sensor and associated readout electronics are easily integratable into a handheld device technology that is easily used by care providers and medical technicians who do not have clinical laboratory skills. |
