Process for stabilizing the content of glycated protein of a sample on a matrix material

• US 7,078,480 B2
• Filed: 03/28/2003
• Issued: 07/18/2006
• Est. Priority Date: 08/24/1995
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Nagel, Rolf, Mistele, Jürgen
• Primary Examiner(s): Gupta, Anish
• Application Number:
  US10/402,757
• Publication Number:
  US 20030199079A1
• Time in Patent Office: 1,208 Days
• Field of Search: None
• US Class Current: 530/322
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6842 Proteomic analysis of subsets of protein mixtures with reduced complexity, e.g. membrane proteins, phosphoproteins, organelle proteins
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin
• CPC Class Codes: G01N 33/726 Devices

Abstract

The invention concerns a method for stabilizing the content of glycated protein in a sample on a matrix material, which is characterized in that the matrix material is impregnated with boric acid buffer with a pH which is larger or equal to 10.5 or a transition metal salt as well as an appropriate matrix material, an element for collecting, transporting and storing sample material to be analysed with such a matrix material and a system containing such an element and a sealable covering.

Claims

1. An element for collecting, transporting or storing a sample to be analyzed, said element comprises an absorptive matrix material, wherein the matrix material is a fibrous material carrying a water soluble, non-ionically bound transition metal salt which dissolves off of said matrix material by an aqueous solution, and

wherein the element contains a first layer and a second layer of absorptive material, said first and second layers positioned on an inert carrier and in contact with each other to enable transfer of a liquid in such a way that the liquid can pass from the first layer into the second layer when the first layer is filled with the liquid and wherein the first layer can be completely separated from the second layer after application and drying of the sample.

2. The element of claim 1 wherein the first layer carries the water soluble, non-ionically bound transition metal salt which dissolves off of said matrix material by an aqueous solution.

3. The element of claim 1 wherein the transition metal salt is a nickel salt or a copper salt.

4. An element for collecting a liquid sample containing a glycated protein, said element comprising:

a first layer impregnated with a dried boric acid and buffer combination selected to maintain a solution at a pH of at least 10.5 when solubilized or a transition metal salt; and

a second layer positioned on the element in contact with the first layer, said second layer comprising a material selected to have greater absorption of the liquid material than the first layer, wherein the first layer is separable from the second layer.

5. The element of claim 4, wherein the first layer is sized to absorb between about 5 μ

l and about 20 μ

l of the liquid sample.

6. The element of claim 4 wherein the first layer is a fibrous matrix.

7. The element of claim 6 wherein the first layer is composed of a material selected from the group consisting of:

fleeces, fabrics, knitted fabrics, glass, cellulose, polyester fibers and polyvinyl alcohol.

8. The element of claim 4 wherein the first layer is non-fibrous.

9. The element of claim 4 wherein the first layer is impregnated with a dried boric acid and buffer combination selected to maintain a solution at a pH of at least 11 when solubilized.

10. The element of claim 4 wherein the first layer is impregnated with nickel salt or a copper salt.

11. The element of claim 10 wherein the first layer is impregnated with a water soluble nickel salt.

12. The element of claim 10 wherein the first layer is impregnated with greater than about 5 g/m² of the nickel salt or the copper salt.

13. The element of claim 4 wherein the first layer is sized to absorb between about 5 μ

l and about 20 μ

l.

14. The element of claim 4 wherein the second layer partly overlaps the first layer.

15. The element of claim 4 wherein the second layer is sized to absorb between about 10 μ

l and about 50 μ

l.

16. The element of claim 4 comprising an inert carrier positioned underneath the first and second layers and selected from the group consisting of:

plastic foil, cardboard, and coated paper.

17. A system for collecting, transporting or storing a sample to be analyzed, said system comprising:

an element comprising a first layer impregnated with a dried boric acid and buffer combination selected to maintain a solution at a pH of at least 10.5 when solubilized or a transition metal salt and a second layer positioned in contact with the first layer, said second layer comprising a material selected to have greater absorption of the liquid material than the first layer, wherein the first layer is separable from the second layer; and

,

a sealable covering configured to receive the element.

18. The system of claim 17 wherein the sealable covering comprises a sealable envelope.

19. The system of claim 17 wherein the sealable covering is configured to receive the first layer separated from the second layer.

20. The system of claim 17 wherein the element comprises an inert carrier positioned underneath the first and second layers.

21. The system of claim 20 wherein the sealable covering is sized to receive the element.