Devices and formulations for detecting, screening and monitoring levels of certain constituents in bodily fluids and method

摘要

A device and method are disclosed for use in the conduct of a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid, which analysis utilizes an indicator formulation that changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A stabilizing formulation is carried in a vessel for mixing with a sample of the bodily fluid to be analyzed. The stabilizing formulation includes a first component for promoting formation of a film, a second component for adjusting the pH of the sample and inhibiting microbial digestion of the certain constituent carried by the bodily fluid, and a third component for reducing interference of ascorbic acid present in the bodily fluid. Where the certain constituent is glucose, the stabilizing formulation includes a microbial digestion inhibitor.

主权项

1. A method for use in the conduct of a non-invasive analysis of a bodily fluid to determine the presence and the level of a certain constituent carried by the bodily fluid, in which analysis a sample of the bodily fluid is exposed to an indicator formulation capable of changing color in response to exposure to the certain constituent provides a visible indication of the presence and the level of the certain constituent carried by the bodily fluid, the method comprising:
providing a vessel having a receptacle for receiving the sample of the bodily fluid; providing a receptor construct within the vessel in juxtaposition with the receptacle; providing a stabilizer formulation carried by the receptor construct in position to be exposed to the sample of the bodily fluid upon introduction of the sample into the receptacle; the stabilizer formulation consisting essentially of:
a first component for promoting formation of a film;a second component for adjusting the pH of the sample and inhibiting microbial digestion of the certain constituent carried by the bodily fluid; anda third component for reducing interference of ascorbic acid present in the bodily fluid; introducing the sample into the receptacle of the vessel prior to exposure of the sample to the indicator formulation; and mixing the sample with the stabilizer formulation retained upon the receptor construct to prepare a mixture of the sample and the stabilizer formulation prior to exposure of the mixture to the indicator formulation and subsequent conduct of the non-invasive analysis.