Microalbumin creatinine assay detection flag and methods of production and use related thereto

Patent metadata

Field	Value
Publication number	US-11971415-B2
Application number	US-201917259361-A
Country	US
Kind code	B2
Filing date	Jun 20, 2019
Priority date	Jul 13, 2018
Publication date	Apr 30, 2024
Grant date	Apr 30, 2024

Abstract

Devices, kits, and methods related to embodiments of an improved liquid test sample injection device comprising a sample mixture that comprises at least one sample flag compound for detecting the presence or non-presence of a patient's liquid test sample upon being interrogated by a pre-determined wavelength of light.

First claim

What is claimed is:

1. A method for preparing a diagnostic assay device for performing at least one diagnostic assay on a liquid test sample, the diagnostic assay device comprising a reaction vessel having a liquid test sample dispensing device inserted into a portion thereof, wherein the liquid test sample dispensing device is configured for collecting the liquid test sample and dispensing the liquid test sample into the reaction vessel for performing at least one diagnostic assay in the reaction vessel, the method comprising the steps of:
(a) preparing a solution, the solution comprising at least one sample flag compound, at least one protein, at least one sugar, and at least one alcohol solvent, the solution being contained within a receptacle;
(b) placing the liquid test sample dispensing device into the receptacle, the liquid test sample dispensing device comprising:
a capillary portion, the capillary portion comprising a capillary having at least one outer surface, at least one inner surface, a first end, a second end, and an opening located at the second end of the capillary, wherein the capillary is in fluid contact with the solution such that a volume of the solution enters into and is retained within the capillary via the opening such that the solution is in fluid contact with the at least one inner surface of the capillary; and

(c) removing the liquid test sample dispensing device from the receptacle and heating at least the capillary portion of the liquid test sample dispensing device to a temperature wherein the at least one alcohol solvent evaporates from the solution contained within the capillary, and further wherein granules of the at least one sample flag compound are deposited on the at least one inner surface of the capillary, thereby coating the at least one internal surface of the capillary with the at least one sample flag compound; and
(d) inserting and securing the liquid test sample dispensing device in the reaction vessel to form the diagnostic assay device, wherein the reaction vessel comprises at least one sample read window for interrogation of the at least one sample flag compound in the capillary at a first wavelength of light, and wherein the reaction vessel further comprises a reaction chamber containing at least one diagnostic assay reagent that is interrogated at a second wavelength of light that is different from the first wavelength.

2. The method of claim 1 , wherein the at least one sample flag compound is dissolvable in the presence of a patient's liquid test sample selected from the group consisting of whole blood, plasma, serum, and urine.

3. The method of claim 1 , wherein the at least one sample flag compound is selected from the group consisting of ferricyanide, metabisulfite, taurine and combinations thereof.

4. The method of claim 1 , wherein the at least one protein comprises bovine serum albumin (BSA).

5. The method of claim 1 , wherein the at least one sugar is selected from the group consisting of monosaccharides, disaccharides, oligosaccharides, polysaccharides, and combinations thereof.

6. The method of claim 5 , wherein the at least one sugar is selected from the group consisting of fructose, galactose, glucose, lactose, maltose, sucrose, and combinations thereof.

7. The method of claim 1 , wherein the at least one alcohol solvent is selected from the group consisting of monohydric, polyhydric, unsaturated aliphatic, alicyclic alcohols, and combinations thereof.

8. The method of claim 7 , wherein the at least one alcohol solvent is selected from the group consisting of methanol, ethanol, propanol, butanol, pentanol, cetyl alcohol, ethylene glycol, propylene glycol, glycerol, erythritol, xylitol, mannitol, volemitol, allyl alcohol, geraniol, propargyl alcohol, inositol, menthol, and combinations thereof.

9. The method of claim 1 , wherein volume of the solution entering into and retained within the capillary is about 35 microliters.

10. The method of claim 1 , wherein the temperature to which the liquid test sample dispensing device is heated is in a range of from about 25° C. to about 37° C.

11. The method of claim 10 , wherein the capillary portion is heated via a heater selected from the group consisting of a commercial-grade dryer, a vacuum dryer, and combinations thereof.

12. The method of claim 1 , wherein the at least one diagnostic assay comprises a microalbumin creatinine diagnostic assay.

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Kauffmann Aaron

Classifications

• G01N33/58 Primary

  involving labelled substances (G01N33/53 takes precedence) · CPC title

• B01L3/502

  with fluid transport, e.g. in multi-compartment structures · CPC title

• G01N33/70

  involving creatine or creatinine · CPC title

• B01L2300/16

  Surface properties and coatings · CPC title

• B01L2400/0406

  capillary forces · CPC title