Apparatus for combined assay for current glucose level and intermediate or long-term glycemic control

• US 6,670,192 B1
• Filed: 01/05/2000
• Issued: 12/30/2003
• Est. Priority Date: 04/07/1995
• Status: Expired due to Fees

• Current Assignee: Gebhard Neyer, John F. Burd, Robert S. Galen, Talei Hoblitzell
• Original Assignee: Gebhard Neyer, John F. Burd, Robert S. Galen, Talei Hoblitzell
• Inventors: Neyer, Gebhard, Galen, Robert S., Hoblitzell, Talei, Burd, John F.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): GAKH, YELENA G
• Application Number:
  US09/477,900
• Time in Patent Office: 1,455 Days
• Field of Search: 422/56, 422/57, 422/61, 435/14, 435/970, 435/287.7, 435/287.9, 436/828, 436/67, 436/86, 436/95
• US Class Current: 422/67
• CPC Class Codes: C12Q 1/34 involving hydrolase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 2326/12 3,3',5,5'-Tetramethylbenzidine, i.e. TMB
• CPC Class Codes: C12Q 2326/14 Ortho-Tolidine, i.e. 3,3'-dimethyl-(1,1'-biphenyl-4,4'-diamine)
• CPC Class Codes: C12Q 2326/92 Nitro blue tetrazolium chloride, i.e. NBT
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: G01N 2333/42 Lectins, e.g. concanavalin, phytohaemagglutinin
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/828 Protein A
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The present invention is directed to a single test system and method for determining the integrated glycemic condition of a subject by measuring the concentration of glucose and the level of protein-bound glucose in a subject'"'"'s body fluid, such as whole blood. The glucose concentration is indicative of the subject'"'"'s immediate glycemic condition, whereas the protein-bound glucose concentration is indicative of either intermediate or long-term glycemic condition. Optionally, other analytes indicative of glycemic condition, such as ketone bodies or fatty acid derivatives, can also be measured. The present invention also provides a method of diagnosing diabetes. The invention additionally provides a method for analyzing the concentration of fructosamine in less than or equal to five minutes without the use of a reaction accelerator.

Claims

1. Method for determining the long-term integrated glycemic condition of a subject with a single test device responsive to a signal producing system indicative of glucose concentration and a signal producing system indicative of glycated protein concentration, consisting of the steps of:

(a) applying a body fluid sample to a first test strip containing a signal producing system indicative of glucose concentration present in the body fluid sample;

(b) applying a body fluid sample to a second test strip containing a signal producing system indicative of glycated protein concentration present in the body fluid sample; and

(c) determining in either order (1) the glucose concentration and (2) the glycated protein concentration present in the body fluid sample applied to the first and second test strips, respectively,

using a single test device having a glucose concentration determining means that is responsive to the signal producing system indicative of glucose concentration and

a glycated protein concentration determining means that is responsive to the signal producing system indicative of glycated protein concentration,

said test device preset to be responsive to only these two means, said test device further having an automatic determining means coupled to a display means and further having a receiving port for a test strip in connection with the automatic determining means;

wherein the glucose concentration and the glycated protein concentration indicate long-term integrated glycemic condition of a subject.

2. The method of claim 1, wherein the body fluid sample of step (a) and the body fluid sample of step (b) are whole blood.

3. The method of claim 1, wherein the body fluid sample of step (a) and the body fluid sample of step (b) are separate body fluid samples.

4. The method of claim 1, wherein the glycated protein is glycated hemoglobin.

5. The method of claim 4, wherein the glycated protein is glycated hemoglobin A₀.

6. The method of claim 4, wherein the glycated protein is glycated hemoglobin A₂.

7. The method of claim 4, wherein the glycated protein is glycated hemoglobin F.

8. The method of claim 4, wherein the glycated protein is glycated hemoglobin A₁.

9. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1a1.

10. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1a2.

11. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1b1.

12. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1b2.

13. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1b3.

14. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1c.

15. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1d.

16. The method of claim 8, wherein the glycated protein is glycated hemoglobin A_1e.