Devices and Formulations for Detecting, Screening and Monitoring Levels of Certain Constituents in Bodily Fluids and Method

• US 20130203094A1
• Filed: 03/15/2013
• Published: 08/08/2013
• Est. Priority Date: 10/23/2010
• Status: Active Grant

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: Altschul, Randice Lisa, Rapkin, Myron, O'Brien, Rebecca
• Granted Patent: US 9,005,914 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

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.

Claims

1. A device 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 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 device comprising:

a vessel having a receptacle for receiving a sample of the bodily fluid;

a receptor construct within the vessel in juxtaposition with the receptacle;

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; and

a third component for reducing interference of ascorbic acid present in the bodily fluid;

such that the stabilizer formulation is retained in place upon the receptor construct for subsequent mixing with the sample prior to conduct of the non-invasive analysis.

2. The device of claim 1 including a closure for sealing the receptacle subsequent to placement of the sample within the receptacle so as to militate against escape of the sample while the vessel is agitated to mix the stabilizing formulation with the sample.

3. The device of claim 1 wherein the first component is PVP-K15.

4. The device of claim 1 wherein the second component is benzoic acid.

5. The device of claim 1 wherein the third component is ascorbate oxidase.

6. The device of claim 1 wherein the certain constituent is glucose, and the stabilizing formulation includes a further microbial digestion inhibitor.

7. The device of claim 6 wherein the further microbial digestion inhibitor is sodium fluoride.

8. 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 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 a 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; and

a third component for reducing interference of ascorbic acid present in the bodily fluid;

introducing the sample into the receptacle of the vessel; and

mixing the sample with the stabilizer formulation retained upon the receptor construct prior to conduct of the non-invasive analysis.

9. The method of claim 8 including a closure for sealing the receptacle subsequent to placement of the sample within the receptacle so as to militate against escape of the sample while the vessel is agitated to mix the stabilizing formulation with the sample.

10. The method of claim 8 wherein the first component is PVP-K15.

11. The method of claim 8 wherein the second component is benzoic acid.

12. The method of claim 8 wherein the third component is ascorbate oxidase.

13. The method of claim 8 wherein the certain constituent is glucose, and the stabilizing formulation includes a further microbial digestion inhibitor.

14. The method of claim 13 wherein the further microbial digestion inhibitor is sodium fluoride.